(21 days)
The Trilogy® Longevity® Constrained Liner is indicated for primary or revision total hip arthroplasties where there is a high risk of hip dislocation due to a history of instability, bone loss, joint, muscle or tissue laxity, or disease condition. This device is intended for patients for whom all other options to constrained acetabular components have been considered.
The Trilogy Longevity Constrained Liner is a polyethylene/metal acetabular liner, which, when used with a Trilogy or Trabecular Metal ™ Modular Acetabular Shell, forms the acetabular component of a total hip prosthesis. The device consists of a Longevity Highly Crosslinked Polyethylene Liner and a Tivanium ® alloy constraining ring. The liner allows for mechanical capture of the metal femoral head and greater flexion/extension range of motion than hooded constrained liner designs.
The provided text is for a 510(k) premarket notification for a medical device (Trilogy® Longevity® Constrained Liner). It focuses on establishing substantial equivalence to a predicate device based primarily on non-clinical performance (mechanical testing). Therefore, many of the requested details related to clinical studies, human readers, ground truth, and training sets are not applicable or not present in this document.
Here's the breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Mechanical performance of the modified device (Trilogy Longevity Constrained Liner) should be substantially equivalent to the predicate device (Epsilon Durasul Constrained Acetabular Liner). | Mechanical testing of the modified device indicates that it is substantially equivalent to the predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not applicable. The "test set" in this context refers to the samples used for mechanical testing of the device, not a clinical data set. The specific number of devices tested is not provided, only that "mechanical testing" was performed.
- Data Provenance: Not applicable for clinical data. The mechanical testing would have been performed in a laboratory setting, likely in the submitter's (Zimmer, Inc.) facilities in the USA.
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" in this context is not established by human experts interpreting clinical data, but rather by objective measurements from mechanical testing as per relevant standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept primarily applies to clinical studies where expert consensus or agreement is needed for diagnoses or outcomes. Mechanical testing results are objective measurements.
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. A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, as this is a mechanical medical device and not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This is a mechanical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for demonstrating substantial equivalence was based on objective mechanical testing results compared against the predicate device's known performance or established standards for such devices.
8. The sample size for the training set
Not applicable. This device is not an AI or machine learning model that would require a training set.
9. How the ground truth for the training set was established
Not applicable. There was no training set for this device.
§ 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.”