(49 days)
The Trabecular Metal Revision Shell Liner is indicated for cemented use in the Trabecular Metal Revision Shell for initial placement or as an in situ replacement polyethylene bearing surface for joint instability, wear and/or damage.
This modified device is intended for cemented use in conjunction with a Trabecular Metal Revision Shell. The liner is offered in a broad range of sizes with 0- and 10-degree face angle versions to accommodate a variety of patient anatomies.
The provided text describes a 510(k) premarket notification for a medical device called "Trabecular Metal™ Revision Shell Liners." This submission is a "Special 510(k): Device Modification" and relies on substantial equivalence to a predicate device.
Here's an analysis of the requested information based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of specific performance thresholds for sensitivity, specificity, or similar metrics. Instead, it focuses on substantial equivalence to a predicate device.
The reported device performance comes from non-clinical testing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device | Non-clinical testing demonstrated that the Trabecular Metal Revision Shell Liners are substantially equivalent to the predicate device. |
Note on Acceptance Criteria: For a 510(k) submission, especially a Special 510(k) for device modification, the primary "acceptance criterion" is often demonstrating that the modified device is as safe and effective as a legally marketed predicate device, and that any changes do not raise new questions of safety or effectiveness. This is typically achieved through comparative testing against the predicate or relevant standards.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document states "Non-clinical testing demonstrated that the Trabecular Metal Revision Shell Liners are substantially equivalent to the predicate device." It does not provide details on the number of units tested, the specific tests conducted, or the sample size used in those tests.
- Data Provenance: The tests are described as "Non-clinical Performance," suggesting laboratory or bench testing. The country of origin of the data is not specified, but the submitter (Zimmer, Inc.) is based in Warsaw, IN, USA. The data is implicitly retrospective in the sense that the testing was performed and then reported, but it is not clinical data derived from patients.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This device is not an AI/ML device, and the evaluation relies on non-clinical performance testing rather than expert-derived ground truth from interpreting images or patient data.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this is about non-clinical performance (bench testing), not expert consensus on interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data and conclusions were not needed for this device."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) study was done
Not applicable. This is not an AI/ML device with an algorithm for standalone performance.
7. The Type of Ground Truth Used
The "ground truth" for this submission is implicitly established by established engineering and material science principles and performance standards. The non-clinical testing would have been designed to measure physical and mechanical properties relevant to the device's function and safety, comparing them to the predicate device and potentially relevant ASTM or ISO standards.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/ML device that requires a training set.
In summary, this document describes a traditional medical device submission (a Special 510(k) for a modification) that relies on non-clinical bench testing to demonstrate substantial equivalence to a predicate device. It does not involve AI/ML components, clinical studies, or expert-derived ground truth, which are typically found in submissions for AI-enabled devices.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.