(76 days)
The SurgiQuest™ Elastomeric Optical Trocar and Cannula has applications in abdominal and thoracic minimally invasive surgical 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 subject is a surgical trocar and cannula composed of biosafe materials. The device incorporates an expandable elastomer sheath, which serves to hold the cannula vertically in place during endoscopic surgery. The device is used to create and maintain a port of entry during endoscopic surgery. It is fully disposable and is intended for single use only.
The provided text describes a 510(k) submission for the SurgiQuest™ Elastomeric Optical Trocar & Cannula. However, it does not include detailed acceptance criteria or a comprehensive study report with specific performance metrics that would allow for the construction of the requested table. The "TESTING" section is very brief and general.
Therefore, I cannot fully complete the table and the requested information points. Based on the limited information, here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Maintain position within abdominal wall during laparoscopic surgery | "The device has been tested to show its ability to adequately maintain its position within the abdominal wall during laparoscopic surgery." (No specific quantitative metric or threshold provided) |
| Insertion forces substantially equivalent to predicate devices | "bench top and animal testing has confirmed that insertion and removal forces are substantially equivalent to the predicate devices." (No specific quantitative metric or threshold provided) |
| Removal forces substantially equivalent to predicate devices | "bench top and animal testing has confirmed that insertion and removal forces are substantially equivalent to the predicate devices." (No specific quantitative metric or threshold provided) |
Missing Information for Table: The document does not provide specific acceptance thresholds (e.g., "maintain position with less than X mm of displacement," "insertion force within Y% of predicate"). It also doesn't provide the actual measured performance values that were achieved in the tests, only a qualitative statement of equivalence.
Regarding the study details:
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 (Test Set): Not specified. The document mentions "bench top and animal testing" but gives no numbers for either.
- Data Provenance: Not specified (e.g., country of origin). The testing included "bench top and animal testing," indicating it was likely prospective testing, but no further details are given.
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. This device is a surgical instrument, not an AI or diagnostic imaging device that would require expert-established ground truth in the traditional sense. Performance is assessed through physical and mechanical testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept is for diagnostic studies with human interpretation, not for evaluating the mechanical performance of a surgical instrument.
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 algorithm or AI device. The testing described ("bench top and animal testing") is a standalone performance evaluation of the physical device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the physical properties, the "ground truth" would be established by objective measurements against engineering specifications and comparison to the predicate devices' known performance. The document doesn't detail the specific methods or standards used to define this "ground truth" (e.g., "position maintained" might be measured against a predefined displacement limit, and "forces" against a range from predicate devices).
8. The sample size for the training set
- Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI device.
Summary of Limitations:
The provided 510(k) summary (K063859) is a regulatory document confirming substantial equivalence to predicate devices for a physical medical instrument. It focuses on declaring that testing was performed and that the results show equivalence. It does not provide the detailed quantitative study results, specific acceptance criteria thresholds, or methodology that would be expected in a scientific publication or a more detailed technical report for an AI/diagnostic device. The information required for many of your points is simply not present in this type of regulatory summary for this kind of 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.