(143 days)
Laparoscopic Retractors are designed to retract or elevate organs and tissues to provide better visualization access to surgical sites during minimally invasive laparoscopic procedures.
The proposed Laparoscopic retractors are inserted through the trocar cannula and into the abdomen in order to provide visualization during laparoscopic surgery by retracting and manipulating organs at the surgical site.
The provided text describes a 510(k) premarket notification for Laparoscopic Retractors by Cardinal Health. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving performance through a clinical study with detailed metrics typically associated with AI/software devices.
Therefore, many of the requested categories are not applicable to the information provided. The document primarily details the regulatory process and asserts equivalence based on design, materials, and functional characteristics.
Here's an analysis based on the provided text, indicating where information is not available or not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Materials used in device must be acceptable for intended use as per ISO 10993 Part-1 "Biological Evaluation of Medical Devices". | "All materials used in the fabrication of the Laparoscopic Retractors were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 'Biological Evaluation of Medical Devices'. These materials also were evaluated in accordance with industry recognized test methods and were found to be acceptable for the intended use." |
| Functional Equivalence: Device performance must demonstrate substantial equivalence to currently marketed predicate devices with regard to functional characteristics. | "Performance testing demonstrated that the proposed device is substantially equivalent to the currently marketed predicate devices with regard to functional characteristics." |
| Design and Material Equivalence: Device must be composed of the same or similar design, materials, and manufacturing characteristics as predicate devices. | "The proposed device and the predicate devices are composed of the same or similar design, materials and manufacturing characteristics." |
2. 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 describes non-clinical performance testing and biological qualification tests, not a clinical test set with patient data. No sample size for a "test set" of patient data is mentioned.
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. As no clinical "test set" involving expert review is described, this information is not relevant. The "ground truth" here relates to material safety and functional equivalence, established through scientific standards (ISO 10993) and engineering performance testing. The qualifications of the personnel conducting these non-clinical tests are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No adjudication method is mentioned as there is no clinical test set requiring expert consensus.
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 a physical medical device (laparoscopic retractors), not an AI-assisted diagnostic or therapeutic device. No human readers or AI assistance are involved in its primary function or testing as described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device. There is no algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" or basis for evaluation for this device is established through:
- Scientific Standards: Adherence to ISO 10993 Part-1 for biocompatibility.
- Engineering Performance Testing: Evaluation against industry-recognized test methods to compare functional characteristics with predicate devices.
- Material Characterization: Comparison of materials and manufacturing characteristics to predicate devices.
8. The sample size for the training set
- Not Applicable. No training set is mentioned as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not Applicable. No training set is mentioned.
§ 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.