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The Trident® II Acetabular System is intended for use in total hip arthroplasty and is intended for either primary or revision Total Hip Arthroplasty.

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 Liners:
• 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.

The Trident® II Acetabular Shells, 6.5mm Low Profile Hex Screws and Hex Dome Hole Plug are sterile, single-use devices that are intended for cementless fixation into a prepared acetabulum for either primary or revision Total Hip Arthroplasty. The Trident® II Acetabular System is an extension of the Trident System product line and features the same locking mechanism as the current Trident® and Trident® II Tritanium® product lines. The Trident® II Acetabular Shells are intended to be used with existing Trident® polyethylene inserts, Trident Constrained Acetabular Inserts, MDM® liners and both new and existing surgical instruments.

The Trident® II Tritanium® implant consists of a unique configuration of both solid and porous sections that are simultaneously built using a Laser Rapid Manufacturing (LRM) method of additive manufacturing, applying Stryker's proprietary Tritanium® In-Growth Technology. Tritanium® is a novel highly porous titanium material designed for biological fixation. The Trident® II PSL® Clusterhole HA and Trident® II Clusterhole HA Acetabular Shells feature hydroxylapatite coating over a Commercially Pure Titanium plasma sprayed surface for cementless fixation.

This document describes a 510(k) premarket notification for the "Trident® II Acetabular System," a medical device for total hip arthroplasty. The submission asserts substantial equivalence to previously marketed predicate devices, and therefore, clinical testing was not required. The information provided focuses on non-clinical testing.

Here's an analysis of the provided text in relation to your request:

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

The document does not explicitly present acceptance criteria in a table format with corresponding reported performance for each criterion. Instead, it lists a series of non-clinical tests performed, implying that the device "meets the requirements" or was "characterized according to methods" outlined in various ASTM standards and FDA guidance documents.

Here's a partial reconstruction of what could be inferred as acceptance criteria and "device performance" based on the text:

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Bencox M Stem (Bencox Hip System) is intended for Cementless use in partial or total hip arthroplasty in primary or revision surgery for the following conditions:

a. Non-inflammatory degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis
b. Inflammatory degenerative joint disease, such as rheumatoid arthritis
c. Treatment of non-union, femoral neck fracture and trochantric fractures of the proximal femur with head involvement, unmanageable using other techniques
d. Patients with failed previous surgery where pain, deformity, or dysfunction persists
e. Revision of previously failed total hip arthroplasty

The Bencox ID Cemented Stem (with Centralizer) & Bencox Bone Plug is intended for cemented use in total or partial hip arthroplasty and in primary or revision surgery for the following conditions,

a) Non-inflammatory. degenerative joint disease, such as avascular necrosis, osteoarthritis, traumatic arthritis
b) Inflammatory degenerative joint disease, such as rheumatoid arthritis
c) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques
d) Patients with failed previous surgery where pain, deformity, or dysfunction persists
e) Revision of previously failed total hip arthroplasty

The Centralizer is intended to be used with Bencox ID Cemented Stem to centralize the femoral stem within the intramedullary canal.

The Bencox Bone Plug is intended to be used with cemented hip replacement procedures to control and restrict the flow of cement within the intramedullary canal.

Bencox M Stem (Bencox Hip System) - Sterile
The Bencox M Stem is a double tapered wedge shaped stem intended for press-fit partial or total hip arthroplasty. When used in total hip arthroplasty the stem is coupled to a Femoral Head and used with Bencox Acetabular Cups cleared under K103431, K112019, K120924. K121665 & K150007. When used in partial hip arthroplasty Bencox M Stem is coupled to a Femoral Head and used with Bencox Bipolar Cup cleared under K112019.

Bencox M Stem is made of Ti6AI4V alloy conforming to ASTM F136. The proximal half of the stem is plasma sprayed coating of pure titanium as per ASTM F1580. The materials used in subject device, Bencox M Stem, have been cleared for use in K112019 & K150007 for Bencox ID Stem & Bencox ID Stem (offset). The stem has a tapered rectangular section. The stem has a neck with a standard 12/14 conical taper to couple to Bencox Femoral Heads which have been cleared earlier. The Bencox M Stem is available 13 sizes with CCD angle of 132°. The stem is available in 13 sizes.

All the above described technological characteristics of subject device is similar to the identified predicate devices.

