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The Ringloc® Constrained Liners II are indicated for use as a component of a total hip prosthesis in primary and revision patients at high risk of dislocation due to a history of prior dislocation, bone loss, joint or soft tissue laxity, neuromuscular disease, or intra-operative instability, and for whom all other options to constrained acetabular components have been considered.

The Ringloc® Constrained Acetabular Liners II are polyethylene liners with a 10° beveled inner edge that, with a locking ring, captures the modular head. The modifications made to the new devices include a thicker locking ring, increase in polyethylene around the ring groove on the liner, and a thicker polyethylene bummer on the liner.

This document is a 510(k) premarket notification for a hip implant device, the Ringloc® Constrained Liner II. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with defined performance metrics. Therefore, much of the requested information regarding acceptance criteria, specific device performance numbers, and detailed study designs (like MRMC, standalone performance, training/test set details, and expert qualifications) is not present in this type of submission.

Here's a breakdown of what can be extracted and what is not available based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated as numerical performance targets (e.g., specific thresholds for wear, fatigue life, or dislocation rates). The 510(k) process for this device relies on demonstrating substantial equivalence to predicate devices. The "acceptance criteria" here are implicitly related to demonstrating that the modifications (thicker locking ring, increased polyethylene around the ring groove, thicker polyethylene bumper) do not introduce new risks and that the device performs similarly to or better than the predicate devices in terms of mechanical integrity and clinical function.
• Reported Device Performance:
  • The document states: "Mechanical testing, published medical literature, and engineering justifications determined that the Ringloc® Constrained Liners II presented no new risks and are, therefore, substantially equivalent to the predicate device."
  • This indicates that the device met the implicit acceptance criteria of demonstrating no new risks and substantial equivalence through these methods. No specific numerical performance results (e.g., wear rate in mm/year, fatigue cycles to failure) are provided in this summary.

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

• Sample Size: Not explicitly mentioned in terms of a specific number of devices tested for each mechanical test. The statement "Mechanical testing" is broad.
• Data Provenance: The document refers to "published medical literature" and "engineering justifications" as part of the evidence. For clinical data, it notes, "The device in this 510(k) premarket notification is a modification of the device that was part of an approved IDE study for the Ringloc® Constrained Liner-#G990138." This implies the original design had prospective clinical data, but for this modified version, new clinical studies were not required for 510(k) clearance due to the nature of the modifications and reliance on equivalence.

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

• This type of information is generally not applicable to a 510(k) clearance for a mechanical orthopedic device. "Ground truth" in this context would relate to the physical and mechanical properties of the device, established through standardized engineering tests, not expert interpretation of images or clinical outcomes in the same way as an AI diagnostic device.

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

• Not applicable. Adjudication methods are typically for subjective assessments or disagreements in clinical trials or image interpretation, which are not detailed for this 510(k).

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-assisted 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 algorithm.

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

• For the non-clinical testing, the "ground truth" would be the established mechanical properties (e.g., strength, wear resistance, fatigue life) of the device, determined through standardized engineering tests according to relevant ASTM or ISO standards.
• For the clinical aspect, the reliance on the "approved IDE study for the Ringloc® Constrained Liner-#G990138" suggests that the original design had clinical outcomes data, which would have served as the "ground truth" for its safety and effectiveness. The modifications in this 510(k) were deemed not to change the fundamental safety and effectiveness profile such that new extensive clinical data was required.

8. The sample size for the training set:

• Not applicable. This is not a machine learning or AI device that undergoes "training."

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

• Not applicable.

In summary:

This 510(k) submission for the Ringloc® Constrained Liner II establishes substantial equivalence to predicate devices based on:

• Mechanical Testing: Performed to show that the modified design does not introduce new risks. Specific test results (e.g., specific load capacities, wear rates) are not provided in this summary but would have been part of the full submission.
• Engineering Justifications: Likely detailed comparisons of the new design features with the predicate devices and the original Ringloc® Constrained Liner to argue that the changes improve or maintain performance without new risks.
• Published Medical Literature: Used to support the general safety and effectiveness of similar constrained liners.
• Reference to an approved IDE study (G990138): For the original Ringloc® Constrained Liner, indicating prior clinical evidence of safety and effectiveness, which supports the modified device through equivalence.

The "acceptance criteria" were met by demonstrating that the modifications did not negate the substantial equivalence to the predicate devices and that the device presented "no new risks," primarily through non-clinical mechanical testing and engineering analysis.

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