(272 days)
The reprocessed endoscopic trocars are designed to provide a pathway for entry of minimally invasive instruments to a body organ or cavity during general, abdominal, thoracic, gynecologic or other minimally invasive surgical procedures.
The Reprocessed Endoscopic Trocar is a sterile instrument consisting of a radiolucent sleeve and obturator in sizes ranging from 75 to 150 mm in length and 5 to 12 mm in diameter. Reprocessed Endoscopic Trocars are devices that provide a pathway for entry of minimally invasive instruments to a body organ or cavity during abdominal, thoracic or gynecologic surgical procedures.
The provided text describes the 510(k) summary for SterilMed, Inc.'s Reprocessed Endoscopic Trocar. However, it does not contain specific acceptance criteria or a detailed study description with performance metrics in the format requested.
The document primarily focuses on establishing substantial equivalence to predicate devices based on functional design, materials, indications for use, and manufacturing methods. It mentions "Functional and Safety Testing" and "Process validation testing" but does not elaborate on the specific acceptance criteria or the quantitative results of these tests.
Therefore, the following information is not available in the provided text:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets.
- Data provenance (country of origin, retrospective/prospective).
- Number and qualifications of experts for ground truth.
- Adjudication method for test set.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
- Results of a standalone (algorithm only) performance study.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for testing.
- Sample size for the training set.
- How ground truth for the training set was established.
Summary of available information:
1. Acceptance Criteria and Device Performance:
The document states: "Representative samples of reprocessed endoscopic trocars underwent bench testing to demonstrate appropriate functional performance. Process validation testing was performed to validate the cleaning and sterilization procedures as well as the device's packaging. In addition, the manufacturing process includes visual and functional testing of all products produced."
It concludes that the device is "substantially equivalent" to predicate devices based on "similarities in functional design, materials, indications for use and methods of construction."
No specific quantitative acceptance criteria or corresponding performance scores are provided in the text.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions "Representative samples," but does not give a number.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a medical device, not an AI/imaging device requiring expert ground truth for classification. The testing focused on functional performance, cleaning, and sterilization validation.
4. Adjudication method for the test set:
- Not applicable.
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 is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used:
- For "Functional and Safety Testing," the ground truth would be established scientific and engineering standards for device performance, cleanliness, and sterility. These are typically defined by regulatory standards (e.g., ISO, ASTM) and internal specifications. The document doesn't explicitly state the specific standards used.
8. The sample size for the training set:
- Not applicable. This device is reprocessed hardware, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.