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510(k) Data Aggregation
(204 days)
Key Surgical, Inc.
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(15 days)
KEY SURGICAL, INC.
The disposable cautery tip cleaner is a single use sterile device intended to be used as an electrosurgical accessory to remove eschar buildup from the tips of electrosurgical cauterization blades during surgical procedures.
The disposable cautery tip cleaner is a 50mm by 50mm small foam pad with an abrasive surface, and adhesive back layer, which are used to aid in the removal of eschar on electrosurgical blades during surgical procedures. The abrasive surface is made from aluminum oxide 'gravel', with a polyurethane foam pad and polyurethane adhesive layer containing a barium monofilament for x-ray detection. The adhesive back allows for universal placement and keeps the device in place while the tip of the electrosurgical cauterization device is scratched on the abrasive surface to remove eschar buildup. The product does not come in contact with the patient, is provided sterile and is single-use.
The document discusses the Key Surgical® Cautery Tip Cleaner and its substantial equivalence to a predicate device. It addresses performance data primarily for sterility, functional aspects, and packaging, rather than diagnostic accuracy or AI assistance.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Requirement | Specification | Reported Performance |
|---|---|---|
| Sterility | SAL 10-6 | Pass |
| Functional Requirements | Product adhesive backing must be easily removed | Pass |
| Packaging (Vacuum leak test) | ISO 11607, ASTMF 1980 | Pass |
| Packaging (Dye penetration test) | ASTMF 1929, ASTMF 1980 | Pass |
| Packaging (Agar contact-attack test) | ISO 11607, ASTMF 1980 | Pass |
| Packaging (Tensile seal strength test) | ASTMF 88, ASTMF 1980 | Pass |
| Packaging (Accelerated aging test) | ASTMF 1980, ISO 11737 | Pass |
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 does not specify the sample sizes used for each test or the data provenance (country of origin, retrospective/prospective). The tests listed are for device manufacturing and packaging quality, not for clinical performance on patients directly.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The tests performed are engineering and manufacturing quality control tests (e.g., sterility, adhesive function, packaging integrity), not clinical studies requiring expert interpretation of results to establish ground truth for a diagnostic or AI-assisted device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically relevant for clinical studies where multiple experts evaluate cases and discrepancies need to be resolved. This document describes tests for product quality where results are determined by standardized methods.
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. The device is a "Cautery Tip Cleaner," a physical accessory for surgical tools, not a diagnostic imaging device or an AI-assisted tool requiring human interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or software; it is a physical medical accessory.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the tests described are the established specifications and methods outlined in recognized standards (e.g., ISO 11137-2, ISO 11607, ASTM F series). For example:
- Sterility: Ground truth is defined by the SAL 10-6 specification, confirmed using ISO 11137-2 methods.
- Functional (adhesive removal): Ground truth is the observable characteristic of being "easily removed," likely assessed against internal engineering standards.
- Packaging: Ground truth is the successful adherence to specific physical properties and integrity tests as defined by the cited ISO and ASTM standards.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."
9. How the ground truth for the training set was established
Not applicable. Since there is no training set, there is no ground truth to establish for it.
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