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The Prime E-CLASS™ XLPE Liner is an acetabular liner intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. This device is indicated for the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankyloses, protrusion acetabuli, and painful hip dysplasia;
2. inflammatory degenerative joint disease such as rheumatoid arthritis;
3. correction of functional deformity; and,
4. revision procedures where other treatments or devices have failed.
   Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.

The Prime E-CLASS™ XLPE Liner is an additional liner option for MicroPort Orthopedics' Prime Acetabular Cup System (K170444; K180798). The subject Liner is intended to be used with Acetabular Shells and optional Cancellous Bone Screws as part of a total acetabular system.
The Prime E-CLASS™ XLPE Liner is manufactured from E-CLASS™, a vitamin E blended XLPE, conforming to ASTM F2695-12. The subject Liner is available in Standard, Lipped, and Lateralized/Face-changing configurations. The subject Liner has a two-part locking detail featuring 12 anti-rotational tabs and a lock flange, which is intended to mate with the 12 antirotational pockets and lock groove of the compatible Prime Acetabular Shells (K170444; K180798).

The provided document is a 510(k) Summary for a medical device (Prime E-CLASS™ XLPE Liner), which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria with quantifiable performance metrics.

Therefore, the information required for a table of acceptance criteria and proven device performance as typically expected for a diagnostic AI/ML device is not available in this document. The document describes non-clinical testing performed to establish substantial equivalence for a physical implant, not a software algorithm.

Here's a breakdown of why the requested information cannot be fully provided based on the input text:

• Acceptance Criteria & Device Performance: The document does not define specific clinical or diagnostic acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) that the device must meet. Instead, it details non-clinical tests (bacterial endotoxin, mechanical testing, material properties, wear analysis, fatigue, range of motion) to show the device performs similarly to predicate devices. The "reported device performance" are the results of these non-clinical tests, which aim to demonstrate equivalence rather than meeting independent performance criteria.

• Study Type: This is a premarket notification (510(k)) for a physical medical implant, not a study of an AI/ML diagnostic or prognostic device. The "study" here refers to non-clinical bench testing and analysis to show equivalence.

Given the nature of the document, most of the requested fields are not applicable or the information is not present.

However, I can extract what is available regarding the "studies" (non-clinical testing) performed:

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

As mentioned, specific acceptance criteria in terms of clinical performance metrics are not provided. The "acceptance criteria" for this 510(k) submission are implied by successful completion of tests demonstrating substantial equivalence to predicate devices. The "reported device performance" refers to the outcomes of these non-clinical tests.

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 explicitly stated for each non-clinical test. For mechanical tests, standard testing protocols define sample sizes, but these are not enumerated here.
• Data Provenance: Not applicable. This refers to bench testing of physical components, not patient data.

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 clinical data is not relevant to this type of non-clinical device testing.

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

• Not applicable. Adjudication is typically for human assessment of images or clinical outcomes, not for mechanical bench testing.

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 diagnostic device.

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

• Not applicable. This is not an AI/ML diagnostic device.

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

• For non-clinical testing, the "ground truth" is established by adherence to recognized national and international standards (ASTM, ISO, FDA Guidance) and laboratory measurements using calibrated equipment. For example, the ground truth for endotoxin levels is defined by the USP limit. For mechanical properties, it's the measured values compared to established benchmarks or predicate device performance.

8. The sample size for the training set

• Not applicable. This is not an AI/ML diagnostic device, and thus no "training set" of data in that context. The "training" for the device's design comes from engineering principles, material science, and prior designs.

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

• Not applicable. No "training set" in the context of AI/ML.

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PROCOTYL® PRIME hip system is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.

Indications for Use

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankyloses, protrusion acetabuli. and painful hip dysplasia:

2. inflammatory degenerative joint disease such as rheumatoid arthritis;

3. correction of functional deformity; and,

4. revision procedures where other treatments or devices have failed.

Shells with BIOFOAM® metal foam coating are intended only for uncemented arthroplasty.

The PROCOTYL® PRIME E-CLASS™ XLPE Liner is an additional liner option for MicroPort Orthopedics' PROCOTYL® PRIME Acetabular Cup System (K170444). The design features are summarized below:

• Manufactured from E-CLASS™ vitamin E blended highly crosslinked ultra high . molecular weight polyethylene (VEXLPE) conforming to ASTM F2695-12
• Available in Standard, Lipped, or Face-Changing Lateralized Configurations .
• Inner Diameter sizes 22mm to 44mm o

The provided text describes a 510(k) premarket notification for a medical device, the PROCOTYL® PRIME E-CLASS™ XLPE Liner. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through extensive clinical trials with specific acceptance criteria as might be seen for a novel device. Therefore, the response will focus on the non-clinical testing performed to establish this substantial equivalence.

1. Table of acceptance criteria and the reported device performance

Since this is a 510(k) submission, the "acceptance criteria" are generally implied to be meeting the performance of existing, legally marketed predicate devices and established standards (ASTM, ISO). The "reported device performance" refers to the results of the non-clinical tests that demonstrate this equivalence.

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

The document does not specify the exact sample sizes (e.g., number of test specimens) for each non-clinical test. It generally states that "testing was performed" or "underwent testing." The data provenance is internal to MicroPort Orthopedics, Inc. and is generated through their non-clinical testing. This is typically prospective in nature for these types of bench and animal studies. No country of origin of the data is explicitly mentioned beyond the company's location in Arlington, Tennessee.

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 to a non-clinical 510(k) submission focused on demonstrating substantial equivalence through bench and animal testing. "Ground truth" established by experts is typically relevant for clinical studies, particularly those involving diagnostic accuracy or human interpretation.

4. Adjudication method for the test set

This information is not applicable to the non-clinical testing described. Adjudication methods (like 2+1, 3+1) are used in clinical studies to resolve discrepancies in expert interpretations or assessments.

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 comparative effectiveness study was done. The document explicitly states: "Clinical data was not provided for the subject devices." This implies that no human reader studies (with or without AI assistance) were conducted as part of this submission. The device is a physical implant, not an AI-assisted diagnostic tool.

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

No standalone algorithm performance study was done. The device is a physical implant, not an algorithm.

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

Given that "Clinical data was not provided," there is no "ground truth" in the sense of clinical outcomes or expert diagnoses from human patients. The "ground truth" for the non-clinical tests would be the established scientific principles, engineering standards (e.g., ASTM F2695-12 for the material), and performance characteristics of predicate devices against which the new liner's properties are compared.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is a physical medical device, not an AI algorithm requiring a training dataset.

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

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

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