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Mpact Constrained Liner is intended to be used as part of a Total Hip Arthroplasty, uncemented in combination with the Mpact and Mpact 3D Metal System acetabular shells.

Total Hip Arthroplasty is indicated in the following cases:

• Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polyarthritis or congenital hip dysplasia
• Avascular necrosis of the femoral head
• Acute traumatic fracture of the femoral head or neck
• Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty.

Mpact Constrained Liner is intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. Mpact Constrained Liner should be considered only for patients with limited functional demand, as it offers a smaller range of motion than the standard total hip replacement components.

The Mpact Constrained Liner is an acetabular preassembled liner consisting of an UHMWPE liner incorporating a bipolar head.

The subject device is available in six sizes and two configurations, flat or 10° face-changing.

The Mpact Constrained Liner implants are provided sterile and individually packaged.

The provided document, an FDA 510(k) clearance letter for the "Mpact Constrained Liner," focuses on establishing substantial equivalence for a medical implant. It DOES NOT describe the acceptance criteria or a study proving that a device meets acceptance criteria in the context of an AI/algorithm-based medical device performance study.

The document details the physical characteristics, intended use, and comparison to predicate devices for a hip joint prosthesis liner. The "Performance Data" section lists various non-clinical tests and validations (e.g., mechanical tests, biocompatibility, shelf-life) which are standard for implantable devices to ensure their physical integrity, safety, and compatibility with the human body. These are not related to "acceptance criteria" and "study proving device meets acceptance criteria" as requested in the prompt, which specifically implies evaluation of an algorithm's performance (e.g., diagnostic accuracy, sensitivity, specificity).

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes for test/training, expert and adjudication details, MRMC study, standalone performance, ground truth types, training set details) from this document, as it pertains to a physical medical device and not an AI/algorithm-based device.

To provide the information requested in your prompt, I would need a document describing the regulatory submission and performance evaluation of an AI/algorithm-based medical 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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The R3™ Constrained Liner Acetabular System is an uncemented prosthesis intended to replace a hip joint. The Constrained Liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. The R3 Constrained Liner is intended for single use only.

Subject of this Traditional premarket notification is the addition of new liner sizes to the Smith & Nephew R3" Constrained Liner Acetabular System. The R3 Constrained Liner Acetabular System currently consists of the R3 Constrained Liner offered in sizes of 52mm to 66/70mm cleared via premarket notification K111635. The proposed devices are additional sizes to the R3 Constrained Liners that were previously cleared. The proposed devices will be offered in sizes of 48mm, 50mm, 72-74mm, and 76-80mm, and will be marketed as part of the R3 Constrained Liner Acetabular System.

The new R3 Constrained Liner sizes are line additions to the primary predicate R3 Constrained Liners cleared via premarket notification K111635. The subject devices are similar to the primary predicate R3 Constrained Liners in that they are a multipiece acetabular component consisting of a bipolar bearing that articulates with a captured outer polyethylene liner, locking ring, and outer poly support ring. The subject devices and the primary predicate R3 Constrained Liners utilize a tripolar design allowing motion at two interfaces: the femoral head with the bipolar bearing and the bipolar bearing with the outer liner. The subject devices are identical in design to the cleared R3 Constrained Liners, with the exception that they are smaller or larger in overall size. The new R3 Constrained Liner sizes are also similar to the following additional predicates: R3 Constrained Liners (K122139), REFLECTION Constrained Liners (K021803, K033442), R3 XLPE Liners (K113848), and DePuy Self-Centering Hip Prostheses (K033273). The subject devices are also similar to reference predicate Osteonics Constrained Acetabular Inserts (P960047). The subject devices utilize seven components manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE), forged Titanium Alloy (Ti-6Al-4V), and Cobalt Chrome (CoCr).

The provided document is a 510(k) premarket notification for a medical device, specifically the Smith & Nephew, Inc. R3TM Constrained Liner. This type of submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its safety and effectiveness from scratch through clinical studies. Therefore, much of the information requested in a typical AI/ML medical device study (e.g., sample size for training/test sets, expert qualifications, MRMC studies, standalone performance) is not applicable or not provided in this context.

However, I can extract information related to the acceptance criteria and the type of study conducted to demonstrate equivalence for this specific device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated as this was mechanical and LAL testing, not a clinical study on a patient population. The document refers to "the subject devices" and "the new R3 Constrained Liner sizes," implying a representative number of physical devices were tested.
• Data Provenance: The testing was conducted internally by the manufacturer, Smith & Nephew, Inc. The document does not specify a country of origin for the data beyond that it's for a US regulatory submission. The studies were prospective in the sense that they were designed and executed to evaluate the new device sizes.

