(74 days)
The Smith & Nephew Laparoscopes are indicated for use in illumination and visualization to surgical sites within the body. This includes, but not limited to uses such as gallbladder and appendix removal, hernia repair, and examination of the abdominal cavity, appendix, gallbladder and Liver.
Smith & Nephew Bariatric Laparoscopes are indicated for illumination and visualization to surgical sites within the body. This includes, but not limited to uses such as gallbladder and appendix removal, hernia repair, appendix, gallbladder and Liver.
The proposed Smith+Nephew 4KO Direct View/Video Laparoscopes are surgical instruments used for illumination and visualization of surgical sites within articular cavities, body cavities, hollow organs and canals. A Laparoscope is a medical optical instrument that is intended for visualization of the insides of the human body by inserting the instrument into a natural or artificial opening.
The Laparoscopes are designed with various angle specifications for directions of view and working lengths for access to various locations. The design consist of a long tube containing a series of rod lenses that work to transfer the image of the patient's anatomy. through an associated visualization camera system, to a central monitor for clinical use in treatment.
The direct view scopes require attachment to an endocoupler and the VideoEndoscopes are attached to a Smith & Nephew C-Mount camera head.
Illumination is provided through a bundle of optical fibers internal to the Endoscope that transmits light from an external source to illuminate the image.
The provided text describes a 510(k) premarket notification for Smith & Nephew Laparoscopes. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with acceptance criteria in the manner typically seen for novel AI/ML medical devices.
Therefore, the document does not contain the detailed information required to fill out a table of acceptance criteria, describe a study proving the device meets those criteria, or provide specifics on training/test sets, expert adjudication, or MRMC studies for an AI/ML device.
Here's why and what information is available:
Reasoning for Missing Information:
The submitted document pertains to a 510(k) submission for conventional medical devices (laparoscopes) and not an AI/ML-driven device. As such:
- Acceptance Criteria & Performance Table: The document states the device met established performance specifications but does not list specific quantitative acceptance criteria for metrics like sensitivity, specificity, AUC, or other clinical performance measures that would be relevant for an AI/ML device. The performance testing mentioned is "Optical Performance, Leakage Integrity Testing, Electrical Safety Testing, Electromagnetic Compatibility," which are engineering/safety metrics, not clinical performance metrics.
- Sample Size (Test Set) & Data Provenance: This information is not applicable in the context of this 510(k). The "test set" for this device would refer to testing of the physical device's engineering specifications, not a dataset of medical images or patient records.
- Experts for Ground Truth & Qualifications: Not applicable. Ground truth, in the context of an AI/ML device, refers to definitive labels for data points (e.g., presence/absence of disease, exact lesion boundaries). For a laparoscope, the "ground truth" of its function is determined by its physical performance and safety.
- Adjudication Method: Not applicable.
- MRMC Study: Not applicable. MRMC studies are designed to assess the impact of AI assistance on human reader performance. This device is not an AI algorithm.
- Standalone Performance: Not applicable. Standalone performance refers to the algorithm's performance without human intervention. This device is a physical instrument.
- Type of Ground Truth: The "ground truth" for this device is its adherence to engineering specifications and safety standards, not clinical diagnostic accuracy.
- Training Set Sample Size & Ground Truth Establishment (for Training): Not applicable, as this is not an AI/ML device that undergoes a training phase with a dataset.
Information Available in the Document Related to "Performance":
The document mentions "Performance Testing" to demonstrate that the devices meet "established performance specifications."
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Type of Performance Testing:
- Optical Performance
- Leakage Integrity Testing
- Electrical Safety Testing
- Electromagnetic Compatibility
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Conclusion: "The Smith & Nephew Laparoscopes met all specified criteria and did not raise new safety or effectiveness questions."
In summary, the provided text describes a regulatory submission for physical medical devices (laparoscopes) and not an AI/ML-driven diagnostic or therapeutic system. Therefore, the detailed requirements for describing AI/ML device acceptance criteria and study designs are not present in this document.
§ 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.