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510(k) Data Aggregation
(165 days)
COPAL knee moulds
COPAL® knee moulds are designed to prepare spacers by filling the moulds with bone cement. COPAL® knee moulds are disposable cement spacer mold a temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-stage procedure due to a septic process. The molded temporary knee spacer is indicated for an implantation period of 180 days or less. Because of inherent mechanical limitations of the device material (PALACOS® R+G bone cement), the molded temporary spacer is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.
COPAL® knee moulds are sterile single-use moulds used for the preparation of spacers that are intended as temporary knee replacements as part of two-stage septic joint prosthesis revision.
COPAL® knee moulds comprise a tibial component and a femoral component, which together form a bearing and move aqainst one another. They can be used in both the right and the left knee joint. The spacer function provides that after removal of the prosthesis the existing joint space is retained and contraction of the musculature and the surrounding tissues is prevented.
COPAL® knee moulds are intended for single use and must not be re-used or resterilised.
The provided text does not describe a study involving an AI/Machine Learning (ML) device, but rather a traditional medical device (COPAL® knee moulds). Therefore, many of the requested categories related to AI/ML device performance and testing (e.g., ground truth, MRMC studies, effect size of AI assistance, training set information) are not applicable.
Here's an analysis of the provided information based on the request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance (COPAL® knee moulds) |
|---|---|
| Biocompatibility | Met ISO 10993-1 guidance requirements. Tested for Cytotoxicity, Sensitization, Irritation, Material-mediated Pyrogenicity, Acute Systemic Toxicity. |
| Mechanical & Functional | Demonstrated to be mechanically and functionally similar to predicate devices. Function as intended and are safe and effective. |
| Sterilization | Validated according to ISO 11135, achieving a sterility assurance level (SAL) of 10⁻⁶ via ethylene oxide gassing. Met FDA Guidance document for Sterility Information in 510(k) Submissions. |
| Pyrogenicity | Not performed as not required for this device type (not sterile implantable in contact with non-intact tissue, intravascular, intralymphatic, intrathecal, or intraocular contact). |
| Substantial Equivalence | Demonstrated to be substantially equivalent to predicate devices (Tecres Spacer-K K032522) based on intended use, design, technological characteristics, and performance testing. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for the mechanical, functional, or biocompatibility tests. It also does not provide details on the data provenance in terms of country of origin or whether studies were retrospective or prospective, as these are typically not detailed in 510(k) summaries for this type of device. The studies are laboratory-based tests.
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. This device is a physical medical device, not an AI/ML diagnostic tool requiring expert ground truth for image interpretation or similar tasks. The "ground truth" here refers to established scientific and engineering standards and validated testing methodologies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication of expert opinions for a test set. Acceptance criteria are based on objective, standardized laboratory test results.
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 not an AI-assisted diagnostic tool, so no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance of the COPAL® knee moulds is established by adherence to recognized international and FDA standards for biocompatibility (ISO 10993-1), sterilization (ISO 11135), and general mechanical and functional performance relevant to medical devices of this type. This involves objective measurements against predefined thresholds and specifications, not expert consensus on interpretations.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML algorithm.
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