(27 days)
The SPY Laparoscope is intended to be used for gynecological and general procedures that clinicians deem appropriate for the adult or pediatric patient aged one month or older, when the dimensions of the SPY Laparoscope are appropriate for the patient size and anatomy.
The SPY Laparoscope is part of Stryker's rigid endoscope product portfolio. The SPY Laparoscope is an optical instrument used to visualize or image a patient's anatomy during minimally invasive, endoscopic procedures for examination, diagnosis or therapy. The SPY Laparoscope transmits light in both the visible and near-infrared spectrum to illuminate the anatomy, then forms and relays the image of the surgical site to a camera system for image processing and display.
The provided FDA 510(k) clearance letter for the SPY Laparoscope primarily details bench testing and compliance with various recognized standards to demonstrate substantial equivalence to a predicate device. It explicitly states that "The subject device does not require clinical studies to support the determination of substantial equivalence."
Therefore, the information you've requested regarding acceptance criteria and study proving performance, particularly related to human-in-the-loop performance, multi-reader multi-case studies, and the specifics of clinical ground truth establishment, is not available in this document. The clearance is based on a demonstration of equivalent technical performance and safety through non-clinical testing.
Here's how we can address your request based on the provided text, focusing on the available information:
Acceptance Criteria and Device Performance (Based on Non-Clinical Testing)
Since no clinical study data is presented, the "acceptance criteria" here refers to meeting the performance specifications and standards compared to the predicate device, primarily through bench testing.
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Acceptance Criteria Category | Reported Device Performance (Summary from Submission) |
|---|---|
| Packaging | Conforms to ASTM D4169:2022 (FDA-recognized standard) |
| Optical Verification | Equivalent to reference device for: Fiber Transmission, Illumination, Optical Transmission, Vignetting, Modulated Transfer Function (MTF), Distortion, Chromatic Aberration, NIR Transmission, Field of View (FOV), Apparent Field of View (AFOV), Image Runout. Conforms to ISO 8600-1:2015, ISO 8600-3:2019, ISO 8600-4:2023, ISO 8600-5:2020 (FDA-recognized standards). |
| Electrical Safety | Conforms to IEC 60601-1:2020, IEC 60601-2-18:2009 (FDA-recognized standards). |
| Biocompatibility | Conforms to ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-11:2017, ISO 10993-23:2021 (FDA-recognized standards). |
| Cleaning, Disinfection & Sterilization (Reprocessing) | Conforms to AAMI TIR12:2020/(R)2023, ANSI AAMI ST98:2022, ANSI AAMI ST79:2017 + A1:2020, A2:2020, A3:2020, A4:2020, ANSI AAMI ST58:2024, ISO 17664-1:2021, ISO 17665:2024, ISO 14937:2009, ISO 22441:2022, ISO 15883-1:2006 + A1:2014, ISO 15883-2:2006, ISO 15883-5:2021 (FDA-recognized standards). |
| Risk Management | Concluded that benefits outweigh residual risk; overall residual risk is acceptable. Conforms to ISO 14971 (FDA-recognized standard). |
Information Not Available (Due to Reliance on Non-Clinical Testing)
The following points cannot be addressed from the provided document because the 510(k) clearance was based on non-clinical testing for substantial equivalence, not on clinical performance studies involving human subjects or AI:
2. Sample size used for the test set and the data provenance: Not applicable in the context of clinical data. The "test set" here refers to the physical units of the SPY Laparoscope and reference devices used in the various bench tests. Data provenance is internal lab testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for bench testing is derived from metrology and engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 an endoscope, not an AI-driven image analysis tool. The document explicitly states "The subject device does not require clinical studies to support the determination of substantial equivalence."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware device; no AI algorithm is mentioned or evaluated in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For non-clinical tests, "ground truth" is defined by established engineering and optical standards, and measurements. For example, FOV measurements are compared against an acceptable range, not a clinical diagnosis.
8. The sample size for the training set: Not applicable. This is not an AI or machine learning device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.
In summary: The FDA clearance for the SPY Laparoscope, as described in this 510(k) summary, is based entirely on a demonstration of non-clinical substantial equivalence to a predicate device. This includes demonstrating equivalent optical performance, electrical safety, biocompatibility, reprocessing efficacy, and overall risk management. Clinical studies or studies involving human-in-the-loop performance, AI, or advanced diagnostic accuracy metrics were not part of this clearance process.
§ 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.