(56 days)
The MD-6W Wireless Critical Data Viewer is intended to display patient vital signs in such a way that the data is continuously in a medical specialist's field of view. A typical application would be to view the vital signs of a patient undergoing surgery.
The MD-6W Wireless Critical Data Viewer contains a mobile viewer (consisting of an LCD display unit, non-prescription safety glasses, and a control box with signal converter and lithium-ion rechargeable battery) and a base station that connects via cable to a patient monitor. The LCD display unit is mounted on the non-prescription safety glasses and is connected via a four-foot cable to the control box. The control box receives signal via wireless telemetry from the base station. The battery is recharged using a separate battery charger.
Acceptance Criteria and Device Performance Study for MD-6W Wireless Critical Data Viewer
This document describes the acceptance criteria and the study that proves the MD-6W Wireless Critical Data Viewer meets these criteria, based on the provided 510(k) summary.
Note: The provided document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo performance studies with detailed statistical analyses for novel devices.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Technological Characteristics | Indication, display format, field of view, focal range similar to predicate device (MD-6 Critical Data Viewer). | The MD-6W Wireless Critical Data Viewer is similar to the predicate device in terms of indication, display format, field of view, and focal range. |
| Performance Testing | Acceptability demonstrated through standard optical, electrical, firmware, and mechanical tests. | The MD-6W Wireless Critical Data Viewer has been subjected to standard optical, electrical, firmware, and mechanical tests to demonstrate the acceptability of the device. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not explicitly detail a specific "test set" or its sample size in the way one might expect for a de novo performance study involving human subjects or image analysis. The performance testing appears to be centered on engineering and technical validation rather than clinical efficacy measured in a patient cohort.
- Sample Size for Test Set: Not specified. The testing described (optical, electrical, firmware, mechanical) would typically involve testing of device units/components rather than a patient or clinical data set.
- Data Provenance: Not applicable in the context of a clinical test set. The tests are likely internal engineering and quality assurance tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable or provided in the context of the described performance testing. The "ground truth" for optical, electrical, firmware, and mechanical tests would be defined by engineering specifications and industry standards, not expert consensus from medical professionals.
4. Adjudication Method for the Test Set
This information is not applicable or provided. Since the testing focuses on technical performance (optical, electrical, mechanical), there would not be an adjudication method like 2+1 or 3+1 used for expert consensus in a clinical evaluation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or performed. The 510(k) summary focuses on substantial equivalence to a predicate device and technical performance testing, not on the impact of the device on human reader performance (e.g., medical specialists). Therefore, no effect size of human readers improving with AI vs. without AI assistance can be determined from this document. The device is a display tool, not an AI-powered diagnostic aid.
6. Standalone Performance Study
Yes, a standalone performance assessment was conducted, but it was purely technical. The summary states, "The MD-6W Wireless Critical Data Viewer has been subjected to standard optical, electrical, firmware, and mechanical tests to demonstrate the acceptability of the device." This implies an evaluation of the device's technical specifications and functionality independent of human interaction beyond basic usability. It's not a standalone clinical performance study, but a standalone engineering performance evaluation.
7. Type of Ground Truth Used
The "ground truth" for the performance testing cited (optical, electrical, firmware, and mechanical) would be based on:
- Engineering Specifications: The design and performance parameters defined by MicroOptical Corporation.
- Industry Standards: Relevant electrical safety, optical performance, and mechanical durability standards.
- Predicate Device Performance: Implicitly, the performance of the predicate device (MD-6 Critical Data Viewer) sets a benchmark for substantial equivalence.
It does not involve expert consensus, pathology, or outcomes data in the context of clinical "ground truth."
8. Sample Size for the Training Set
Not applicable. This device is a display system, not a machine learning or AI-driven diagnostic tool that requires a "training set" of data. Its function is to display vital signs, and its performance is evaluated based on its ability to do so reliably and according to its specifications.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for this device, a method for establishing its ground truth is not relevant.
§ 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.