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Acetabular Liners:
The Trabecular Metal™ Revision Shell Liner is indicated for cemented use in the Trabecular Metal Revision Shell for initial placement or as an in situ replacement polyethylene bearing surface for joint instability, wear and/or damage.

Constrained Liners:
The Trabecular Metal Acetabular Revision System Cemented Constrained Liner is intended to be cemented into a Trabecular Metal Acetabular Revision System shell; the 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 complex 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 (TMARS) Acetabular Liner and Cemented Constrained Liner are polyethylene/metal acetabular liners, which, when used with a Trabecular Metal Acetabular Revision System Shell, forms the acetabular component of a total hip prosthesis. The acetabular liner constructs are manufactured from Longevity highly cross-linked ultra-high molecular weight polyethylene (UHMWPE). The cemented constrained liners are manufactured from Longevity highly cross-linked UHMWPE and contain a titanium alloy constraining ring. All devices in the scope of this 510(k) are sterile, single-use items.

The provided FDA 510(k) clearance letter (K243571) for the Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through the kind of study layout often associated with novel AI/software devices.

This submission is for a medical device (hip joint prosthesis components) and the "studies" conducted are non-clinical bench tests to ensure the new device performs similarly and safely to already approved devices. Therefore, the response will reflect the information provided, which is typical for a traditional medical device 510(k) clearance.

Here's an analysis of the provided document against your requested criteria:

Acceptance Criteria and Device Performance for Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners (K243571)

Based on the provided 510(k) summary, the device's acceptance criteria are primarily demonstrated through non-clinical bench testing, ensuring the new device's performance is comparable to its predicate devices and meets relevant material standards. The goal is to establish substantial equivalence, not to demonstrate a specific improvement in performance over a human baseline or a novel AI-driven diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not detail specific sample sizes for each non-clinical test (e.g., how many liners were tested for push-out). These are typically bench tests conducted on a sufficient number of samples to statistically validate the mechanical properties. The "data provenance" in this context is from laboratory bench testing, not patient data. Therefore, concepts like country of origin or retrospective/prospective don't apply as they would for clinical studies.

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

This information is not applicable (N/A) for this type of device submission. Ground truth, typically established by expert consensus or pathology in diagnostic studies, is not a concept used for evaluating mechanical components of a hip prosthesis in a 510(k) de novo submission. The "ground truth" here is adherence to engineering standards and comparison to predicate device performance through physical testing.

4. Adjudication Method for the Test Set

This information is not applicable (N/A). Adjudication methods (like 2+1, 3+1, none) are relevant for studies involving human interpretation (e.g., radiologists reviewing images) where disagreements need resolution to establish a ground truth. For mechanical bench testing, the results are objectively measured against defined criteria or compared to predicate performance.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic algorithms, often comparing human readers with and without AI assistance on a set of cases. This 510(k) is for an orthopedic implant, not a diagnostic AI device.

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

This information is not applicable (N/A). This product is a physical medical device (an acetabular liner), not an AI algorithm. Therefore, "standalone algorithm" performance is not relevant.

7. The Type of Ground Truth Used

As mentioned in point 3, the concept of "ground truth" in the diagnostic AI sense (expert consensus, pathology, outcomes data) is not applicable here. The "truth" or reference for this device's performance is established by:

• Engineering specifications and material standards (e.g., ASTM F648).
• Performance of legally marketed predicate devices (demonstrating substantial equivalence through comparative bench testing).
• Biocompatibility standards (ISO 10993-1).

8. The Sample Size for the Training Set

This information is not applicable (N/A). This device is not an AI/ML algorithm that requires a "training set."

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

This information is not applicable (N/A). As there is no training set for an AI algorithm, there is no ground truth to establish for it.

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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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1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
2. Rheumatoid arthritis
3. Correction of functional deformity
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
5. Revision procedures where other treatment or devices have failed

Porous acetabular shells and femoral stems are indicated for uncemented biological fixation. Non-coated or polyethylene components may be used with mating components that are indicated for either cemented use.

Indications for G7® Vivacit-E® Freedom® Constrained Liner:

The G7® Vivacit-E® Freedom® Constrained Liner is indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of distory of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability, and for whom all other options to constrained acetabular components have been considered.