BENCOX ID Cemented Stem (with Centralizer) & Bone Plug - Sterile
Bencox ID Cemented Stem has bone plug and centralizer as accessories. The Collarless Bencox ID Cemented Stem consists of a polished double tapered distal geometry which generates the radial compressive load in distal body. The neck shape is similar to cleared Corentec's hip femoral stems in K103431, K122099 and K150007. The standard Morse taper (12/14) is used for femoral head assembly similar to cleared devices to couple to Bencox Femoral Heads and their compatible acetabular components which have been cleared in previous premarket notifications. The Bencox ID Cemented Stem is available 06 sizes with CCD angle of 132°. Bencox ID Cemented Stem is made of SS allov.

The deformable centralizer is made of PMMA with flexible wing like projections that extend outwards from the base of the centralizer and fits over the outside diameter of the stem tip. These projections contact the walls of the femoral canal, centralizing the hip stem within the canal. The hollow centralizer is designed to allow stem to engage distally within the cement mantle, subjecting the cement to compressive loading, and reducing end bearing of the stem directly onto the cement. The centralizer is a molded acrylic device manufactured from PMMA.

Bencox bone plug has a double flanged geometry very similar to the predicate devices. The plug blocks the propagation of the doughy bone cement downward in the medullary cavity. The proximal flange provides a proximal barrier, while the more flexible distal flange forms a secondary seal to prevent cement leakage. Bencox bone plug is manufactured from UHMWPE.

All the above described technological characteristics of subject device is similar to the identified predicate devices.

Accessory BENCOX Hip Instrumentation: (Non Sterile)
The Bencox Hip Instrumentation is a set of accessories to be used with Bencox Hip Implants. The instruments are designed to be simple, conventional, and accurate and all parts of which are used for their respective procedures by qualified orthopedic surgeons.

The parts of the instruments are made of stainless steel and/or polymers and/or silicon which are cleared for use in previous premarket notifications of Corentec.

Bencox Hip System Instrumentation to be used Bencox M Stem (Bencox Hip System) & Bencox ID Cemented Stem is same with Instrumentation cleared under K103431, K112019, K120924 & K122099 along with the inclusion of instruments specific to Bencox M Stem such as Rasp, Impactor etc.

The provided text is a 510(k) summary for the Bencox M Stem and Bencox ID Cemented Stem (with Centralizer) & Bone Plug. This document describes a medical device and its equivalence to previously approved predicate devices, primarily based on non-clinical performance data. It does not describe a study involving patient data, ground truth establishment, or clinical performance metrics in the way your request outlines for AI/software-based devices.

Therefore, for the specific questions related to acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types, the information is not applicable or not available within this document because it pertains to a different type of device evaluation (hardware instead of software/AI).

However, I can extract the relevant performance data based on the non-clinical testing conducted for this orthopedic implant.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is an orthopedic implant, the "acceptance criteria" and "reported device performance" are based on mechanical properties and material standards rather than diagnostic accuracy metrics. The document asserts that the device met these criteria through various tests, demonstrating substantial equivalence to predicate devices.

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

• Sample Size (Test Set): Not applicable in the context of diagnostic accuracy. For mechanical testing, "samples" would refer to the number of physical devices or components tested. This number is not specified in the 510(k) summary, but it would typically be a statistical minimum required by the testing standard.
• Data Provenance: Not applicable for clinical data. The performance data is derived from in vitro mechanical testing conducted by the manufacturer, Corentec Co., Ltd., in South Korea.

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

• Not applicable. This device is a physical implant, not a diagnostic AI/software. There is no "ground truth" derived from expert interpretation in the clinical diagnostic sense. The ground truth for mechanical properties is established by adherence to recognized engineering and material standards.

4. Adjudication method for the test set:

• Not applicable. There is no expert adjudication for mechanical testing of this nature. Test results are compared against predefined acceptance criteria from international 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 physical orthopedic implant, not an AI/software.

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

• Not applicable. This is a physical orthopedic implant, not an AI/software.

7. The type of ground truth used:

• Ground Truth Type: For orthopedic implants, the "ground truth" is defined by adherence to established engineering and material standards (e.g., ISO and ASTM standards for mechanical properties, material composition, and sterilization validation). The device's performance is compared against the requirements and benchmarks set by these standards, and against the equivalent performance of legally marketed predicate devices.

