(30 days)
The Implex Continuum Knee Hedrocel® Tibial Spacers are indicated for use in the reconstruction of bony defects in knee reconstruction due to severe degeneration, trauma, or other pathology of the knee joint, and in the revision or salvage of failed, previously reconstructed knee procedures and implants. This device is intended for cemented use only.
Not Found
The provided document is a 510(k) premarket notification for a medical device (Implex Continuum Knee System Hedrocel® Tibial Spacers), not a study evaluating device performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, experts, and MRMC studies cannot be extracted from this document.
However, I can extract the following limited information:
1. Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria for the device. Instead, it relies on a statement that "Previous testing of the Hedrocel® porous tantalum demonstrates that Hedrocel® should function as intended."
| Criteria Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional Performance | Not specified | "should function as intended" based on previous testing of the Hedrocel® porous tantalum. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified, other than "Previous testing of the Hedrocel® porous tantalum." It does not mention country of origin or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The document does not describe a study involving expert assessment of device performance or ground truth establishment in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No such study or adjudication method is described.
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 device is a physical implant (tibial spacer), not an AI diagnostic tool involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not explicitly stated. The performance is based on "Previous testing of the Hedrocel® porous tantalum," which likely refers to biomechanical, biocompatibility, and material properties testing, rather than clinical ground truth like pathology or outcomes data in the context of diagnostic accuracy.
8. The sample size for the training set:
Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this device type.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.