(26 days)
EndoClear™ Laparoscopes Accessory is intended to be used by qualified physicians to provide endoscope lens cleaning for uninterrupted visualization of internal structures in a wide variety of diagnostic and therapeutic laparoscopic procedures.
The Virtual Ports EndoClear™ system is an accessory tool for laparoscopic procedures that consists of the EndoClear™ Lens Cleaner and the Virtual Ports Applier. The EndoClear™ Lens Cleaner is an internally anchored, hands-free, laparoscope lens cleaning device that is attached to the internal operating cavity wall and remains in position until completion of the surgery, enabling the surgeon to effectively clean the laparoscope lens of blood, fat, fog, and secretions without removing it from the cavity. The EndoClear™ Lens Cleaner is introduced via a cannula using the Virtual Ports Applier, which introduces the EndoClear™ Sens Cleaner into the cavity, enables positioning of the device under endoscopic guidance, anchors it to the internal cavity wall, and removes the EndoClear™ Lens Cleaner at the end of the surgical procedure.
The provided document is a 510(k) summary for the Virtual Ports Ltd. EndoClear™ System. It focuses on demonstrating substantial equivalence to a predicate device through technical characteristics and bench testing. Crucially, this document does not contain information about a study proving the device meets specific acceptance criteria in the context of AI performance or clinical efficacy.
Instead, it states that "Bench tests were performed to ensure that the device performs as intended. All testing results demonstrated satisfactory performance." This suggests a verification of engineering specifications rather than a comparative study for acceptance criteria related to clinical outcomes or AI performance, as the original request implies.
Therefore, many of the requested categories cannot be populated from the provided text.
Here's a breakdown of what can and cannot be answered based on the input:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device performs as intended | "All testing results demonstrated satisfactory performance." |
| Materials are biocompatible (in contact with human body) | "Materials of the EndoClear™ System that are in contact with the human body are biocompatible in accordance with ISO 10993-1" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be determined from the provided text. The document only mentions "bench tests."
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):
- Cannot be determined from the provided text. This information is typically relevant for studies involving human interpretation or clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be determined from the provided text.
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 study was not described. The device is a physical accessory for laparoscopic procedures, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone AI algorithm performance study was not described. The device is a physical accessory.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "bench tests," the ground truth would likely be engineering specifications and test protocols designed to verify the device's mechanical, material, and functional performance as intended. The document states "device performs as intended," indicating adherence to pre-defined functional requirements.
8. The sample size for the training set:
- Not applicable / Cannot be determined. This device is hardware, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable / Cannot be determined. This device is hardware, not an AI algorithm.
Summary of Device and Performance Information Available from the Text:
The EndoClear™ System is an accessory for laparoscopic procedures designed to clean endoscope lenses internally. The performance validation cited in this 510(k) summary relies on:
- Bench tests: These tests were performed to ensure the device performs "as intended," and all results were "satisfactory." The specific criteria for "satisfactory performance" in these bench tests are not detailed.
- Biocompatibility testing: The materials in contact with the human body were confirmed to be biocompatible in accordance with ISO 10993-1.
The document's primary purpose is to demonstrate substantial equivalence to a previously cleared predicate device (K080051) based on having the "same intended use" and incorporating the "same technology," despite some engineering and material changes, and a labeling change. The "performance validation" described serves to support this claim of substantial equivalence for mechanical and material aspects, not a clinical effectiveness study or AI performance evaluation.
§ 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.