8. The sample size for the training set:

• Not applicable. This is a physical orthopedic implant. There is no "training set" in the context of machine learning. Design and manufacturing processes would be informed by engineering principles and historical data on similar devices, but not a "training set" in the requested sense.

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

• Not applicable. As above, there is no training set. Design and manufacturing are based on established engineering principles and compliance with international standards.

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The Stryker Orthopaedic Acetabular Shells for use with the Total Hip Instruments are intended for use in total hip arthroplasty and are intended for either primary or revision total hip arthroplasty. The Stryker Orthopaedic Hip Implant Stems for use with the Total Hip Instruments are intended for use in total or hemi-arthroplasty of the hip and are intended for either primary or revision procedures. The Direct Superior Approach does not change the intended use of the subject devices.

Indications for Use (Trident PSL Shell, Tritanium Shell, Trident Hemispherical Shells):

• 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.
  The Trident shells are intended for cementless fixation within the prepared acetabulum.

Indications for Use (Tritanium Acetabular Shell System):

• 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.
  The Tritanium Acetabular Shell System is intended for cementless use only.

Indications for Use (Accolade II Femoral Stem):
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 Accolade II 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.
  Accolade II Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

Indications for Use (Secur-Fit Advanced Hip Stem):
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 Secur-Fit Advanced 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.
  Secur-Fit Advanced Hip Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

Indications for Use (Anato Hip Stem):
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 Anato Hip 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 Anato Hip Stem is intended for cementless use only and is intended for total and hemiarthroplasty procedures.

The devices covered by this submission include Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments. The Instruments consist of Retractors, Cup Impactors, U-Joint Bolt Driver, Alignment Guide, Angled Reamer Handle, Instrument Trays and a Case. All instruments are hand-held surgical instruments used during orthopaedic surgery and are nonsterile, reusable devices. All Class II devices in this submission have been previously determined substantially equivalent in prior 510(k) submissions and are commercially available. The acetabular shells and femoral stems are manufactured from the following materials: titanium (Ti-6Al-4V) alloy, commercially pure (CP) titanium plasma spray, commercially pure titanium and PureFix® hydroxylapatite (HA).

This document is a 510(k) premarket notification from Stryker Orthopaedics to the FDA for their Acetabular Shells, Femoral Stems, and Total Hip Instruments for use with the Direct Superior Approach.

It is important to note that this submission is for a labeling modification to introduce a new surgical approach (Direct Superior Approach) for existing devices, not for a new device requiring extensive performance studies. Therefore, the details requested for acceptance criteria and studies proving device performance (like sample sizes, expert qualifications, etc., which are typically associated with evaluating a new device's diagnostic or predictive performance) are largely not applicable in the context of this specific regulatory submission.

Here's an attempt to address your request based on the provided document, highlighting what is (and isn't) present:

1. Table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or report on device performance based on a study, because the submission is for a labeling modification of already cleared and marketed devices. The core of the submission is to demonstrate that the new surgical approach (Direct Superior Approach) does not fundamentally change the intended use, safety, or effectiveness of the previously cleared devices.

Instead of performance metrics, the document focuses on demonstrating substantial equivalence to predicate devices. This means that the new labeling (for the Direct Superior Approach) does not raise new questions of safety or effectiveness and that the devices, when used with this new approach, are as safe and effective as existing legally marketed predicate devices.

The "performance" in this context is the general safety and efficacy of the existing devices, which was established in their original 510(k) clearances.

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

Not applicable. No specific test set to evaluate device performance for a new device was used. The submission focuses on the surgical approach for existing devices.

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

Not applicable. No new test set requiring expert ground truth establishment for a diagnostic or predictive device was involved. The safety and effectiveness of the devices themselves were established in prior 510(k)s.

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

Not applicable. There was no test set requiring ground truth adjudication.

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/diagnostic device submission.

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

Not applicable. This is not an AI/diagnostic device submission.

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

Not applicable in the sense of a new performance evaluation for a new device. The "ground truth" for this submission is the established safety and efficacy of the predicate devices.

8. The sample size for the training set

Not applicable. No new device or algorithm requiring a training set was involved.

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

Not applicable. No new device or algorithm requiring a training set was involved.

Summary of the Study (as per the document):

The document explicitly states:

• Non-Clinical Testing: "Performance testing was not required in support of this submission because this submission covers a labeling modification to introduce an additional surgical protocol, Direct Superior Approach."
• Clinical Testing: "Clinical testing was not required as a basis for substantial equivalence."

