(190 days)
The SISS Inc. (d.b.a. MediSISS) Reprocessed electrosurgical instruments have applications in a variety of minimally invasive surgical procedures to manipulate and manage internal soft tissue by grasping, cutting, and/or to facilitate coagulation. transection, resection, mobilization, and dissections of tissue.
Reprocessed Electrosurgical Instruments mav consist of hand-manipulated devices with electrocautery capability and with or without rotation capability. The distal end of the Ethicon device consists of a scissor distal end configuration. The U.S Surgical device consists of a dissector distal end configuration. The devices are designed to be inserted through an appropriately sized trocar sleeve or cannula. The end effectors are operated by the handpiece handles may be designed to be suppressed and released to activate the instruments end-effector. The device's insulated shaft may be designed to (depending on the device model and type) be rotated (up to 360") either direction (using a knob on the handle.)
This document describes the validation and acceptance criteria for reprocessed electrosurgical instruments by SISS Inc. (d.b.a. MediSISS). This is NOT a study of an AI/ML device, but rather a submission for a 510(k) premarket notification for a medical device. Therefore, many of the requested categories related to AI/ML studies are not applicable.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific quantitative acceptance criteria or detailed numerical performance metrics for individual reprocessed instruments. Instead, it relies on demonstrating substantial equivalence to legally marketed predicate devices and compliance with established standards.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Intended Use | Same as predicate devices. |
| Technological Characteristics | Same as predicate devices (materials, design, energy, performance specifications, methods of operation). |
| Functional Characteristics | Bench testing demonstrated appropriate functional characteristics. |
| Cleaning Validation | Process validation performed. |
| Sterilization Validation | Process validation performed, complying with ANSI/AAMI/ISO 11135-1994, ANSI/AAMI/ISO 10993-7:1995. |
| Packaging Validation | Process validation performed. |
| Biocompatibility | Testing demonstrated equivalence and safety, complying with ANSI/AAMI/ISO 10993-1:1997. |
| Safety and Effectiveness | Demonstrated to be equivalent to predicate devices. |
| Manufacturing Process | Includes 100% visual and mechanical testing of all products prior to packaging, labeling, and sterilization. |
| Compliance with Standards | Complies with ANSI/AAMI/ISO 11135-1994, ANSI/AAMI/ISO 10993-7:1995, ANSI/AAMI/ISO 10993-1:1997. |
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 mentions "representative samples of reprocessed electrosurgical instruments underwent bench testing." It does not specify the exact sample size for these tests. The provenance of the data is prospective, as it involves testing of the reprocessed devices themselves. The country of origin for the testing is not explicitly stated but can be inferred as the U.S. where the company is based and seeking FDA approval.
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)
This is not applicable to this type of device submission. The "ground truth" for reprocessed medical instruments is typically established through adherence to validated cleaning, sterilization, and functional performance protocols, and comparison to validated predicate devices, rather than expert consensus on individual "cases."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like "2+1" or "3+1" are characteristic of human evaluation of data, often in clinical trials or image interpretation studies, which are not described here. The evaluation of reprocessed instruments primarily involves engineering and microbiological testing.
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
This is not applicable. This submission is for a physical medical device (reprocessed electrosurgical instruments), not an AI/ML diagnostic or assistive tool. Therefore, MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the established performance, safety, and effectiveness of the original, legally marketed predicate devices, as well as compliance with relevant international standards for medical device reprocessing (cleaning, sterilization, biocompatibility). It also includes the manufacturer's own validated internal functional and mechanical testing results. The goal is to demonstrate that the reprocessed devices meet these established benchmarks.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of reprocessed physical medical instruments as there's no AI/ML algorithm being developed or trained.
9. How the ground truth for the training set was established
This is not applicable as there is no training set.
§ 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.