(172 days)
indicated for use in a variety of gynecologic, general, thoracic, and urologic endoscopic procedures to create and maintain a port of entry.
VersaOne™ Bladed Trocar is available in diameter 5mm, cannula fixation and smooth, and length standard and short. VersaOne™ Bladed Trocar consists of an obturator component with a bladed tip and a cannula assembly. The devices are supplied sterile single-use.
This FDA 510(k) summary is for a medical device (VersaOne™ Bladed Trocar), which means its "acceptance criteria" and "performance" are related to mechanical and biological safety and efficacy, not AI algorithm performance metrics like sensitivity/specificity.
Therefore, the requested information elements related to AI algorithm studies (such as sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance with AI, and type of ground truth) are not applicable to this document.
The document describes material and performance testing against specifications, rather than a clinical study evaluating diagnostic or prognostic algorithmic performance.
Here's an interpretation of the document in the context of the requested table, focusing on what is available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (What the device must achieve) | Reported Device Performance (What the device achieved) |
|---|---|
| Biocompatibility: Complies with ISO 10993-1 standard. | Acceptable results demonstrated VersaOne™ Bladed Trocar complies with ISO 10993-1 standard. |
| Performance: Performs to specifications. | Results from performance testing demonstrated the proposed VersaOne™ Bladed Trocar perform to specifications. |
| Comparability: Comparable to predicate devices (K062326 and K112349). | Results from performance testing demonstrated the proposed VersaOne™ Bladed Trocar is comparable to predicate devices K062326 and K112349. |
| Functionality: Bladed tip cuts tissues, shield covers blade upon entry, seal system prevents loss of Pneumoperitoneum, cannula bevel reduces penetration forces, stopcock for insufflation/desufflation. | Implicitly met: The device description outlines these functional characteristics, and performance testing confirmed it performs to specifications, implying these functions were successful. |
The study that proves the device meets the acceptance criteria is referred to as "performance testing" and "biocompatibility evaluation."
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: This document describes a medical device's mechanical and material performance testing, not a clinical study involving human data or AI algorithms. The "test set" would refer to the physical devices tested. The number of devices tested is not specified, nor is their "provenance" in the context of country of origin for clinical data.
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: "Ground truth" in this context would refer to established engineering and biocompatibility standards (e.g., ISO 10993-1). The "experts" would be the personnel conducting the testing and evaluating the results against these standards, but their number or specific qualifications are not detailed in this summary, as it is standard practice in medical device testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: This refers to clinical data adjudication, which is not relevant to medical device performance 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
- Not Applicable: This applies to AI-assisted diagnostic or screening tools. This device is a surgical trocar.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This applies to AI algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The ground truth for this device's performance is based on established engineering specifications, material science standards (e.g., ISO 10993-1 for biocompatibility), and comparability to predicate devices as demonstrated through physical and mechanical testing.
8. The sample size for the training set
- Not Applicable: This applies to AI algorithms.
9. How the ground truth for the training set was established
- Not Applicable: This applies to AI algorithms.
§ 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.