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ArTT Augments and Buttresses are indicated to be used, in combination with EMPOWR Acetabular Cup System, as an alternative to structural allograft in skeletally mature patients in cases of segmental acetabular deficiencies.

ArTT Augments and Buttresses are indicated for cementless use to the bone interface; and are affixed to the mating acetabular cup using bone cement.

This 510(k) submission aims at introducing new device components, the ArTT Augments and Buttresses and Bone Screws (Revision Bone Screws (Dia. 6.5mm), Locking Bone Screws (Dia. 6.5mm), Locking Bone Screws (Dia. 4mm), Bone Screws (Dia. 4mm)) to be used in combination with the EMPOWR Acetabular Cup System (K190057) manufactured by Encore Medical, L.P.

ArTT Augments and Buttresses are manufactured from Ti6Al4V 3D printed (ISO 5832-3) and are indicated for cementless use to the bone interface; they are affixed to the mating acetabular cup using bone cement. ArTT Augments are available in 9 diameters (Dia. 50mm to 66mm) and 3 eccentricities (Ecc. 10mm, Ecc. 15mm, Ecc. 20mm), while ArTT Buttresses are available in 3 diameters (Dia.50mm, Dia.56mm, Dia.62mm), 3 heights (H. 15mm, H. 30mm, H. 60mm) and 3 configurations (Neutral, Left, Right).

Bone Screws are manufactured from Ti6Al4V (ISO 5832-3 - ASTM F1472); they are intended for cancellous or cortical bone and are available in several lengths.

This FDA 510(k) clearance letter pertains to
"ArTT Augments and Buttresses and Bone Screws" for orthopedic use. It's important to note that this document is a clearance letter, not a detailed scientific study publication. As such, it provides summary information about the device and the types of testing performed to demonstrate substantial equivalence, rather than a deep dive into specific study methodologies or acceptance criteria with detailed performance metrics.

Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state specific quantitative acceptance criteria (e.g., minimum tensile strength, maximum wear rate, specific pull-out force thresholds) or precise numerical performance results for the ArTT Augments and Buttresses and Bone Screws.

Instead, it states:

• "Mechanical tests demonstrated that the device performance fulfilled the intended use, and that the device is substantially equivalent to the predicate device."
• "Other performance requirements were fulfilled through rationales and comparisons with previously cleared components (K210717, latest 510(k) approval)."

This implies that the acceptance criteria were based on:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: The document states that mechanical testing was performed on "worst case components or constructs." However, it does not specify the exact number of samples or specimens used for each test (e.g., how many augments, how many screws of each type).
• Data Provenance: The studies were "Non-clinical testing" conducted by the manufacturer, Limacorporate S.p.A. The location of the testing laboratories or specific origin of data (e.g., retrospective/prospective in a clinical sense) is not described, as these are non-clinical (mechanical) tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

This section is not applicable as the studies described are non-clinical (mechanical) tests. The "ground truth" for mechanical testing is typically established by engineering standards (e.g., ASTM F543) and internal protocols, not by expert consensus from medical professionals.

4. Adjudication Method for the Test Set:

This section is not applicable for non-clinical mechanical testing, where adjudication methods like 2+1 or 3+1 by human experts are not used. Performance is measured against engineering specifications and standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No, an MRMC comparative effectiveness study was not done. The clearance is for a physical orthopedic implant system, not an AI software/diagnostic device that would involve human readers interpreting cases.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

No, a standalone (algorithm only) performance study was not done. This device is a physical implant system, not an algorithm or AI.

7. The Type of Ground Truth Used:

For the mechanical tests conducted, the "ground truth" implicitly refers to:

• Engineering Standards: Specifically mentioned is ASTM F543 for torsional properties, driving torque, and pull-out load of bone screws.
• Internal Protocols: Used for fretting fatigue testing.
• Performance of Predicate Devices: The measured performance of the ArTT Augments and Buttresses was deemed "substantially equivalent" to that of the predicate devices. This means the performance of the predicate likely served as a benchmark or reference point for establishing acceptable performance.

8. The Sample Size for the Training Set:

This section is not applicable as this is a physical medical device, not an AI/machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This section is not applicable for the same reason as above (physical medical device, no training set).

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1. Metastatic tumor (i.e. osteosarcoma, chondrosarcoma, giant cell tumor or osteoma) where massive resection and transplantation are needed.

2. Severe knee joint damage resulting from trauma where massive resection and transplantation are needed.

3. Non-inflammatory degenerative joint disease such as avascular necrosis, osteoarthritis, or traumatic arthritis.

4. Revision of previously failed total joint arthroplasty, osteotomy, or arthrodesis.

5. Joint instability resulting from excessive bone resection

For Femoral component, Hinged/ Tibial baseplate, Hinged/ Cemented tibial stem/ Cemented Straight stem, RHS, non coated/ Cemented Curved stem, RHS, non coated/ Cemented Straight stem, RHS/ Cemented Curved stem, RHS/ Tibial Augment: These devices are single use implant and intended for cemented use only.

For Distal Femoral Component, RHS/ Proximal Tibial Component, RHS/ Tibial stem/ Segment Part, RHS/ Segment Part, RHS, Bridge: These devices are single use implant and PSC and intended for cementless use only.

"United" USTAR II System is used for patients who present large quantity of bone loss and deformity associated with previous failed arthroplasty, ligament deficiencies, tumor resection, or trauma and may require a further operation or reconstruction. The USTAR II System includes implanted arthroplasty components of both the USTAR II Knee System and USTAR II Hip System.

For the subject device, it's an extension line of 510(K) cleared device USTAR II System (K190100), which introduces two new variations:

1. Cemented curved stem, RHS, non-coated: diameter 17×200 mm
2. Tibial stem: stem length from 30mm to 150 mm by stem diameter from diameter 9 to diameter 24

The compatibility of cemented curved stem, RHS, non-coated and tibial stem is same as that of the 510(k) cleared USTAR II system (K190100).

