(119 days)
OsteoSymbionics PK Shield (PEEK Patient Specific Cranial Implant) is designed individually for each patient to correct defects in cranial bone.
OsteoSymbionics Patient-Specific Cranial Implant (PEEK), manufactured by OsteoSymbionics, LLC, is a prosthetic cranioplasty implant. Each implant is sized and shaped from one or more pieces to fit the specific patient's cranial skeleton. The devices are manufactured from PEEK and provided non-sterile for sterilization prior to implantation. Implantable prosthetic cranioplasty implants are intended to fill a specific patient's defect, so each device is manufactured one at a time to custom-order based upon the patient's CT scan. The device can be crafted to include perfusion holes (2mm in diameter, spaced 10mm apart) upon surgeon preference (on order sheet). The implants are attached to the native bone with commercially available cranioplasty fasteners.
Here's a breakdown of the acceptance criteria and study information based on the provided K121102 document, organized as requested:
Acceptance Criteria and Study Information for OsteoSymbionics PEEK Patient-Specific Cranial Implant
This device is a PEEK Patient-Specific Cranial Implant, which is a physical medical device, not an AI/software device. Therefore, the questions related to AI performance, ground truth establishment, training sets, and expert adjudication are not applicable in the context of this 510(k) submission. The equivalence is established through material biocompatibility, manufacturing process validation, and mechanical testing, demonstrating comparability to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a physical implant and not an AI-driven diagnostic device, the acceptance criteria are not typically expressed in terms of sensitivity, specificity, or accuracy. Instead, they focus on material properties, manufacturing validation, and mechanical performance comparable to existing devices.
| Acceptance Criteria Category | Specific Criteria (Implicitly Met for Substantial Equivalence) | Reported Device Performance (Summary) |
|---|---|---|
| Material Biocompatibility | PEEK material must be biocompatible for implantation. | "The PEEK materials are shown to be biocompatible..." |
| Manufacturing Process | Manufacturing processes must not introduce risk of contamination. | "...that manufacturing processes do not introduce risk of contamination." |
| Software Validation (for manufacturing) | Software facilitating manufacturing must be validated. | "The software used to facilitate the difference in manufacturing process between the original PMMA device and the PEEK device made by OsteoSymbionics has been validated." |
| Mechanical Performance | Mechanical properties (e.g., strength, durability) must be comparable to predicate devices. | "Mechanical testing has shown the PEEK implant to be comparable to the PMMA implant made by OsteoSymbionics." |
| Sterilization | Sterilization instructions must be validated. | "The sterilization instructions on the instruction for use have been validated." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in terms of patient sample size for performance evaluation. For mechanical and material testing, the "sample size" refers to the number of test specimens. This document does not specify those numbers.
- Data Provenance: Not applicable in the context of clinical data provenance for an AI device. The data refers to material testing, manufacturing process validation, and software validation. Specific locations or retrospective/prospective nature are not detailed, but it would have been conducted as part of the device development and validation process by OsteoSymbionics, LLC.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable, as this is a physical medical implant, not an AI diagnostic device requiring expert-established ground truth from clinical cases.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This type of study is relevant for comparing diagnostic performance of medical imaging interpretation by human readers, often with and without AI assistance. This device is a physical implant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable, as this is a physical medical implant, not an algorithm or software.
7. The Type of Ground Truth Used
The "ground truth" for this device's validation is based on established engineering principles, material science standards, and performance specifications for cranioplasty implants.
- Biocompatibility: Adherence to ISO standards for medical device biocompatibility.
- Mechanical Performance: Comparison to the known mechanical properties of the predicate PMMA implant and other PEEK cranial implants, likely through standardized ASTM or ISO mechanical testing (e.g., strength, fatigue, impact resistance).
- Manufacturing Quality: Validation of the manufacturing process to ensure consistency and sterility.
- Software Validation: Confirmation that the software used in the design and manufacturing process performs as intended.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 882.5330 Preformed nonalterable cranioplasty plate.
(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).