(62 days)
The ENDOPATH® III Bladeless Trocar has applications in abdominal, thoracic, and gynecologic minimally invasive procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
The ENDOPATH® III Dilating Tip Trocar has applications in thoracic, gynecologic laparoscopy and other abdominal procedures to establish a path of entry for endoscopic instruments.
The ENDOPATH® III Blunt Tip Trocar has applications in thoracic, gynecologic, laparoscopic and other abdominal procedures to establish a path of entry for minimally invasive instruments.
The ENDOPATH® III Trocars are sterile single patient use instruments consisting of a radiolucent sleeve and obturator in sizes ranging from 5-12 mm in diameter. There are three different obturators Bladeless, Blunt Tip and Dilating Tip. The Bladeless obturator contains a clear, tapered optical element, which when used with an endoscope, provides visibility of individual tissue layers during insertion. The Bladeless obturator accommodates an appropriately sized zero endoscope. The Blunt Tip obturator has a blunt plastic tip, which gently moves aside any internal viscera that may be adjacent to the abdominal or thoracic wall. The Dilating Tip obturator has a sharp flat-bladed tip and a spring-loaded shield. The shield on the Dilating Tip obturator is designed to cover the flat-bladed tip to protect internal structures from puncture or laceration once the abdominal or thoracic cavity has been entered.
The trocar sleeve contains two seals, an outer integrated removable self-adjusting seal to accommodate instruments ranging from 5mm to 12mm in diameter where indicated and an internal seal. Together, these seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. The 5mm trocar sleeve does not contain an integrated removable seal and accommodates only 5mm instruments. A stopcock valve is compatible with standard luer lock fittings and provides attachment for gas insufflation and desufflation. The stopcock is in closed position when it is parallel to the sleeve.
The provided text describes the ENDOPATH® III Trocar System, a medical device. However, it does not contain detailed information about specific acceptance criteria or a study that rigorously proves the device meets such criteria with quantitative metrics, sample sizes, expert involvement, or adjudication methods typically found in modern medical device testing for AI/ML algorithms.
The document is a 510(k) Premarket Notification summary from 2003, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria using the detailed scientific study methods you've requested.
Here's an attempt to answer your request based on the limited information available in the provided text, while also highlighting what is not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| As intended | All testing demonstrated satisfactory performance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified.
- Data provenance: Not specified. It's implied to be internal bench testing, not patient 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. The document describes bench testing of a physical medical device (trocar system), not an AI/ML algorithm that requires expert-established ground truth from medical images or data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Bench testing of a physical device would not typically involve adjudication in the sense of reconciling expert opinions on ground truth.
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
- No, an MRMC comparative effectiveness study was not done. This device is a physical surgical instrument, not an AI/ML diagnostic tool, and therefore, human reader performance with or without AI assistance is not relevant to its evaluation in this document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For bench testing, the "ground truth" would likely be based on physical measurements and functional tests against engineering specifications or design requirements. The specific type of "ground truth" for these tests (e.g., precise dimensional measurements, seal integrity tests, insertion force measurements, etc.) is not detailed in the document.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
Summary of what the document does state about performance:
The document states: "Performance Data: Bench testing was performed to ensure that the device performs as intended. All testing demonstrated satisfactory performance."
This is a very high-level statement typically found in older 510(k) summaries for physical devices, indicating that the device met its internal design and functional specifications through internal testing. It does not provide the granular detail you would expect for AI/ML device approval in contemporary contexts, which often requires extensive clinical validation and detailed performance metrics against clearly defined acceptance criteria.
§ 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.