(124 days)
The PEEK Customized Cranial Implant Kit is indicated for the augmentation of bony and/or soft tissue deformities in the cranial and craniofacial skeleton (orbital rim, zygoma, and adjacent bone); including but not limited to, the correction and prevention of persistent temporal hollowing (PTH) in patients 3.5 years of age and older.
The PEEK Customized Cranial Implant Kit product provides a customized cranial or craniofacial patient specific implant solution based on patient CT/CBCT data and surgeon input. This submission is to expand the Stryker PEEK CCI product portfolio to include the single stage option.
The provided text describes a 510(k) premarket notification for the Stryker PEEK Customized Cranial Implant Kit (K203055). This submission expands an existing product portfolio to include a single-stage option. The device is a custom implant for cranial and craniofacial bone and soft tissue deformities.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided document:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | No change in material, duration of contact, or reprocessing methods compared to the predicate device. |
| Sterility | No change in manufacturing processes, materials, or packaging processes compared to the predicate device. |
| Performance Bench Testing - Implant Fit | All V&V activities that were performed met their respective acceptance criteria. All end-user validation tasks were completed, passed successfully, and supports the substantial equivalence of the subject device to the predicate device. |
| Performance Bench Testing - Single Stage Surgical Procedure with/without surgical aid options (Marking guides/guided; Virtual template/Navigation system; w/out surgical aid) | All V&V activities that were performed met their respective acceptance criteria. All end-user validation tasks were completed, passed successfully, and supports the substantial equivalence of the subject device to the predicate device. |
Study Proving Acceptance Criteria:
The study that proves the device meets the acceptance criteria is an End-User Validation Lab as part of Performance Bench Testing. The document explicitly states: "Additionally, an end-user validation lab was conducted to evaluate the subject device and to support the basis for substantial equivalence."
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the sample size (number of implants, tests, or end-users) used for the end-user validation lab.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It describes a "lab" setting, suggesting a controlled, prospective evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. While an "end-user validation lab" implies involvement of relevant personnel (likely surgeons or qualified medical professionals), the number and specific qualifications are not detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
The document does not specify any adjudication method for the end-user validation lab.
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:
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted. This device is a passive implant, not an AI-assisted diagnostic or therapeutic tool.
- Effect Size: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The device itself is an implant, not a standalone algorithm. The "single stage surgical procedure with/without surgical aid options" described in the performance bench testing evaluates the implant's fit and the use of aids, which inherently involves human interaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the end-user validation lab appears to be based on successful completion of tasks and meeting pre-defined acceptance criteria for implant fit and surgical procedure performance, likely evaluated by the participating end-users and study observers. The document doesn't mention pathology or long-term outcomes data for this specific validation.
8. The sample size for the training set:
Not applicable. This device is a physical implant, not an AI or machine learning model that requires a training set in the conventional sense.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device. The design and manufacturing processes are validated against established standards and predicate device characteristics.
§ 882.5320 Preformed alterable cranioplasty plate.
(a)
Identification. A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).