(85 days)
Laparoscope Lens Shield Device (LENS), a sterile, single-use and disposable laparoscopic accessory lens shield device, is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.
The Laparoscope Lens Shield Device (LENS) is a laparoscope accessory lens shielding device consisting of multi-lumen sheath that slides over the laparoscope. The sheath assembling consists of 2 concentric sheaths: one outer and one end-to-end connected inner sheaths. The outer sheath provides protection and cover for the inner sheath and shielding film. It is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.
The document describes the Medeon Biodesign, Inc. Laparoscope Lens Shield Device (LENS). However, it does not contain a detailed study report that proves the device meets specific acceptance criteria for its performance (e.g., maintaining intra-operative view consistently), nor does it provide a table of acceptance criteria with reported device performance metrics like sensitivity, specificity, accuracy, or effect sizes for human readers.
The provided information primarily focuses on establishing substantial equivalence to a predicate device (K151117) for a modified version of the LENS device, and lists types of tests conducted (biocompatibility, mechanical, functional).
Here's an analysis of what information is available and what is missing based on your specific questions:
1. A table of acceptance criteria and the reported device performance
- Missing. The document confirms that functional testing was performed ("Device functionality was tested in the animal model to demonstrate that the intended use is fulfilled."). However, it does not provide a table of quantitative acceptance criteria for this functional performance (e.g., a specific percentage reduction in lens soiling, or a duration for which the view is maintained without cleaning) nor the reported performance against such criteria. It only states qualitatively that "design modifications do not alter the device function and intended use."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document mentions "animal model" for functional testing but does not specify the sample size (e.g., number of animals, number of trials).
- Data Provenance: The document does not specify the country of origin for the animal model data. It is implied to be prospective testing carried out for regulatory submission.
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)
- Not applicable / Not specified. For a device like a lens shield, ground truth would likely be established based on direct observation of the lens cleanliness or image clarity during the functional tests, not typically through expert consensus on interpretations of output. The document does not mention experts or their qualifications being used to establish ground truth for the functional testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not specified. Adjudication methods are typically relevant for studies where subjective interpretation or classification is involved, often in diagnostic imaging. For a functional device like this, the assessment of "device function and intended use" would likely be based on objective observations (e.g., visual clarity, presence of debris) rather than an adjudication process among multiple reviewers.
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 a physical laparoscopic accessory, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related metrics are not relevant to this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical shield, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the functional testing, the ground truth would likely be based on:
- Direct observation of the laparoscopic view: Assessment of image clarity, presence or absence of debris on the lens.
- Measurement of physical parameters: Potentially measuring the time before the lens requires cleaning, or the number of cleanings prevented.
- The document states testing was done "to demonstrate that the intended use is fulfilled," which implies a ground truth defined by the successful maintenance of the intra-operative view. However, the specific criteria for this "ground truth" are not detailed.
8. The sample size for the training set
- Not applicable. Historical data or previous versions of the device might implicitly "train" the design process, but for a physical device, there isn't a "training set" in the sense of a machine learning algorithm.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
Summary Table of Available Information vs. Missing Information:
| Feature | Information from Document | Status |
|---|---|---|
| Acceptance Criteria & Performance Table | Not provided. "Device functionality was tested in the animal model to demonstrate that the intended use is fulfilled." | Missing (specific criteria and quantitative results) |
| Test Set Sample Size | "animal model" - specific number not provided. | Missing (specific number) |
| Data Provenance (Test Set) | Implied prospective testing. Country of origin not specified. | Missing (Country) |
| Number & Qualifications of Experts (Test Set GT) | Not applicable / Not mentioned. | N/A / Missing |
| Adjudication Method (Test Set) | Not applicable / Not mentioned. | N/A / Missing |
| MRMC Comparative Effectiveness Study | Not applicable. Device is a physical shield, not AI. | N/A |
| Standalone Performance Study (Algorithm Only) | Not applicable. Device is a physical shield, not an algorithm. | N/A |
| Type of Ground Truth Used | "Device functionality was tested... to demonstrate that the intended use is fulfilled." Likely visual clarity/debris assessment during animal model testing. | Not fully detailed |
| Training Set Sample Size | Not applicable (physical device). | N/A |
| How Ground Truth for Training Set was Established | Not applicable (physical device). | N/A |
§ 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.