(95 days)
The Smith & Nephew Tablet Application is indicated for wireless control of compatible Smith & Nephew passive surgical and endoscopic devices including camera control unit and patient information system.
The Tablet Application acts as a tool to remotely capture still and motion pictures, patient file management, and limited redundant control of medical devices. The Tablet Application currently supports the LENS Integrated System and Integration Broker.
The provided text describes the Smith & Nephew Tablet Application, which is indicated for wireless control of compatible Smith & Nephew passive surgical and endoscopic devices, including camera control units and patient information systems.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The text does not explicitly state specific quantitative acceptance criteria or detailed device performance metrics. It generally states that "Testing demonstrated that the Tablet Application has met the performance specifications" and "met all specified criteria."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device functions as intended for wireless control of compatible surgical/endoscopic devices. | "Testing demonstrated that the Tablet Application has met the performance specifications" and "met all specified criteria." |
| No new safety or effectiveness concerns are raised compared to the predicate device. | "did not raise new safety or effectiveness questions." |
| Software operates reliably and performs its specified functions. | "Software Verification and Validation" was conducted. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Software Verification and Validation" was conducted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention an MRMC comparative effectiveness study, nor does it discuss an effect size of human readers improving with AI vs. without AI assistance. The device is for controlling surgical and endoscopic devices, not for diagnostic interpretation by human readers.
6. Standalone Performance Study
The document indicates that "Software Verification and Validation" was conducted, which implies evaluation of the algorithm's performance in a standalone context to ensure it meets its specifications. However, specific details of this standalone performance are not enumerated beyond the general statement of meeting criteria.
7. Type of Ground Truth Used
The document does not specify the type of ground truth used. For a device intended for wireless control, the "ground truth" would likely involve objective measures of functionality, such as successful command execution, accurate data transfer, proper control of connected devices, and adherence to communication protocols, rather than expert consensus, pathology, or outcomes data typically associated with diagnostic or prognostic devices.
8. Sample Size for the Training Set
This information is not provided in the document. The device is a software application for control, so a "training set" in the machine learning sense may not be directly applicable, or if it involves configuration data, its size is not mentioned.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document. As noted above, the concept of a "training set" might not be relevant in a conventional sense for this type of device. If there was a training phase for any adaptable components of the software, the method for establishing ground truth for that phase is not given.
§ 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.