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The Stemless Shoulder System is comprised of modular humeral heads to be used in total shoulder arthroplasty.

The Stemless Shoulder System is indicated for a severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis.

The Stemless humeral components are intended for press-fit fixation without the use of bone cements are intended only for use with bone cement.

The GLOBAL ICON Stemless Shoulder System includes cobalt-chromium alloy humeral heads that mate with titanium alloy anchor plates. The anchor plates include four grooved peripheral legs which are seated in the proximal humerus, and hydroxyapatite coating on all bone- contacting surfaces.

The document describes the GLOBAL ICON Stemless Shoulder System, a medical device for total shoulder arthroplasty. It details the device's indications for use, technological characteristics, and a summary of non-clinical and clinical tests conducted to demonstrate substantial equivalence to predicate devices.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the GLOBAL ICON Stemless Shoulder System were based on a composite success endpoint at 24 months post-operative in a clinical study. The criteria and reported performance are summarized in the table below:

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The clinical study included 128 subjects for the 24-month interim data analysis.
• Data Provenance: The document does not explicitly state the country of origin for the data. However, it is a submission to the U.S. Food & Drug Administration (FDA), indicating the device is intended for the U.S. market. The study is described as having "interim 24-month data," which suggests it is a prospective study (following subjects forward in time).

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

The document does not provide details on the number or qualifications of experts used to establish ground truth for the test set. It mentions "Radiographs indicate" and "adjusted Constant-Murley score," suggesting these assessments were made by healthcare professionals, but specific qualifications (e.g., radiologist with X years of experience) or the number of such experts are not specified.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the clinical outcomes or radiological assessments in the test set.

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

No. The document presents a clinical study evaluating the device's performance directly, not a comparative effectiveness study involving human readers with and without AI assistance for interpretation. The device itself is a physical medical implant, not an AI diagnostic tool.

6. Standalone Performance Study (Algorithm Only)

No. The device is a surgical implant (GLOBAL ICON Stemless Shoulder System), not an algorithm or AI software. Therefore, a standalone (algorithm only) performance study is not applicable. The clinical study evaluates the performance of the implanted device in human subjects.

7. Type of Ground Truth Used

The ground truth for the clinical study was established using a combination of:

• Radiological assessment: To determine the presence or absence of continuous radiolucent lines around the humeral component.
• Clinical outcome scores: Specifically, the adjusted Constant-Murley score, which is a functional assessment used in shoulder arthroplasty.
• Device integrity/removal data: Tracking whether the humeral component was removed for any reason.
• Adverse event reporting: Documentation of device-related serious adverse events.

8. Sample Size for the Training Set

The document describes a clinical study for device approval, not an algorithm's development. Therefore, there is no mention of a "training set" in the context of machine learning. The 128 subjects are part of the clinical evaluation for the device's performance.

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

As this is not a study involving an AI algorithm that requires training data, the concept of establishing ground truth for a "training set" is not applicable to this document. The clinical study evaluated the device's performance in patients.

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The DELTA XTEND Prosthesis is indicated for use in treatment of a grossly deficient rotator cuff joint with:
• severe arthropathy and/or;
• a previous failed joint replacement and/or;
• Fracture-dislocations of the proximal humerus where the articular surface is severely communited, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory
The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device.
DELTA XTEND hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for the revision of a previously failed DELTA XTEND Reverse Shoulder. Porous-coated epiphysis are indicated for use in total shoulder replacement only.
The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation. The modular humeral stem is HA coated and is intended for cementless use. The HA coated humeral epiphysis is intended for cementless use. The porous-coated epiphysis is intended for cemented or cementless use.
All other metallic components are intended for cemented use only.

The DELTA XTEND Reverse Shoulder System consists of humeral stem, modular epiphysis, humeral spacer, humeral cup, glenosphere, metaglene and metaglene screws used for reverse shoulder arthroplasty. The humeral spacer can be added between the epiphysis and the humeral cup if necessary. Humeral head can be used in hemi-shoulder arthroplasty in place of the humeral cup and glenoid components.

