(50 days)
These instruments are manually operated surgical devices intended for abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments and endoscopes.
The MTP Disposable Trocars body contact material is polycarbonate.
This submission pertains to the MTP Disposable Trocars, which are manually operated surgical devices. The provided documents focus on the 510(k) submission process for these devices, asserting their substantial equivalence to predicate devices already on the market. Crucially, the documents do not contain information about specific acceptance criteria or a study demonstrating that the device meets such criteria.
Therefore, I cannot provide the requested table or detailed study information.
Here's why and what information is available:
- Type of Device: The MTP Disposable Trocars are a surgical instrument. For devices like these, substantial equivalence is often established based on similarities in materials, design, intended use, and performance characteristics to legally marketed predicate devices. This typically involves demonstrating that the new device does not raise new questions of safety or effectiveness.
- Missing Information: The provided text is a 510(k) summary and the FDA's clearance letter. These documents confirm the regulatory pathway and clearance but do not contain detailed performance study data, acceptance criteria, sample sizes, expert qualifications, or ground truth methodologies that would be found in a comprehensive clinical or performance validation study report.
Summary of available information as per your request, indicating where information is lacking:
-
A table of acceptance criteria and the reported device performance:
- Not provided. The document focuses on demonstrating substantial equivalence, not on specific performance metrics or acceptance criteria for a new, unique performance claim.
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided. No performance study is detailed.
-
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 provided. No test set or related ground truth establishment is described.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not provided. No test set or adjudication method is described.
-
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/Not provided. This device is a manual surgical instrument, not an AI-assisted diagnostic or therapeutic tool with human readers.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. This device is a manual surgical instrument, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not provided. No ground truth establishment for performance is described. The "ground truth" for regulatory assessment here is typically the established safety and effectiveness of the predicate devices.
-
The sample size for the training set:
- Not applicable/Not provided. This is not an AI/algorithm-based device and thus does not have a training set in that context.
-
How the ground truth for the training set was established:
- Not applicable/Not provided. As above, no training set is relevant for this type of device in the context of the provided documentation.
In essence, the provided documents represent the regulatory clearance of a medical device based on substantial equivalence, rather than a detailed performance study with specific acceptance criteria and results for an AI or diagnostic tool.
§ 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.