The G7 Acetabular System currently offers a constrained Vitamin E infused highly crosslinked ultra high molecular weight polyethylene (UHMWPE) liner, branded E1 polyethylene, with a preassembled titanium alloy constraining ring. The constrained liner is designed for use in primary or revision total hip arthroplasty (THA) patients that are at a greater risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intraoperative instability.

Zimmer Biomet has designed and developed a new constrained liner for use within the G7 Acetabular System, the G7® Vivacit-E® Freedom® Constrained Liner. The purpose of this submission is to obtain clearance for this new constrained liner.

The provided text describes the 510(k) submission for the G7® Vivacit-E® Freedom® Constrained Liner, a medical device for total hip arthroplasty. The document does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of a diagnostic AI/ML device.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device, which is a common pathway for medical device approval in the United States. This involves comparing the new device's characteristics and performance to a legally marketed predicate device.

Therefore, I cannot extract the requested information from the provided text for the following reasons:

• No acceptance criteria for an AI/ML device are described. The document pertains to a physical orthopedic implant, not a diagnostic AI/ML software. Acceptance criteria for mechanical implant devices typically involve benchmarks for physical properties, wear, and mechanical strength, which are mentioned in the "Summary of Performance Data," but these are not the type of diagnostic performance metrics expected for an AI/ML device.
• No study proving diagnostic performance is detailed. The studies listed are engineering performance tests for a physical implant (e.g., insertion energy, torque out, wear testing, fatigue testing, range of motion), not studies to assess diagnostic accuracy, sensitivity, or specificity of an AI/ML algorithm.
• No information on ground truth, expert consensus, or training/test sets for an AI/ML model is present. These concepts are not applicable to the type of device described in the document.

In summary, the provided document does not align with the request to describe acceptance criteria and a study for an AI/ML diagnostic device. It describes a traditional medical device (a hip implant component) and its substantial equivalence submission to the FDA.

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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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Components of the Signature Orthopaedics hip replacement range are intended to replace a hip joint where bone stock is sufficient to support the implant. When a surgeon has selected prosthetic replacement as the preferred treatment, the devices are indicated for:

• Non-inflammatory degenerative joint disease including osteoarthritis or avascular necrosis
• Inflammatory joint disease including rheumatoid arthritis
• Correction of functional deformity including congenital hip dysplasia
• Traumatic injury involving the hip joint including traumatic arthritis or femoral head or neck fracture
• Failed previous hip surgery including internal fixation or joint fusion, reconstruction, hemiarthroplasty, surface replacement, or total replacement

Signature Orthopaedics' Origin, NEO-T, Remedy and Pegasus femoral stems, and Logical acetabular cups are intended for cementless fixation only. Signature Orthopaedics' Evolve femoral stems are intended for cemented fixation only.

Signature Orthopaedics' constrained liner components are indicated particularly for patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease or intraoperative instability.

Signature Orthopaedics' Evolve UniPolar Head and BiPolar Head are intended for hemihip arthroplasty only, where the natural acetabulum does not require replacement. The Evolve UniPolar Head and BiPolar Head are indicated for bone fractures or pathologies involving only the femoral head/neck and/or proximal femur, such as:

• Acute femoral head or neck fracture
• Fracture dislocation of the hip
• Avascular necrosis of the femoral head
• Non-union of femoral neck fractures
• Certain high subcapital and femoral neck fractures in the elderly
• Degenerative arthritis involving only the femoral head

The Logical C-Series Acetabular Shell is a metal backed cementless acetabular cup that is compatible with a highly cross-linked polyethylene liner from the Origin Total Hip System predicate device (K121297), as well as the Logical Constrained Liner and Logical 20° Hooded Liner. The shell's substrate is manufactured from Ti6A14V alloy per ASTM F136. The outer surface of the shell is sequentially coated with commercially pure titanium (per ASTM F1580) and Hydroxylapatite (per ISO 13779-2). The shell is available in no-hole. 3-hole or multi-hole configurations to allow use of bone screws for supplemental fixation.

