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Cases of acetabular erosion or protrusio are not un-common. These problems are usually caused by a prior, failed acetabular implant, or a trauma induced fracture, or as a result of progressive joint disease. The surgical re-construction of the acetabular it is necessary to restore the floor or defect in the natural acetabular joint cavity. Using the mesh cup or mesh sheet as a scaffold. This creates a sound foundation or base for the definitive load bearing acetabular cup replacement devise:

Link Acetabular Mesh Cup and Sheet

This document is a 510(k) premarket notification letter from the FDA regarding a medical device, the "Acetabular Revision Mesh and Cup" (Link America, Inc. Acetabular Mesh Cup and Sheet). It confirms substantial equivalence and permits marketing of the device.

The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory approval document focusing on substantial equivalence to previously marketed devices. Therefore, I cannot extract the requested details from the given input.

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The indications for the use of the Osteonics® Restoration Acetabular Rings, in keeping with those of other legally marketed Osteonics acetabular components, are as follows:

• Painful, disabling joint disease of the hip resulting from: degenerative arthritis, rheumatoid . arthritis, post-traumatic arthritis or late stage avascular necrosis.
• . Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
• Clinical management problems where arthrodesis or alternative reconstructive techniques . are less likely to achieve satisfactory results.
• Where bone stock is of poor quality or is inadequate for other reconstructive techniques o as indicated by deficiencies of the acetabulum.
• . Class II cavitary or protrusio defects.

The Osteonics Restoration Acetabular Rings are single use components which are intended for placement within the acetabulum, and which are intended to provide an articulating surface for corresponding, Osteonics' femoral head/stem components. Each Osteonics" Restoration Acetabular Ring is assembled from two separate components: an Osteonics" Restoration Acetabular Shell and a predicate Osteonics Omnifit "Cup Insert, Osteonics "Concentric Polyethylene Acetabular Cup, or Osteonics Flanged Polyethylene Acetabular Cup.

The bodies of the Osteonics" Omnifit" Cup Insert, Osteonics" Concentric Polyethylene Acetabular Cup, and Osteonics" Flanged Polyethylene Acetabular Cup are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The Osteonics Omnifit" Cup Insert, Osteonics Concentric Polyethylene Acetabular Cup, or Osteonics Flanged Polyethylene Acetabular Cup, when used with the Osteonics" Restoration Acetabular Ring, is intended to be affixed to the shell via polymethylmethacrylate (PMMA) bone cement.

The Osteonics" Restoration Acetabular Rings are manufactured from ASTM F-67 Commercially Pure Titanium (CP Ti). The shells are available in a range of outer diameter shell sizes. The Osteonics Restoration Acetabular Ring features a basic spherical geometry, thirteen or sixteen acetabular dome screw holes (depending on the size of the shell), a built up 20° superior lip, an inferiorly located acetabular notch hook, and satin-finished interior and exterior surfaces.

Bone screws placed through the dome and/or lip of the acetabular shell are used to secure the Osteonics" Restoration Acetabular Ring within the prepared acetabulum. The shells are designed to allow some of the bone cement (used to fix the polyethylene liner to the shell) to be extruded through any unoccupied acetabular dome screw holes. In addition to traditional acetabular dome screws, and in order to further enhance the potential for initial and long term stable shell fixation despite small bony defects, the Osteonics" Restoration Acetabular Ring employs an inferior hook and a superior lip. The inferior hook is crimped around the acetabular notch. The superior lip of the shell covers the superior rim of the acetabular cavity and can be secured to the acetabulum with 6.5mm cancellous bone screws.

The provided document is a 510(k) Premarket Notification Summary for a medical device (Osteonics® Restoration Acetabular Ring). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a full clinical efficacy study with acceptance criteria and performance metrics in the way a novel device might.

Therefore, the document does not contain information typically found in acceptance criteria and study designs for validating AI/software performance, such as sensitivity, specificity, or reader studies. Instead, it relies on demonstrating equivalence through material properties, design, and mechanical testing.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Detailed Study Information (Based on interpretation of a 510(k) submission which does not involve traditional clinical studies):

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

  • Sample Size: Not applicable in the context of human data. For mechanical testing, the specific number of test articles is not mentioned, but it would typically involve a statistically relevant number to demonstrate fatigue and assembly strength.
  • Data Provenance: Not applicable as this is a premarket notification primarily based on design and mechanical equivalence to an existing device. The mechanical testing would have been conducted in a lab environment.

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

  • Not applicable. Ground truth, in the clinical sense, is not established for this type of submission. "Ground truth" here is effectively the accepted design, material, and performance characteristics of the predicate device, against which the new device is compared. This comparison is performed by engineers and regulatory personnel, not clinical experts establishing a diagnosis.

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

  • Not applicable. There is no clinical test set requiring adjudication in the context of expert consensus or diagnostic accuracy.

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

  • Not applicable. This is a hip implant, not an AI diagnostic device.

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

  • Not applicable. This is a hip implant, not an algorithm.

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

  • The "ground truth" for this submission is implicitly the established safety and efficacy profile, material specifications, and design principles of the predicate device (Osteonics® Restoration Acetabular Cup Series), as demonstrated through historical use and prior FDA clearance. The new device is deemed "substantially equivalent" if it meets these established characteristics. Mechanical testing results for fatigue strength and assembly method further support this equivalence for the physical attributes.

• 8. The sample size for the training set

  • Not applicable. There is no "training set" for physical device equivalence.

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

  • Not applicable.

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The Exeter Mesh is intended to be used to reinforce bone when additional strengthening and support is required.

The Exeter Mesh is available in four (4) styles to fit a variety of anatomical requirements. The mesh is intended to be either cemented in place or affixed with screws. Screws are provided that are 3.5mm in diameter and range in length from 10mm to 35mm.

