(159 days)
The ADVANCE® Spiked Porous Tibial Base is indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:
- noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or 1) avascular necrosis;
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- inflammatory degenerative joint disease including rheumatoid arthritis;
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- correction of functional deformity:
- revision procedures where other treatments or devices have failed; and 4)
- treatment of fractures that are unmanageable using other techniques. ૨)
The ADVANCE® Spiked Porous Tibial Base is for use without bone cement and is a single use device.
The design features of the ADVANCE® Spiked Porous Tibial Base are described below.
- 4 spikes on the distal surface .
- . Available with or without screw holes
- Manufactured from titanium alloy .
- Titanium porous coating .
This submission describes a medical device, the ADVANCE® Spiked Porous Tibial Base, which is a knee implant component. The provided text is a 510(k) summary for premarket notification to the FDA. For such devices, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of device performance as one might expect for a digital health or AI/ML device is not directly applicable.
Instead, the FDA 510(k) process for devices like the ADVANCE® Spiked Porous Tibial Base relies on demonstrating substantial equivalence to a previously cleared predicate device. This means showing that the new device is as safe and effective as a legally marketed device.
Here's how to interpret the request based on the provided document:
1. A table of acceptance criteria and the reported device performance:
Since this is a substantial equivalence submission for a physical implant, "acceptance criteria" isn't about specific performance metrics like sensitivity, specificity, or accuracy (as it would be for a diagnostic AI). Instead, the "acceptance criteria" are implied by the requirements for substantial equivalence.
| Acceptance Criteria (Implied by Substantial Equivalence via 510(k)) | Reported Device Performance (as demonstrated by the submission) |
|---|---|
| Intended Use Equivalence: The new device has the same intended use as legally marketed predicate device(s). | The ADVANCE® Spiked Porous Tibial Base is indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with conditions such as noninflammatory degenerative joint disease (osteoarthritis, traumatic arthritis, avascular necrosis), inflammatory degenerative joint disease (rheumatoid arthritis), correction of functional deformity, revision procedures, and treatment of unmanageable fractures. This aligns with the generally accepted indications for knee arthroplasty components. The submission states, "The design features, material, and indications for use of the ADVANCE® Spiked Porous Tibial Base are substantially equivalent to previously cleared predicate devices." |
| Technological Characteristics Equivalence: The new device has the same technological characteristics as the predicate device(s), or if there are differences, those differences do not raise different questions of safety and effectiveness. | Design Features: |
- 4 spikes on the distal surface.
- Available with or without screw holes.
- Manufactured from titanium alloy.
- Titanium porous coating.
The submission explicitly states, "The design features of the ADVANCE® Spiked Porous Tibial Base are substantially equivalent to the design features of other devices previously cleared for market."
Materials: Manufactured from titanium alloy with titanium porous coating. The submission states, "The design features, material, and indications for use of the ADVANCE® Spiked Porous Tibial Base are substantially equivalent to previously cleared predicate devices." This implies the material is also equivalent or does not raise new safety/effectiveness concerns. |
| Performance Data: If differences in technological characteristics exist, appropriate data (e.g., non-clinical bench testing, clinical data) are provided to demonstrate that the device is as safe and effective as the predicate device. | The summary states: "The safety and effectiveness of the ADVANCE® Spiked Porous Tibial Base is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification." While specific bench testing results (e.g., fatigue, wear, fixation strength) are not detailed in this summary, the general statement confirms that such data were provided to the FDA as part of the full 510(k) submission to support the claim of substantial equivalence. This type of submission would typically include biomechanical testing relevant to the implant's function and material properties. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
For a 510(k) submission based on substantial equivalence for a physical implant, there is typically no "test set" in the sense of a clinical dataset used to evaluate diagnostic accuracy or AI model performance. The "testing" primarily refers to non-clinical bench testing (e.g., mechanical strength, corrosion, wear) and material characterization, guided by established standards for orthopedic implants.
- Sample Size: Not applicable in the context of a "test set" for performance metrics like AI. For bench testing, samples are typically specimens of the device or its materials. The number of samples would depend on the specific test and relevant ASTM/ISO standards.
- Data Provenance: Not applicable in the context of clinical data. Bench testing is performed in laboratories, not on patient data.
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. There is no concept of "ground truth" established by experts for a test set in a 510(k) for a physical implant. The evaluation is against engineering specifications, material standards, and comparisons to legally marketed predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is relevant for clinical or image-based studies requiring consensus, not for mechanical device equivalence.
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. MRMC studies are used for evaluating diagnostic imaging devices or AI-assisted diagnostic tools, not physical implants.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical knee implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" for this type of device relies on established engineering principles, material science, and the long-term clinical performance and safety profile of the predicate devices. The "truth" is that the device meets safety and performance standards equivalent to similar, already-approved devices.
8. The sample size for the training set:
Not applicable. This device does not involve a "training set" as it is not an AI/ML algorithm.
9. How the ground truth for the training set was established:
Not applicable.
§ 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.