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

Hardware: The hardware consists of the following components: Monitor, keyboard, image processor, Xenon light source, camera unit, power supply, printer, handpiece (which incorporates the camera head and light cable), a slide-out working surface, and a storage drawer.

Software: The software enhances the image from the scope to remove fiber optic pixelation. The software allows the operator to record and print still images as well as record and archive audio and video information recorded during the procedure.

Scope: A rigid fiberoptic scope designed for one time use.

Supplemental Instruments: Supplemental instruments consist of 4 pieces that can be used interchangeably throughout the procedure. The four components of the instrumentation are the cannula, the trocar, the obturator, and the cannula plug.

Procedural Kit: The procedural kit contains many sterile items to aid in the procedure.

AI/ML Overview

This 510(k) summary describes a medical device, the InnerVue™ Diagnostic Scope System. However, it explicitly states that clinical testing was not used to establish substantial equivalence to predicate devices. Instead, equivalence was based on similarities in intended use, non-clinical testing, physical characteristics, and geometry.

Therefore, many of the requested criteria regarding acceptance criteria and study details cannot be provided from this document, as a formal study proving the device meets specific acceptance criteria based on clinical performance was not conducted or submitted with this 510(k).

Here's what can be extracted based on the provided text, and what cannot:

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

Acceptance Criteria: Not explicitly stated in terms of performance metrics or thresholds. The 510(k) process for this device relied on demonstrating substantial equivalence to a predicate device (Davlite Microendoscope, K020310) based on non-clinical aspects.
Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy) are reported since no clinical study was conducted. The device's "performance" is implicitly deemed equivalent to the predicate through its design and intended use similarities.

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

Not applicable. No test set was used for a clinical study to establish performance, as clinical testing was not conducted.

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. No test set requiring expert ground truth was used for performance evaluation.

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

Not applicable. No test set requiring adjudication was used.

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 device is an endoscope system, not an AI-assisted diagnostic tool. No MRMC study was conducted.

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

Not applicable. This is a hardware/software system for viewing, not an algorithm-only diagnostic system. No standalone algorithm performance was assessed for regulatory purposes.

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

Not applicable. No clinical ground truth was established or used for performance validation of this device.

8. The sample size for the training set

Not applicable. This device does not use machine learning in a way that would require a "training set" for performance evaluation in the context of diagnostic accuracy. The software mentioned "enhances the image... to remove fiber optic pixelation," which implies image processing rather than a learnable AI model requiring a training set for diagnostic classification.

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

Not applicable. No training set for a diagnostic AI was used.

Summary based on the document:

The InnerVue™ Diagnostic Scope System's acceptance was based on substantial equivalence to an existing legally marketed device (Davlite Microendoscope, K020310). This equivalence was established by demonstrating similarities in:

Intended Use: Viewing the interior cavity of the human body through surgical or natural openings.
Non-clinical testing: Not detailed in this summary, but implies bench testing or other engineering evaluations.
Physical characteristics and geometry: Design and form factor comparisons.

Crucially, this device did not undergo clinical testing to establish its performance or meet specific diagnostic acceptance criteria.

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.