(53 days)
The reprocessed scissor tips are intended to be used with a reusable hand piece and are designed for use in mininally invasive and/or open surgical procedures to facilitate cutting, preparation, mobilization and coagulation of tissue.
SterilMed's reprocessed scissor tips are laparoscopic electric devices that are inserted into a reusable hand piece and are designed to be used in laparoscopic and open surgical procedures to facilitate coagulation, preparation, mobilization and cutting of tissue. The devices are monopolar and have a cautery connector on the handle or a connector cable. These devices were originally manufactured by Aesculap (Braun), Encision, Microline, and Snowden Pencer. Note: Only the scissor tip is the subject of this submission, the reusable hand piece, the cautery cable and the generator are not included in the scope of this submission.
Here's an analysis of the provided text regarding the acceptance criteria and study for SterilMed's Reprocessed Scissor Tips.
However, it's important to note that the provided document is a 510(k) Premarket Notification Summary for a medical device reprocessing company. These submissions focus on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy or safety through traditional clinical trials or AI performance metrics. Therefore, many of your requested points regarding AI, ground truth, and expert studies are not applicable to this type of regulatory submission and device.
This document primarily discusses functional and safety testing to ensure the reprocessed device performs like the original, new device.
Acceptance Criteria and Device Performance for Reprocessed Scissor Tips
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Functional Characteristics | "Appropriate functional characteristics" (e.g., cutting ability, coagulation effectiveness, mechanical integrity, proper fit with handpiece) | "Representative samples of reprocessed scissor tips were tested to demonstrate appropriate functional characteristics." |
| Cleaning Procedures | Validation of cleaning effectiveness (e.g., removal of biological debris, prevention of cross-contamination) | "Process validation testing was performed to validate the cleaning... procedures." |
| Sterilization Procedures | Validation of sterilization effectiveness (e.g., achievement of sterility assurance level) | "Process validation testing was performed to validate the... sterilization procedures." |
| Device Packaging | Validation of packaging integrity (e.g., maintaining sterility, protection during transport) | "Process validation testing was performed to validate the... device packaging." |
| Visual Inspection | Meeting predefined visual quality standards (e.g., absence of damage, corrosion, residue) | "the manufacturing process includes visual and validated functional testing of all products produced." |
| Method of Construction | Maintaining material properties and design similarity to predicate devices. | "This conclusion is based upon the devices' similarities in functional design (principle of operation), materials, indications for use and methods of construction." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states "Representative samples of reprocessed scissor tips were tested." No specific numerical sample size is provided. The types of scissor tips reprocessed are listed (Aesculap, Encision, Microline, Snowden Pencer, with several models each), suggesting samples were drawn from these variations.
- Data Provenance: The testing was performed by SterilMed, Inc. It is retrospective in the sense that the reprocessed devices are compared to the performance characteristics of the original new devices (predicates). The country of origin for the data generation would be the United States (Maple Grove, MN, where SterilMed is located).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This document describes functional and process validation testing of physical medical devices, not a study involving human expert interpretation of data (like imaging or clinical diagnoses). "Ground truth" for these tests would likely involve objective measurements and established engineering/scientific standards rather than expert consensus on interpretation.
4. Adjudication Method for the Test Set
- Not Applicable. As there are no human experts interpreting subjective data, an adjudication method for consensus is not relevant here. The testing involves objective measurements against established specifications.
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 a regulatory submission for reprocessed surgical scissor tips, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. As above, this is not an AI-driven device.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- The "ground truth" implicitly used for the functional and safety testing of these reprocessed devices is the performance specifications and characteristics of the original, new predicate devices, as well as established engineering and scientific standards for cleaning, sterilization, and material integrity. For example, a "ground truth" for cutting ability would be that it must perform as well as a new scissor tip, and sterility "ground truth" would be an acceptable sterility assurance level (SAL).
8. The Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of this device and submission. The performance of the reprocessed devices is validated against the known performance of new devices, not by training an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set, this question is not relevant.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.