(74 days)
The Bioplate® ZIP® Craniotomy Fixation System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. The device is used to align and stabilize bony tissue while normal healing occurs. Each device is intended for single use only and may be combined only with other titanium and titanium alloy implants.
The Bioplate® ZIP® Craniotomy Fixation System consists of two circular caps, in a parallel configuration that is connected by an internal, serrated post. The devices will be available in several sizes with cap diameters in the range of 12mm to 20mm to be used for varying cranial closure techniques.
This document describes the Bioplate® ZIP® Craniotomy Fixation System and its substantial equivalence to predicate devices, focusing on regulatory approval rather than a detailed performance study with acceptance criteria. As such, most of the requested information regarding acceptance criteria, study details, sample sizes, and expert adjudication for a device performance study is not available in the provided text.
The text primarily covers:
- Device identification and classification
- Intended use
- Comparison to predicate devices, stating "All of the technical characteristics are substantially equivalent to the corresponding characteristics of the predicate devices, and any minor differences raise no new issues of safety and efficacy."
- FDA's 510(k) clearance, indicating substantial equivalence to legally marketed predicate devices without requiring a full clinical performance study with specific acceptance criteria.
Therefore, many parts of your request cannot be fulfilled based on the provided input.
Here is the information that can be extracted or deduced:
| Category | Description |
|---|---|
| 1. Acceptance Criteria and Reported Device Performance | Not explicitly stated. The document asserts "substantial equivalence" to predicate devices K013050 and K020088. This implies that the device meets the same performance standards as the predicates, but no specific quantitative acceptance criteria (e.g., in terms of strength, fixation stability, biocompatibility, etc.) or corresponding reported performance values are provided within this text. |
| 2. Sample size and Data Provenance (test set) | Not applicable / Not provided. The 510(k) submission primarily relies on a comparison to predicate devices, not on a new clinical study with a test set that would have a sample size or data provenance. |
| 3. Number and Qualifications of Experts (test set) | Not applicable / Not provided. Ground truth for a test set based on expert opinion is not described. |
| 4. Adjudication Method (test set) | Not applicable / Not provided. No adjudication method for a test set is described. |
| 5. MRMC Comparative Effectiveness Study | No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned. |
| 6. Standalone Performance Study | No. A standalone algorithm-only performance study with human-in-the-loop performance is not mentioned, as this is a physical medical device, not an AI/software device. |
| 7. Type of Ground Truth Used | Not applicable / Not provided. For the 510(k) clearance, the "ground truth" is inferred from the established performance and safety of the legally marketed predicate devices. No specific pathology, outcomes data, or expert consensus serving as ground truth for a new performance study of this specific device's clinical efficacy is detailed. |
| 8. Sample Size for Training Set | Not applicable / Not provided. As this is not an AI/ML device, there are no training sets or associated sample sizes in the context of an algorithm. |
| 9. Ground Truth for Training Set | Not applicable / Not provided. No training set ground truth is established for this type of device. |
§ 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).