(70 days)
The OPTETRAK Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, theumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revious reconstructions where sufficient bone stock and soft tissue integrity are present. In the USA, the OPTETRAK Comprehensive Knee Systems are indicated for cemented use only, except for the OPTETRAK Logic PS and CR Porous Femoral Components, which are indicated for cemented or cementless use.
One Logic femoral components are part of the Optetrak / Optetrak Logic device family and are for use in resurfacing femoral bone as part of tri-compartmental total knee arthroplasty employing modular components.
Cemented One Logic PS femoral components represent modifications to Optetrak Logic Total Knee System femoral components cleared per 510(k) submission K093360. Proposed cemented One Logic CR femoral components represent modifications to Optetrak Logic CR femoral components cleared per 510(k) submissions K111400 and K121307.
Porous-coated PS and CR One Logic femoral components represent modifications to porous PS and CR Optetrak Logic femoral components cleared per 510(k) submission K123687 and can be used in either press-fit or cemented applications.
One Logic femoral components operate using the same fundamental scientific technology, have the same intended use and Indications for Use statements, are offered in the same product size scopes, have the same device compatibility, and are implanted using the same instrumentation and surgical techniques as cited corresponding predicate Optetrak Logic femoral components.
This document is a 510(k) premarket notification for a medical device called "Optetrak One Logic Femoral Components." It's an FDA submission, and as such, it does not contain the kind of detailed study data, acceptance criteria, or ground truth information typical for an AI/ML device performance evaluation as outlined in your request.
The information provided pertains to a traditional medical device (knee replacement components), not an AI-powered diagnostic or predictive tool. Therefore, many of the requested categories are not applicable.
Here's why many of your specific questions cannot be answered from this document:
- AI/ML Device: The device described is a physical knee implant, not an AI/ML software or system. Therefore, concepts like "test set," "training set," "experts to establish ground truth," "adjudication method," "MRMC comparative effectiveness," "standalone performance," and "effect size of human readers with/without AI assistance" are not relevant.
- Acceptance Criteria for Performance: For a mechanical device like this, acceptance criteria typically relate to material properties, mechanical strength, wear resistance, and biocompatibility, rather than diagnostic accuracy metrics (e.g., sensitivity, specificity). The document mentions "mechanical patellofemoral constraint testing," but it doesn't specify the acceptance criteria for this test or the detailed results against those criteria. It only states that the testing was performed and supports substantial equivalence.
- Study Details: The document refers to "engineering studies" and "testing", but it does not provide detailed study protocols, results, or statistical analyses that would allow for a breakdown of sample sizes, data provenance, ground truth establishment, or performance metrics in the way you've requested for an AI/ML device.
However, I can extract the following limited information that is somewhat related to your request, keeping in mind the context of a physical medical device:
1. A table of acceptance criteria and the reported device performance:
This document does not provide a table of acceptance criteria and reported device performance in the manner you've requested for an AI/ML device (e.g., sensitivity, specificity, accuracy against a threshold). For a physical implant, acceptance criteria would typically involve engineering specifications (e.g., material strength, wear rates, fatigue life).
The document states: "This submission includes results for mechanical patellofemoral constraint testing." and "Results of engineering studies referenced in this 510(k) submission demonstrate proposed One Logic devices are substantially equivalent to cited cleared predicate Optetrak Logic devices." This indicates that the device met its performance criteria by demonstrating substantial equivalence to predicates through these engineering tests, but the specific numerical acceptance criteria and performance metrics are not detailed in this summary.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable in the context of an AI/ML test set. For mechanical testing of a physical device, sample sizes would refer to the number of components tested for strength, wear, etc. This information is not detailed in this summary.
- Data Provenance: Not applicable in the context of an AI/ML test set. The "data" here would be mechanical test results from laboratory settings, typically performed by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. "Ground truth" in this context would be defined by engineering specifications and material science standards for the physical implant, not by expert consensus on diagnostic images or data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are used for resolving disagreements among human reviewers of diagnostic data, which is not relevant for mechanical testing of an implant.
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 is an AI/ML specific study type, not relevant for a physical knee implant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is an AI/ML specific performance metric, not relevant for a physical knee implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable in the AI/ML sense. For this device, the "truth" is established by adherence to engineering design specifications, material standards, and performance in standardized mechanical tests, as well as clinical experience with predicate devices.
8. The sample size for the training set:
Not applicable. This is an AI/ML specific concept.
9. How the ground truth for the training set was established:
Not applicable. This is an AI/ML specific concept.
In summary, this document is an FDA 510(k) clearance letter for a conventional medical device (knee implant components) and does not contain the detailed performance study information, acceptance criteria, or ground truth methodologies that would be relevant for an AI/ML-powered device.
§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.