The Logical Constrained Liner and the Logical 20° Hooded Liner are line range extensions to the Logical Liner per K121297. The Logical Constrained Liner differs from the original range in that it provides greater than 180 degree head coverage to constrain the head within liner. The Logical 20° Hooded Liner differs from the original range in that it incorporates a 20° hood as opposed to the original 10° hood. The Logical Constrained Liner and Logical 20° Hooded Liner are manufactured from highly crosslinked polyethylene (XLPE) identical to the Logical Liner per K121297. The Logical Constrained Liner further incorporates a titanium alloy collar to support the liner's rim. Furthermore, the Logical Constrained Liner is assembled with the Logical Shell and Logical Constrained Liner Collar via titanium alloy snapring. The Logical Constrained and 20° Hooded Liners articulate with a femoral head of appropriate diameter.

The provided text is a 510(k) summary for the Logical C-series Acetabular Shell, Logical Constrained Liner, and Logical 20° Hooded Liner. This document focuses on demonstrating substantial equivalence to previously marketed devices rather than establishing novel safety and effectiveness through a traditional clinical study with acceptance criteria for device performance.

Therefore, the requested information regarding acceptance criteria, a study proving the device meets these criteria, sample sizes for test/training sets, expert involvement, and ground truth establishment is not explicitly detailed in the provided document in the context of a new efficacy study.

However, I can extract information related to the non-clinical performance testing conducted to support substantial equivalence.

Here's an analysis based on the provided text, addressing the points where information is available and noting where it is not:

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

The document does not provide specific acceptance criteria or quantitative performance results in a table format for the device itself against novel safety and effectiveness endpoints. Instead, it states that "Non-clinical testing and engineering evaluations were conducted to verify that the performance of the Logical C-Series Shell, Constrained Liner and 20° Hooded Liner devices are adequate for anticipated in-vivo use." The conclusion drawn is that "Non-clinical testing results support the substantial equivalence claim." This implies that the device's performance, as measured by the non-clinical tests, was comparable to or met the established performance of the predicate devices.

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

The document describes "non-clinical testing and engineering evaluations." This typically refers to laboratory-based tests on physical samples of the medical device components. It does not refer to clinical patient data. Therefore, concepts like country of origin for data or retrospective/prospective studies are not applicable here. The sample sizes for these engineering tests are also not specified in the provided text.

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 and not provided as the document describes engineering and non-clinical performance testing of mechanical components, not a study evaluating diagnostic accuracy or a similar clinical outcome requiring expert ground truth establishment.

4. Adjudication method for the test set

This information is not applicable and not provided for the same reasons as point 3.

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 information is not applicable and not provided. The device in question is an orthopedic implant (hip replacement components), not an AI-powered diagnostic or assistive tool for human readers.

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

This information is not applicable and not provided. The device is an orthopedic implant, not an algorithm.

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

This information is not applicable and not provided as it relates to non-clinical engineering tests on device components. The "ground truth" in this context would be the objective measurements and engineering standards applied to the device components during laboratory testing.

8. The sample size for the training set

This information is not applicable and not provided. This is not an AI/machine learning study requiring training data.

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

This information is not applicable and not provided for the same reasons as point 8.

Summary of available information related to performance testing:

The device's performance was evaluated through the following non-clinical tests:

• Range of motion analysis
• Shell stiffness testing
• Modular component connection strength testing
• Cup-Liner Push Out testing
• Head-Liner Assembly / Disassembly Testing
• Liner-Shell Assembly Testing
• Various coating characterization, abrasion and adhesion strength testing

These tests were conducted to demonstrate that the device performs "adequately for anticipated in-vivo use" and to support "substantial equivalence" to predicate devices. The specific quantitative results or direct acceptance criteria for each test against which the device's performance was measured are not detailed in this 510(k) summary. The implication is that the device met the performance benchmarks implicitly or explicitly established based on the predicate devices or relevant industry standards.

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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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Exactech Novation Crown Cup TM Constrained Liners and Rings are components of the Exactech Novation® non-cemented acetabular cup system. The device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. They are intended for press-fit fixation and are compatible with Exactech press-fit or cemented femoral stem components.