Cemented Curved Stem, RHS, non-coated is an extension in terms of sizes to 510 (k) cleared device USTAR II system (K190100). Its design, materials, geometrical characteristic, locking mechanism, and manufacturing process are identical to that of the 510(k) cleared Cemented Curved Stem, RHS, non-coated.

Tibial stem's design, materials, geometrical characteristic, locking mechanism, and manufacturing process are identical to that of the 510(k) cleared Tibial Stem while the only difference lies in its specification

Please note: The provided FDA 510(k) clearance letter and summary describe a medical device (Stem Extension Line for the USTAR II System), which is an orthopedic implant. This document does not describe an AI/Software as a Medical Device (SaMD).

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/SaMD, including details like "number of experts used to establish ground truth," "adjudication method," "MRMC study," "standalone performance," "training set size," and "ground truth establishment for training set," are not applicable to this type of device submission.

The provided text focuses on the mechanical and design equivalence of the new implant variations to a previously cleared predicate device. The "study" mentioned refers to non-clinical mechanical analyses.

Below is an interpretation of the requested points adapted to the context of this orthopedic implant:

Acceptance Criteria and Study for the Stem Extension Line (USTAR II System)

1. Table of Acceptance Criteria and Reported Device Performance

For this orthopedic implant, the acceptance criteria are based on established international standards for the mechanical performance of prosthetic components and demonstrate equivalence to the predicate device.

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated as a number of physical implants or test articles in the provided summary. For mechanical testing, typically a defined number of test samples are used per standard, but the specific quantity is not given here.
• Data Provenance: The studies are non-clinical mechanical analyses performed to international standards (ISO, ASTM). The origin of the "data" itself would be the laboratory where these mechanical tests were conducted. It's a prospective design verification process, not a retrospective or prospective clinical study with human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This is a non-clinical, mechanical device clearance. "Ground truth" in the context of clinical interpretation or diagnosis by experts (e.g., radiologists) is not relevant here. Ground truth is established by standardized material properties, engineering specifications, and mechanical test results per the referenced ISO and ASTM standards. Experts involved would be engineers and material scientists responsible for the design, testing, and analysis, ensuring compliance with manufacturing and performance standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. Adjudication methods like 2+1 or 3+1 typically refer to consensus readings or evaluations by multiple human experts in studies involving subjective interpretation (e.g., imaging, clinical outcomes). For mechanical testing, the results are quantitative and objective, measured against predefined acceptance criteria from engineering standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. MRMC studies are specific to evaluating the clinical performance of diagnostic aids, particularly those involving human interpretation, and are commonly used for AI/ML in medical imaging. This submission concerns the mechanical safety and functionality of an orthopedic implant. No human reader involvement or AI assistance is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. "Standalone performance" refers to the performance of an AI algorithm independent of human input. This device is a physical orthopedic implant, not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this type of device is based on engineering standards and specifications. This includes:
  • Material properties: Verifying components meet specified material strengths and compositions.
  • Geometric tolerances: Ensuring dimensions align with design specifications.
  • Mechanical performance: Demonstrating the implant can withstand anticipated loads and stresses as defined by the ISO and ASTM test standards (e.g., fatigue life, static strength).
  • Equivalence to Predicate Device: The primary "ground truth" is that the new variations perform equivalently to or better than the already cleared predicate device under the same test conditions.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device where a "training set" of data is used to develop an algorithm. The "design" and "manufacturing process" are based on established engineering principles and prior validated designs (the predicate device).

9. How the ground truth for the training set was established

• Not Applicable. As there is no "training set" in the context of an AI/ML algorithm for this physical device, there is no method for establishing its "ground truth." The design and manufacturing processes are validated through engineering analyses and quality control processes to meet the required specifications and standards.

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Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:

• Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
• Inflammatory joint disease including rheumatoid arthritis
• Correction of functional deformity including congenital hip dysplasia & fracture non-union or mal-union
• Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
• Failed previous hip surgery including internal fixation or joint fusion, hemiarthroplasty, surface replacement, or total hip replacement
• Dislocation risks (when used with SignaSure Dual Mobility System)

Signature Orthopaedics' Longboard Revision Stem is intended for individuals undergoing revision surgery of the hip only.

Signature Orthopaedics' Origin, Origin TT, Aria, Remedy, Origin-NS, Pegasus, Spartan, World, Everglade and Longboard Hip femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only.

The Longboard Revision Stem is a femoral stem and a partially threaded distal locking screw intended for single use and cementless fixation for revision hip arthroplasties. The components are manufactured from titanium alloy as per ISO 5832-3 and ASTM F136 and the stem has a titanium alloy grit blast along the body. The Longboard Revision Stem is a symmetrical with a neck angle of 135°. The stem body is tapered and finned, while the distal tip is finless to allow for initial version adjustments. The stem neck features a 12/14 taper which allows for compatibility with Signature Orthopaedics' range of previously cleared femoral head components.

This FDA 510(k) Clearance Letter for the Longboard Revision Hip Stem describes a medical device (an orthopedic implant), not a software or AI/ML-based device. Therefore, the questions regarding acceptance criteria and study design for performance evaluation of algorithms and AI/ML systems (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by experts) are not applicable to this document.

The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing for mechanical properties and material characteristics, as is standard for orthopedic implants.

Here's an analysis of the provided information relevant to the device's acceptance criteria and the study that proves it meets them, framed within the context of a physical medical device:

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

For physical medical devices like the Longboard Revision Hip Stem, acceptance criteria primarily revolve around:

1. Safety and Effectiveness: Ensuring the device is safe for its intended use and performs as expected.
2. Biocompatibility: Materials used must be compatible with the human body.
3. Mechanical Performance: The device must withstand anticipated physiological loads and stresses without failure for its expected lifespan.
4. Conformity to Standards: Compliance with established industry and regulatory standards.
5. Substantial Equivalence: Demonstrating that the device is as safe and effective as a legally marketed predicate device.