This document is a 510(k) Premarket Notification for the DELTA XTEND™ Reverse Shoulder System, a medical device (shoulder prosthesis). It describes the non-clinical performance testing conducted to demonstrate substantial equivalence to legally marketed predicate devices.

Therefore, the requested information about "acceptance criteria and the study that proves the device meets the acceptance criteria" refers to engineering and material performance tests, not a study involving human-in-the-loop AI or diagnostic performance.

Here's an analysis of the provided text in relation to your questions, framed for a medical device rather than an AI/diagnostic system:

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

The document does not explicitly present a table of numerical acceptance criteria with corresponding performance values for the device. Instead, it lists the types of non-clinical tests performed to demonstrate safety and efficacy and asserts that the device was "determined as substantially equivalent."

Here's what can be inferred/extracted:

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

• Sample Sizes: The document does not specify the sample sizes (e.g., number of implants or test specimens) used for each non-clinical test (Fatigue Analysis, Biocompatibility, etc.).
• Data Provenance: The data provenance is from non-clinical laboratory testing of the device components. The specific country of origin of these tests is not stated, but the manufacturer "DePuy (Ireland)" is based in Ireland. These are prospective tests performed on newly manufactured devices or components to demonstrate performance characteristics.

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

This question is not applicable to this type of device submission.

• Ground Truth: For a shoulder prosthesis, "ground truth" for performance is established through engineering principles, material science, and regulatory standards (e.g., ISO, ASTM standards for implant testing). It's based on objective measurements rather than expert consensus on individual cases.
• Experts: While engineers, material scientists, and regulatory experts would have designed and overseen these tests, the document does not specify their number or qualifications as it would for, say, a clinical diagnostic study.

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

This question is not applicable to this type of device. Adjudication methods like 2+1 or 3+1 are used in clinical studies where human readers (e.g., radiologists) interpret images and their interpretations need to be reconciled for ground truth establishment. For mechanical device testing, results are objective measurements from laboratory equipment and are compared against predetermined engineering specifications.

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

This question is not applicable. An MRMC study is relevant for AI-powered diagnostic devices where the performance of human readers, potentially aided by AI, is being evaluated. This submission is for a mechanical medical implant, not a diagnostic imaging device or AI.

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

This question is not applicable. There is no algorithm in this medical device. The "standalone performance" for this device would be its mechanical performance in a laboratory setting, which is what the non-clinical tests assessed.

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

The "ground truth" for this medical device's performance is based on:

• Engineering and material science principles: Adherence to established mechanical, physical, and chemical properties required for an implantable device.
• Regulatory standards: Compliance with international and national standards for implantable medical devices (e.g., for fatigue, biocompatibility, endotoxin levels).
• Comparison to predicate devices: The "ground truth" of performance is largely the established safe and effective performance of previously cleared, substantially equivalent devices.

8. The sample size for the training set

This question is not applicable. This device is a mechanical implant; there is no "training set" in the context of machine learning or AI.

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

This question is not applicable, as there is no "training set."

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Total hip replacement or hip arthroplasty is indicated in the following conditions:

1. A severely painful and/or disabled joint from osteoarthritis, traumatoid 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, arthrodesis, hemi-arthroplasty, surface replacement arthroplasty, or total hip replacement.
5. Certain cases of ankylosis.

Partial hip replacement or hip hemi-arthroplasty is indicated in the following conditions:

1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.
2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
3. Avascular necrosis of the femoral head.
4. Non-union of femoral neck fractures.
5. Certain high subcapital and femoral neck fractures in the elderly.
6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemi-arthroplasty.

HA coated stems of the Corail Hip System are indicated for cementless use only.