The proposed Novation® Constrained Acetabular Liners are modifications of the previously cleared AcuMatch A-Series predicates. The design features of the subject devices are summarized below:

NOVATION CONSTRAINED LINERS

• Sphere and taper inner diameter geometry for compatibility with the Novation . Crown Cup
• Increased range-of-motion and lever-out moment by decreasing the height of the . constraining petals, increasing the constraining diameter and increasing the lead in chamfer
• Addition of a 36mm ID option. .

NOVATION CONSTRAINED RINGS

• The constraining ring will be made of Ti-6Al-4V per ASTM F1472 instead of Ti- 6Al-4V per ASTM F136.
• Ring snaps into a locking feature on the Novation Crown Cup instead of press-. fit.
• Inner and outer diameter of the constraining ring modified for compatibility with . the proposed constrained liner and Novation Crown Cup.

The provided text describes a 510(k) submission for the Exactech® Novation Crown Cup™ Constrained Liners and Rings. This is a medical device submission, and as such, the "acceptance criteria" and "study" are not in the context of typical AI/ML performance metrics, but rather engineering evaluations and substantial equivalence to a predicate device.

Here's an interpretation based on the given information:

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices like this, the "acceptance criteria" for a 510(k) submission are typically related to a demonstration of substantial equivalence to an already legally marketed (predicate) device, and the "performance" is verified through engineering evaluations to ensure it's "adequate for anticipated in vivo use."

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is referred to as "Engineering evaluations."

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

• Sample Size for Test Set: Not specified in the provided text. For mechanical testing of medical devices, sample sizes are typically determined by statistical methods for specific tests (e.g., fatigue, wear, pull-out strength). The summary only states "Engineering evaluations were conducted."
• Data Provenance: Not specified, but generally, such engineering evaluations are conducted in a laboratory setting by the manufacturer (Exactech, Inc.) based in the USA (Gainesville, Florida). The data would be prospective, as it's generated specifically for this submission.

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

This concept (experts establishing ground truth) is primarily applicable to studies involving human interpretation (e.g., radiology for AI models). For a mechanical device 510(k) submission, "ground truth" is typically objective engineering measurements and established material science standards.

• No specific number of human "experts" establishing ground truth for the test set (engineering evaluations) is mentioned. The "experts" in this context would be the engineers and scientists conducting and reviewing the tests, following established ASTM/ISO standards for medical device testing. Their qualifications would be in biomedical engineering, materials science, mechanical engineering, etc., likely with experience in orthopedic implants.

4. Adjudication Method for the Test Set

Again, "adjudication" usually refers to resolving disagreements between human readers/interpreters. For engineering evaluations, the "adjudication" is inherent in the scientific and engineering review process, ensuring test protocols are followed, data is correctly analyzed, and conclusions drawn are valid.

• No explicit "adjudication method" like 2+1 or 3+1 is mentioned or applicable in the context of engineering evaluations for a mechanical device.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools where human readers are involved. The Novation Crown Cup™ is a mechanical orthopedic implant, not an AI diagnostic device.

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

• No, a standalone (algorithm only) study was not done. This concept applies to AI/ML software. The Novation Crown Cup™ is a physical medical device.

7. Type of Ground Truth Used

• For the engineering evaluations, the "ground truth" would be objective physical measurements and adherence to established engineering standards (e.g., ASTM F1472 for material, other ASTM/ISO standards for mechanical properties like fatigue, wear, range-of-motion, lever-out moment testing). The "truth" is whether the device meets predefined mechanical performance thresholds or demonstrates equivalent performance to the predicate device under specific test conditions.

8. Sample Size for the Training Set

• This concept is not directly applicable. In the context of mechanical device design, there isn't a "training set" in the machine learning sense. Instead, design iterations and simulations might be performed, but these are not referred to as training data for an algorithm. The 510(k) process focuses on validating the final product, not on the data used to "train" its design.

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

• Not applicable, as there is no "training set" in the AI/ML sense for this mechanical device. The design evolution and verification are based on engineering principles, materials science, clinical experience with previous devices, and established standards, rather than machine learning "ground truth."

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