(34 days)
The V. Mueller® Camera Controller is intended for use by surgeons for holding rigid endoscopes with diameters from 5 - 10 mm during diagnostic and therapeutic surgical procedures. The system includes a storage cart to be used for setup, storage, and transport of the device.
The V.Mueller Camera Controller with Storage Cart is a manually operated, mechanical surgical device. The instrument provides for the one handed control for the positioning/repositioning of an endoscope during surgical procedures. The V.Mueller Camera Controller eliminates the need for the surgeon or assistant to continuously hold the endoscope during surgical procedures. The system includes a storage cart to be used for setup, storage, and transport of the device.
The provided documents (K093616) describe a medical device, the V.Mueller Camera Controller with Storage Cart, which is an endoscope holder. The submission focuses on substantial equivalence to a predicate device and does not involve the type of AI/ML performance evaluation typically associated with acceptance criteria tables, advanced statistical studies (like MRMC), or detailed ground truth establishment.
Therefore, many of the requested elements for describing acceptance criteria and study details are not applicable to this 510(k) submission. However, I will answer the applicable points based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The submission states that the device was evaluated through "non-clinical tests under various conditions to assess the design performance and conformance to design specifications." It then concludes, "Performance testing demonstrated that the proposed device is substantially equivalent to the currently marketed predicate device with regard to functional characteristics." Specific, quantifiable acceptance criteria or detailed performance metrics are not provided in the given text. The primary acceptance criterion was likely substantial equivalence in functional characteristics to the predicate device (Statarius Endoscope Holder, K061292).
| Acceptance Criteria (Inferred from "Substantial Equivalence") | Reported Device Performance |
|---|---|
| Functional characteristics equivalent to predicate device | Demonstrated substantial equivalence in functional characteristics to predicate device. |
| Intended Use: Holding rigid endoscopes with diameters 5-10mm | Device is intended for this use. Performance was tested to confirm this. |
| Provides one-handed control for positioning/repositioning | Device is described as providing this control. |
| Materials and manufacturing characteristics similar to predicate | Device composed of same or similar principals of operation, design, materials and manufacturing characteristics as predicate. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document mentions "non-clinical tests under various conditions" but does not detail the number of units tested or the duration/extent of testing.
- Data Provenance: The tests were "non-clinical" and likely conducted by the manufacturer, CareFusion, as part of their design verification and validation process. Country of origin of data is not explicitly stated but would typically be where the manufacturer is located or where the tests were performed (McGaw Park, IL, USA, based on the sponsor address). The study was prospective in the sense that the tests were conducted specifically for this 510(k) submission to demonstrate substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. The device is a mechanical endoscope holder, not an AI/ML algorithm requiring expert-established ground truth for diagnostic accuracy. The testing would have focused on mechanical functionality, durability, and safety, likely against engineering specifications or comparative performance with the predicate device.
4. Adjudication method for the test set
This is not applicable. As it's a mechanical device, there is no "adjudication" of results in the sense of reconciling differing expert opinions. The testing would rely on objective measurements and observations of mechanical performance.
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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices that assist human readers (e.g., radiologists interpreting images). The V.Mueller Camera Controller is a mechanical surgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a mechanical endoscope holder, not an algorithm.
7. The type of ground truth used
This is not applicable in the context of diagnostic accuracy. For this mechanical device, the "ground truth" for testing would be objective engineering specifications, performance metrics (e.g., force required to move, stability, grip strength on endoscopes), and safety standards. The primary comparison point (not "ground truth" in the diagnostic sense) was the performance of the legally marketed predicate device.
8. The sample size for the training set
This is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
This is not applicable. There is no "training set" or associated ground truth for this mechanical device.
§ 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.