(199 days)
The Trilogy Constrained Liner is indicated for use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability and for whom all other options to constrained acetabular components have been considered.
The Trilogy Constrained Liner is a polyethylene liner assembly used in conjunction with a Trilogy Acetabular System metal shell in total hip arthroplasty procedures. The liner consists of two pieces: a liner and a constraining ring. The liner is manufactured from ultra-high molecular-weight polyethylene (UHMWPE) and the constraining ring is manufactured from Tivanium® Ti-6A1-4V Alloy.
The Trilogy Constrained Liner is offered with a 32mm internal diameter and 50-80mm outer diameter sizes. The inner diameter and face of the liner is oblique by 10 degrees resulting in offset and slight eccentricity between the internal and external diameter centers. This resultant offset acts to reduce soft tissue laxity and increase length which can contribute to joint instability. The 10-degree face can be rotated to reposition coverage opposite the direction of anticipated instability.
The provided text is a 510(k) premarket notification for a medical device, the Trilogy® Acetabular System Constrained Liner. It does not contain a detailed study proving the device meets acceptance criteria in the manner typically described for diagnostic or AI-driven medical devices. Instead, it focuses on demonstrating substantial equivalence to a predicate device through manufacturing materials, design, and general testing. Therefore, many of the requested categories for a study on acceptance criteria cannot be directly extracted from this document.
However, I can extract the relevant information that is present and indicate where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from "Comparison to Predicate Devices") | Reported Device Performance |
|---|---|
| Material Composition: Liner manufactured from UHMWPE, constraining ring from titanium alloy. | The Trilogy Constrained Liner's liner is manufactured from ultra-high molecular-weight polyethylene (UHMWPE) and the constraining ring is manufactured from Tivanium® Ti-6A1-4V Alloy. |
| Intended Use/Indications: To replace the bearing surface of the acetabulum in patients at high risk of dislocation. | Indicated for use as a component of a total hip prosthesis in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intraoperative instability. |
| Physical Design/Assembly: Features a constraining ring assembled by the surgeon at the time of surgery. | The device consists of a liner and a constraining ring. The constraining ring is assembled by the surgeon at the time of surgery. |
| Mechanical Performance: Perform as intended and similar to other legally marketed devices. | "Static assembly and lever-out evaluations indicated that this device would perform as intended and similar to other legally marketed devices." |
2. Sample size used for the test set and the data provenance
The document refers to "Static assembly and lever-out evaluations" but does not provide a specific sample size or detailed methodology for these evaluations. It also does not specify data provenance (e.g., country of origin, retrospective or prospective) for these evaluations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The "evaluations" mentioned appear to be mechanical tests rather than assessments by medical experts.
4. Adjudication method for the test set
This information is not provided as the nature of the "evaluations" seems more objective (mechanical testing) than requiring expert adjudication.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable and not mentioned in this document. This is a premarket notification for an orthopedic implant, not a diagnostic or AI-assisted device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation (algorithm only) is not applicable and not mentioned in this document. This is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for the device's performance appears to be established through mechanical testing (static assembly and lever-out evaluations) to demonstrate that it performs as intended and similarly to the predicate device. This is a performance-based ground truth related to the device's physical properties and function, rather than an expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set
This information is not applicable and not provided. The document describes a physical medical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided for the same reason as above.
§ 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.”