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510(k) Data Aggregation
(217 days)
Sterile NS System
The Sterile NS System is intended for use in selective trauma of the cranial surgery and reconstructive procedures.
The Sterile NS System consists of bone plates in a variety of shapes and sizes, bone screws to secure the plates, and accessories to assist in the operational procedures. The Sterile NS System is made of pure titanium (ASTM F67) and titanium Alloy (ASTM F136). It is intended for use in selective trauma of cranial skeleton, cranial surgery and reconstructive procedures.
The provided text describes a 510(k) premarket notification for a medical device called the "Sterile NS System." This notification seeks to demonstrate substantial equivalence to previously cleared predicate devices. The information provided heavily emphasizes the comparison to predicate devices rather than a standalone study with defined acceptance criteria and performance metrics for the novel device itself.
Based on the provided text, the following information can be extracted and interpreted regarding the "acceptance criteria" and "study."
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" in the traditional sense, such as specific thresholds for sensitivity, specificity, or accuracy for a diagnostic algorithm. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices. The performance is assessed through non-clinical tests to verify compliance with design specifications and standards.
| Acceptance Criteria (Implied by Substantial Equivalence and Non-Clinical Testing) | Reported Device Performance (from "Non-Clinical Test Summary") |
|---|---|
| Functional Equivalence: Same intended use as predicate devices. | "The Sterile NS System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedures." (Same as predicate) |
| Material Equivalence: Same materials as predicate devices. | Plate: Pure titanium Grade4 (ASTM F67); Screw: Titanium alloy (Ti-6AL-4V ELI, ASTM F136) (Same as predicate) |
| Design Feature Equivalence: Same design features (thickness, dimensions, surface) as predicate devices. | Plate: Plate thickness 0.3mm ~ 1.0mm, Surface: Anodized; Screw: Screw Outer Dia. 1.4 ~ 1.8mm, Screw Length 2.2~5.0mm, Surface: N/A (Same as predicate). Compliance ensured by "Dimension test" for both plate and screws. |
| Biocompatibility: Conform to relevant standards. | "Conform" (Same as predicate) |
| Sterilization Efficacy & Safety: New sterilization method (radiation-sterile) does not raise new safety or performance issues compared to predicate's non-sterile (steam sterilization by user). | "The performance test data provided in this submission proves that this differences do not raise new issues in safety and performance." (Specific results of these "performance tests" for sterilization are not detailed in this summary, but are implied to be part of the submission.) |
| Compliance with Standards & Worst Case Criteria: Device meets all design specifications and applicable standards. | "The test results demonstrated that the proposed device complies with the following standards and worst case criteria report." (Specific standards and precise results are not detailed but are stated as met. Implied tests: Dimension test for plate and screws.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "No clinical studies were considered necessary and performed." Therefore, there is no test set in the sense of patient data. The "test set" refers to the physical devices that underwent non-clinical testing. The sample size for these non-clinical tests (e.g., how many plates or screws were dimensionally tested) is not specified in the provided text. The data provenance is also not specified beyond the manufacturer being in Korea.
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)
Not applicable. This device is a physical medical implant, not an AI/diagnostic software, and no human ground truth establishment (e.g., by clinicians or radiologists) is described or relevant for the substantial equivalence claim.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As this is not a diagnostic device involving human interpretation, adjudication methods are not relevant.
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. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" would be the engineering specifications and established standards (e.g., ASTM F67, ASTM F136). The tests (e.g., "Dimension test") verify that the manufactured devices conform to these pre-defined specifications.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
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