Search Results

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.

Ask a specific question about this device

Z1 Hip System is intended for total or hemi hip arthroplasty and is indicated for the following conditions:

• Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases.
• Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemi-arthroplasty or total hip replacement (THR).
• Acute traumatic fracture of the femoral head or neck.
• Avascular necrosis of the femoral head.

Z1 Hip System is for cementless use only.

The Z1 Hip System consists of femoral hip stems intended for use in total or hemi hip arthroplasty. The stem is designed for cementless implantation in the proximal femur and mates with compatible femoral heads and adapters for use in total or hemi hip arthroplasty through a 12/14 male taper connection. The stems are manufactured from titanium alloy Ti-6Al-4V and have a wedge-shaped design, with a proximal-to-distal taper. Apart from the highly polished femoral neck region and the taper, the entire surface of the stem is grit-blasted, proximally sprayed with a Ti-6Al-4V titanium alloy plasma coating, and followed by a hydroxyapatite (HA) overcoat. Offered in multiple sizes and neck lengths, the stems are available in standard, high offset, and coxa vara offsets and as collared or collarless stems in each offset to accommodate various patient anatomies. The hip stems are provided sterile and are for single use only. System-specific instrumentation is available to prepare the femur for implantation of the Z1 Hip System femoral stems. The stems are compatible with previously cleared Zimmer Biomet modular femoral heads and/or acetabular components.

The provided text is an FDA 510(k) clearance letter for the Z1 Hip System, which is a medical device for hip arthroplasty. The document details the administrative aspects of the clearance, the device description, intended use, and a summary of non-clinical testing.

However, the question asks for information related to a "study that proves the device meets the acceptance criteria," specifically in the context of an AI/Software as a Medical Device (SaMD). The Z1 Hip System is a physical orthopedic implant, not an AI/SaMD. The document clearly states:

• "No clinical testing was conducted." (Page 6)
• The tests performed are "Distal Fatigue Testing per ISO 7206-4", "Proximal Fatigue Testing per ISO 7206-6", "Evaluation of Compatibility with Femoral Heads", and "Evaluation of Range of Motion" (Page 6). These are all mechanical and performance tests for a physical implant, not studies involving AI algorithms, expert reads, or clinical outcomes data as would be relevant for an AI/SaMD.

Therefore, I cannot provide the requested information as the provided text does not contain any details about acceptance criteria or a study design relevant to an AI/SaMD. The information requested (multi-reader multi-case studies, ground truth establishment, sample size for training sets, etc.) is specific to the validation of AI algorithms, which is not applicable to the Z1 Hip System described in this 510(k) clearance.

Ask a specific question about this device

The DePuy RECLAIM Monobloc Revision Femoral Stem is indicated for cementless use in the treatment of failed previous hip surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement.

The subject devices in this line extension to the RECLAIM Monobloc Revision Femoral Stem (previously cleared through Primary Predicate 510(k) K221462 and with MRI Conditional status cleared through 510(k) K231873) include four new Standard length RECLAIM Monobloc Revision Femoral Stems and twenty-three new Short length RECLAIM Monobloc Revision Femoral Stems.

The line extension will extend the DePuy RECLAIM Monobloc Revision Femoral Stems portfolio by twenty-seven product codes.

The Subject Device RECLAIM Monobloc Revision Femoral Stems are revision implants that are intended to treat patients with prior failed hip replacement devices. They are made of Ti6Al4V alloy and present a grit-blasted tapered fluted intramedullary region with splines that are intended to be in interference of the previously reamed femoral cavity and in contact with the cortical bone in the canal in an uncemented use.

The provided text describes a 510(k) clearance letter for the RECLAIM Monobloc Revision Femoral Stem. This is a medical device, specifically a hip joint prosthesis, not an AI/Software as a Medical Device (SaMD). Therefore, the questions related to AI/SaMD performance criteria, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone algorithm-only performance," "number of experts for ground truth," and "training set size," are not applicable to this submission.

The clearance is for an expansion of the existing RECLAIM Monobloc Revision Femoral Stem (K221462 and K231873) to include additional sizes. The regulatory review focuses on mechanical performance and substantial equivalence to the predicate devices.

Here's the information extracted from the provided text regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for the mechanical tests (Neck Fatigue, MRI Safety, Range of Motion, Stem Fatigue). However, for medical device mechanical testing, typically a representative number of samples (e.g., 3-6 or more) for each configuration are tested according to relevant ISO or ASTM standards.

The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. As these are physical device tests, they would be conducted in a laboratory setting.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This is a physical device, not an AI/SaMD for which expert-established ground truth would be required. The "truth" is determined by mechanical testing against established engineering standards.

