(65 days)
The METRx™ Microscope is indicated for visualization of the surgical field in any area of the body cut open during a surgical procedure. When used in the cervial, thoracic, or lumbar spine either from an anterior or posterior direction, for example, the METRx Microscope and accessories are intended to aid the surgeon's visualization of the surgical area and allow him/her to perform any type of surgical spinal procedure such as herniated disc repair, visualization of the circumferential decompression of the nerve roots, aiding in the search and removal of nucleus material, spinal fusion, or insertion of spinal implants. Other examples of generic surgical use of the METRx Microscope would be for use in the knee, ankle, shoulder, hand, wrist, and temporomandibular joint (TMJ).
Not Found
This 510(k) summary for the METRx Microscope and Accessories (K002931) does not contain the information requested to describe acceptance criteria and associated study results for a device that relies on an algorithm or AI.
The document is a traditional 510(k) premarket notification for a medical device (a microscope and its accessories) and focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and intended use. This type of submission predates the widespread use of AI/ML in medical devices and therefore does not include the detailed performance evaluation against predefined criteria that would be required for such a device today.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This document does not define specific performance metrics or acceptance criteria in the way an AI/ML device submission would.
- Sample size used for the test set and the data provenance: Not applicable as there is no mention of a "test set" in the context of algorithm performance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of what the document does provide:
- Device Name: METRx™ System (Microscope and Accessories)
- 510(k) Number: K002931
- Submission Date: September 2000
- Clearance Date: November 24, 2000
- Indications for Use: Visualization of the surgical field in any area of the body cut open during a surgical procedure, with specific examples for cervical, thoracic, or lumbar spine procedures (herniated disc repair, nerve root decompression, nucleus material removal, spinal fusion, implant insertion) and other generic surgical uses (knee, ankle, shoulder, hand, wrist, TMJ).
- Basis for Clearance: Substantial equivalence to predicate devices based on technological characteristics.
To obtain the requested information, a document describing the validation of an AI/ML medical device would be needed.
§ 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.