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The Prime Acetabular Cup 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, ankylosis, protrusio 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® coating are intended only for uncemented arthroplasty.

MicroPort is introducing the Prime BIOFOAM® Multi-Hole Shells as a line extension of its existing Prime Acetabular System (K170444, K171181, K180798, and K181598). The subject implants are single use only, are provided sterile, and are to be implanted only by orthopedic specialists in an operating room setting. Associated instrumentation is reusable, provided nonsterile, and are to be used only by orthopedic specialists in an operating room setting.

The Prime BIOFOAM® Multi-Hole Shell includes 10, 12, or 14 screw hole variations. The subject acetabular shells can be used with existing MicroPort devices listed in Section G, Table 3 to form a complete total hip system.

• Multi-Hole Acetabular Shells
  • Material: Ti alloy conforming to ASTM F620 O
  • Coating: Commercially Pure Ti Foam conforming to ASTM F67 O (BIOFOAM®)
  • Outer diameters: 42mm to 68mm with 2 mm increments O
  • Variants: 10, 12, or 14 screw holes O
  • Sterilized using Gamma Radiation O

This FDA 510(k) summary (K201157) is for the Prime BIOFOAM® Multi-Hole Shells, an acetabular shell used in total hip arthroplasty. The document asserts substantial equivalence to existing predicate devices based on design features, materials, and nonclinical bench testing.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a table format, nor does it provide numerical performance results against such criteria. Instead, it relies on demonstrating equivalence to predicate devices through design similarity and standard mechanical testing.

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

• Sample Size: Not specified. The document states "bench testing was performed" for mechanical tests, but doesn't quantify the number of units tested. For MR conditionality, predicate test results were leveraged, so no new test set was used for the subject device in this regard.
• Data Provenance: The document implies the mechanical bench testing was conducted by MicroPort Orthopedics Inc. The general provenance is regulatory submission data. The studies are non-clinical (bench) studies, not human subject studies, so concepts like "country of origin of the data" or "retrospective/prospective" do not directly apply in the same way they would for clinical trials. The data is generated ex vivo.

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

This section is not applicable as the studies described are non-clinical bench tests. "Ground truth" in this context typically refers to clinical diagnosis or outcomes for human subjects. For mechanical and material testing, the "ground truth" is defined by the physical properties measured against established standards (e.g., ISO, ASTM).

4. Adjudication Method for the Test Set

This section is not applicable as the studies described are non-clinical bench tests. Adjudication methods like "2+1" or "3+1" are relevant for clinical studies where expert consensus is needed to establish ground truth from patient data.

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 section is not applicable. The device described is a physical orthopedic implant (acetabular shell), not an AI/software device that assists human readers in interpreting medical images. Therefore, an MRMC study is outside the scope of this device's evaluation.

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

This section is not applicable. The device is an orthopedic implant, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is established by:

• Standardized Test Methods: Adherence to recognized international and national standards such as ISO 7206 series and ASTM F series (F620, F67, F3090, F1820, F2068, F2052, F2119, F2503, F2182). These standards define how performance characteristics (like fatigue, frictional torque, material properties) are measured and evaluated.
• Material Specifications: Compliance with ASTM standards for material composition (e.g., ASTM F620 for Ti alloy, ASTM F67 for Commercially Pure Ti Foam).

8. The Sample Size for the Training Set

This section is not applicable. As a physical orthopedic implant (not an AI/ML device), there is no "training set" in the context of machine learning. The design and manufacturing process are subject to engineering design principles and quality control, not algorithmic training.

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

This section is not applicable for the same reason as point 8.

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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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