(86 days)
The 1688 Video Camera is indicated for use in general laparoscopy, ear endoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ arthroscope/ sinuscope/ sinuscope is indicated for use. The 1688 Video Camera is indicated for adults and pediatric patients.
The 1688 4K Camera System with Advanced Imaging Modality is an endoscopic camera system that produces live video in the surgical field during surgical endoscopic procedures. The system is sensitive in the visible and infrared spectrum. The optical image is transferred from the surgical site to the camera head by a variety of rigid and flexible endoscopes, which are attached to the camera head. The 1688 4K Camera System consists of three main components: (1) a camera control unit (CCU); (2) a camera head with an integral cable that connects to the CCU; and (3) a coupler for attaching an endoscope to the camera head.
The provided document does not contain information about acceptance criteria and a study that proves a device meets acceptance criteria related to performance metrics like accuracy, sensitivity, or specificity for a specific medical condition.
Instead, the document is a 510(k) Premarket Notification from the FDA for a Stryker 1688 4K Camera System with Advanced Imaging Modality. This notification focuses on demonstrating substantial equivalence to a previously cleared predicate device (K211202) for an endoscopic camera system used in various surgical procedures.
The "Performance Data" section (Page 6) describes testing completed to ensure the device meets safety, electromagnetic compatibility, cleaning, disinfection, sterilization, software integrity, usability, and general bench/animal performance standards. These are regulatory compliance tests, not a clinical study to prove the device's diagnostic or therapeutic efficacy against specific performance criteria related to a disease state.
Here's a breakdown of what is provided regarding acceptance criteria (for regulatory compliance) and the "study" (referring to the testing performed):
1. Table of Acceptance Criteria and the Reported Device Performance:
| Test | Acceptance Criteria (Method) | Reported Device Performance |
|---|---|---|
| Electrical Safety | ANSI/AAMI ES60601-1:2005 + A1:2012, IEC 60601-2-18:2009, IEC 60601-1-6:2010 + A1:2013 | Pass |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2014 | Pass |
| Cleaning | AAMI TIR30:2011 (R2016), ISO/TS 15883-5:2005 | Pass |
| Disinfection | AAMI TIR12:2020, ISO 17664:2017, EN ISO 15883-2:2009 | Pass |
| Sterilization | AAMI TIR12:2020, AAMI ST79:2017, ISO 17664:2017, ISO 14937:2009, ISO 17665-1:2006 | Pass |
| Software | IEC 62304:2006/AMD1:2015 | Pass |
| Usability | IEC 62366-1:2020 | Pass |
| Performance - Bench | In accordance with design input specifications | Pass |
| Performance - Animal | In accordance with device user needs | Pass |
2. Sample size used for the test set and the data provenance:
- The document does not provide details on specific sample sizes for each test in the "Performance Data" section. It lists the standards followed.
- Data provenance (e.g., country of origin, retrospective/prospective) and clinical test sets are not applicable to the compliance testing described. The "Animal" performance test suggests in vivo testing, but no details on animal models, sample size, or specific outcomes are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the tests are for regulatory compliance (e.g., electrical safety, software standards, cleaning validation) rather than evaluating performance against a diagnostic 'ground truth' established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for the types of compliance tests listed.
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:
- No, an MRMC comparative effectiveness study was not done. The device is an endoscopic camera system, not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a camera system, not an AI algorithm. Its performance is as an imaging tool used by surgeons.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" for these tests are the requirements and specifications outlined in the referenced standards (e.g., electrical safety limits, sterilization efficacy, software bug-free operation).
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device requiring a training set for an algorithm.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.