4. Adjudication Method for the Test Set

Not applicable. This is a physical device, not an AI/SaMD where adjudications of expert interpretations are relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

Not applicable. This is a physical medical device (hip implant), not an AI/SaMD that assists human readers.

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

Not applicable. This is a physical medical device, not an AI/SaMD.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" is established by:

• Engineering Standards: Bench testing against industry-accepted standards (e.g., ISO, ASTM) for fatigue, range of motion, and other mechanical properties.
• Predicate Device Performance: Demonstrating that the subject device performs "as well as" or equivalently to the legally marketed predicate devices, which have already established safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/SaMD, therefore a "training set" in the context of machine learning is not relevant.

9. How the Ground Truth for the Training Set was Established

Not applicable. As above, there is no "training set" for this type of device.

Ask a specific question about this device

General Indications:
The MobileLink Acetabular Cup System is indicated for mobility-limiting diseases, fractures or defects of the hip joint or proximal femur which cannot be treated by conservative or osteosynthetic procedures.

Indications:

• Primary and secondary osteoarthritis
• Rheumatoid arthritis
• Correction of functional deformities
• Avascular necrosis
• Femoral neck fractures
• Revision after implant loosening dependent on bone mass and quality

Dual Mobility Insert (in addition to the indications and general indications):

• Dislocation risk

The MobileLink Acetabular Shells are intended for cementless fixation.

The TrabecuLink Augments are intended for cementless fixation to the bone and for cemented fixation to the mating shell.

Additional indications specific to the TrabecuLink Augments:

• Primary or revision surgery for hip replacement as a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.

The MobileLink Acetabular Cup System is a versatile cup system, designed to provide several options for surgeons and patients within one system.

MobileLink PlasmaLink and TiCaP Shells: The MobileLink System consists of press-fit metal shells made of a Ti6Al4V alloy. The system offers two designs, a cluster hole shell, with closing screws and a polar screw, and a multi hole shell. Both shells are available with two different coatings, either titanium plasma sprayed (TPS) coating (brand name: PlasmaLink) or a double coating consisting of titanium plasma spray coating plus calcium phosphate (CaP) coating (brand name: TiCaP). The MobileLink PlasmaLink and TiCaP Shells are compatible with polyethylene liners (K182321, K241636), acetabular bone screws (K192559), Dual Mobility Inserts (K200607) with BiMobile Dual Mobility Liners (K171273, K190535), Shell/Insert Adapters ("Face Changers", K200607), and TrabecuLink Augments (K241636).

This FDA 510(k) clearance letter is for a medical device called the "MobileLink Acetabular Cup System - inhouse coatings." It does not involve AI software and therefore does not have the acceptance criteria and study information typically associated with AI/ML-based devices.

The submission is specifically for a change in the coating supplier for an existing device from an external vendor to an in-house process. This means the core design and function of the acetabular cup system are already established and cleared.

Therefore, the requested information elements (acceptance criteria table, sample size for test set, experts for ground truth, adjudication, MRMC study, standalone performance, type of ground truth, training set sample size, how training ground truth was established) are not applicable to this specific 510(k) submission.

Here's why and what information is provided:

• Device Type: This is a physical orthopedic implant (hip replacement component), not an AI/ML software device.
• Reason for Submission: The primary reason for this 510(k) is to notify the FDA of a change in the manufacturing process (in-house coating application instead of external). This is a manufacturing/materials change, not a new device with new performance claims requiring extensive clinical or AI performance studies.
• Performance Testing: The document states:
  • "Non-clinical performance testing and analysis were provided, including: Characterization of the TPS and TiCaP inhouse coatings."
  • "Biocompatibility evaluation."
  • "The results of non-clinical performance testing demonstrate that the device is as safe and effective as the predicate device, and therefore Substantially Equivalent."
  • "Clinical performance testing was not required to demonstrate the substantial equivalence of this device."

This means the acceptance criteria and supporting studies were focused on material characterization and biocompatibility to ensure the new in-house coating process yields a product that is equivalent to the predicate device in terms of safety and performance (e.g., adhesion, wear resistance, biological response), rather than diagnostic accuracy or human-AI interaction.

In summary, there is no information in this document to answer the questions about acceptance criteria related to AI/ML performance studies, as this is not an AI/ML device submission.

Ask a specific question about this device

NEXUS® Hip stems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
2. inflammatory degenerative joint disease such as rheumatoid arthritis;
3. correction of functional deformity; and,
4. revision procedures where other treatments or devices have failed

Titanium plasma spray and HA coatings applied to implant surfaces are intended for uncemented arthroplasty.

