(183 days)
The Stryker CMF MEDPOR Customized Implant is intended for the augmentation or restoration of bony contour in craniofacial defects.
The Stryker CMF MEDPOR Customized Implant is sold as a kit of two identical implants plus one host bone model. The customized craniofacial implant is molded from porous high density polyethylenc (HDPE) to the specific dimensions indicated by the surgeon via submission of CT scans. The porous HDPE Implant is fixed into place using compatible Stryker screws.
The provided text details a 510(k) submission for the Stryker CMF MEDPOR Customized Implant. This is a traditional 510(k) for a medical device (implant), not an AI/ML software. Therefore, the typical "acceptance criteria and study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (such as sensitivity, specificity, F1-score, etc.) and studies with ground truth established by experts, MRMC studies, or standalone algorithm performance are not applicable here.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through various non-clinical performance data.
Here's a breakdown of the requested information based on the provided text, adapted to the context of a medical implant:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria/Tests Performed | Reported Device Performance (Summary from text) |
|---|---|---|
| Material Equivalence | - Biocompatibility testing (ISO 10993-1, ISO 10993-5) | Demonstrated by clearance of predicate devices and in vitro cytotoxicity testing performed per ISO 10993-5. |
| Sterilization Efficacy | - Sterilization (ISO 11135, ISO 11137, ISO 11737) | Performed in accordance with specified ISO standards. |
| - EO residuals testing (ISO 10993-7) | Performed per ISO 10993-7. | |
| - Pyrogenicity testing (LAL per AAMI ST72) | Performed via LAL according to AAMI ST72. | |
| Manufacturing/Design Process Validation | - Virtual Implant Design Process (VIDP) Validation | Validation performed, mirroring original VIDP Validation (cleared under K103010). |
| Product Integrity/Packaging | - Packaging validations (ISO 11607, ASTM F1886, F1929, D642, F88) | Performed to ensure sterility maintained throughout shelf life. |
| - Ship testing (ISO 11607, ASTM F1886, F1929, D642, F88) | Performed to ensure sterility maintained throughout shelf life. | |
| Functional Equivalence | - Bench testing (to demonstrate equivalence to predicate devices) | Performed to demonstrate equivalence of the subject device to the predicate devices. |
| Safety and Effectiveness | - No new clinical testing required | It was determined that none of the modifications impact safety and 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 applicable to this type of submission. The performance data is based on bench testing of the physical implant, manufacturing process validation, and biocompatibility testing, not on clinical patient data in the way an AI/ML study would utilize it. No "test set" in the context of patient data is mentioned.
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 is not applicable. Ground truth for an AI/ML model is established by experts reviewing data. For a medical implant, "ground truth" relates to material properties, strength, sterility, and biocompatibility, which are verified through laboratory tests and engineering validations, not expert consensus on medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used in clinical studies or expert review processes, which are not described here.
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. MRMC studies are specific to evaluating diagnostic devices, especially those involving human interpretation, often in conjunction with AI. This submission is for a physical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is derived from:
- Standards Compliance: Demonstrating adherence to established ISO and ASTM standards for biocompatibility, sterilization, packaging, and pyrogenicity.
- Bench Test Results: Objective measurements of the implant's physical and mechanical properties.
- Validation of Manufacturing Processes: Ensuring that the Virtual Implant Design Process (VIDP) consistently produces implants to specifications.
- Predicate Device Data: Leveraging the safety and effectiveness data of previously cleared, substantially equivalent devices.
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of device submission.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth established for it.
§ 878.3550 Chin prosthesis.
(a)
Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.(b)
Classification. Class II.