(158 days)
The Ringloc® Constrained Liner is indicated for use as a component of a total hip prosthesis in primary and revision 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, and for whom all other options to constrained acetabular components have been considered.
The Ringloc® Constrained Acetabular Liners are polyethylene liners with a 10° beveled inner edge that, with a locking ring, captures the modular head.
The provided text describes a medical device, the Ringloc® Constrained Liner, and its submission for 510(k) clearance. However, it does not contain information about acceptance criteria, device performance metrics, or a study specifically designed to assess these aspects for a new AI/software device.
The document states:
- Non-Clinical Testing: "Mechanical testing, published medical literature, and engineering justifications determined that the Ringloc® Constrained Liner presented no new risks and is, therefore, substantially equivalent to the predicate device."
- Clinical Testing: "This device was part of the Ringloc® Constrained Liner Clinical Study- IDE #G990138. Please refer to the clinical data in the annual progress report that was submitted to the FDA on March 8, 2002."
This indicates that clinical data exists from an IDE study, but the summary provided does not include the details of that clinical study's acceptance criteria or performance results. It focuses on demonstrating substantial equivalence to a legally marketed predicate device (Johnson & Johnson S-ROM® Poly-Dial Constrained Liner PMA #P960054 and Osteonics Constrained Acetabular Insert PMA #P960047) rather than reporting specific performance metrics against pre-defined acceptance criteria for the new device as would be done for an AI/software device.
Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.
Specifically:
- A table of acceptance criteria and the reported device performance: Not provided. The document relies on substantial equivalence to predicate devices and refers to an IDE study's annual report for clinical data, which is not included here.
- Sample size used for the test set and the data provenance: Not provided. The clinical data is referenced but not detailed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/provided. This is a medical implant, not an AI diagnostic device.
- Adjudication method for the test set: Not applicable/provided.
- 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 device.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI device.
- The type of ground truth used: For mechanical testing, it would be engineering specifications and perhaps bench test results. For clinical testing, it would likely be clinical outcomes (e.g., dislocation rates, revision rates, patient satisfaction), but the specifics are not given.
- The sample size for the training set: Not applicable. This is not an AI device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
§ 888.3310 Hip joint metal/polymer constrained cemented or uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (§ 888.3027).(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Hip Joint Metal/Polymer Constrained Cemented or Uncemented Prosthesis.”