The MicroPort NEXUS® Hip Stem is manufactured from titanium alloy (Ti6Al4V per ASTM F620) and includes titanium plasma sprayed coating conforming to ASTM F1580 and a hydroxyapatite (HA) coating conforming to ASTM F1185. The proximal body of the hip stem has a dual titanium and HA plasma spray coating while the distal portion of the hip stem has HA coating only. The NEXUS Hip Stem features collared and collarless options and sizes 0 through 12 with standard and high offsets. The NEXUS Hip Stem is provided sterile and is a single use device. The subject NEXUS Stems are compatible with previously cleared MicroPort femoral head and shell/liner components.

This document is a 510(k) clearance letter for the NEXUS® Hip Stem, a medical device. It does not contain information about an AI/ML medical device, clinical study performance data, or details about the establishment of ground truth by experts. The relevant sections for describing device performance are focused on non-clinical (mechanical) testing of the hip stem itself.

Therefore, I cannot fulfill your request for information related to acceptance criteria, study details, expert involvement, and ground truth establishment in the context of an AI/ML device. The provided FDA clearance letter is for a physical medical implant, not an AI software.

The sections you've asked about (acceptance criteria, sample size, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are typically found in clinical performance studies for AI/ML-driven medical devices, especially those involving image analysis or diagnostic support. This document is instead a regulatory clearance for a traditional orthopedic implant, where "performance" relates to mechanical and material characteristics and "testing" involves physical simulations or analyses, not analysis of clinical data by AI.

To illustrate what you would expect to find if this were an AI/ML device, and why it's not present here:

An AI/ML device would typically have acceptance criteria related to its diagnostic or predictive performance metrics (e.g., sensitivity, specificity, AUC, FROC curves) on a test set. The study proving these criteria would describe:

• A table of acceptance criteria and reported device performance: This would list target thresholds (e.g., "Sensitivity >= 90%") and the actual observed performance (e.g., "Sensitivity = 92.5%").
• Sample size and data provenance: Details on how many cases (e.g., images, patient records) were in the test set, where they came from (e.g., multi-center, specific countries), and if they were collected retrospectively or prospectively.
• Experts for ground truth: The number and qualifications of clinicians (e.g., board-certified radiologists with X years of experience, specializing in Y disease) who reviewed the test cases to establish the definitive diagnosis or finding.
• Adjudication method for ground truth: How disagreements among experts were resolved (e.g., 2-out-of-3 majority vote, third independent expert review, consensus meeting).
• MRMC comparative effectiveness study: If the AI was intended to assist human readers, there would be a study comparing human reader performance with AI assistance vs. without AI assistance. The effect size (e.g., improvement in AUC or reading time) would be reported.
• Standalone performance: The algorithm's performance by itself without human intervention.
• Type of ground truth: Whether it was expert consensus, biopsy-proven pathology, long-term patient outcomes, or a combination.
• Training set size and ground truth establishment: Similar details for the data used to train the AI model.

Since none of this information is available in the provided text, I cannot create the table or answer the specific questions posed using the given input. The input is purely for a physical implant, not an AI product.

Ask a specific question about this device

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.

Ask a specific question about this device

The Zimmer Biomet Ceramic Heads are indicated for the following conditions: (1) a severely painful and/or disabled hip joint as a result of osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia, (2) avascular necrosis of the femoral head, (3) acute traumatic fracture of the femoral head or neck, (4) failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, (5) certain cases of ankylosis, (6) nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

When used with constrained acetabular liners, the Zimmer Biomet Ceramic Heads are intended for 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 and for whom all other options to constrained acetabular components have been considered.

The Zimmer Biomet Ceramic Heads are made from a composite ceramic containing approximately 75% alumina (Al2O3) and 25% zirconia (ZrO2) (percentage by weight). They are supplied with a 12/14 bore or a Type 1 bore. The scope of the subject submission is limited to the 22.2mm head diameter with multiple neck configurations.
The subject ceramic heads are intended for mating with Ti-6Al-4V alloy, Ti-6Al-7Nb alloy stems with tapered necks. They may only be used in combination with highly crosslinked or conventional polyethylene (PE) or metal-back polyethylene liners.

This document is a 510(k) clearance letter for a medical device: "Zimmer Biomet Ceramic Heads (22.2mm diameter)". It describes the device, its intended use, and states that no non-clinical or clinical tests were submitted to determine substantial equivalence.

