Search Results
Found 1 results
510(k) Data Aggregation
(669 days)
Speedy Flap System is intended for use in the fixation of cranioplasty plates, and fixation of cranial fractures.
The Speedy Flap is designed for the fixation of cranioplasty plates, covering burr holes, and fixation of cranial fractures. This device is made of the Titanium Alloy (ASTM F136). The Speedy Flap is composed of three parts: upper plate, lower plate and rod. This device supplied sterile and single use only.
The provided text describes the "Speedy Flap System", a medical device for cranioplasty plate and cranial fracture fixation, and its comparison to predicate devices, CranioFix and CranioFix 2 Titanium Clamp Systems, for 510(k) clearance. This means the studies conducted are primarily non-clinical, mechanical, and material tests to demonstrate substantial equivalence, rather than clinical studies on human performance or AI effectiveness. Therefore, many of the requested points related to AI, human readers, and ground truth in a clinical context are not applicable.
Here's the information extracted and organized based on your request, with "N/A" for inapplicable points:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance (Speedy Flap System) |
|---|---|---|
| Dimension Test | Within ±5% error range | Within ±5% |
| Movement Force Test | Performance comparable to or better than predicate device (CranioFix 2) | SF-12F: 141N; SF-20F: 98N (Predicate: 11mm: 94N, 20mm: 96N) - Higher, thus better |
| Separation Force Test | Performance comparable to or better than predicate device (CranioFix 2) | SF-12F: 323N; SF-20F: 198N (Predicate: 11mm: 312N, 20mm: 147N) - Higher, thus better |
| Separation Force testing before and after rod cutting | No significant change in separation force after rod cutting | No significant change; supports upper disk will not loosen |
| Climatic conditioning, Package performance, Visual inspections, Gross leak detection (bubble) and seal strength (peel) testing | No anomalies; suitability of package configuration for distribution environment | No anomalies; suitable package configuration confirmed |
| Chemical Analysis (Qualitative analysis of organic residual) | No other elements on the surface other than raw material elements; no residual detected | No other elements on surface besides titanium alloy; no residual detected |
| Shelf Life Test (Accelerated and real-time) | Product meets all acceptance criteria after aging (3-year shelf life) | Product met all acceptance criteria |
| Sterilization Validation Test | Sterilization method validated as effective | Sterilization method validated as effective through study |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" in the context of clinical data. The tests performed are non-clinical, mechanical, and material tests. The sample sizes for these tests (e.g., number of devices tested for movement force, separation force) are not explicitly stated in the summary, nor is the provenance of "data" in terms of country of origin or retrospective/prospective. The data is generated from laboratory testing of the physical devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. As this is a non-clinical device clearance, there is no "ground truth" established by medical experts in the context of diagnostic or treatment performance on human cases. The ground truth for mechanical/material tests is derived from engineering standards and measurements.
4. Adjudication method for the test set
N/A. There is no "adjudication method" described as the tests are for physical properties against defined standards, not for interpretation of medical images or patient outcomes.
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
N/A. This device is a physical medical implant, not an AI-assisted diagnostic or treatment system. Therefore, an MRMC study and AI-related effectiveness are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for the non-clinical tests is based on:
- Engineering specifications and measurements: For dimension, movement force, and separation force.
- Established standards: Such as ASTM D4332-13, ASTM F136-11, ISO 11137-1, etc., for package integrity, material composition, and sterilization validation.
- Visual inspection and chemical analysis results: For material integrity and cleanliness.
8. The sample size for the training set
N/A. There is no concept of a "training set" in the context of this device's non-clinical safety and effectiveness testing.
9. How the ground truth for the training set was established
N/A. As there is no training set, this question is not applicable.
Ask a specific question about this device
Page 1 of 1