(184 days)
Both the Auto Suture* Cannula** and the Auto Suture* Modified Versaport* Trocar (K954108) are intended for use in a variety of gynecologic, general, thoracic, and urologic endoscopic procedures to create and maintain a port of entry
The Auto Suture* Cannula** is a two piece device which consists of a reusable sleeve and a disposable plastic housing with seal adapter. While the Auto Suture* Modified Versaport* Trocar (K954108) is a totally disposable trocar with cannula.
The provided text is a 510(k) summary for a surgical instrument (Trocar Cannula) from 1997. This type of submission focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use, rather than conducting extensive clinical studies with acceptance criteria for performance metrics like accuracy, sensitivity, or specificity that are common for diagnostic AI devices.
Therefore, the requested information regarding acceptance criteria, study details, human reader performance, and ground truth establishment is not applicable to this 510(k) summary for a manual surgical instrument.
Here's why each point isn't applicable:
- A table of acceptance criteria and the reported device performance: Not present. The 510(k) process for this type of device relies on comparing design, materials, and intended use to a legally marketed predicate, not on quantitative performance metrics.
- Sample size used for the test set and the data provenance: Not applicable. No clinical "test set" in the context of diagnostic performance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic performance is not relevant for this device.
- Adjudication method for the test set: Not applicable.
- 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 not an AI device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable. This is not an AI device.
- How the ground truth for the training set was established: Not applicable. This is not an AI device.
The 510(k) summary provided details about:
- Submitter and Contact Person: United States Surgical Corporation, Janet G. Johnson.
- Date Prepared: August 9, 1996.
- Classification Name: Manual Surgical Instrument for general use.
- Common Name: Trocar Cannula.
- Proprietary Name: Trademark name not yet determined.
- Predicate Device: Auto Suture* Modified Versaport* Trocar (K954108).
- Device Description: A two-piece device consisting of a reusable sleeve and a disposable plastic housing with seal adapter. Compared to the predicate which is totally disposable.
- Intended Use: For use in various endoscopic procedures (gynecologic, general, thoracic, urologic) to create and maintain a port of entry.
- Materials: Component materials are in accordance with ISO Standard #10993-1, indicating biocompatibility assessment.
In summary, the provided document is a regulatory submission for a physical medical device, not a diagnostic AI or imaging device, and therefore the requested information regarding performance studies and acceptance criteria is not found within this context.
§ 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.