(26 days)
Orthopedic surgical instrumentation supplied by Cartiva, Inc. is indicated for use in the press-fit fixation of the implantable medical device products manufactured by Cartiva, Inc.
Orthopedic surgical instruments designed for osteochondral implants with press-fit fixation are devices intended to manipulate bone and cartilage tissue or the implant for the positioning, alignment, defect creation, and placement of press-fit osteochondral implants that utilize no additional means of fixation (e.g., suture fixation, adhesives). This type of device includes instruments specific to the geometry of the implant.
The provided text describes a 510(k) premarket notification for the Cartiva® SCI Reusable Instrumentation Set. This submission is for orthopedic surgical instrumentation, specifically an instrumentation set, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device studies (such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information) are not applicable to this document.
The document focuses on demonstrating substantial equivalence to a predicate device for this instrumentation set, specifically the addition of two new sizes (6mm and 12mm) to an existing product line.
Here's an analysis of the provided information, tailored to the context of a medical instrumentation submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Type of Testing) | Reported Device Performance (Summary of Results) |
|---|---|
| Biocompatibility per ISO 10993-1 | Cytotoxicity (ISO 10993-5): Data demonstrated safety. |
| Sensitization (ISO 10993-10): Data demonstrated safety. | |
| Irritation (ISO 10993-10): Data demonstrated safety. | |
| Reprocessing | |
| - Cleaning validation | Cleaning validation per AAMI TIR30 and AAMI TIR12: Data demonstrated safety and performance was not affected. |
| - Sterilization validation | Sterilization validation per AAMI TIR39, ISO 17665-1 and ANSI/AAMI ST79: Data demonstrated safety and performance was not affected. |
| Performance/Functional Testing | |
| - Ship studies | Ship studies per ASTM D4169: Data demonstrated functionality. |
| - Simulated Use Testing | Simulated Use Testing in beyond use conditions to demonstrate functionality: Data demonstrated functionality. |
| Overall Conclusion | All data demonstrated that the safety and performance of the Cartiva SCI Reusable Instrumentation is not affected by the proposed modification to add two additional sizes, 6mm and 12mm, to the Cartiva existing reusable instrumentation product line. The new Cartiva SCI Reusable Instrumentation sizes 6mm and 12mm have demonstrated to provide the same level of performance as the predicate device, Cartiva SCI Instrumentation. The modification does not raise any new questions of safety or effectiveness. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The filing is for a physical medical device (instrumentation set), and the "testing" performed relates to material properties, cleaning, sterilization, and basic functionality, not clinical performance with a test set of data in the way an AI/ML device would be evaluated. The tests performed are likely in vitro and bench-top studies.
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)
This information is not applicable as the device is an instrumentation set and does not involve AI/ML or diagnostic assessment that would require clinician-established ground truth. Expert involvement would be in the design, testing protocols, and assessment of physical device performance, but not in establishing ground truth for diagnostic accuracy.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable for the same reasons as point 3.
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
This information is not applicable. The device is an instrumentation set, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable as the device is an instrumentation set, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable for the clinical context as the device is an instrumentation set. For the engineering performance testing, the "ground truth" would be established by validated test methods (e.g., ISO, AAMI, ASTM standards) against predetermined specifications for material properties, sterility assurance levels, cleaning efficacy, and functional integrity.
8. The sample size for the training set
This information is not applicable as the device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
§ 888.4505 Orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation.
(a)
Identification. Orthopedic surgical instruments designed for osteochondral implants with press-fit fixation are hand-held devices intended to manipulate bone and cartilage tissue or the implant for the positioning, alignment, defect creation, and placement of press-fit osteochondral implants that utilize no additional means of fixation (e.g., suture fixation, adhesives). This type of device includes instruments specific to the geometry of the implant.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9. The special controls for this device are:(1) Technical specifications regarding geometry of the instruments must be specified and validated to demonstrate that the instruments can safely position and place the implant.
(2) The patient contacting components of the device must be demonstrated to be biocompatible.
(3) Labeling must include:
(i) Identification of implant(s) and instruments which have been validated for use together; and
(ii) Validated methods and instructions for reprocessing any reusable parts.