(169 days)
The Olympus "Trocar System according to Hasson" has been designed for first puncture technique according to Hasson in laparoscopic applications.
Trocar System according to Hasson. Common/Usual Name: Trocar, blunt and cone for laparoscopic application.
This document is a 510(k) summary for the Olympus Trocar System according to Hasson. It states that the device is substantially equivalent to predicate devices for its intended use, which is for "first puncture technique according to Hasson in laparoscopic application."
Based on the provided text, there is no acceptance criteria or study information that would allow me to populate the table or answer the specific questions about device performance, sample sizes, ground truth, or expert involvement.
The 510(k) process for this type of device (a Class II surgical instrument) typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with acceptance criteria directly related to performance metrics like sensitivity, specificity, or reader improvement. The focus is on demonstrating that the new device is as safe and effective as the predicate device.
Therefore, the table and answers below reflect the absence of this information in the provided document.
Acceptance Criteria and Device Performance
| Criterion Category | Specific Criterion | Acceptance Criteria | Reported Device Performance | Study to Prove Acceptance (Yes/No) |
|---|---|---|---|---|
| Clinical Performance | (Not specified) | (Not specified) | (Not specified) | No |
| Premarket Equivalence | Substantial Equivalence to predicate devices for intended use | Demonstrated by comparison to predicate devices, providing equivalent safety and effectiveness. | The device is deemed "substantially equivalent" to the predicate devices listed for its intended use. | Yes (through 510(k) submission) |
| Technical Specifications | (Not specified) | (Not specified) | (Not specified) | No |
| Safety | (Not specified, beyond general safe design) | (Not specified) | Presumed to be safe and effective as a substantially equivalent device. | No (inherent in 510(k) process) |
| Usability/Human Factors | (Not specified) | (Not specified) | (Not specified) | No |
Detailed Study Information (Based on provided text):
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not Applicable. The document does not describe a clinical "test set" or a performance study with human subjects or data in the way an AI/diagnostic device would. The 510(k) process for this device relies on a demonstration of substantial equivalence to predicate devices, not on a new clinical study with a test set.
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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. As no specific "test set" or ground truth establishment relevant to an AI or diagnostic claim is described, expert involvement for this purpose is not mentioned. The FDA reviewers (Celia M. Witten, Ph.D., M.D., Director, Division of General and Restorative Devices) are the experts who evaluated the submission for substantial equivalence.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or adjudication method for clinical performance is described.
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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. This device is a surgical instrument (trocar system), not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a manual surgical instrument; it is not an AI algorithm, and therefore, a standalone algorithm performance study is irrelevant and was not performed.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. The concept of "ground truth" as it applies to diagnostic or prognostic AI systems is not relevant here. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices to which the Olympus Trocar System is being compared, assuming those predicates were legally marketed.
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The sample size for the training set:
- Not Applicable. As this is not an AI/machine learning device, there is no "training set."
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How the ground truth for the training set was established:
- Not Applicable. No training set exists for this device.
§ 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.