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

• This information is not applicable. The "ground truth" for mechanical and LAL testing is the established engineering specifications and pyrogen limits, not expert human assessment of images or clinical outcomes.

4. Adjudication method for the test set:

• Not applicable. This device underwent mechanical and LAL testing, not human adjudication of results.

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

• Not applicable. This is not an AI/ML device, and no MRMC study was performed.

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

• Not applicable. This is not an AI/ML device. The "standalone" performance here refers to the device's mechanical and biological properties independent of human interaction during testing.

7. The type of ground truth used:

• Mechanical Testing: Engineering specifications and performance standards for hip prostheses.
• Biological Testing: Established pyrogen limits (≤ 20 EU/device).

8. The sample size for the training set:

• Not applicable. As a mechanical medical device, there is no "training set" in the context of AI/ML. The device's design is based on established biomechanical principles and materials science.

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

• Not applicable. There is no training set. The "ground truth" for the device's design and manufacturing is derived from engineering design principles, materials science, and compliance with relevant industry standards for orthopedic implants.

Summary:

This 510(k) submission demonstrates substantial equivalence by showing that the new R3 Constrained Liner sizes have equivalent technological characteristics and performance to already legally marketed predicate devices. The "study" here involves mechanical testing (attachment loads, dislocation resistance, range of motion) and biological testing (Limulus Amebocyte Lysate (LAL) test for pyrogens). The primary goal was to ensure that the new, larger/smaller sizes of the liner did not introduce any new issues related to safety or effectiveness compared to the previously cleared sizes and other predicates. Clinical data was explicitly stated as "not needed to support substantial equivalence."

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EXPRT™ Revision Hip System is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.

The EXPRT™ Revision Hip System includes non-porous distal femoral stem implants and nonporous proximal body implants, with bolt, all made from titanium alloy (Ti6Al4V) per ASTM F1472. System specific instrumentation allows the surgeon to prepare the bone to accept the EXPRT™ Revision Hip System implants.

The provided document is a 510(k) premarket notification for a medical device called the EXPRT™ Revision Hip System. This type of notification is submitted to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device, and it typically does not include extensive clinical study data with acceptance criteria for device performance as would be found in a PMA (Premarket Approval) application or a more comprehensive clinical trial report for AI/software devices.

Instead, the document focuses on demonstrating substantial equivalence based on indications for use, material, design features, dimensions, surgical implantation technique, intended use, packaging, sterilization, and non-clinical testing.

Therefore, many of the requested items regarding acceptance criteria, performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment are not applicable or not provided in this specific FDA 510(k) document.

However, I can extract the information that is present:

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

The document does not provide a table with specific performance acceptance criteria (e.g., sensitivity, specificity, accuracy) or reported performance metrics often associated with AI/diagnostic devices. Instead, the "performance" here refers to the device's ability to meet non-clinical testing standards and be substantially equivalent to predicates.

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

This information is not provided as a formal clinical test set with specific sample sizes. The "testing" mentioned refers to non-clinical fatigue and endotoxin testing, not a clinical study on human subjects with a test set.

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 information is not applicable as there was no clinical study or test set requiring expert-established ground truth for performance evaluation of a diagnostic or AI algorithm.

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

This information is not applicable as there was no clinical study or test set requiring 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

An MRMC study is not applicable as this is a physical medical device (hip replacement system), not an AI or diagnostic software.

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

This is not applicable as this is a physical medical device.

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

This is not applicable for the purpose of this 510(k). The "ground truth" for the device's safety and effectiveness is largely based on its similarity to legally marketed predicate devices and its ability to pass non-clinical engineering and material tests.

8. The sample size for the training set

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

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

This is not applicable as this is a physical medical device.

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Exprt™ Revision Hip System is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.

The EXPRT™ Revision Hip System includes non-porous distal femoral stem implants and nonporous proximal body implants, with bolt, all made from titanium alloy (Ti6Al4V) per ASTM F1472. System specific instrumentation allows the surgeon to prepare the bone to accept the EXPRT™ Revision Hip System implants.

This document is a 510(k) summary for the EXPRT™ Revision Hip System, a medical device. It does not describe an AI/ML medical device, and therefore the requested information regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of AI/ML performance metrics, is not present.

The document is a regulatory submission for a traditional medical device (a hip replacement system). The "acceptance criteria" and "study" mentioned here refer to the non-clinical and pre-clinical testing required for substantial equivalence, not performance metrics for an AI algorithm.

