(116 days)
Mitek Sports Medicine Arthroscopes are indicated for use in arthroscopic procedures (such as the knee, shoulder, hip, ankle, elbow) to provide visualization during surgery.
The Mitek Arthroscope is a multi-angle, rigid 4.3 mm arthroscope that has the capability of varying direction of view from 10° to 90° which enables surgeons to maximize and optimize their field of view inside the joint from any given port. This reduces the need for multiple fixed-angle arthroscopes. The direction of view is altered by the direction of view dial; the direction of view is indicated by markings on the scope body. The Mitek Arthroscope provides a 55° field of view and a depth of field from 5mm to 40mm. The device shaft can also rotate by rotating the device (typically by the light post). A standard eyepiece located on the proximal end of the device is compatible with a standard camera coupler. The light post on the subject device is compatible with an ACMI light source. There are two light post stainless steel adaptors that accompany the Mitek Arthroscope. Two adapters are provided to facilitate connection with medical light source cables with a diameter of 5.0mm and smaller. The Mitek Arthroscope is a reusable device and must be cleaned and sterilized according to the user manual prior to every use.
This document describes the premarket notification (510(k)) for the Mitek Arthroscope, a medical device.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the successful adherence to recognized standards and the passing of all specific tests.
| Acceptance Criteria (Implied by Standards & Tests) | Reported Device Performance |
|---|---|
| Performance: | |
| Field of View meets specifications | Passed |
| Fixed Focus meets specifications | Passed |
| Direction of View Range meets specifications | Passed |
| Direction of View Torque meets specifications | Passed |
| Rotation of View meets specifications | Passed |
| Illumination meets specifications | Passed |
| Scope Resolution meets specifications | Passed |
| Visual Inspection meets specifications | Passed |
| Hermetic sealing meets specifications | Passed |
| Free from aberrations | Passed |
| Cleaning & Sterilization: | |
| Cleaning validation (conforms to ISO 17664) | Performed & Conforms |
| Sterilization (Moist Heat, EO) Validation (conforms to ANSI/AAMI/ISO 17665-1, ISO 11135-01) | Performed & Conforms |
| Biocompatibility: | |
| Evaluation and testing (conforms to ISO 10993-1) | Performed & Conforms |
| Electrical Safety: | |
| Basic Safety & Essential performance (conforms to EN 60601-18) | Performed & Conforms |
| Electromagnetic compatibility (conforms to IEC 60601-1-2) | Performed & Conforms |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the individual performance tests (Field of View, Fixed Focus, etc.). It mentions that "Verification tests of the Mitek Arthroscope included performance, cleaning validation and biocompatibility." The data provenance is not specified, but these are likely internal laboratory tests performed by the manufacturer. It is a prospective study in the sense that the tests were performed on the newly developed device to demonstrate its performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This device is an arthroscope, a medical instrument, not an AI or diagnostic device. Therefore, the concept of "ground truth established by experts" in the context of interpretation of medical images or data is not applicable here. The "ground truth" for the performance tests would be the established engineering specifications and measurement standards.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method in the context of multiple observers or interpretations, as this is a device performance test, not a diagnostic study. The "adjudication" is implied by the "Passed" results against established criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices or AI systems to assess their impact on human reader performance. The Mitek Arthroscope is a surgical visualization device.
6. Standalone Performance Study
Yes, a standalone performance study was done. The "Summary of Testing" table (Table 3) directly presents the results of various performance tests of the Mitek Arthroscope itself (e.g., Field of View, Fixed Focus, Scope Resolution). The entire "Non-Clinical Testing" section describes these standalone performance assessments.
7. Type of Ground Truth Used
The ground truth used for the performance tests was based on engineering specifications and recognized national and international standards. For example, DIN ISO 8600-3:2004 (Optics and optical instruments -- Medical endoscopes and endoscopic accessories -- Part 3: Determination of field of view and direction of view of endoscopes with optics) explicitly defines how certain optical parameters should be measured and what constitutes acceptable performance. Similarly, other standards like EN 60601-18 and ISO 10993-1 provide the "ground truth" for electrical safety and biocompatibility, respectively.
8. Sample Size for the Training Set
This document describes the clearance of a physical medical device (an arthroscope), not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of machine learning. The device is manufactured based on design specifications.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI algorithm in this context, this question is not applicable.
§ 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.