(36 days)
The ATTUNE Revision Cones are intended for use with the DePuy Revision Knee Systems in a revision total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, posttraumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention.
The ATTUNE Revision cone is to be fixated into either the proximal tibia or distal femur with or without bone cement. After implantation of the mating compatible tibial or femoral component is affixed into the revision cone using bone cement.
THE POROUS TITANIUM ATTUNE REVISION CONES ARE INTENDED FOR CEMENTED OR CEMENTLESS USE.
The ATTUNE® Revision Cones provide supplemental metaphyseal fixation when necessary to make up for either the proximal tibia or distal femur bone loss. The ATTUNE Revision Cones are available in a variety of sizes of Femoral, Concentric, Tibial Tri-Lobe configurations. They are compatible with select, commercially available DePuy Orthopaedics tibial base plates and stemmed femoral components. The ATTUNE Revision Cones are manufactured from Titanium alloy (Ti-6Al-4V).
Here's an analysis of the provided text regarding the acceptance criteria and study for the ATTUNE® Revision Cones, specifically addressing the requested information:
Analysis of the Provided Text:
The document is a 510(k) summary for the ATTUNE® Revision Cones. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device with performance-based acceptance criteria against a specific medical outcome. The submission explicitly states that "Clinical testing was not required to demonstrate substantial equivalence."
Therefore, many of the requested points related to clinical performance, ground truth, and human reader studies are not applicable to this 510(k) submission. The "acceptance criteria" here implicitly refer to meeting the requirements for substantial equivalence by demonstrating similar safety and efficacy through non-clinical testing and comparison to an established predicate.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Similar Indications for Use | The indications for use are stated as "the same as the predicate device" (ATTUNE® Revision Cones K212746). |
| Similar Technological Characteristics | The subject device shares "principle of operation, intended use, classification, design, raw material, and fixation" with the predicate (ATTUNE® Revision Cones K212746). |
| Acceptable Performance in Non-Clinical Testing | Two specific non-clinical tests were performed: * Oxygen Content Study * EOS M290 3D Printer Recycling Study The document concludes that these tests, performed per relevant FDA guidance, "demonstrate substantial equivalence of safety and efficacy with the predicate devices." No specific quantitative performance metrics from these tests are provided in the summary, only the fact that they were conducted and supported substantial equivalence. |
| Material Equivalence (with noted difference) | The subject device uses Titanium alloy (Ti-6Al-4V) with Grade 5 chemistry (ASTM F-2924), while the predicate uses Grade 23 chemistry (ASTM F-3001) of the same alloy. This difference is acknowledged, and presumably, the non-clinical tests address the potential implications of this change to maintain equivalence. |
| Manufacturing Process Equivalence | Both the subject and predicate devices utilize "AFFIXIUM™ 3DP Technology printed titanium porous structure for biological fixation," indicating a consistent manufacturing approach for the porous structure. |
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- This is a 510(k) submission based on non-clinical testing for substantial equivalence, not a clinical study involving a "test set" of patients or data in the traditional sense.
- The "samples" would refer to the physical devices or materials tested in the Oxygen Content Study and EOS M290 3D Printer Recycling Study. The specific number of samples tested for these non-clinical studies is not provided in this summary.
- Data provenance for these engineering tests would typically be from the manufacturer's labs (DePuy Ireland UC). Since clinical data was not required, there is no patient data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. As this is a non-clinical submission for substantial equivalence, there was no "ground truth" to be established by experts in the context of clinical diagnosis or outcome. The "truth" here is compliance with engineering standards and demonstration of equivalence through lab testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. As there is no clinical "test set" requiring interpretation or adjudication, this concept does not apply.
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 revision cone for knee replacement surgery, not an AI or imaging diagnostic device. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical implant, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence rests on:
- Regulatory definitions: Demonstrating that the device meets the criteria set forth in relevant FDA regulations and guidance documents (e.g., 21 CFR 888.3565, and the "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses").
- Engineering standards: The non-clinical tests (Oxygen Content Study, EOS M290 3D Printer Recycling Study) would have a "ground truth" based on established material science and engineering principles, and potentially specified ASTM or ISO standards for material properties and manufacturing processes.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning 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.