The study described to prove the device meets these criteria is the non-clinical performance testing and engineering evaluations.

1. Table of Acceptance Criteria and the Reported Device Performance

The document doesn't provide a precise "table" of numerical acceptance criteria in the format typically seen for AI/ML performance (e.g., "Sensitivity >= X%"). Instead, acceptance is inferred from the successful completion of specified engineering tests and adherence to industry standards, followed by a conclusion of substantial equivalence.

• ISO 21535 (Hip Joint Replacement Implants)
• ASTM F2996 (FEA for Hip Femoral Stems)
• ISO 7206-4 (Endurance of Stemmed Femoral Components)
• ISO 7206-6 (Endurance of Neck Region)
• ASTM F543 (Metallic Medical Bone Screws) |
  | Substantial Equivalence: The device is as safe and effective as existing legally marketed predicate devices. | "The Longboard Revision Hip Stem have the same intended use and same indications for use as the predicate devices. The subject devices use the same operating principle, incorporate the same basic design, and are manufactured using the same materials as the predicate devices. Any differences do not raise new questions of safety and effectiveness as established with performance testing. The subject devices are at least as safe and effective as the legally marketed predicate devices." |

Information Not Applicable/Provided for a Physical Device:

The following points are primarily relevant to software, AI/ML, or diagnostic devices, and therefore are not applicable to this 510(k) for a physical orthopedic implant:

2. Sample size used for the test set and the data provenance: Not applicable. Testing is primarily mechanical/physical on device samples, not on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical implant is its physical behavior under load, measured by engineering methods, not expert consensus on images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is for diagnostic interpretation, not an implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm here.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable in the context of image interpretation. Ground truth for this device is mechanical integrity, material properties, and functionality under specified conditions, verified by laboratory testing.
8. The sample size for the training set: Not applicable as there is no training set for a mechanical device.
9. How the ground truth for the training set was established: Not applicable.

In summary: The clearance of the Longboard Revision Hip Stem relies on non-clinical, laboratory-based mechanical and materials testing of physical device samples against established industry standards and comparison to predicate devices, to demonstrate its safety and effectiveness for its intended use, rather than on clinical data or AI/ML performance metrics.

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Restoration ADM and MDM Systems (ADM/MDM X3 Inserts, MDM Acetabular Inserts, MDM Acetabular Liners)

Indications for Use:
The indications for use for total hip arthroplasty include:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. Rheumatoid arthritis;
3. Correction of functional deformity;
4. Revision procedures where other treatments or devices have failed; and,
5. Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
6. Dislocation risks

MDM Liners are intended for cementless use only.

Trident II Acetabular System (Trident II Cups (Clusterhole HA, PLS Clusterhold HA, Tritanium Clusterhole, Tritanium Multihole, Tritanium Solidback))

Indications for Use:

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

When used with MDM Liners

• Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
• Dislocation risks

When used with Constrained Liner:

• The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.

The Trident II Acetabular Shells are indicated for cementless use only.

Restoration® Modular Hip System

The Restoration® Modular Hip System is indicated for use in:

• Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• Rheumatoid arthritis;
• Correction of functional deformity;
• Revision procedures where other treatments or devices have failed; and,
• Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Additional indications specific to the Restoration Modular Hip System

The Restoration® Modular Hip System is intended to be used for primary and revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press fit into the proximal femur.

Secur-Fit Advanced

The indications for use for total hip arthroplasty with stems include:

• noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• rheumatoid arthritis;
• correction of functional deformity;
• revision procedures where other treatments or devices have failed; and,
• nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Additional indication specific to use of the Femoral Stem with compatible Howmedica Osteonics Constrained Liners:

• When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.

The Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

Accolade II Femoral Stems

The indications for use of the total hip replacement prostheses include:

• noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• rheumatoid arthritis;
• correction of functional deformity;
• revision procedures where other treatments or devices have failed; and,
• nonunions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Additional indication specific to use of the Femoral Stems with compatible Howmedica Osteonics Constrained Liners:

• When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra- operative instability.

The Stems are intended for cementless use only and are intended for total and hemiarthroplasty.

TRIDENT AND TRITANIUM ACETABULAR COMPONENTS

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

The HOWMEDICA OSTEONICS TRIDENT and TRITANIUM Acetabular Shells are intended for cementless use only.

Dome hole plug is indicated for cemented or cementless hip arthroplasty, when an acetabular shell plug is thought to be advantageous

V40 COBALT-CHROME (COCR) FEMORAL HEADS (LFIT V40™ Femoral Heads)

• Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
• Revision of previous cup arthroplasty or other procedures
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies in the acetabulum.

Insignia Hip Stem

Hip Arthroplasty Indications:

• Painful, disabling joint disease of the hip resulting from: noninflammatory degenerative joint disease (including osteoarthritis or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.
• Revision of previous unsuccessful femoral head replacement, hip arthroplasty or other procedure.
• Correction of functional deformity
• Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Additional indication specific to use of lnsignia Hip Stems with compatible Howmedica Osteonics Constrained Liners:

• When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.

Additional indication specific to use of lnsignia Hip Stems with compatible ADM and MDM Acetabular Components:

• When the stem is to be used with compatible Howmedica Osteonics ADM and MDM Acetabular Components, the device is indicated for Dislocation risks

Insignia Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

Restoration Anatomic Shells

Indications for Use

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, posttraumatic arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

When used with MDM Liners

• Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
• Dislocation risks

When used with Constrained Liner:

• The Trident Constrained Acetabular Insert is indicated for use in primary and revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.

The Restoration® Anatomic Shell is indicated for cementless use only.

Trident X3, Trident X3 Elevated Rim, Trident X3 Eccentric Inserts)

Indications for Use:

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
• Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies of the acetabulum.

