(425 days)
ÆQUOS- Knee- Endoprosthesis is intended to provide mobility and reduce pain by replacing the damaged knee joint articulation. Candidates for total knee joint includes patients with a severely painful and/or severly disabled joint resulting from different syndromes.
The indications are:
- . Damaged and seriously damaged and painful knee joints with relevant malfunction, instability or subluxation of the joint
- Therapy resistant bow contracture of more than 20° or non compensable . malposition of the anatomical axis from approximatly 15-20°
- Double sided joint anchylosis or anchylosis of the opposite hip joint ●
- All conservative therapies were unsuccessful or joint conserving operations . provide no success or have already failed
- Failure after implantation of monocondylar implants .
- Stiffening of the joint is contraindicated .
The ÆQUOS knee endoprosthesis consists of:
- Femoral components in anatomic and asymmetrical design a) manufactured from cast CoCr alloy (ASTM F75). Femoral components are intended for cemented use only.
- b) Tibial baseplate in anatomic design manufactured from cast CoCr alloy (ASTM F75). The tibial baseplate is a non-porous, stemmed configuration and intended for cemented use only.
- c) Tibial inserts in anatomic and asymmetrical design manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE)
- d) Tibial spacers
The provided document, K033260, is a 510(k) summary for the ÆQUOS Knee Endoprosthesis, which is a medical device. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices.
Crucially, a 510(k) summary for a knee endoprosthesis does not typically include clinical studies or data on device performance against specific acceptance criteria in the way that an AI/ML medical device submission would. The basis of a 510(k) for this type of device relies on material composition, design, and intended use comparison to predicate devices, along with adherence to recognized performance standards (e.g., ASTM, ISO) for physical and mechanical properties.
Therefore, I cannot extract the information required for the prompt as it pertains to a device cleared through substantial equivalence based on physical and material characteristics, rather than a performance-based clinical study typical of AI/ML devices.
Specifically:
- A table of acceptance criteria and the reported device performance: Not present in this type of submission. Performance is implied by meeting material and design specifications and substantial equivalence to established predicate devices. There are no "reported device performance" metrics like sensitivity, specificity, or accuracy for a knee implant in this context.
- Sample size used for the test set and the data provenance: Not applicable. There isn't a "test set" of clinical cases or data in the context of an AI/ML device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth, as this is not a diagnostic device.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
What is present and relevant to the closest interpretation of "acceptance criteria" for this type of device are:
- Performance Standards: The document states, "Devices are manufactured according to cGMP's, applicable ASTM requirements, and applicable harmonised standards ISO 9001 / EN 46001." These standards define the "acceptance criteria" for the physical and mechanical properties of the implant materials and manufacturing processes.
- Material Composition: ÆQUOS Knee Endoprosthesis components are manufactured of Cobalt Chromium Alloy (ASTM F75) and Ultra-High Molecular Weight PolyEthylene (ISO 5834-2). Adherence to these material standards is an "acceptance criterion."
- Sterilization Validation: Sterilization is validated according to ISO 11137 to achieve a Sterility Assurance Level (SAL) of 10⁻⁶, which is an "acceptance criterion" for sterility.
- Substantial Equivalence: The primary "study" or justification for a 510(k) is demonstrating substantial equivalence to legally marketed predicate devices (Anatomic Total Knee (K000978), Columbus (CR) Total Knee System (K023788), Nexgen Complete Knee Solution Trabecular Metal (K024161), Maxim Accel Knee System (K023546)). The "study" in this case is a comparison of technological characteristics, noting "Æquos is substantially equivalent to the predicate devices with respect to physical/technical and material characteristics."
To reiterate, the provided document does not contain the information requested in the prompt because it pertains to a different category of medical device submission.
§ 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.