The DePuy Corail AMT hip stems are manufactured from forged titanium alloy (Ti6Al4V) and plasma-sprayed with a hydroxyapatite (HA) coating for bone fixation. The stem consists of a wide range of stem neck designs and sizes allowing an accurate anatomical match for each patient. Corail AMT stems are available with or without a collar, with various neck angles and with various neck offsets. The stems are compatible with both unipolar and bipolar heads intended for hip hemi-arthroplasty and with modular femoral heads intended for total hip arthroplasty.

The document provided is a 510(k) premarket notification for a medical device, specifically the DePuy Corail AMT Hip Prosthesis. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific acceptance criteria through a study. Therefore, the information requested (acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth, and training set information) is generally not applicable or available within this type of regulatory document.

The 510(k) submission focuses on comparing the new device to existing legally marketed devices to show that they are as safe and effective. The "Performance Data" section primarily lists non-clinical tests conducted to support substantial equivalence, rather than detailed studies with acceptance criteria and reported performance values in the way you've described for an AI/algorithm-based device.

Here's why each point is largely unaddressable and what information is available:

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

• Not Applicable in this context. This document doesn't present acceptance criteria for an AI algorithm's performance. Instead, it describes physical and material characteristics of a hip prosthesis and confirms it meets standards typically through engineering tests.
• Available Information: The document lists non-clinical tests performed, such as:
  • Neck fatigue testing in accordance with ISO 7206-6:1992
  • Distal fatigue testing in accordance with ISO 7206-4:2010
  • Taper compatibility test
  • Range of motion in accordance with ISO 21535:2009
  • Reamer verification test
  • Pyrogenicity testing using the Bacterial Endotoxin Testing (BET) method as specified in ANSI/AAMI ST72:2011
  • Hydroxyapatite coating process validations
• However, specific acceptance criteria values (e.g., "fatigue strength must exceed X MPa") and the exact reported performance values from these tests are not provided in this summary document. The submission implicitly states these tests were conducted successfully to demonstrate substantial equivalence, meaning the results were comparable to the predicate device and met relevant industry standards.

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

• Not Applicable. As this is for a physical orthopedic implant, there isn't a "test set" of data in the sense of a dataset for an AI algorithm. The tests mentioned are engineering and material science tests.

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

• Not Applicable. "Ground truth" in the context of an AI algorithm is not relevant here. The "ground truth" for the performance of a hip prosthesis would be defined by engineering standards, material properties, and clinical outcomes over time, rather than expert interpretation of a specific dataset.

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

• Not Applicable. Adjudication methods are associated with reviewing and resolving discrepancies in expert labeling or diagnoses on data, which is not relevant for this device.

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

• Not Applicable. MRMC studies are used to evaluate diagnostic imaging systems, often in conjunction with AI. This document pertains to a physical hip implant, so such studies are not relevant.

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

• Not Applicable. This is a physical device, not an algorithm.

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

• Not Applicable. See point 3. "Ground truth" for this device would relate to validated engineering specifications, biomechanical properties, material analyses, and ultimately long-term clinical follow-up data (which is not part of a 510(k) submission for substantial equivalence).

8. The sample size for the training set

• Not Applicable. This is a physical device, not an AI algorithm. There is no "training set" of data.

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

• Not Applicable. This is a physical device, not an AI algorithm. There is no "training set" of data or ground truth to be established for it.

In summary: The provided document is a 510(k) premarket notification for a physical medical device (hip prosthesis). It demonstrates substantial equivalence to predicate devices through comparisons of intended use, materials, design features, and by stating that non-clinical engineering and material tests were conducted in accordance with relevant standards. It explicitly states that "No clinical tests were conducted to demonstrate substantial equivalence." The questions posed are primarily relevant to the evaluation of AI/software as a medical device, which is not what this document addresses.

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The ATTUNE Revision LPS Insert is intended for use in prosthetic constructs for replacement of distal femur and resurfacing of the proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include:

· malignant tumors (e.g., osteosarcomas, giant cell tumors, bone tumors) requiring extensive resection and replacement;

· patient conditions of non-inflammatory degenerative joint disease (NIDJ), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement;

· revision cases for a failed previous prosthesis requiring extensive resection and replacement;

· severe trauma requiring extensive resection and replacement.

