(10 days)
The mi-eye 2 is indicated for use in diagnostic and operative arthroscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.
The Camera Enabled Probe is a battery operated, portable, visualization device that uses a probe with integrated camera and separate LCD monitor attached via cable. The sterile, single-use probe includes the camera and image capture features with LED light source. The LCD Monitor displays real-time video from the probe and is attached via cable to provide power to the probe. The probe scope extends from the handle as a rigid shaft with retractable needle and flushing port for cleaning the field of view. The distal tip of the probe contains the camera, illumination, and imaging optics. The mi-eye 2 devices are identical in design and function and available in three lengths: 50mm, 95mm, and 160mm. The monitor has a 10.8" (diagonal) screen. The entire unit weight is less than 300 grams.
This document, a 510(k) Summary for the mi-eye 2 and mi-eye 2 Monitor, provides some, but not all, of the requested information. The device is an arthroscope used for diagnostic and operative arthroscopic and endoscopic procedures.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that the mi-eye 2 underwent various testing in accordance with industry standards to verify that its design meets functional and performance requirements. However, it does not provide a specific table detailing the acceptance criteria for each test and the corresponding reported device performance values. It only lists the types of tests conducted:
| Test Category | Standards Referenced | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process | Not specified |
| Software | Not specified | Not specified |
| Electrical | ANSI / AAMI / EN-60601-1-2 Medical Electrical Equipment -- Part 1-2: General Requirements for Basic Safety and Essential Performance | Not specified |
| Mechanical | ISO-11135-1 > Sterilization of Health Care Products. Ethylene Oxide. Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices | |
| ISO-9626 > Stainless Steel Needle Tubing for the Manufacture of Medical Devices | ||
| ISO-7864 > Sterile Hypodermic Needles for Single Use | Not specified |
The conclusion states: "The changes made were tested using the same acceptance criteria as the predicate device and provide objective evidence that there are no new risks and the device is substantially equivalent." This implies that the mi-eye 2 met the acceptance criteria established for its predicate device (K141119 – mi-eye Camera Enabled Probe), but the specific criteria and performance values are not detailed here.
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not specify the sample size used for the test set for any of the listed tests (biocompatibility, software, electrical, mechanical). It generally refers to "representative samples of the device."
The data provenance is not mentioned. It is implied to be from the manufacturer's internal testing as part of the 510(k) submission process, but no details regarding the country of origin of data or whether it was retrospective or prospective are provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not provided because the testing described (biocompatibility, electrical, mechanical, software) are typically engineering and laboratory-based tests, not clinical studies requiring expert ground truth for interpretation. The device itself provides visualization, and its performance testing focuses on its ability to generate images, not on the interpretation of medical images by experts.
4. Adjudication Method for the Test Set:
Not applicable, as the tests described are technical performance evaluations, not clinical interpretations requiring adjudication.
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 MRMC comparative effectiveness study is mentioned. This device is an arthroscope for direct visualization, not an AI-powered diagnostic tool that assists human readers in interpreting medical images. Therefore, the concept of human readers improving with or without AI assistance is not relevant to the described device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The mi-eye 2 is a visualization device, not an algorithm. Its performance is inherent in its ability to capture and display images, which is directly observed and used by a human operator (the surgeon or clinician).
7. The Type of Ground Truth Used:
For the technical performance tests (biocompatibility, electrical, mechanical, software), the "ground truth" would be established by the specifications and standards themselves (e.g., a certain level of electrical safety, material biocompatibility, mechanical durability). There is no "expert consensus," "pathology," or "outcomes data" in the typical sense for these types of tests.
8. The Sample Size for the Training Set:
Not applicable. This device does not involve AI or machine learning that would require a "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this device.
In summary, the provided document focuses on the technical and safety aspects of the mi-eye 2 device as part of a 510(k) submission, confirming its substantial equivalence to a predicate device. It does not contain information related to clinical performance studies involving interpretation of medical images or AI algorithms.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.