BIOLOX Delta Ceramic V40 Femoral Heads (V40)

The femoral heads are intended for mechanical fixation to their mating hip stems, and can be used in cemented or cementless hip arthroplasty procedures.

For Use as a Total Hip Replacement:

• Painful disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
• Revision of previous cup arthroplasty or other procedures.
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques as indicated by deficiencies in the acetabulum.

For Use as a Bipolar Hip Replacement

• Femoral head/neck fractures or non-unions.
• Aseptic necrosis of the femoral head.
• Osteo-, rheumatoid, and post traumatic arthritis of the hip with minimal acetabular involvement or distortion.
• Pathological considerations or age considerations which indicate a more conservative acetabular procedure and an avoidance of the use of bone cement in the acetabulum.
• Salvage of failed total hip arthroplasty

"D" femoral heads

The Novae® Dual Mobility and Hype® hip Systems are indicated for total hip replacement, which includes:

• osteoarthritis,
• femoral neck fracture,
• dislocation risk,
• osteonecrosis of the femoral head,
• revision procedures where other treatments or devices have failed and if bone reconstruction so permits.
• Sunfit TH, Novae® E TH, and Coptos TH acetabular cups are intended for press-fit use and Novae® Stick acetabular cup is indicated for cemented use.
• Hype® SCS, SCC, SCL, SCV, SCC Mini, and SCLA Mini hip stems are intended for press-fit use.

"C" femoral heads

The Novae® Dual Mobility and Hype® hip Systems are indicated for total hip replacement, which includes:

• osteoarthritis,
• femoral neck fracture,
• dislocation risk,
• osteonecrosis of the femoral head,
• revision procedures where other treatments or devices have failed and if bone reconstruction so permits.
• Sunfit TH, Novae® E TH, and Coptos TH acetabular cups are intended for press-fit use and Novae® Stick acetabular cup is indicated for cemented use.
• Hype® SCS, SCC, SCL, SCV, SCC Mini, and SCLA Mini hip stems are intended for press-fit use.

Hype® SC cementless hip stems

The Novae® Dual Mobility and Hype® hip Systems are indicated for total hip replacement, which includes:

• osteoarthritis,
• femoral neck fracture,
• dislocation risk,
• osteonecrosis of the femoral head,
• revision procedures where other treatments or devices have failed and if bone reconstruction so permits.
• Sunfit TH, Novae® E TH, and Coptos TH acetabular cups are intended for press-fit use and Novae® Stick acetabular cup is indicated for cemented use.
• Hype® SCS, SCC, SCL, SCV, SCC Mini, and SCLA Mini hip stems are intended for press-fit use.

Novae® dual mobility acetabular cup range including Novae® cementless or cemented metal‑backs, CI E and XPEO‑E liners, pegs and VCI screws

• Novae® dual mobility acetabular cups are indicated for total hip replacement, which includes:
  • osteoarthritis,
  • femoral neck fracture,
  • dislocation risk,
  • osteonecrosis of the femoral head,
  • revision procedures where other treatments or devices have failed and if bone reconstruction so permits.
• "Sunfit TH", "Novae E TH" and "Coptos TH" acetabular cups are intended for press-fit use.
• Novae® Stick acetabular cup is intended for cemented use.

The devices covered by this submission are Stryker and Serf femoral stems, femoral heads, acetabular shells and liner, and Serf acetabular bone screw, to form traditional hip or dual mobility (DM) hip systems. All devices are commercially available and have been cleared in prior 510(k) submissions.

This FDA 510(k) clearance letter details the clearance of Stryker and Serf hip devices. It's important to note that this document is for traditional medical devices (implants) and NOT for a medical device (AI/ML) software. Therefore, many of the requested categories related to AI/ML software performance (like accuracy, F1 score, sample sizes for test/training sets, expert ground truth, MRMC studies) are not applicable to this submission.

The "device" in this context refers to the physical hip implant components. The submission (K250989) is primarily for updating labeling to inform users of compatibility between components from Stryker and Serf, and for adding MR safety information to Serf products.

Here's an analysis of the provided text based on the requested information categories, indicating when a category is not applicable:

1. Table of acceptance criteria and the reported device performance

Since this is for physical hip implant components and primarily a labeling update for compatibility, the "acceptance criteria" and "reported device performance" are based on engineering analyses verifying the physical and functional compatibility and MR safety of the combined components, rather than typical performance metrics for AI/ML software.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not applicable in the context of clinical images or AI/ML data. The "test set" here refers to the physical samples of the hip implant components and their combinations. The document does not specify the exact number of physical samples tested for each engineering analysis (wear, impingement, etc.).
• Data Provenance: Not applicable in the context of clinical images. The data provenance would be internal laboratory testing results performed by the manufacturer. No country of origin for clinical data is relevant here. The studies were non-clinical (engineering analyses).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. For physical device compatibility and MR safety, ground truth is established through engineering principles, mechanical testing, and standardized MR safety protocols, not by expert consensus on clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical adjudication of results from image analysis is relevant for this type of device submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI/ML software device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Given the nature of the device (physical hip implants), the "ground truth" for the engineering analyses would be:

• Established engineering standards and specifications: For wear, impingement, range of motion, and femoral head disassembly.
• International standards for MR safety: Such as ASTM standards for MR compatibility testing (e.g., heating, displacement, induced torque, image artifact).

8. The sample size for the training set

Not applicable. This is not an AI/ML software device.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML software device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study that proves the device meets the (implied) acceptance criteria is a series of non-clinical engineering analyses. The submission states:

• Non-Clinical Testing: "Performance of the subject combinations of Stryker and Serf hip devices were evaluated in a series of engineering analyses. These included wear and articular surface tolerances, impingement, range of motion, femoral head disassembly, and MR safety (including heating, displacement, induced torque, and image artifact)."
• Clinical Testing: "Clinical testing was not required as a basis for substantial equivalence."
• Conclusion on Equivalence: "Based upon a comparison of the intended use, indications for use, design, material, sterilization method, technical and performance characteristics, and operational principles, the Stryker and Serf subject hip devices, when used in the proposed compatible combinations with each other, are substantially equivalent to the predicate devices identified in this premarket notification."