Here's a breakdown of why the requested information cannot be extracted from this document:

• No AI/ML Component: The device is a physical hip implant (EXPRT™ Revision Hip System). There is no mention of any AI or machine learning component.
• "Acceptance Criteria" Context: For a physical device like a hip implant, "acceptance criteria" typically relate to mechanical strength, biocompatibility, material properties, and manufacturing quality, not diagnostic performance or AI model accuracy.
• "Study" Context: The document mentions "Non-Clinical Testing: ROM testing and distal fatigue testing," and "Endotoxin Assessment," which are standard tests for orthopedic implants to determine their mechanical integrity and safety. It explicitly states, "Clinical Testing: Clinical testing was not required." This indicates that the substantial equivalence was based on non-clinical data comparing it to existing predicate devices.

Therefore, it is impossible to provide the requested information in the format specified because it pertains to an AI/ML context that is not applicable to this document.

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The R3 Constrained Liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained Liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. The R3 Constrained Liner is intended for single use only.

The R3 Constrained Liners were previously cleared for market via premarket notification K111635. Subject of this premarket notification are minor modifications to the R3 Constrained Liner components, specifically the bipolar shell and inner poly liner.

The R3 Constrained Liners are available with inner diameters of 22 and 28mm and outer diameters from 52mm through 66/70mm. The devices are assembled from components that are made of ASTM F75 CoCr, ASTM F90 CoCr, ASTM F1472 Ti-6AI-4V, and ASTM F648 UHMWPE.

The provided 510(k) summary (K122139) for the Smith & Nephew R3 Constrained Liner describes modifications to an existing device, not an AI/ML-driven device. Therefore, the information requested regarding acceptance criteria, study details, and ground truth establishment, which are typical for AI/ML device evaluations, is not present in this document.

The document focuses on demonstrating substantial equivalence to previously cleared predicate devices through mechanical testing, rather than clinical performance studies.

Here's a breakdown of what is available in the document in relation to your request, and what is not:

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

• Acceptance Criteria: The document mentions that "Mechanical testing has been conducted to address the attachment loads (push-in, push-out, shuck-out) of the R3 Constrained Liner components as well as to address simulated intraoperative dislocation." The implicit acceptance criterion is that the new device's performance in these mechanical tests demonstrates equivalence to the legally marketed predicate devices.
• Reported Device Performance: The summary states: "A review of the results indicates that the R3 Constrained Liners are equivalent to existing, legally marketed predicate devices with regards to mechanical performance and that there are no new issues related to the safety and effectiveness of the subject devices." Specific numerical performance data from these mechanical tests are not provided in this summary.

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

• Not Applicable/Not Provided: Since this is a mechanical testing study on device components, there is no "test set" in the traditional sense of patient data. The "sample size" would refer to the number of physical device components tested, which is not specified in this summary. Data provenance (country of origin, retrospective/prospective) is also not applicable for mechanical testing.

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

• Not Applicable: This type of expert assessment is relevant for clinical studies or image interpretation, not mechanical testing of physical implants. The "ground truth" for mechanical tests would be defined by engineering standards and test protocols.

4. Adjudication method for the test set:

• Not Applicable: Adjudication is typically used in clinical studies involving interpretation or outcome assessment.

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: This is explicitly for AI/ML devices with human-in-the-loop components. This device is a physical hip implant component.

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

• No: See point 5.

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

• Mechanical Standards/Engineering Specifications: For mechanical testing, the "ground truth" is established by adherence to recognized engineering standards (e.g., ASTM standards for material properties and test methods) and comparison against the performance of predicate devices as per their design specifications and previous testing.

8. The sample size for the training set:

• Not Applicable/No Training Set: This device does not involve machine learning, so there is no training set.

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

• Not Applicable/No Training Set: See point 8.

In summary of the provided text:

The device (R3 Constrained Liner) received 510(k) clearance based on demonstrating substantial equivalence to predicate devices. This was achieved through mechanical testing that assessed attachment loads (push-in, push-out, shuck-out) and simulated intraoperative dislocation. The "acceptance criteria" were met by showing that the modified R3 Constrained Liners performed equivalently to the predicate devices in these mechanical tests, suggesting no new safety or effectiveness concerns. Specific quantitative results of these mechanical tests are not detailed in this summary. No clinical data or AI/ML performance studies were performed or required.

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The R3 Constrained Liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained Liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. The R3 Constrained Liner is intended for single use only.

