(191 days)
The Greatbatch Scientific MR Compatible Arthroscopes and Small Joint Arthroscopes and Accessories are intended for use by practioners to treat the small joints of the wrist, knee, ankles, elbow, shoulder, and the temporal- mandibular joint of patients in a MR or an interventional MR environment, not to exceed a shielded 1.5 Tesla magnet.
The Greatbatch Scientific MR Compatible Arthroscopes and Small Joint Arthroscopes are available in standard and autoclavable 1.7mm, 2.7mm and 4.0mm sizes, with 0°, 30° or 70° angles.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Greatbatch Scientific MR Compatible Arthroscopes and Small Joint Arthroscopes:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided 510(k) summary, the core acceptance criterion is related to MR compatibility.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| MR Compatibility in a 1.5 Tesla static magnetic field environment | "The device was tested for MR Compatibility and was found to be acceptable for use in a 1.5 Tesla static magnet field." |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the sample size used for the MR compatibility testing. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective). This information is typically found in the detailed test report, which is not included here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to a device like an arthroscope, which is evaluated for physical performance characteristics (like MR compatibility) rather than for diagnostic accuracy based on expert interpretation of images or other data. The "ground truth" for MR compatibility would be established through engineering tests and measurements, often against established standards.
4. Adjudication Method for the Test Set
This concept is not applicable to the type of performance data presented here. Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation (e.g., of medical images) where there might be disagreement among experts. For physical device testing, the results are usually objective measurements, not subject to adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and 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 tools where human readers are involved in interpreting output. The Greatbatch Scientific MR Compatible Arthroscopes are physical medical devices, not AI software.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
No, a standalone study in the context of an algorithm or AI performance was not done. This device is a physical instrument, not an algorithm. The testing performed was related to the physical properties of the device itself (MR compatibility).
7. The Type of Ground Truth Used
The "ground truth" for this study was established through engineering and performance testing related to MR compatibility. This would involve objective measurements of electromagnetic interference, heating, and other physical interactions with an MRI environment, likely against predefined limits (e.g., as per ASTM standards for MR safety). It's not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This concept is not applicable. The device is a physical arthroscope, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
This concept is not applicable as there is no training set for a physical medical device like this arthroscope.
§ 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.