The FDA's clearance is based on the determination that these engineering analyses confirm the safety and effectiveness of the proposed compatible combinations and MR safety, demonstrating substantial equivalence to previously cleared predicate devices. The acceptance criteria are implicit in the successful completion of these standard engineering tests for orthopedic implants.

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Mfinity femoral stems are indicated in patients requiring hip arthroplasty.

Total or partial hip arthroplasty is indicated in the following cases:

• Severely painful and/or disabled joint as a result of osteoarthritis, post-traumatic arthritis, inflammatory arthritis or hip dysplasia.
• Avascular necrosis of the femoral head.
• Acute fracture of the femoral head.
• Acute fracture of the proximal femur, suitable to be treated by means of hip arthroplasty.
• Non-union of proximal femur fracture, suitable to be treated by means of hip arthroplasty.
• Primary pathology involving the femoral head but with a non-deformed acetabulum.
• Failure of previous hip surgery:
  • Conservative hip surgery.
  • Internal fixation.
  • Arthrodesis.
  • Partial or total hip arthroplasty.
  • Hip resurfacing replacement.

The Mfinity Femoral System includes implantable devices provided individually packed, sterile and single-use intended for cementless use in total or partial hip arthroplasty to replace the native femoral neck for primary or revision surgery. The product range is composed of three different versions (Mfinity collarless, Mfinity collared and Mfinity L) available in standard and lateral offset.

The Mfinity femoral stem can be combined with the CoCr ball head (K072857, K080885 and K103721), Endo Head (K111145), the MectaCer BIOLOX® forte (K073337), MectaCer BIOLOX® Delta Femoral Heads (K112115) or MectaCer BIOLOX® Option Heads (K131518).

The subject devices are made of titanium alloy according to ISO 5832-11 and coated with Titanium plasma spray according to ASTM F1580 and Hydroxyapatite according with ASTM F1185.

The provided text is an FDA 510(k) clearance letter for the Mfinity Femoral System, which is a hip prosthesis, not a diagnostic AI device. Therefore, the information requested regarding acceptance criteria and studies that prove a device meets those criteria, specifically concerning AI performance metrics, expert adjudication, training set, and test set details, is not applicable to this document.

The document discusses the substantial equivalence of the Mfinity Femoral System to predicate devices based on non-clinical performance data (fatigue tests, ROM evaluation, surface analyses, biocompatibility, shelf-life, pyrogenicity) and states that no clinical studies were conducted.

The acceptance criteria for this type of medical device (hip prosthesis) would typically involve demonstrating mechanical strength, durability, biocompatibility, and sterilization effectiveness based on recognized standards (e.g., ISO, ASTM, European Pharmacopoeia, USP). The "reported device performance" would consist of the results of these non-clinical tests meeting the specified limits of those standards.

Below is a general interpretation of what "acceptance criteria" and "reported device performance" would entail for a hip prosthesis based on the provided document, acknowledging that specific numerical details of these criteria and results are not explicitly stated in this letter but would be in the full 510(k) submission.

Based on the provided FDA 510(k) Clearance Letter for the Mfinity Femoral System:

This document describes the clearance of a hip prosthesis, not an AI-powered diagnostic device. Therefore, the typical elements of acceptance criteria and study designs relevant to AI (such as sensitivity, specificity, AUC, expert consensus, training/test set sizes, etc.) are not applicable to this submission.

The "acceptance criteria" for this device would generally refer to meeting established mechanical, material, and biological performance standards for medical implants. The "study that proves the device meets the acceptance criteria" refers to the non-clinical performance testing conducted.

Here's an attempt to populate the requested table and answer the questions based on the information available, while highlighting the irrelevance of AI-specific questions:

1. Table of Acceptance Criteria and the Reported Device Performance

• Pull-off strength of femoral head
• Range of Motion (ISO 21535) | - Mfinity Fatigue tests performed according to ISO 7206-4 and ISO 7206-6 (Results are assumed to have met specified limits)
• Pull-Off Test On CoCr Femoral Head performed (Results are assumed to have met specified limits)
• Evaluation of ROM according to ISO 21535 performed (Results are assumed to have met specified limits) |
  | Material Performance | - Coating characteristics (cross-section, SEM, XRD) | - Cross sectioned area evaluation of double coated implant surfaces performed
• Scanning Electron Microscopy pictures of double coated implant surfaces taken
• XRD analyses comparing HA coating on Mfinity stem and planar samples performed (Results are assumed to demonstrate acceptable coating properties) |
  | Biocompatibility | - Material safety
• Cytotoxicity, sensitization, irritation, genotoxicity, chronic toxicity, etc. | - Biocompatibility assessment performed (Results are assumed to demonstrate compliance with standards) |
  | Sterilization & Endotoxin| - Bacterial endotoxin levels (European Pharmacopoeia §2.6.14 / USP )
• Pyrogenicity (USP ) | - Bacterial endotoxin test (LAL test) performed
• Pyrogen test performed (Results are assumed to meet requirements, though note indicates not labeled as non-pyrogenic or pyrogen free) |
  | Shelf-Life | - Maintain integrity and performance over specified shelf-life | - Shelf-life evaluation performed (Results are assumed to demonstrate acceptable shelf-life) |

