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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.

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The PINNACLETM Constrained Acetabular Liner is indicated for use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history or prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability and for whom all other options of constrained acetabular components have been considered.

The PINNACLETM Constrained Acetabular Liner is indicated for use with the PINNACLETM Acetabular Cup in cementless application.

The PINNACLE™ Constrained Acetabular Liner is part of a modular system designed to replace the natural articular surface of the hip joint in total hip replacement. The liner is manufactured from ultra-high molecular weight polyethylene (UHMWPE), which locks into a porous coated, hemispherical outer shell component manufactured from titanium alloy (Ti-Al6-V4). The liner component articulates with a metal femoral head of an appropriate diameter.

The PINNACLE™ Constrained Acetabular Liner mechanically constrains the femoral head within the inner diameters of the liner by providing greater than 180 degrees femoral head capture combined with a titanium constraining ring which fits over the opening diameter of the liner. The UHMWPE liner is held in the metal shell by means of a titanium locking ring.
The PINNACLE™ Constrained Acetabular Liners are UHMWPE acetabular cup liners that are available in a lateralized neutral or lateralized face-changing orientation. The liners have inner diameters compatible with standard metal femoral heads sized 28, 32, and 36mm, as well as larger diameter unipolar, Self-Centering (bipolar) and Modular M femoral heads sized 40 and 44mm. The outer diameters (OD) are geometrically the same as other Pinnacle Acetabular Liners, in a 48mm-76mm size range offering.

This document is a 510(k) premarket notification for the PINNACLETM Constrained Acetabular Liners. The submission is not for a new device but for an expansion of the labeling to include updated MRI compatibility information, standardization of language and symbols, and inclusion of new internationally recognized symbols and implant cards for international markets. Crucially, the document states: "There is no change to the indications, intended use, safety, fit, form or technological characteristics of the devices."

Therefore, the acceptance criteria and study information typically associated with a new or significantly modified device, especially regarding clinical performance or algorithm evaluation, are not provided in this regulatory document. The focus of this submission is on demonstrating the device's acceptable performance in an MRI environment.

Here's an analysis based on the provided text, but it will be limited due to the nature of the submission:

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

The document focuses on MRI safety evaluation. The acceptance criteria are implicit in the adherence to established ASTM standards for MRI compatibility. The reported performance indicates that the device met these standards.

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

The document refers to "Non-clinical testing" and "full test data present and reviewed in the FDA cleared submission 'K231873 - DePuy Hip Portfolio MRI Bundled Traditional 510(k)'". This indicates that the testing was non-clinical (ex-vivo/in-vitro), not involving human subjects. The sample size would refer to the number of devices or components tested, but this specific detail (the exact number of liners tested) is not provided in this document. The provenance is not explicitly stated beyond "DePuy Ireland UC" as the submitter, implying the testing was conducted or overseen by them.

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 as the study involved non-clinical MRI safety testing of a physical device, not an AI or diagnostic device requiring human expert ground truth establishment.

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

This is not applicable for non-clinical testing of device properties like MRI compatibility.

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

An MRMC study was not done. This submission is for a physical orthopedic implant.

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

This is not applicable. This submission is for a physical orthopedic implant, not an algorithm.

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

The "ground truth" here is the objective measurement of physical properties of the device under MRI conditions, compared against the limits established by the referenced ASTM standards.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This is not applicable for the same reason as above.

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Total hip replacement is indicated in the following conditions:

1. A severely painful and/or disabled joint (typically due to non-inflammatory degenerative joint disease).
2. Failed previous hip surgery.
3. Dislocation risks.
   EMPHASYS Dual Mobility Liners and Mobile Bearing Heads are intended for cementless applications.

The EMPHASYS Dual Mobility System includes Co-Cr-Mo Dual Mobility Liners and AOX Polyethylene Mobile Bearing Heads as well as other previously cleared compatible components.

This is a 510(k) summary for a medical device called the EMPHASYS™ Dual Mobility System, specifically for hip replacement. The document does not describe a study involving an algorithm or AI, but rather a series of physical performance tests conducted on the device itself to demonstrate its substantial equivalence to existing predicate devices.

Therefore, many of the requested categories related to AI model evaluation, such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, and training set details, are not applicable to this type of device clearance submission.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" with numerical targets in a table alongside reported performance results in an easy-to-digest format. Instead, it lists various performance tests conducted to demonstrate substantial equivalence to predicate devices. The implicit acceptance criteria are that the device performs "as well as" or equivalently to the predicate devices under these tests.

No direct table of acceptance criteria vs. reported performance is provided in the document. The document states: "Results of performance testing and analyses demonstrate that the EMPHASYS Dual Mobility System performs as well as the predicate devices."

The tests conducted are:

• EMPHASYS Mobile Bearing Head Thickness Assessment
• EMPHASYS Dual Mobility Liner Thickness Assessment
• Range of Motion Analysis- ISO 21535:2007
• EMPHASYS Mobile Bearing Head Impingement-ASTM F2582-20
• EMPHASYS Dual Mobility Impingement Testing to ASTM F2582-20
• EMPHASYS Dual Mobility Liner Push-Out- ASTM F1820-22
• EMPHASYS Dual Mobility Liner Offset Pull-Out- ASTM F1820-22
• EMPHASYS Dual Mobility Liner Torque-Out- ASTM F1820-22
• EMPHASYS Mobile Bearing Head Lever-Out
• EMPHASYS Dual Mobility ASTM F1875 Method I Test
• EMPHASYS Dual Mobility Non-Aged Standard Walking Wear Test- ISO 14242-1:2014 and ISO 14242-2:2016.
• EMPHASYS Dual Mobility Standard Walking with Mode 3 Third Body Abrasive Wear Test - ISO 14242-1:2014, ISO 14242-1 AMD 1:2018, ISO 14242-2:2016 and ISO 14242-4:2018.
• EMPHASYS Dual Mobility High Angle Standard Walking Wear Test- ISO 14242-1:2014, ISO 14242-2:2016 and ISO 14242-4:2018.
• EMPHASYS Dual Mobility Worst Case Outer Bearing Wear of EMSYS DM under Standard Walking Wear- ISO 14242-1:2014 and ISO 14242-2:2016
• EMPHASYS Dual Mobility Friction Test- ASTM F3143-20
• MRI Safety Evaluation Testing of Total Hip Systems- ASTM F2503-23, ASTM F2182 -19e2, ASTM F2052-21, ASTM F2213-17, and ASTM F2119-07

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

Not applicable. This pertains to physical device testing rather than a software or AI evaluation with patient data. The "test set" would be the physical devices and components manufactured for testing. The document does not specify the number of individual devices or components tested for each category.

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

Not applicable. The "ground truth" for these physical tests is established by recognized engineering standards (e.g., ISO, ASTM) and comparative performance against predicate devices, not by expert medical interpretation of data.

4. Adjudication method for the test set

Not applicable. This applies to medical imaging or diagnostic studies, not physical device performance testing against 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. This is a hardware device (hip prosthesis) clearance, not an AI software clearance.

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

Not applicable. This is a hardware device clearance.

7. The type of ground truth used

The "ground truth" in this context refers to the established performance requirements and benchmarks defined by international and national engineering standards (ISO and ASTM) and the performance characteristics of previously cleared predicate devices. The device must demonstrate that its performance meets these standards and is equivalent to the predicate.

8. The sample size for the training set

Not applicable. This is a hardware device clearance, not an AI software clearance.

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

Not applicable. This is a hardware device clearance, not an AI software clearance.

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