The R3 Constrained Liners were previously cleared for market notification K083566. In August of 2010, Smith & Nephew launched a voluntary recall of the devices due to reports of intraoperative distocations .- The subject devices have been modified to address the intraoperative failure mode. Design features have been incorporated into the inner locking and support ring components of the R3 Constrained Liner construct which increase the device's resistance to dislocation under dynamic loading. The R3 Constrained Liners are available with inner diameters of 22 and 28mm and outer diameters from 52mm through 66/70mm. The devices are assembled from components that are made of ASTM F75 CoCr, ASTM F90 CoCr, ASTM F1472 Ti-6Al-4V, and ASTM F648 UHMWPE.

The provided text describes a medical device submission (K111635) for a modified R3 Constrained Liner to the FDA. The submission focuses on demonstrating substantial equivalence to previously cleared devices through mechanical testing, not through a clinical study involving human readers or AI. Therefore, most of the requested information regarding acceptance criteria for AI performance, sample sizes for test sets, expert involvement, and ground truth establishment, is not applicable to this document.

However, I can extract the relevant information regarding the device itself and the type of evaluation performed.

Here's a breakdown of the information based on your request and what's available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative, measurable format like a table for specific performance metrics (e.g., accuracy, sensitivity, specificity) as one would expect for an AI/CADe device. Instead, the "acceptance criteria" for this device, which is a physical implant, are implicitly met by demonstrating substantial equivalence to predicate devices through mechanical testing.

The "reported device performance" is a qualitative statement of equivalence.

The following points are not applicable to this submission because it is for a physical medical device (hip implant), not an AI/CADe device that performs analysis or diagnosis. The evaluation was based on mechanical testing and comparison to predicates, not a clinical study involving experts or human-in-the-loop performance.

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 describes mechanical testing of a physical device, not a test set for an AI algorithm.

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 for an AI algorithm is not relevant here. The "ground truth" for this device would be its mechanical integrity, which is assessed through engineering tests.

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

• Not Applicable. There was no test set in the context of AI evaluation.

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 study was conducted, as this is not an AI-assisted diagnostic device.

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

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

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

• Not Applicable. The "ground truth" for the device's performance would be the results of the mechanical tests proving its structural integrity and resistance to dislocation.

8. The sample size for the training set

• Not Applicable. There is no AI training set for this physical device.

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

• Not Applicable. There is no AI training set.

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The Longevity IT Constrained Liner is indicated as a component of a total hip prosthesis in primary or revision total hip arthroplasties where there is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle or tissue laxity, or disease condition. This device is intended for patients for whom all other options to constrained acetabular components have been considered.

The Longevity Integrated Taper (IT) Constrained Liner is a modular acetabular shell liner intended to capture the femoral head of a total hip prosthesis to reduce the incidence of joint dislocation. The liners feature integral polyethylene "fingers" reinforced with a modular Tivanium® ring to capture the mating femoral head. The Longevity IT Constrained Liners are intended to mate with Continuum and Trilogy IT acetabular shells.

The provided text is a 510(k) summary for a medical device, the Longevity® IT Highly Crosslinked Polyethylene Constrained Liner. It details the device's description, intended use, and substantial equivalence to predicate devices, supported by non-clinical performance data.

Here's an analysis of the document for the requested information:

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

The document states that "Non-Clinical testing was conducted on the proposed device per FDA's Guidance Document, "Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis". This testing demonstrated that the Longevity IT Constrained Liners performed as intended and met all acceptance criteria."

However, the specific quantitative acceptance criteria (e.g., minimum load for pull-out, maximum displacement, etc.) and the precise reported device performance values for each test are not explicitly listed in this summary. The summary only names the types of tests performed.

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 describes non-clinical performance testing. This refers to laboratory-based mechanical and materials testing of the device, not clinical data involving human subjects. Therefore, the concepts of "test set sample size," "country of origin," "retrospective or prospective" for human patient data are not applicable here. The testing was conducted on samples of the device itself. The specific number of devices tested for each non-clinical test is not specified in this summary.

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 submission. The "ground truth" in this context is established by engineering standards and FDA guidance for device performance, not by expert interpretation of patient data.

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

This question is not applicable as it pertains to clinical studies involving human subject data requiring adjudication, which was not performed for this 510(k) submission.

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

This question is not applicable as no clinical efficacy or comparative effectiveness study involving human readers or AI was conducted or reported in this 510(k) summary. The submission is based on non-clinical performance data for a mechanical implant.

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

This question is not applicable as this device is a mechanical implant and does not involve an algorithm or AI.