· post-infection bone loss, where the surgeon has elected to excise the bone and replacement is required.

The ATTUNE Revision LPS Inserts are designed to replace the tibio-femoral articular surface of the knee joint when used in conjunction with a femoral, tibial, patellar, and other associated prostheses as required. The ATTUNE Revision LPS Insert consists of an AOX™ Antioxidant Polyethylene bearing, AOX Antioxidant Polyethylene bushings, and a forged cobalt chrome molybdenum hinge post.

This document describes the FDA's clearance of the ATTUNE® Revision LPSTM Inserts, a medical device. It does not contain information about an AI/ML-driven device or study results related to AI performance. Therefore, I cannot extract the requested information to describe acceptance criteria and study that proves the device meets the acceptance criteria for an AI/ML-driven device.

The provided text pertains to a knee joint prosthesis and its 510(k) premarket notification to the FDA. The "acceptance criteria" and "study" discussed in this document relate to the mechanical performance, materials, and manufacturing processes of this physical medical device, demonstrating its substantial equivalence to previously cleared predicate devices.

Specifically:

• Acceptance Criteria and Device Performance: These are detailed under "Non-Clinical Testing" on page 4. The device performance is deemed acceptable if it meets the requirements of the listed functional verification tests (e.g., A/P Shear Fatigue, Insert Subluxation, Hinge Post Fatigue) and ANSI AAMI ST-72:2011 for bacterial endotoxin testing. The document states that the testing "verified that the implant performance is substantially equivalent to predicate devices for anticipated in-vivo loading."
• Sample size for test set and data provenance: Not applicable in the context of AI/ML. The "test set" here refers to the prototypes of the physical device or materials used for mechanical and material testing. The document doesn't specify the exact number of physical units tested but refers to standard engineering tests.
• Number of experts and qualifications, adjudication method, MRMC study, standalone performance: These concepts are relevant to the evaluation of AI/ML models, not physical medical devices like a knee implant. Therefore, this information is not present.
• Type of ground truth: For this physical device, the "ground truth" is defined by established engineering and biomechanical principles, industry standards (e.g., FDA Guidance, ANSI AAMI ST-72:2011), and comparison to the performance of predicate devices.
• Training set sample size and ground truth establishment for training set: Not applicable to a physical device. There's no "training set" in the AI/ML sense. The "training" for such a device would involve its design, manufacturing processes, and quality control, ensuring it meets established specifications.

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The Delta Xtend Shoulder Prosthesis is indicated for use in treatment of a grossly deficient rotator cuff joint with: · severe arthropathy and/or; · a previously failed joint replacement and/or: · fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. Delta Xtend hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for the revision of a previously failed Delta Xtend Reverse Shoulder. The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation. The modular humeral stem and humeral epiphysis components are HA coated and intended for cementless use. All other metallic components are intended for cemented use only.

The Delta Xtend Reverse Shoulder System consists of humeral stem, modular epiphysis, humeral spacer, humeral cup, glenosphere, metaglene and metaglene screws. The glenosphere and metaglene are used for total reverse shoulder arthroplasty. The humeral spacer can be added between the epiphysis and the humeral cup if necessary. Humeral head can be used in hemi-shoulder arthroplasty in place of the humeral cup and glenoid components.

The provided document pertains to the 510(k) premarket notification for the DePuy Delta Xtend™ Reverse Shoulder System, specifically for the addition of lateralized glenosphere components. This document is a regulatory submission for a medical device (a shoulder prosthesis), NOT an AI/ML medical device. Therefore, the information requested regarding acceptance criteria and study proving device performance for an AI/ML device (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth sources) is not applicable here.

The document discusses the substantial equivalence of the new components to predicate devices based on:

1. Biocompatibility: Confirmed per ISO10993-1.
2. Range of Motion: Theoretical simulated range of motion analyses showed an increase compared to the predicate non-lateralized glenosphere.
3. Glenoid Loosening/Disassociation: A study demonstrated substantial equivalency of glenoid fixation performance to the predicate.