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified in the FDA letter. For non-clinical tests (like fatigue or material analysis), sample sizes would be determined by the specific ISO/ASTM standards referenced, but these are not diagnostic "test sets" in the AI context.
• Data Provenance: The data comes from the "Non-Clinical Studies" and "Performance Testing" conducted by Medacta International S.A. No country of origin is explicitly stated for the testing labs or data generation, but the company is based in Switzerland. The studies are by nature prospective in that they are conducted specifically to test the device's performance against standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This is a hip prosthesis, not an AI diagnostic device. There is no concept of "ground truth" established by experts in the context of interpreting images or medical conditions for this device. The "ground truth" for the performance tests would be the established scientific and engineering principles and the limits defined by the relevant ISO/ASTM standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. As this is not an AI diagnostic device, no adjudication method was used. Performance is assessed directly against objective engineering and material standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This is a hip prosthesis, not an AI-assisted diagnostic tool. No MRMC study was performed, and there is no AI assistance involved. The letter explicitly states: "No clinical studies were conducted."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is not an algorithm or AI device. The device (a physical implant) is evaluated standalone based on its inherent properties and performance against physical and material standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for the non-clinical performance tests is based on established engineering and material science standards and specifications (e.g., ISO 7206, ISO 21535, ASTM F1580, ASTM F1185, European Pharmacopoeia, USP). The device's performance is compared against the requirements and acceptance limits set forth in these standards.

8. The sample size for the training set

• Not Applicable. This device did not involve machine learning or a "training set."

9. How the ground truth for the training set was established

• Not Applicable. This device did not involve machine learning or a "training set."

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The ONVOY Acetabular System is intended for use in reconstruction of the articulating surface of the acetabular portion of the hip that is severely disabled and/or very painful resulting from:

1. Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty.
6. Dislocation risks.

The ONVOY Acetabular System is used in conjunction with Globus/StelKast Hip Systems. The acetabular components of this hip system are intended for cementless fixation.

The ONVOY™ additional implants consist of acetabular shells, liners, and dual mobility liners and bearings that are used as part of a complete total hip system in conjunction with a femoral head and femoral stem in total hip arthroplasty. New femoral head sizes are also being introduced. Implants are available in various configurations and sizes to fit a wide variety of patient anatomy. Shells are available in a cluster-hole design, liners are available in hooded, non-hooded, and lateralized designs used in conjunction with ONVOY shells. Dual mobility polyethylene bearings are used with dual mobility liners.

ONVOY™ acetabular shells are additively manufactured from titanium alloy powder per ASTM F3001. Acetabular liners and dual mobility bearings are manufactured from highly crosslinked ultra-high molecular weight polyethylene (UHMWPE) with Vitamin E. Dual mobility liners are manufactured from Cobalt Chrome (CoCr) alloy and femoral heads are manufactured from alumina matrix composite ceramic.

This document is an FDA 510(k) clearance letter for a medical device called the "ONVOY™ Acetabular System." It details the device's purpose, indications for use, and the basis for its substantial equivalence to other legally marketed devices.

However, it does not contain information about acceptance criteria and a study proving a device meets those criteria for an AI/Software as a Medical Device (SaMD).

This clearance is for an orthopedic implant (hip prosthesis components: acetabular shells, liners, dual mobility implants, and femoral heads), not a software device or an AI application. Therefore, the questions related to MRMC studies, ground truth establishment, training sets, and expert adjudication are not applicable to the content provided in this FDA 510(k) letter.

The "Performance Data" section solely refers to mechanical and material testing standards relevant to orthopedic implants (fatigue, wear, range of motion, material composition, etc.) and states that "Performance data demonstrate substantial equivalence to the predicate devices." It does not describe any clinical study involving human readers or AI performance metrics.

In summary, based on the provided text, I cannot describe acceptance criteria and a study that proves a device meets those criteria, as the document pertains to an orthopedic implant and not an AI/SaMD.

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The indications for the Trinity™ EVO Acetabular Shell as a total hip arthroplasty include:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• Rheumatoid arthritis.
• Correction of functional deformity.
• Developmental dysplasia of the hip (DDH)/Congenital dislocation of the hip (CDH)

The Trinity™ EVO acetabular shell is also indicated for use in revisions of a previously failed total hip arthroplasty.

The Trinity™ EVO Acetabular Shell is indicated for cementless use only.

The Trinity™ EVO acetabular shell forms part of a modular acetabular system. The Trinity™ EVO acetabular shell is a hemispherical press fit titanium alloy shell for use with cobalt chrome alloy (Trinity™ Dual Mobility only) or polyethylene liners and a dedicated range of ceramic and cobalt chrome alloy modular 12/14 taper femoral heads providing ceramic on polyethylene and metal on polyethylene articulations for use in total hip arthroplasty (THA) procedures using Corin metal stems with a 12/14 taper connection. The Trinity™ EVO acetabular shell has a porous structure manufactured from titanium alloy powder, produced via additive manufacturing using Laser Powder Bed Fusion (LPBF), and is available with or without an additional layer of electrochemically deposited calcium phosphate. The Trinity™ EVO acetabular shell is provided in sizes permitting the use of titanium bone screws to provide additional fixation, if required. The Trinity™ EVO acetabular shell is also available without screw holes. A titanium occluder is provided to occlude the apical introducer hole.

The Trinity™ EVO acetabular shell is intended for use in primary and revision THA in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged hip joint articulation when there is evidence of sufficient sound bone to seat and support the components.

The provided document is a 510(k) Clearance Letter for the Trinity EVO Acetabular Shell. This type of submission focuses on demonstrating substantial equivalence to a previously cleared device, not necessarily proving clinical efficacy through a direct comparative study like a Multi-Reader Multi-Case (MRMC) study for an AI-powered diagnostic device.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the non-clinical performance testing conducted to show that the new device performs as safely and effectively as its predicate devices, rather than a clinical trial with human readers.

Here's a breakdown based on the provided document:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the standards and internal protocols cited for the non-clinical testing. The device is deemed to meet these criteria if the test results demonstrate comparable or acceptable performance to the predicate devices. The document states: "The results of this testing show that the Trinity™ EVO Acetabular Shell is substantially equivalent to the predicate devices."

