(25 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 text describes a 510(k) submission for the Stryker 1688 4K Camera System with Advanced Imaging Modality (AIM). This submission focuses on administrative updates and confirms substantial equivalence to a previously cleared device (K211202).
Based on the provided information, the request for a detailed description of acceptance criteria, study details, and performance for this particular 510(k) submission (K220895) cannot be fully met because the document explicitly states:
"The 510(k) submission was not re-reviewed." (page 0)
"Please note that CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading." (page 1)
"Additionally, the device modifications to the 1688 4K Camera System do not require clinical studies to support the determination of substantial equivalence." (page 7)
Therefore, the provided document does not contain a study explicitly designed to prove that the current modified device (K220895) meets specific acceptance criteria based on human reader performance, ground truth establishment, or clinical effectiveness studies.
The document states that substantial equivalence is based on the previous 1688 4K Camera System (K211202) and that the current submission primarily addresses minor modifications and regulatory updates.
However, I can extract the information that is available about the performance data provided for this submission (K220895), which relates to software verification.
Here's the available information extracted from the provided text, recognizing the limitations mentioned above:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test) | Method | Reported Device Performance (Result) |
|---|---|---|
| Software Verification | IEC 62304:2015 | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" sample size in the context of clinical or diagnostic performance evaluation, as it explicitly states that clinical studies were not required for this submission. The software verification test would likely involve testing various software modules and functionalities, but sample sizes for such engineering tests are not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical or diagnostic performance study requiring expert ground truth establishment was conducted for this specific 510(k) submission.
4. Adjudication method for the test set
Not applicable, as no clinical or diagnostic performance study requiring adjudication was conducted for this specific 510(k) 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. The document states that the device modifications did not require clinical studies. Also, the device is an endoscopic camera system, not explicitly an AI-assisted diagnostic tool for interpretation that would typically necessitate an MRMC study comparing human readers with and without AI assistance in this context.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a camera system used by human surgeons for visualization during endoscopic procedures. While it has an "Advanced Imaging Modality," the focus of this submission is on the camera system itself, not a standalone AI algorithm for diagnosis or interpretation. The document explicitly says "clinical studies to support the determination of substantial equivalence" were not required.
7. The type of ground truth used
Not applicable for this submission in the context of clinical performance. The "ground truth" for the software verification would be the expected behavior and outcomes defined by the IEC 62304:2015 standard.
8. The sample size for the training set
Not applicable. The document does not describe the development or training of an AI model that would require a dedicated training set. The referenced "Advanced Imaging Modality" (AIM) is mentioned as part of the camera system but no details regarding specific AI model training are provided in this submission summary.
9. How the ground truth for the training set was established
Not applicable, as no AI model training specific to this submission's evaluation is described.
§ 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.