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

For the non-clinical performance testing, the "ground truth" is defined by established engineering and biomechanical principles, industry standards, and the specific test methodologies outlined in the FDA's "Class II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis." The compliance with these defined performance requirements constitutes the "ground truth" for the device's safety and effectiveness.

8. The sample size for the training set

This question is not applicable as this device is a mechanical implant and does not involve a "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 for the reasons stated above.

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The R3 Constrained Liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained Liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acefabular components have been considered. The R3 Constrained Liner is intended for single use only.

The R3 Constrained Liner and Shell Construct is a multi-piece acetabular component made up of an R3 Shell and the Constrained Liner Constrained Liner Construct includes a bipolar bearing which articulates with a captured outer polyethylene liner, locking ring and outer poly support ring.

The R3 Constrained Liner may be used with previously implanted femoral stems, femoral heads and acetabular shells as in a revision case, or it may be used in primary cases and implanted along with a shell, head and stem. The R3 Constrained liner was designed to be used with existing Smith & Nephew hip components. The R3 Constrained Liner should not be used with ceramic femoral heads or skirted femoral heads of any material.

The provided document is a 510(k) summary for the Smith & Nephew R3 Constrained Liners. This document details the regulatory clearance process for a medical device and relies on showing "substantial equivalence" to a predicate device, rather than explicit acceptance criteria and performance studies for the new device.

Therefore, the document does not contain the requested information regarding specific acceptance criteria, a study proving the device meets those criteria, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

Instead, the document states:

• D. Summary of Technological comparison: "The intended use, design, and materials of the R3 Constrained Liners are substantially equivalent to the previously cleared Osteonics Constrained Liners (P960047). Design Control Activities have been completed and the results indicated that the subject device is safe and effective."

This indicates that the safety and effectiveness of the R3 Constrained Liners were established through design control activities and a comparison to a predicate device, rather than through a performance study against predefined acceptance criteria for the new device as would be typical for software or AI medical devices.

To answer your request, if this were a software/AI device, I would need a different type of submission document that would detail performance studies.

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The Trabecular Metal Acetabular Revision System (TMARS) Cemented Constrained Liner is intended to be cemented into a TMARS shell is intended for cementless fixation into the acetabulum. The Trabecular Metal Acetabular Revision System Cemented Constrained 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 of prior dislocation, bone loss. soft tissue laxity, neuromuscular disease, or intraoperative instability and for whom all other options to constrained acetabular components have been considered.

The Trabecular Metal Acetabular Revision System Cemented Constrained Liner is a polyethylene/metal acetabular liner, which, when used with a Trabecular Metal Acctabular Revision Shell (K050937, cleared May 11, 2005), forms the acetabular component of a total bip prosthesis. The device consists of a Longewire highly crosslinked polyethylene liner and a Tivanium " Titanium alloy constraming ring. The liner allows for mechanical capture of the metal fernoral head and greater flexion/extension range of motion than hooded constrained liner designs. Subject acetabular liners are available in mner diameters of 28. 32 and 36mm.

The provided text describes a medical device submission (K072121) for the Trabecular Metal™ Acetabular Revision System Cemented Constrained Liner.

1. Table of Acceptance Criteria and Reported Device Performance

The submission is a 510(k) premarket notification, which establishes substantial equivalence to a predicate device rather than setting new, specific performance-based acceptance criteria for a novel device. Therefore, the "acceptance criteria" are implied by the demonstration of substantial equivalence.

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

• The document explicitly states: "Clinical data and conclusions were not needed for this device."
• Therefore, there was no test set of clinical data (images, patient outcomes, etc.) used. The evaluation was based on non-clinical (mechanical) testing.
• Data Provenance: Not applicable, as no clinical data was used.

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

• Not applicable, as no clinical test set requiring expert ground truth was used.

4. Adjudication Method for the Test Set

• Not applicable, as no clinical test set requiring adjudication was used.

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 MRMC study was done, as this is a physical medical device (an acetabular liner) and not an AI-based diagnostic or assistive technology.

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

• Not applicable, as this is a physical medical device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For the non-clinical mechanical testing, the "ground truth" would be established by engineering standards and specifications for mechanical properties (e.g., strength, wear resistance, range of motion). The mechanical testing would assess if the device meets these pre-defined engineering performance targets and compares favorably to the established performance of the predicate device under similar testing conditions.

8. The Sample Size for the Training Set

• Not applicable, as no AI/machine learning model was being trained. The "training set" concept does not apply to the mechanical testing of this physical device.

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

• Not applicable, as there was no training set for an AI/machine learning model. For mechanical testing, the equivalent would be the established engineering specifications and the performance characteristics of the predicate devices.

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