Therefore,Based on the provided FDA 510(k) clearance letter for the "Zimmer Biomet Ceramic Heads (22.2mm diameter)", it is explicitly stated that no non-clinical and/or clinical tests were submitted to determine the substantial equivalence of the subject device with the predicate.

This means that the information requested regarding acceptance criteria and the study proving the device meets these criteria cannot be provided from this document. The clearance was based on:

• Technological Comparison: The only difference between the subject device and the predicate device (K181171, K200823) is the addition of a contraindication for the use of 22.2mm ceramic heads with stainless steel femoral stems. All other technological characteristics are identical.
• Indications for Use Comparison: The indications for use and intended use are identical to the predicate device.

Since no testing was performed or reported in this submission for device performance, the following information cannot be extracted:

1. A table of acceptance criteria and the reported device performance: No performance data was submitted.
2. Sample sizes used for the test set and the data provenance: No test set was used.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable as no test set was evaluated.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, as per the text "No Non-Clinical and/or Clinical Tests were submitted".
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device (hip prosthesis component), not an AI/software algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable as no training set (for an algorithm) was used.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) clearance relied on substantial equivalence to a predicate device based on identical technology and indications for use, with the only change being an additional contraindication. It did not involve new performance studies.

Ask a specific question about this device

The CATALYSTEM Femoral Stems are intended for total and partial hip arthroplasty in skeletally mature patients for the following indications:

Hip components are indicated for individuals undergoing primary surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis.

Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, congenital dysplasia, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocation of the hip.

The CATALYSTEM Femoral Stems are intended for use without bone cement.

The purpose of this Special 510(k) is to notify the FDA of Smith & Nephew's intent to market the CATALYSTEM Femoral Stems with additional femoral head compatibility. The CATALYSTEM Femoral Stems were previously cleared by the FDA under K240381.

The CATALYSTEM Femoral Stems consists of femoral stem implants intended for primary in skeletally mature patients. The CATALYSTEM Femoral Stems are provided sterile to the user via gamma irradiation.

The subject CATALYSTEM Femoral Stems are comprised of two variants: CATALYSTEM Collared and CATALYSTEM Collarless. Both variants are available in standard and high neck offset options.

The CATALYSTEM Femoral Stems are intended to be used with Smith & Nephew femoral heads and acetabular components for total hip arthroplasty and hip hemiarthroplasty.

This document is a 510(k) clearance letter for the CATALYSTEM Femoral Stems. It primarily addresses the regulatory approval process rather than detailing a study proving the device meets specific acceptance criteria in the context of an AI/software device.

The provided text does not contain information related to AI/software device performance or studies proving such a device meets acceptance criteria. It describes a medical device (femoral stems for hip replacement) and its regulatory clearance based on substantial equivalence to a predicate device.

Specifically, it states:

• "No clinical tests were performed to support safety and efficacy of the subject device."
• Bench testing was performed for mechanical properties (e.g., fatigue, range of motion, impingement), which are relevant to orthopedic implants, not AI performance.
• The clearance is a "Special 510(k)" primarily for "additional femoral head compatibility."

Therefore, I cannot extract the requested information about acceptance criteria and a study proving an AI device meets them from this document. The concepts of ground truth, expert adjudication, MRMC studies, standalone performance, training sets, and test sets are not applicable to the information provided in this 510(k) clearance letter for a mechanical implant.

Ask a specific question about this device

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 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), 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 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

The Signature Orthopaedics Origin™ TT Stem is intended for single use and cementless fixation. It is manufactured from titanium alloy as per ISO 5832-3 and has a proximal plasma spray coating of titanium as per ASTM F1580 and hydroxyapatite as per ISO 13779-2. It features a 12/14 taper and is compatible for use with Signature CoCr Femoral Heads (K121297 and K163081), Ceramic Femoral Heads (K190704), Logical™ PX, G and C Series Acetabular Cups (K121297 and K153131), Logical™ Liners (K121297, K153131 and K241690), Logical™ Constrained Liners (K153131), BiPolar Heads (K133370 and K163081) and Evolve™ UniPolar Heads (K143184).

The provided text describes the regulatory review for a medical device called the "Origin™ TT Stem," which is a femoral hip prosthesis. However, the document does not contain any information regarding acceptance criteria, study methodologies for device performance, sample sizes, expert involvement, ground truth establishment, or multi-reader multi-case studies.

The document primarily focuses on:

• Regulatory classification and product codes for the device.
• Indications for Use of the hip replacement system, including various components beyond just the Origin™ TT Stem.
• Comparison to predicate devices to establish substantial equivalence.
• Non-clinical performance testing (Range of Motion, Stem and Neck Fatigue FEA, Stem and Neck Fatigue Testing) conducted according to established ISO and ASTM standards to demonstrate the strength and safety of the device.

