(40 days)
The Smith & Nephew MIS Instruments are intended to be used in the surgical management of soft tissue. The instruments are intended to be used to grasp, dissect, and cut soft tissue. The Smith & Nephew MIS Instruments are indicated for use in endoscopic procedures, including thoracoscopic surgery and laparoscopic procedures.
The Smith & Nephew MIS Instruments are a line of hand-held, non-sterile, reusable instruments.
This document is a 510(k) summary for the Smith & Nephew MIS Instruments, which are minimally invasive surgical tools. The purpose of this summary is to demonstrate that the device is substantially equivalent to legally marketed predicate devices. As such, the information provided focuses on comparative analysis with predicate devices rather than a detailed study proving performance against specific acceptance criteria for a novel device.
Therefore, many of the requested sections regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not applicable or cannot be extracted from this type of regulatory submission. This document highlights design, material, intended use, and indications for use as the basis for substantial equivalence.
Here's a breakdown of the available and applicable information from the provided text:
1. A table of acceptance criteria and the reported device performance
This document does not specify "acceptance criteria" in the sense of quantitative performance metrics for a novel device, nor does it report specific "device performance" data from a dedicated study. Instead, the "acceptance criteria" for this type of submission are implicit in demonstrating substantial equivalence to predicate devices, focusing on similarities in design, materials, intended use, and indications for use.
| Characteristic | Smith & Nephew MIS Instruments | Predicate Devices (Karl Storz, Richard Wolf, Smith & Nephew & Acufex) |
|---|---|---|
| Product Labeling | non-sterile/reusable | non-sterile/reusable |
| Materials | Stainless steel/Kynar insulation | Stainless steel/insulation, Stainless steel/plastic/insulation, Stainless Steel/Kynar insulation |
| Indications | Endoscopic Surgical Procedures | Endoscopic Surgical Procedures |
| Intended Use | Management of Soft Tissue: graspers, dissectors, scissors | Management of Soft Tissue: graspers, dissectors, scissors |
| Number of separate components | 3 | 3 (Karl Storz, Richard Wolf); 1 (Smith & Nephew & Acufex) |
| Design | Dual / single action jaw design with 360 degree rotation | Dual / single action jaw design with 360 degree rotation |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) premarket notification demonstrating substantial equivalence based on device characteristics, not a clinical study with a test set of data.
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. No ground truth was established for a test set as this is not a study assessing diagnostic or analytical performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no test set requiring adjudication in this submission.
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 device is a surgical instrument, not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI-related effectiveness analysis was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth was established as this submission relies on demonstrating substantial equivalence to predicate devices based on design and intended use specifications, not on clinical performance data requiring a ground truth.
8. The sample size for the training set
Not applicable. There is no training set mentioned or implied as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. There is no training set or ground truth established for a training set.
§ 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.