Table of Acceptance Criteria and Reported Device Performance:

Study Information Specific to the Device Clearance (non-clinical)

The information provided in the 510(k) summary focuses on non-clinical testing. Questions related to "test set," "data provenance," "experts," "adjudication," "MRMC studies," "standalone algorithm performance," and "ground truth" are not applicable in the context of this specific regulatory submission as it's for a physical orthopedic implant, not a diagnostic AI software.

However, based on the general structure, here's what can be inferred or stated as "Not Applicable" for this type of device:

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: For mechanical testing, the "sample size" refers to the number of physical devices or representative specimens tested per condition, as per the respective ASTM/ISO standards. This specific number is not disclosed in the provided summary but would be detailed in the full submission.
   • Data Provenance: The data provenance is from the manufacturing and testing facility of Corin USA Limited, a medical device manufacturer. The tests are "non-clinical" and conducted on physical prototypes/products.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. This is a physical device, and "ground truth" is established by physical measurements and performance against established engineering standards and specifications, not expert interpretation of medical images or clinical outcomes in a diagnostic context. The "experts" involved would be engineers, materials scientists, and quality assurance personnel.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not Applicable. Adjudication relates to resolving discrepancies in expert interpretations, which is relevant for diagnostic studies, not mechanical testing. Test results are objective measurements compared against predefined limits.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. An MRMC study is relevant for evaluating the impact of AI algorithms on human reader performance in diagnostic tasks. This device is a passive, physical implant.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Not Applicable. This is a physical orthopedic implant, not a software algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Engineering Standards and Specifications. The "ground truth" for the device's performance is defined by established international standards (ASTM, ISO) and internal engineering design specifications that ensure the device's mechanical integrity, biocompatibility, and functional characteristics are met.

7. The sample size for the training set:

   • Not Applicable. This is a physical device, not an AI/ML algorithm that requires a "training set." The design and manufacturing processes are refined through engineering development and quality control, not machine learning.

8. How the ground truth for the training set was established:

   • Not Applicable. (See point 7).

In summary, the 510(k) for the Trinity EVO Acetabular Shell demonstrates "substantial equivalence" based on extensive non-clinical (mechanical, materials, and physical) testing to established engineering standards, asserting that it performs as safely and effectively as its predicate devices, rather than through clinical studies involving human readers or AI algorithms.

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This device is intended for use in total and hemi-hip arthroplasty. The device is intended for uncemented, press-fit use only in cases of:

1. Notably impaired hip joint due to osteoarthritis, rheumatoid arthritis, and/or post traumatic arthritis.
2. Previously failed hip surgery.
3. Proximal femoral neck fractures or dislocation.
4. Idiopathic avascular necrosis of the femoral head.
5. Non-union of proximal femoral neck fractures.
6. Treatment of fractures that are unmanageable using other forms of therapy.
7. Benign or malignant bone tumors, congenital dysplasia or other structural abnormalities where sufficient bone stock exists to properly seat the prosthesis.

The subject device is a set of smaller stems that extends the size range of the previously cleared Trivicta® stems (K233758).

Trivicta® is a single-piece, tapered, collared and non-collared, hydroxyapatite (HA) and sintered bead commercially pure (Cp) Titanium coated femoral hip stem designed for single use. The stem has a neck with a 12/14 trunnion taper for modular attachment to femoral heads. Trivicta® is manufactured from titanium alloy and device fixation is achieved through uncemented press-fit in the medullary canal and through the use of biocompatible HA coating and porous sintered bead coating.

The size range of the subject device is: lengths (97-101mm), horizontal offsets (36-43mm), vertical offsets (27-29mm), resection angle of 41°, and neck angle of 132°. The stem is offered with both standard (STD) and extended (EXT) offsets and with and without a collar.

Trivicta® is compatible with the following Ortho Development® devices: CoCr Femoral Heads, Biolox Delta Ceramic Femoral Heads, Solitude™ Unipolar Head, Escalade Acetabular Cup System, Legend® Acetabular Liner, Escalade Legend® Acetabular Shell, and Tri-plus™ DCM Liner.

The provided text is an FDA 510(k) clearance letter and associated summary for a hip stem device. This type of document describes the device, its indications for use, and a comparison to predicate devices, along with performance data to demonstrate substantial equivalence.

However, the information requested in your prompt regarding acceptance criteria for a software device, specifically around AI performance metrics like sensitivity, specificity, MRMC studies, ground truth establishment, training data, etc., is not contained within this FDA clearance document.

The document states under "Clinical Testing" (Page 7): "No clinical testing is required to establish the safety and effectiveness of Trivicta." This indicates that the clearance was based on non-clinical performance data (sterilization, shelf life, biocompatibility, mechanical testing) and comparison to predicate devices, not on a study involving AI performance or human-in-the-loop assessments as would be typical for medical AI devices.

Therefore, I cannot fulfill your request for the specific AI-related acceptance criteria and study details because the provided document is for a mechanical orthopedic implant, not an AI-powered diagnostic or therapeutic device.

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Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:

• Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
• Inflammatory joint disease including rheumatoid arthritis
• Correction of functional deformity including congenital hip dysplasia
• Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
• Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

Signature Orthopaedics' Origin, Origin TT, Aria, Remedy, Origin-NS, Pegasus, Spartan, World and Everglade Hip femoral stems, SignaSure Cementless Cups, Logical and World Acetabular Cups are intended for cementless fixation only.

Signature Orthopaedics' Evolve, Cemented TSI (both CoCr and HNSS variants), and Origin Cemented femoral stems and SignaSure Cemented Cups are intended for cemented fixation only.

Signature Orthopaedics' SignaSure Logical/World Metal Insert is indicated for use with a cementless Signature Orthopaedics' Logical/World Acetabular Cup to provide dual mobility articulation.

