(13 days)
The Intuitive Surgical Seal is Indicated for use in general, abdominal, gynecological, and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments
The Intuitive Surgical Seal is assembled with an Intuitive Surgical cannula and used with a previously approved obturator. The assembly is placed over an incision made through the skin, large enough to accept the tip of the trocar. The trocar assembly is then advanced through the remaining layers of tissue. The obturator is then removed leaving the Intuitive Surgical Seal and Intuitive Cannula in place to allow access to the surgical site for endoscopic instruments while maintaining pneumopertoneum.
The provided document is a 510(k) summary for the Intuitive Surgical Seal, a medical device. It describes the device's intended use and includes a summary of performance data. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria, specific study designs, sample sizes, or expert qualifications.
Based on the provided text, here's what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Inflation | The performance and functional testing demonstrated that the Intuitive Surgical Seal is substantially equivalent to its predicate device [Applied Medical Modular Trocar (K932995)]. |
| Leakage | The performance and functional testing demonstrated that the Intuitive Surgical Seal is substantially equivalent to its predicate device [Applied Medical Modular Trocar (K932995)]. |
Note: The document states that the performance and functional testing "included tests to verify the inflation and leakage as compared to its predicate device." It then concludes that these tests "demonstrated that the Intuitive Surgical Seal is substantially equivalent to its predicate device and it introduces no new safety and effectiveness issues when used as instructed." However, the specific numerical acceptance criteria (e.g., maximum leakage rate, pressure thresholds for inflation) and the actual measured performance values are not provided in this summary. The "reported device performance" is a qualitative statement of substantial equivalence rather than specific quantitative results.
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature of data). It only mentions "performance and functional testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The type of testing described (inflation and leakage) suggests direct physical device testing rather than human expert assessment of a test set.
4. Adjudication method for the test set
This information is not applicable as the testing described is direct physical device performance, not evaluation of a test set requiring adjudication.
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
An MRMC study is not applicable here. The device is a surgical seal, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable to this type of medical device (surgical seal). The testing described is inherent to the device's physical function.
7. The type of ground truth used
For the performance testing mentioned (inflation and leakage), the "ground truth" would likely be defined by established engineering standards and specifications for surgical trocars/seals, and comparison against the predicate device's known performance characteristics. The document does not explicitly state the type of ground truth, but it implies a direct comparison to the predicate device's performance.
8. The sample size for the training set
This information is not provided and is likely not relevant as this is not an AI/machine learning device that would require a "training set."
9. How the ground truth for the training set was established
This information is not provided and is likely not relevant for the reasons stated in point 8.
§ 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.