The document explicitly states:

• "Summary of animal study: Animal study was not necessary."
• "Summary of clinical study: Clinical study was not necessary."

This indicates that clinical trials or studies that would involve human patient data, ground truth establishment by experts, or detailed statistical analysis of performance (as would be typical for AI/ML device validation) were not required for this specific 510(k) submission, as it focused on demonstrating substantial equivalence through non-clinical performance and design comparisons.

Therefore, I cannot extract the information required for an AI/ML device's acceptance criteria and study results from this document.

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Candidates for total knee replacement include patients with a severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.

The ATTUNE Cemented Tibial Base, Fixed Bearing (FB) are available in sizes 1-10. The fixation surface incorporates a stem and keel to provide additional stability as well as recessed undercut cement pockets and a grit blasted surface for enhanced cement fixation. The tibial base utilizes a central universal locking mechanism to capture the tibial insert. The ATTUNE Cemented Tibial Base, FB is manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75. Additionally, the ATTUNE Cemented Tibial Base, FB utilizes a previously cleared Base Protector assembled with the device to minimize potential marring of the proximal bearing surface of the tibial base during impaction. After impaction is completed, the Base Protector is then removed and discarded prior to inserting the ATTUNE Fixed Bearing Insert.

The ATTUNE CR Total Knee is designed to accommodate knee flexion to 150 degrees in those patients able to attain a high degree of knee flexion.

The ATTUNE PS Total Knee is designed to accommodate knee flexion to 145 degrees in those patients able to attain a high degree of knee flexion.

This document describes the premarket notification (510(k)) for the ATTUNE Cemented Tibial Base, Fixed Bearing, a component of a total knee replacement system. The application seeks to demonstrate substantial equivalence to previously cleared predicate devices.

Acceptance Criteria and Device Performance (based on provided text):

The acceptance criteria are implicitly derived from the successful completion of the non-clinical tests and the product's ability to maintain performance comparable to its predicate devices. The study concludes that the device meets these criteria by demonstrating substantial equivalence.

Detailed Study Information:

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

   • The document does not specify the exact sample sizes (e.g., number of units tested) for the non-clinical tests (Fatigue Testing, ROM/pull-off testing, bacterial endotoxin testing).
   • Data provenance: The testing was "non-clinical" and appears to be experimental, rather than based on patient data. This is typically laboratory or bench testing. No country of origin for the data is explicitly mentioned, but the submitter is based in Indiana, USA. The study is not retrospective or prospective in the sense of patient data.

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

   • The document mentions "Surgeon validation" as part of the non-clinical testing. However, it does not specify the number of surgeons, their qualifications, or how their "validation" contributed to establishing a "ground truth" in the context of the device's functional integrity. In this type of device submission, "surgeon validation" typically refers to confirmation of usability or fit, not necessarily establishing a clinical ground truth like in diagnostic AI.

3. Adjudication method for the test set:

   • Not applicable. This is a non-clinical, bench-top and materials testing study, not a study involving human readers or cases needing adjudication.

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

   • No MRMC comparative effectiveness study was done. This document describes a submission for a knee implant component, not an AI or diagnostic device that would involve human readers.

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

   • Not applicable. This is a mechanical/material device, not an algorithm.

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

   • The "ground truth" for this device's performance is established by engineering and biomechanical standards (e.g., ASTM F1800, ANSI AAMI ST-72:2011) and by comparison to the established performance of legally marketed predicate devices. The "truths" are determined by adherence to these standards and demonstrated equivalence in functional testing.

7. The sample size for the training set:

   • Not applicable. This is a medical device (implant component) submission, not an AI or machine learning device that requires a training set. The device itself is the product being evaluated.

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

   • Not applicable, as there is no training set for this type of device.