Therefore, I cannot provide the requested table or answer the specific questions about the study that proves the device meets acceptance criteria, as this information is not present in the provided text.

The document states:

• "Non-clinical testing and engineering evaluations were conducted to verify that the performance of the Signature Orthopaedics Origin™ TT Stem is adequate for anticipated in-vivo use."
• "The results of non-clinical testing show that the strength of the Signature Orthopaedics Origin™ TT Stem is sufficient for their intended use and substantially equivalent to the legally marketed predicate device."

This indicates that internal testing was performed, but the details of the "acceptance criteria" and the specific data from these tests are not provided in the 510(k) summary. The document focuses on demonstrating that the device meets existing standards (ISO, ASTM) and is substantially equivalent to predicate devices, rather than presenting a clinical study with detailed performance metrics against specific acceptance thresholds.

Ask a specific question about this device

Versacem is designed for use in total hip arthroplasty, for selected primary or revision surgery. Total hip arthroplasty is indicated in the following cases:

• Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polvarthritis or congenital hip dysplasia.
• · Avascular necrosis of the femoral head.
• · Acute traumatic fracture of the femoral head or neck.
• · Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty.
  Versacem is also recommended when dislocation prevention is the main driver for the prosthesis choice and the acetabular bone quality is damaged, as in the following cases:
• · Elderly patients or poor bone quality.
• · Revision for recurrent dislocation in elderly patients with poor bone quality.
• · Patients treated with radiotherapy or chemotherapy.
  Versacem is intended for cemented use only.

The purpose of this submission is to gain clearance for the Versacem Acetabular Shell and to add two new sizes of the compatible Double Mobility HC Liners previously cleared within K092265, K131458 and K143453.
The Versacem Acetabular Shell implants and the Double Mobility HC liners are sterile, individually packaged, implantable medical devices intended to be used in Total Hip Arthroplasty.
The devices subject of this submission are:

• . Versacem Acetabular Shell from size Ø40 to size Ø56;
• . Double Mobility HC liner Ø22.2/DMAZ;
• Double Mobility HC liner Ø28/DMC. ●

The provided document is a 510(k) premarket notification from the FDA, clearing the Medacta International S.A. Versacem Acetabular Shell and Double Mobility HC Liners. This type of document does not contain the acceptance criteria or detailed study results for device performance as would be found in a clinical trial report or a comprehensive engineering report.

The 510(k) process primarily demonstrates "substantial equivalence" to a legally marketed predicate device, rather than proving de novo safety and efficacy against predefined clinical acceptance criteria. The "Performance Data" section in the document only lists the types of non-clinical (bench) tests performed.

Therefore, I cannot fulfill most of the requested information based on this document. Below is a breakdown of what can be inferred or what is explicitly stated, and what cannot be provided:

Inferences/Provided Information from the Document:

• Study That "Proves" Device Meets Acceptance Criteria: The document refers to "Performance Data" from "Nonclinical Studies" (bench testing) to support substantial equivalence. These studies include:
  • Design Validation
  • Wear Test
  • Range of Motion Evaluation
  • Fatigue Test
  • Pull-off and Lever-out Tests (for liner)
  • Evaluation of Jumping Distance
  • Evaluation of Impingement Risk
  • Pyrogenicity testing (LAL test, in-vivo evaluation in rabbit)
  • Biocompatibility assessment
  • Shelf-life evaluation

Information NOT available in this document:

• A table of acceptance criteria and the reported device performance: This document only lists the types of tests performed, not the specific acceptance criteria for each test nor the quantitative results. For example, it lists "Wear Test" but doesn't state the acceptable wear rate or the actual wear rate achieved.
• Sample sizes used for the test set and the data provenance: Bench testing results typically refer to the number of samples tested (e.g., how many shells, how many liners), but this is not provided. Data provenance is not applicable as these are bench tests, not clinical studies with human data.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable as these are non-clinical, mechanical/material performance tests, not studies requiring expert interpretation of clinical data or images.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for non-clinical bench testing.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is for a medical device (hip implant), not an AI/imaging device that would involve human readers.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for this type of device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For non-clinical tests, the "ground truth" is typically engineering and material science standards (e.g., force applied, displacement, wear volume, fatigue cycles to failure). These are implied by the test names (e.g., "Fatigue Test" implies testing to a certain number of cycles or until failure, compared against a standard).
• The sample size for the training set: Not applicable. These are physical devices, not AI algorithms trained on data.
• How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device