(30 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 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.
The provided document describes the 510(k) premarket notification for the "Cartiva® SCI Disposable Instrumentation Set". This device is orthopedic surgical instrumentation, and the 510(k) is for a modification to allow for a single-use, disposable option, with minor material changes.
It is important to note that this 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device (Cartiva SCI Instrumentation) by showing that the modifications do not raise new questions of safety or effectiveness. Therefore, the "acceptance criteria" and "device performance" in this context refer to the successful completion of various tests to confirm that the disposable set retains the safety and performance of the original, reusable device. There isn't a direct "performance metric" in the typical sense of diagnostic or AI device studies (e.g., sensitivity, specificity).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance/Conclusion |
|---|---|---|
| Biocompatibility | - Cytotoxicity (ISO 10993-5) | "All data demonstrated that the safety and performance of the Cartiva SCI Instrumentation is not affected by the modification to allow for disposable, single-use instrumentation." (Implies successful completion of these tests, meeting ISO 10993-1 requirements.) |
| - Sensitization (ISO 10993-10) | ||
| - Irritation (ISO 10993-10) | ||
| - Toxicity (ISO 10993-11) | ||
| - Pyrogenicity (ISO 10993-11) | ||
| Sterility & Shelf Life | - Terminal sterilization via Gamma radiation | "The Cartiva SCI Disposable Instrumentation Sets are terminally sterilized via Gamma radiation." |
| - Sterilization validation per ISO 11137 and ISO 11737 (Method VDmax25) | "Sterilization validation methodology per ISO 11137 and ISO 11737, Method VDmax25. Sterility Assurance Level is 10-6." | |
| - Sterility Assurance Level (SAL) | "Sterility Assurance Level is 10-6." | |
| - Non-pyrogenic claims verified through ISO Materials Mediated Rabbit Pyrogen testing | "Non-pyrogenic claims for the Cartiva SCI Disposable Instrumentation Sets were verified through ISO Materials Mediated Rabbit Pyrogen testing." | |
| - Shelf-Life testing (accelerated aging per ASTM F 1980) | "Shelf-Life testing was established as 5 years through accelerated aging per ASTM F 1980. Realtime testing is ongoing to assure stability." | |
| Performance/Functional | - Simulated Use Testing of aged product in beyond use conditions to demonstrate functionality | "Simulated Use Testing of aged product in beyond use conditions to demonstrate functionality." "All data demonstrated that the safety and performance of the Cartiva SCI Instrumentation is not affected by the modification to allow for disposable, single-use instrumentation." "the single use set has been demonstrated to provide the same level of performance as the predicate reusable device." |
| - Ship studies per ASTM D4169 | "Ship studies per ASTM D4169." "All data demonstrated that the safety and performance of the Cartiva SCI Instrumentation is not affected by the modification to allow for disposable, single-use instrumentation." "the single use set has been demonstrated to provide the same level of performance as the predicate reusable device." |
2. Sample size 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 exact sample sizes for each test (e.g., number of units tested for biocompatibility, sterility, or functional testing). The provenance of the data (country of origin, retrospective/prospective) is not mentioned beyond the fact that testing was "carried out" and the manufacturer is based in Alpharetta, Georgia, USA. These are laboratory/bench tests, not clinical studies involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. For a device like surgical instrumentation, "ground truth" as it relates to expert consensus on clinical findings is not relevant. The ground truth for these tests is defined by established scientific and regulatory standards (e.g., ISO, ASTM standards) and the physical/chemical properties of the materials and device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. The tests conducted are laboratory-based, objective measurements against established standards, not studies requiring human interpretation or adjudication in the sense of clinical image analysis or diagnosis.
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 question is not applicable. This device is surgical instrumentation, not an AI, diagnostic, or imaging-related device. There was no MRMC study or AI component. The document explicitly states: "A Clinical Evaluation was determined not to be required as the device design, intended use and indication for use are all preserved."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This device is surgical instrumentation. There is no algorithm or AI component involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the various tests, the "ground truth" is defined by the established scientific and regulatory standards themselves (e.g., ISO 10993 for biocompatibility, ISO 11137 for sterilization, ASTM F 1980 for accelerated aging, ASTM D4169 for shipping). The device's performance is measured against the specifications and requirements outlined in these standards.
8. The sample size for the training set
This question is not applicable. This device is surgical instrumentation; there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This question is not applicable. As there is no AI component or training set, this information is irrelevant.
§ 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.