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Total hip replacement or hip arthroplasty is indicated in the following conditions:

1. A severely painful and/or disabled joint from 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. Certain cases of ankylosis.

Partial hip replacement or hip hemi-arthroplasty is indicated in the following conditions:

1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation.
2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation.
3. Avascular necrosis of the femoral head.
4. Non-union of femoral neck fractures.
5. Certain high subcapital and femoral neck fractures in the elderly.
6. Degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement.
7. Pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hip hemi-arthroplasty.

The DePuy Actis DuoFix Hip Prosthesis is indicated for cementless use only.

The DePuy Actis DuoFix Hip prostheses are manufactured from forged titanium alloy (Ti6Al4V) and have a sintered commercially pure titanium bead porous coating (Porocoat®) and thin layer of plasma-sprayed hydroxyapatite (HA) coating. The stem consists of a wide range of stem neck designs and sizes allowing an accurate anatomical match for each patient. The stems are compatible with both unipolar and bipolar heads intended for hemi-arthroplasty and with modular metal and ceramic femoral heads intended for total hip arthroplasty.

This document describes the DePuy Actis DuoFix Hip Prosthesis, a hip implant. The submission is a 510(k) premarket notification for a line extension (an additional smaller size hip stem) of an already cleared device (K150862).

Here's an analysis of the acceptance criteria and study data provided:

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

For a medical device like a hip prosthesis, "acceptance criteria" usually refer to meeting specific performance standards in mechanical testing. Since this is a line extension of an existing device, the acceptance criteria would be for the new, smaller size stem to perform equivalently to the predicate devices and meet relevant ISO standards for hip prostheses.

The document states that the subject device (new smaller stem) is substantially equivalent to the predicate device (existing DePuy Actis DuoFix Hip Prosthesis). This implies that the new stem meets the same performance criteria as the previously cleared larger stems.

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 primarily refers to non-clinical (bench) testing for mechanical and biocompatibility assessments. Therefore, the "sample size" for the test set would refer to the number of prostheses or components tested in each specific mechanical and pyrogenicity test. This information (e.g., how many stems were subjected to fatigue testing) is not explicitly provided in the summary.

The data provenance is not mentioned in terms of country of origin, but it is non-clinical laboratory data, likely generated internally by DePuy or by contract testing organizations. It would be considered prospective in the sense that the tests were designed and executed specifically for this submission.

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 question is not applicable to this type of device submission. The "ground truth" for hip prostheses in a 510(k) for a line extension is established through adherence to recognized performance standards (e.g., ISO standards) and comparison to the predicate device's established performance. This does not involve expert consensus on clinical cases or image interpretation.

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

This question is not applicable. Adjudication typically refers to resolving discrepancies in expert interpretations of clinical data or images. Since no clinical trials or expert interpretations of such data were conducted for this 510(k) submission, there is no adjudication method.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices often involving artificial intelligence (AI), not for hip prostheses which are mechanical implants.

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

No, a standalone algorithm performance evaluation was not done. This device is a mechanical implant and does not involve an algorithm.

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

The "ground truth" for this device's performance is based on:

• Adherence to internationally recognized standards: Specifically, ISO 7206-6:2013 for neck fatigue and ISO 7206-4:2010 for distal fatigue, and ANSI/AAMI ST-72:2011 for pyrogenicity. These standards define the acceptable performance limits and test methodologies.
• Demonstration of equivalence to a legally marketed predicate device: The predicate device (K150862) had already established its safety and effectiveness through similar performance data. The new device's ground truth is that it performs similarly to the predicate.

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is a mechanical device, not an AI/machine learning algorithm.

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

This question is not applicable for the reasons stated above.