Conclusion of the Study:

The "study" in this case is the review of the modified labeling and comparison to predicate devices, rather than experimental testing of the device itself.

The conclusion is that the Stryker Orthopaedics Acetabular Shells, Femoral Stems, and Total Hip Instruments for use with the Direct Superior Approach are substantially equivalent to the predicate devices identified in the premarket notification. This substantial equivalence is based on:

• The intended use and indications for the implants with the Direct Superior Approach being identical to those of the cleared predicate devices.
• The materials, design features, and functionality for the components being substantially equivalent to previously cleared predicate devices.
• The fundamental scientific technology of the modified device (i.e., the surgical instruments for the new approach) not having changed relative to the predicate devices.
• The material and design of the Total Hip Surgery Instruments for use with the Direct Superior approach being identical to those of the predicate devices cleared for use with other approaches (Posterolateral Approach and Direct Anterior Approach), and their operational principles being similar.

In essence, the "study" for this submission was a comparative analysis of design, materials, intended use, indications for use, and operational principles between the proposed devices (with the new approach) and their already cleared predicates, confirming that no new safety or effectiveness concerns were raised by adding the Direct Superior Approach to the labeling.

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The Anato™ Hip Stem is a sterile, single-use device intended for use in primary and revision total and hemi-hip arthroplasty to alleviate pain and restore function. The stem is designed for use with the currently available compatible Howmedica Osteonics' V40™ femoral heads and their compatible acetabular components. Head compatibility with the stems includes: V40130 Biolox Delta, Biolox Delta Universal Taper Heads and Sleeves, V40™ CoCr Heads, V40™ LFITM CoCr Heads, C-Taper Alumina Heads when used with the V40TM /C-taper Adapter, C-Taper Delta Heads when used with C-taper Adaptor, UHR® Universal Head, Unitrax® Heads when used with the Unitrax® V40™ Modular Adapter.

The indications for use for total hip arthroplasty 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 Anato™ Hip 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 Anato™ Hip Stem is intended for cementless use only and is intended for total and hemi-arthroplasty procedures.

Howmedica Osteonics is introducing a monolithic, non-porous coated femoral hip prosthesis, which is intended for cementless, press-fit application. The basic design of the Anato™ Hip Stem is similar to two other commerically distributed total hip systems, which are Howmedica Osteonics' ABG® II Monolithic and Accolade® II Hip Stems.

The Anato™ and the Accolade® II stem are both made from the same material combinations. The subject device is similar in design to the ABG® II Monolithic stem as they are both anatomic stems with a 130 degree neck angle. There are normalization patterns (scales) on the anterior and posterior aspects of the proximal end of the stem to facilitate press-fit stability and load transmission. Based on 3-Dimensional simulations, these normalizations are designed to convert medial and lateral shear stresses to compressive forces, which may facilitate proximal loading.

The subject stem is manufactured from titanium (Ti-6Al-4V) alloy, commercially pure (CP) titanium coating, and PureFix® hydroxylapatite (HA) coating identical to the previously cleared Accolade® II Hip Stem.

The Anato™ Hip Stem has a shot peened neck and will be available in 8 sizes ranging from size 1 through 8 with two different neck versions (neutral and anteverted). As the stem is anatomic, there will be a right and left component for each size. The stem is designed only for use with compatible Howmedica Osteonics' femoral heads and acetabular components.

Here's the breakdown of the acceptance criteria and the study information based on the provided text, categorized as you requested.

The provided document describes a 510(k) premarket notification for a hip stem, which primarily relies on substantial equivalence to predicate devices rather than independent clinical efficacy studies. Therefore, many of the typical elements of AI/software device evaluation (like ground truth, expert consensus, MRMC studies, training set details) are not applicable in this context.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable. The evaluation was based on non-clinical testing (mechanical fatigue) and comparison to predicate devices, not on a "test set" of clinical data.
• Data Provenance: Not applicable for clinical data. For non-clinical testing, it would refer to the testing facilities and methods as described by ISO standards.

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

• Not applicable. This device relies on mechanical testing standards and comparison to predicate devices, not on expert consensus or ground truth derived from expert review of individual cases. Decisions on substantial equivalence are made by regulatory bodies based on submitted documentation.

