FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The subject device is a manual instrument for endoscopic or open surgical procedures. It employs a trigger handle design with an actuation lever and 5mm shaft. A rod at the end of the shaft engages the underside of the staple and pulls it inside the shaft when the lever is actuated. When the lever is released, the staple is release from within the device. The instrument is re-useable and is sterilized by steam autoclave.

AI/ML Overview

This document, K010620, is a 510(k) summary for the Salute staple removal instrument. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, this document does not contain the detailed information necessary to answer your specific questions about acceptance criteria and a study proving those criteria are met.

Here's why and what information is available:

No Acceptance Criteria or Performance Data: The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device by comparing technical aspects and intended use. It does not present specific quantitative acceptance criteria (e.g., a specific success rate or precision/recall metric) or the results of a study designed to meet such criteria. It's likely that performance was demonstrated through bench testing and a comparison to the predicate device, rather than a formal clinical trial with defined acceptance criteria for a new AI/software device.
Device Type: This device is an "Endoscopic Staple Removal Instrument," which is a physical, reusable surgical instrument, not an AI or software-based diagnostic device. Therefore, many of your questions, such as those related to AI algorithm performance (standalone, MRMC, training sets, ground truth for AI), are not applicable to this physical medical device.

Let's break down what can be answered based on the provided text, and why other questions cannot be:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document does not specify quantitative acceptance criteria or provide a table of reported device performance against such criteria. The basis for clearance is "substantial equivalence" to a predicate device, meaning its safety and effectiveness are considered comparable based on its design and intended use, not necessarily by meeting pre-defined quantitative performance metrics in a clinical trial.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/Not provided. As a physical instrument, a "test set" in the context of AI data is not relevant. The document does not describe any formal clinical or pre-clinical studies with a "sample size" in the way an AI/software device would have. Testing would typically involve bench testing (e.g., staple removal efficacy, durability, sterilization effectiveness) rather than a data-based test set from patients.

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/Not provided. This question relates to establishing ground truth for AI models, which is not relevant for this physical device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. This question is for AI/software device performance evaluation.

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/Not provided. This question is for AI/software device performance evaluation. The device is a surgical instrument.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable/Not provided. This question is for AI/software device performance evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Not provided. This question is for AI/software device performance evaluation.

8. The sample size for the training set

Not applicable/Not provided. This question is for AI/software device development.

9. How the ground truth for the training set was established

Not applicable/Not provided. This question is for AI/software device development.

In summary: The provided 510(k) summary for the "Endoscopic Staple Removal Instrument" is for a physical medical device. It demonstrates substantial equivalence to a predicate device based on similar design, materials (implicitly), and intended use. The questions you've asked are largely tailored to the evaluation of AI or software-as-a-medical-device (SaMD), which operates on a different regulatory and evaluative framework.

Summary

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.