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Candidates for total knee replacement include patients with:

• A severely painful and/or severely disabled joint resulting from osteoarthritis, post-● traumatic arthritis, or rheumatoid arthritis
• Moderate valgus, varus, or flexion deformities
• Avascular necrosis of the femoral condyle
• A previous unsuccessful knee replacement, osteotomy, or other knee procedure ●

ATTUNE Revision Knee System implants are designed for use in total knee arthroplasty for patients with:

• Absence or loss of both cruciate ligaments ●
• Moderate varus-valgus or flexion instability that requires a bearing surface with increased ● constraint in the clinical judgment of the surgeon
• Bone loss that requires supplemental fixation in the clinical judgment of the surgeon

The porous-coated metaphyseal sleeves are intended for either cemented or cementless applications.

Any non porous-coated components are intended for cemented use only.

The ATTUNE® Revision Knee System is a total knee replacement prosthesis consisting of various components including ATTUNE REVISION CRS FEMORAL COMPONENTS, ATTUNE REVISION CRS FIXED BEARING INSERTS, ATTUNE REVISION FIXED BEARING TIBIAL BASES, ATTUNE REVISION STEMS, ATTUNE REVISION FEMORAL SLEEVES, ATTUNE REVISION FEMORAL AUGMENTS, ATTUNE REVISION TIBIAL AUGMENTS, and ATTUNE REVISION OFFSET ADAPTOR. These components are made from materials such as cast Co-Cr-Mo alloy, UHMWPE, and Ti-6Al-4V ELI alloy. The system is designed for use in total knee arthroplasty to replace the damaged knee joint articulation.

The provided document is a 510(k) Premarket Notification for a medical device, the ATTUNE® Revision Knee System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets clinical acceptance criteria through a formal clinical study with ground truth and expert consensus. The FDA document explicitly states, “Clinical testing was not necessary to determine substantial equivalence between the ATTUNE Revision Knee System and the predicate devices.”

Therefore, the requested information regarding acceptance criteria, study data, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types cannot be found in this document.

The document primarily focuses on non-clinical testing to demonstrate substantial equivalence to predicate devices. Below is a summary of the non-clinical performance information provided.

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

The document describes functional testing performed in compliance with FDA Guidance for Knee Joint Prostheses. While explicit numerical acceptance criteria values are not provided, the general statement below indicates that the measured performance met the necessary thresholds.

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. This document refers to non-clinical, in-vitro mechanical and material testing, not human-subject testing involving datasets.

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

Not applicable. No ground truth based on expert review was established in this submission.

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. No MRMC comparative effectiveness study was performed or required for this device.

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

Not applicable. This is a knee implant, not an AI/algorithm device.

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

Not applicable. The "ground truth" in this context is adherence to established engineering standards (ASTM F75, F136, F648, F620, F1537, F799, ANSI AAMI ST-72:2011) and FDA Guidance for mechanical performance testing for knee prostheses.

8. The sample size for the training set:

Not applicable. No training set for an algorithm was used.

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

Not applicable.

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The ATTUNE Cementless CR and PS Femoral Components are intended for cementless use within the ATTUNE total knee replacement system.

Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant (provided that adequate bone is present).

The ATTUNE Cementless cruciate retaining (CR) and posterior stabilized (PS) femoral components have an asymmetric trochlear groove and are available in sizes 1-10 in right and left options. Sizes 3-6 are available in standard and narrow options. The fixation surface is porous coated with Porocoat. The porous coated fixation surface comprises: the bone cut surfaces of the anterior flange, anterior chamfer, distal surface, posterior chamfer, posterior condylar resection, as well as the lugs for additional stability. The fixation of the femoral component to the femoral bone is achieved by biologic fixation via ingrowth into the Porocoat porous coating. The ATTUNE femoral components are manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75. The ATTUNE Cementless CR Femoral Components are compatible with the ATTUNE CR Fixed Bearing inserts (K101433), fixed bearing tibial bases (K101433), and patellae (K103756). The ATTUNE Cementless PS Femoral Components are compatible with the ATTUNE PS Fixed Bearing inserts (K111433), fixed bearing tibial bases (K101433), and patellae (K103756). The ATTUNE CR Total Knee is designed to accommodate knee flexion to 150 degrees in those patients able to attain a high degree of knee flexion. The ATTUNE PS Total Knee is designed to accommodate knee flexion to 145 degrees in those patients able to attain a high degree of knee flexion.