4. Adjudication Method for the Test Set

• Not applicable. There was no "test set" in the sense of clinical cases requiring adjudication. Mechanical test results are objective measurements against a standard.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This is a medical device (hip stem), not an AI or imaging diagnostic tool that would typically involve human readers.
• Effect size of human readers with/without AI assistance: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. This device is a physical hip stem, not an algorithm or software. Its performance is evaluated through mechanical testing and material properties.

7. Type of Ground Truth Used

• Mechanical Testing Standards and Predicate Device Performance Data: Performance was established against recognized international standards (ISO 7206-4 and ISO 7206-6) for mechanical fatigue, and by demonstrating identical material compositions and similar design characteristics to legally marketed predicate devices. The "ground truth" for substantial equivalence is the proven safety and effectiveness of the predicates and compliance with relevant engineering standards.

8. Sample Size for the Training Set

• Not applicable. This is a physical device, not an AI model that requires a training set.

9. How Ground Truth for the Training Set Was Established

• Not applicable. As there is no training set, there is no ground truth for it.

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Indications for use 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. 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 Secur-Fit Advanced Hip Stems with compatible Howmedica Osteonics Constrained Liners:

1. 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.

Secur-Fit Advanced Hip Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

Howmedica Osteonics is introducing the Novel Fit and Fill Hip Stem (aka Secur-Fit Advanced), a tapered non-porous coated femoral stem intended for cementless, press-fit application. The basic design of the Secur-Fit Advanced is similar to other total hip stems that have been commercially distributed such as the Accolade II, Secur-Fit and Rejuvenate Monolithic Hip Stems. The Novel Fit and Fill and the Accolade II stem are both made from the same material combinations. The subject device is similar in design to Secur-Fit and Rejuvenate Monolithic as they are straight stems with a normalization pattern. Three dimensional simulations have shown the normalizations on the anterior and posterior aspects of the proximal end of the stem to facilitate press-fit stability and load transmission in the proximal region of the femur. These normalizations are designed to convert medial and lateral shear stresses to compressive forces, which may facilitate proximal loading.

The stem is manufactured from a Ti-6Al-4V substrate material, Commerically Pure (CP) Titanium coating and Purefix hydroxylapatite (HA) coating identical to the previously cleared Accolade II Hip Stem (K103479, K120578).

The Secur-Fit Advanced Hip Stem has a shot peened neck and includes 16 implant sizes 4-12 (nine 132° stems & seven 127° stems) that provide dual head offsets. The stem is designed only for use with compatible Howmedica Osteonics' femoral heads and acetabular components.

The provided document describes the K122853 510(k) submission for the Secur-Fit Advanced Hip Stem, which is a medical device. This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific clinical acceptance criteria in the manner one might find for a software or AI device.

Therefore, the requested information geared towards AI/software device studies (like sample size for test sets, data provenance, ground truth establishment, MRMC studies, standalone performance, and training set details) is not applicable to this submission. This is a traditional mechanical medical device submission.

Here's the information derived from the document, tailored to the context of a mechanical medical device:

Acceptance Criteria and Device Performance (Mechanical Device)

Study Details (Mechanical Device)

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

   • The document refers to "mechanical testing" (Distal Stem Fatigue Testing and Neck Fatigue Testing). For such tests, the "sample size" would typically refer to the number of physical device units tested according to the specified ISO standards. This specific number is not provided in the summary.
   • Data provenance: Not explicitly stated, but mechanical testing is generally performed in a laboratory setting by the manufacturer or a contracted lab. This is standard pre-market testing for mechanical medical devices. It is not retrospective or prospective in a clinical sense.

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

   • Not applicable. For mechanical device testing, the "ground truth" is adherence to predefined engineering specifications and performance standards (e.g., ISO 7206-4, ISO 7206-6). Expert clinical consensus is not typically used to establish this type of ground truth.

3. Adjudication method for the test set:

   • Not applicable. Test results are typically compared directly against the pass/fail criteria of the specified international standards. There is no "adjudication" in the sense of reconciling human reader opinions.

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:

   • Not applicable. This is a mechanical hip stem, not an AI or software device. MRMC studies are for assessment of reader performance, typically with imaging or diagnostic devices.

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

   • Not applicable. This is a mechanical hip stem, not an AI or software device.

6. The type of ground truth used:

   • Compliance with international mechanical testing standards (ISO 7206-4 and ISO 7206-6) and demonstration of material and design equivalence to legally marketed predicate devices.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

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

   • Not applicable.

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