(270 days)
Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
Trocars and cannulae are designed to establish a port of entry for endoscopic instruments used during minimally invasive surgery. Trocar Cannulae is available with smooth or threaded sleeve in sizes 5-12mm inner diameter and 75- 100mm length. Cannulae are equipped with a sealing system for maintenance of pneumoperitoneum during insertion and withdrawal of instruments and with a luer stopcock port for insufflation and desufflation of the operative cavity. Trocar Obturator is available in bladed configuration, sized 5-12 mm. Bladed obturators are equipped with a safety shield designed to expose the blade during insertion but to retract over the tip once the operative cavity has been penetrated, so as to reduce the risk for vascular or visceral injury.
The provided text describes the 510(k) summary for a reprocessed trocar device (K070059). However, it does not contain the specific details required to complete your request regarding acceptance criteria and a study proving device performance in the context of an AI/human-in-the-loop system.
The document is for a medical device (reprocessed trocars) and pertains to its substantial equivalence to a predicate device based on manufacturing and performance testing, not an AI or digital health device that would typically have acceptance criteria presented in the manner you've outlined.
Here's why the information is missing and what it does provide:
What the document does provide:
- Device Name: Reprocessed Trocars
- Predicate Device: ENDOPATH III Bladeless Trocars, ENDOPATH III Blunt Tip Trocars, ENDOPATH III Dilating Tip Trocars (K032676)
- Indications for Use: Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
- Technological Characteristics: "The design, materials, and intended use of Reprocessed Trocars are identical to the predicate devices. The mechanism of Reprocessed Trocars is identical to the predicate devices... There are no changes to the claims, indications, clinical applications, patient population, performance specifications, or method of operation."
- Performance Data (Testing performed):
- Biocompatibility
- Validation of reprocessing
- Sterilization Validation
- Function test(s)
- Packaging Validation
- Conclusion: "Performance testing demonstrates that Reprocessed Trocars perform as originally intended. Ascent Healthcare Solutions concludes that the modified devices (Reprocessed Trocars) are safe, effective, and substantially equivalent to the predicate devices as described herein."
Why your specific questions cannot be answered from this document:
- Acceptance Criteria Table: The document states that performance testing was conducted, but it does not list specific acceptance criteria values or the reported device performance in a quantitative table format. It only states that the device "perform[s] as originally intended" and is "substantially equivalent."
- Sample Size for Test Set and Data Provenance: This information is not provided. The testing mentioned (biocompatibility, reprocessing validation, etc.) would have involved samples, but the specifics are not detailed. This is not a study on diagnostic accuracy or clinical outcomes that would typically have a "test set" in the context of AI.
- Number of Experts, Qualifications, Adjudication Method: These points are relevant for studies establishing ground truth for diagnostic or AI-assisted tasks. Since this document describes a physical medical device (trocars) undergoing performance and reprocessing validation, these concepts are not applicable.
- MRMC Comparative Effectiveness Study, Effect Size: No such study is mentioned or implied. This is a premarket notification for a reprocessed device, not an AI device demonstrating improvement over human performance.
- Standalone Performance: While the "function test(s)" could be considered a form of standalone performance assessment, it's not described in terms of an algorithm, and no specific metrics are given.
- Type of Ground Truth: For a physical device like a trocar, "ground truth" would be established through engineering specifications, material standards, and successful mechanical function tests, not expert consensus or pathology in the typical sense of AI/diagnostic imaging.
- Sample Size for Training Set, How Ground Truth for Training Set Was Established: These are entirely irrelevant for a reprocessed physical medical device. There is no AI model or "training set" involved in this submission.
In summary, the provided document relates to the regulatory clearance of a reprocessed surgical instrument. It does not describe an AI medical device or a study with "acceptance criteria" and "device performance" in the context of diagnostic accuracy, human-in-the-loop performance, or a comparison to human experts as you've requested.
§ 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.