This document pertains to the 510(k) premarket notification for the ATTUNE® Knee System-Cementless CR and PS Femoral Components. It describes the device and its substantial equivalence to predicate devices, focusing on the lack of need for new studies rather than describing the acceptance criteria or studies of the device itself.

Based on the provided text, there is no information available regarding acceptance criteria or a study that proves the device meets those acceptance criteria for the ATTUNE® Knee System-Cementless CR and PS Femoral Components.

The document explicitly states:

• "Non-Clinical Testing: None provided as it was not necessary to determine substantial equivalence between the ATTUNE Cementless CR and PS Femoral Components and the predicate devices. As the coating for the subject device is identical to that in K062654, the characterization in K062654 also applies to this 510(k)." (Page 6)
• "Clinical Testing: None provided as it was not necessary to determine substantial equivalence between the ATTUNE Cementless CR and PS Femoral Components and the predicate devices." (Page 6)

The submission argues for substantial equivalence based on existing predicate devices:

• The ATTUNE Cementless CR and PS Femoral Components are "identical in design to the ATTUNE CR and PS Femoral Components cleared for cemented use only in K101433 and K111433."
• "The Porocoat porous coating of the ATTUNE Cementless CR and PS Femoral Components is identical to the Porocoat porous coating used on the SIGMA CR Porocoat Femoral Components cleared for Cementless use in K062654."

Therefore, I cannot provide the requested information from the given text as it explicitly states that new testing was not performed for this 510(k) submission.

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The Global UNITE Shoulder System humeral stems, suture collars, epiphyseal components and humeral heads are intended for cemented or uncemented total shoulder or hemi-shoulder replacement in treatment of the following:

1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis
2. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory
3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component)
   Hemi-shoulder replacement is also indicated for:
4. Ununited humeral head fractures
5. Avascular necrosis of the humeral head
6. Deformity and/or limited motion
   When used in a total shoulder replacement, the Global Unite implants are to be used with DePuy glenoids. The glenoids are for cemented use only.
   When well-fixed, the Global Unite humeral stems, in conjunction with existing Delta Xtend epiphyseal components, are also indicated for conversion to a reverse, in treatment of a grossly deficient rotator cuff joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff joint. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary. The Delta Xtend metaglene is HA-coated and is intended for uncemented use with the addition of screws for fixation. The Delta Xtend epiphyseal components are HA-coated and are intended for uncemented use.

The subject devices expand the Global UNITE Shoulder System to include two additional cobalt-chrome alloy humeral heads that mate with existing Global UNITE epiphyseal bodies, as well as new porous-coated anatomic epiphyseal bodies made from titanium alloy that mate with existing Global UNITE humeral heads and stems. In the case of further deterioration of the joint or rotator cuff, the surgeon has the option to remove the Global UNITE anatomic epiphyseal component and replace it with a Delta Xtend Reverse (K120174) epiphyseal component for conversion to a reverse shoulder prosthesis without removing the well-fixed distal stem.

This document describes DePuy Global UNITE Shoulder System. As this is not an AI/ML device, the following information is not applicable:

• Acceptance criteria and device performance table
• Sample sizes for test set and training set
• Data provenance or ground truth establishment
• Number and qualification of experts
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone algorithm performance

The device underwent various non-clinical performance tests to demonstrate substantial equivalence to its predicate devices. These tests, listed below, were performed according to FDA's Guidance for Industry and FDA Staff - Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis. Clinical data was not required for this device.

The performance tests included:

• Epiphysis Comparison
• Head Comparison
• Screw Comparison
• Test Rationale
• Fretting and Corrosion
• Torque Test to Failure for Screw Fastener
• Human Torque Test for Screw Fastener
• Fatigue Test for Complete Implant with Lower Torque
• Cadaver Test Report
• Implant Insertion Test

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