Signature Orthopaedics' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemi-hip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head and BiPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:

• Acute femoral head or neck fracture
• Fracture dislocation of the hip
• Avascular necrosis of the femoral head
• Non-union of femoral neck fractures
• Certain high subcapital and femoral neck fractures in the elderly
• Degenerative arthritis involving only the femoral head

Signature Orthopaedics' Origin™ Cemented Hip Stems are manufactured from nitrogen stainless steel per ASTM F1568 and ISO 5832-9. The subject stem is straight and tapered with a lateral chamfer. The Cemented Origin™ stem is polished and intended for cemented use in total hip arthroplasty. It features a 12/14 taper which allows for compatibility with Signature Orthopaedics' range of previously cleared femoral head components including the Signature CoCr Femoral Heads (K121297 and K163081), Signature Ceramic Femoral Heads (K190704), Signature BiPolar Head (K133370 and K163081) and Evolve UniPolar Head (K143184). Compatible acetabular cups and liners including the Logical Cup (G-Series K121297, PX-Series K121297 and C-Series K153131) and the Logical Liners (Neutral and 10º Hooded, Lateralised K121297), Logical Liners (20º Hooded, Lateralised 20º Hooded K153131), Logical Constrained Liners (K153131) and Logical Liners Vit-E (Neutral and 10º Hooded, Lateralised, 20º Hooded, Lateralised 20º Hooded, High Wall, 10º Face Changing (K241690).

Based on the provided FDA 510(k) Clearance Letter for the Origin™ Cemented Hip Stem, there is no information present regarding acceptance criteria or a study proving that the device meets specific acceptance criteria in the context of an AI/human reader performance study.

This document is a 510(k) clearance for a physical medical device (a hip stem), not a software or AI-enabled device that would typically involve acceptance criteria related to accuracy, sensitivity, specificity, or human reader performance. The "Performance Testing" section refers to non-clinical mechanical and fatigue testing of the physical hip stem, not a clinical or human-in-the-loop study as described in your request.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, sample sizes for test sets, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth establishment for AI/human reader studies.

If you have a document related to an AI/software device, please provide that, and I would be happy to analyze it against your criteria.

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Mpact 3D Metal Augments are intended for cementless use to the bone interface and are affixed to a compatible Medacta Acetabular shell using bone cement in hip replacement surgeries.

Mpact 3D Metal Augments are indicated in cases of:

• Acetabular dysplasia;
• Acetabular fractures;
• Revision of previous implants in the presence of insufficient bone quality or seriously altered bone structures.

The Mpact 3D Metal Augment II is an acetabular implant intended to be used in Total Hip Arthroplasty cemented to its Medacta compatible Acetabular Shell. It is provided sterile and individually packaged to the end user.

The devices subject of this submission are:

• Mpact 3D Metal Augments II from size Ø46 to Ø80, made of Ti6Al4V according to ASTM F2924;
• Double Augment Technique Screw, made of Ti6Al4V according to ISO 5832-3.

The Mpact 3D Metal Augments II represent the second generation of the Mpact 3D Metal Augments cleared within K171966.

This FDA 510(k) clearance letter pertains to a medical device, specifically the Mpact 3D Metal Augments II, which are implants for hip replacement surgeries. The document focuses on establishing substantial equivalence to existing predicate devices based on design and performance testing. However, it does not describe a clinical study in the traditional sense, especially not one that involves human subjects or assesses AI performance.

The provided text details non-clinical performance data and validations to support the device's substantial equivalence to its predicate. It does not contain information about acceptance criteria for AI performance, sample sizes for test sets in an AI context, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

Therefore, many of the requested sections (including specific tables for acceptance criteria and device performance based on AI metrics, details about test sets, ground truth establishment for AI, MRMC studies, and standalone performance) cannot be filled from the provided document.

Here's a breakdown of the information that is available:

1. A table of acceptance criteria and the reported device performance

The document describes performance testing as "Fatigue testing in single and double augment configurations" and "Rationale of comparison – EBM Additive Manufacturing Technology." It also mentions "Design Validation on Mpact 3D metal Augments II." However, it does not disclose specific acceptance criteria or quantitative performance results for these tests. It only states that "testing activities were conducted to written protocols" and these validations are "provided in support of the substantial equivalence determination." This is typical for a 510(k) summary, which generally summarizes the data rather than providing all raw or detailed results.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The "tests" here refer to non-clinical laboratory and material tests, not clinical studies involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to the type of device and study described. There's no "ground truth" to be established by experts in the context of material fatigue or design validation for an orthopedic implant as presented here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable to the type of device and study described. Adjudication methods are typically used in clinical trials or studies involving expert review of medical images or outcomes.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There is no MRMC or comparative effectiveness study mentioned, as this is a physical medical device (hip augments), not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is an orthopedic implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This is not applicable in the sense of medical diagnosis or AI performance. The "truth" for these non-clinical tests would be the physical properties and performance characteristics determined by established engineering and materials testing standards.

8. The sample size for the training set

This is not applicable, as there is no "training set" for an AI algorithm mentioned in this document.

9. How the ground truth for the training set was established

This is not applicable, as there is no "training set" or "ground truth" for it in the context of AI.

Summary of what the document does provide regarding the study/testing:

The document describes non-clinical testing and validations performed to demonstrate the substantial equivalence of the Mpact 3D Metal Augments II to its predicate devices. These tests include:

• Design Validation: Performed on Mpact 3D Metal Augments II (details not provided).
• Performance Testing:
  • Fatigue testing in single and double augment configurations.
  • Rationale of comparison – EBM Additive Manufacturing Technology.
• Pyrogenicity: Control validated using bacterial endotoxin test (LAL test) per ISO11737-3 and European Pharmacopoeia §2.6.14, and in-vivo evaluation in rabbits per USP .
• Biocompatibility assessment.
• Shelf-life evaluation.

The document states that Medacta International S.A., based in Switzerland, submitted this 510(k). The tests are non-clinical, so data provenance regarding country of origin or retrospective/prospective does not apply in the same way as for clinical data. The studies are laboratory-based and conducted according to written protocols to ensure materials and design meet safety and performance standards for orthopedic implants.

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