(13 days)
The OPTETRAK® Total Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. CAUTION: For cemented use only in the USA.
Like the original Optetrak stem extensions, the proposed Optetrak Straight Stem Extension additional sizes are composed of Titanium alloy (ASTM F-1472). The proposed stem extensions have the same Morse taper call out and flute that the existing stem extensions offer. The design incorporates the same design features as the predicate Optetrak stem extensions over new lengths and diameters to create a complete range of sizes for the surgeon. The proposed Straight Stem Extension Line Extensions are fully compatible with the existing Optetrak Tibial Trapezoid trays (#K933610) and the Constrained Condlyar Femoral Component and bushing (#K954208).
The provided document describes a Special 510(k) submission for additional sizes of the Exactech Optetrak Total Knee System Stem Extensions. This type of submission relies heavily on demonstrating substantial equivalence to a predicate device, often by showing that the new device shares the same fundamental technology, materials, and intended use, and that any minor differences do not raise new questions of safety or effectiveness.
Crucially, this submission does not contain a clinical study or performance data that would typically be described with acceptance criteria, sample sizes, expert ground truth, or adjudication methods as commonly found in AI/ML device evaluations.
Instead, the submission states:
"The design assurance reviews for the proposed products did not indicate the need for additional testing since the parts were so comparable to the existing Exactech stem extensions and no new failure modes were identified. According to analytical analysis the proposed stem extension components showed that the stem extension strength was independent of length and diameter. Therefore, the proposed stem extensions should have the similar clinical results to the existing Exactech straight stem extensions." (Section 3)
This means the "study" proving the device meets acceptance criteria is based on analytical analysis and a comparison to predicate devices, rather than a clinical trial or algorithm performance study.
Given this context, I will address your specific points based on the available information:
1. A table of acceptance criteria and the reported device performance
Since this is a submission for additional sizes of an existing PREDICATE device, the "acceptance criteria" are not reported as specific performance metrics in a clinical study. Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device.
| Acceptance Criteria (Implicit from Substantial Equivalence Basis) | Reported Device Performance (as stated in the 510(k)) |
|---|---|
| Design comparability to predicate device (e.g., materials, Morse taper, flute design) | "The proposed stem extensions have the same Morse taper call out and flute that the existing stem extensions offer. The design incorporates the same design features as the predicate Optetrak stem extensions over new lengths and diameters to create a complete range of sizes for the surgeon." (Section 2) |
| Material composition equivalent to predicate device | "Like the original Optetrak stem extensions, the proposed Optetrak Straight Stem Extension additional sizes are composed of Titanium alloy (ASTM F-1472)." (Section 2) |
| Functional equivalence: expected similar strength and clinical outcomes to predicate device. | "According to analytical analysis the proposed stem extension components showed that the stem extension strength was independent of length and diameter. Therefore, the proposed stem extensions should have the similar clinical results to the existing Exactech straight stem extensions." (Section 3) |
| Compatibility with existing components | "The proposed Straight Stem Extension Line Extensions are fully compatible with the existing Optetrak Tibial Trapezoid trays (#K933610) and the Constrained Condlyar Femoral Component and bushing (#K954208)." (Section 2) |
| No new failure modes identified compared to predicate device | "The design assurance reviews for the proposed products did not indicate the need for additional testing since... no new failure modes were identified." (Section 3) |
| Sterilization effectiveness (implicit) | Method: Gamma radiation (Cobalt 60 source); Dose: 25 - 37 kGy; Sterility Assurance Level (SAL): 10^-6 (Section 2) - This confirms the sterilization method, but its effectiveness is assumed to be comparable to predicate devices using similar methods. |
Regarding the remaining points, they do not apply to this type of 510(k) submission, as it is not an AI/ML device or a device requiring a clinical performance study with human readers or structured ground truth annotation.
Here's why:
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No test set or clinical data was used in the manner of an AI/ML or clinical performance study. The evaluation was based on analytical comparison to a predicate device.
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. No expert review of a test set was conducted for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication was used.
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 a medical implant, not an AI-assisted diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. Ground truth in the context of clinical data or AI performance is not relevant here. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate device (the original Optetrak stem extensions).
8. The sample size for the training set
Not applicable. This is a physical medical device; there is no "training set" in the AI/ML sense.
9. How the ground truth for the training set was established
Not applicable. As above, no training set or associated ground truth.
§ 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.