It appears you've provided information about a 510(k) summary for a medical device called "Exeter Mesh K963946," specifically an Acetabular Mesh. However, the provided text does NOT contain any details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement, which are all necessary to answer the questions in your prompt.

The 510(k) summary focuses on general device information, intended use, and substantial equivalence to previously marketed devices. It does not include the type of detailed performance study data you're requesting.

Therefore, I cannot fulfill your request with the information provided. To answer your questions, I would need a different type of document, such as a clinical study report, a detailed performance data summary, or regulatory submission documents that specifically discuss:

1. Acceptance criteria: What performance metrics were required for the device to be considered safe and effective?
2. Reported device performance: What were the results of tests against these criteria?
3. Study design details: Information on sample sizes, data provenance, ground truth establishment (experts, pathology), adjudication, mrmc studies, and standalone performance.

If you can provide a different document that contains this type of information, I would be happy to analyze it and answer your questions.

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The Reflection Acetabular Reinforcement Ring System is indicated as follows: rheumatoid arthritis, avascular necrosis, femoral neck fractures, osteomyelitis, fracture-dislocation of the hip, and unsuccessful cup arthroplasty, endoprosthesis, femoral osteotomy, or girdlestone resection. Indications also include osteoarthritis, traumatic arthritis, slipped capita epiphysis, fused hip, and diastrophic variant. Reflection Acetabular Reinforcement Rings are intended to be used in primary and revision surgeries where the acetabulum has the deficiencies of the acetabular roof, anterior or posterior pillar, medial wall deficiency, and / or protrusion as a result of the indications listed previously. The device is for single use.

The Reflection Acetabular Reinforcement Ring is a device intended to address acetabular defects. The rings are manufactured from titanium in a variety of sizes to accommodate the needs of patients.

This document is a 510(k) summary for a medical device (Reflection Acetabular Reinforcement Rings) submitted in 1996. The information provided is for regulatory clearance based on substantial equivalence to predicate devices already on the market.

It is important to note that this type of submission (510(k)) generally does not involve clinical studies with acceptance criteria, sample sizes, expert ground truth, or comparisons of AI-assisted vs. non-AI-assisted human performance in the way a modern AI/ML device would.

Therefore, I cannot provide the requested information in the format of a typical AI/ML device study. The document focuses on demonstrating similarity to existing devices rather than proving performance against specific acceptance criteria through novel studies.

Here's an explanation based on the provided text, highlighting why the requested information cannot be fully provided:

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

• Acceptance Criteria: Not explicitly stated in the document. For 510(k) submissions of this era for mechanical implants, acceptance criteria would typically revolve around material specifications, dimensional tolerances, and mechanical testing (e.g., fatigue, static strength) to ensure the device performs similarly to predicate devices. These are not detailed in this summary.
• Reported Device Performance: The document states, "The safety and effectiveness of the Reflection Acetabular Reinforcement Rings System is based on the long history of use of these devices in the market place." This implies that the performance is considered equivalent to the predicate devices due to their established clinical use. No specific, quantifiable performance metrics for the Reflection rings themselves are reported from a dedicated study.

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

• Not applicable. No clinical "test set" in the context of an AI/ML study is mentioned. The safety and effectiveness are established by reference to the pre-existing market history of similar devices, not through a prospective or retrospective study of the Reflection Acetabular Reinforcement Rings specifically.

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. There is no "test set" requiring expert-established ground truth mentioned in this 510(k) summary.

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

• Not applicable. No test set or expert adjudication is described.

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 device is a mechanical implant (acetabular ring), not an AI/ML diagnostic aid. Therefore, no MRMC study, human reader performance, or AI assistance is relevant.

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

• Not applicable. This device is a mechanical implant; it does not involve algorithms or AI.

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

• Not applicable. The "ground truth" for this 510(k) clearance is the established safe and effective clinical use of the predicate devices in the market, not a derived ground truth from a specific study for this new device.

8. The sample size for the training set

• Not applicable. This device is a mechanical implant; it does not involve AI/ML requiring a training set.

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

• Not applicable. No training set is involved.

In summary: The provided document is a regulatory submission from 1996 for a mechanical implant. It follows the 510(k) pathway, which focuses on demonstrating substantial equivalence to existing devices rather than presenting novel clinical study data with specific acceptance criteria as would be expected for a modern AI/ML medical device.

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The DePuy Protrusio Cage is intended to be used to reinforce a deficient or weakened medial acetabular wall to prevent the protrusion of an acetabular cup prosthesis into the abdominal cavity and may be indicated for use in cases involving acetabular revision procedures, severe osteoporosis, Protrusio Acetabuli, or a shallow acetabular roof.

The DePuy Protrusio Cage is a rimmed metal shell with multiple holes and ischial "wings". It is intended to reinforce weak acetabula by transferring stress away from the medial wall to the stronger acetabular rim. The wings and rim of the cage can be fixed to solid bone using Titanium bone screws. The reinforcement provided by the Protrusio cage allows improved fixation of an acetabular cup prosthesis, which can be fixed inside the Protrusio cage using bone cement. The DePuy Protrusio cage is available in diameters of 52, 56 and 60mm in right and left configurations. The Titanium bone screws have a diameter of 6.5mm and are available in lengths of 20, 25, 30, 35, 40, 45, 50, 55 and 60mm.

This document does not describe an AI/ML device or a study involving acceptance criteria and device performance in the context of AI.

The provided text is a 510(k) summary for a medical device called "DePuy Protrusio Cages," which is a surgical mesh intended to reinforce a deficient acetabular wall. The summary describes the device's intended use, description, and basis for substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, ground truth, or MRMC studies, as these concepts are specifically relevant to the evaluation of AI/ML-driven medical devices and are not discussed in this document.

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