(90 days)
The Axis Surgical Technologies C-MOR Visualization Device is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.
The C-MOR Visualization Device is a battery operated, portable, visualization device including an integrated LCD monitor and probe. The C-MOR Visualization Device is easily handled in one hand and includes a user interface, electronics, user controls, and LED light source. The LCD monitor displays real-time images from the probe and is flexibly mounted on the handle - allowing adjustment of the LCD viewing angle. The probe extends from the handle as a rigid shaft seating a CMOS camera and fiber optic lighting located at the distal tip.
The overall length of the C-MOR Device 342 mm (approx. 13.5 inches); including the probe portion and handle. The probe length, extending from the handle, is 150 mm (approx. 6 inches). The entire unit weighs less than 300 grams (approx. 0.67 lbs.).
The provided document is a 510(k) Premarket Notification for the "C-MOR Visualization System," an arthroscope manufactured by Axis Surgical Technologies, Inc. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a novel device's performance against specific acceptance criteria in a clinical study.
Therefore, the information requested regarding acceptance criteria, study design, expert involvement, and ground truth establishment is not available within this specific FDA submission document.
Here's why and what can be extracted:
- Substantial Equivalence: The primary goal of a 510(k) is to show that a new device is as safe and effective as a legally marketed predicate device. This is often done by comparing technological characteristics and intended use, and sometimes through non-clinical performance testing (e.g., electrical safety, biocompatibility). It typically does not involve the type of clinical performance study with detailed acceptance criteria and expert reviews that would be associated with a novel device or one requiring a PMA.
- Performance Data Mentioned: The document states: "Performance data supporting the claim of substantial equivalence is included in the body of the premarket notification." The ONLY specific performance data mentioned in the provided text relates to compliance with international standards: "The C-MOR Visualization Device complies with the international standards for EMC, Medical Device Electrical Safety and biocompatibility." This indicates that the "performance data" referred to is about engineering and safety standards, not clinical diagnostic or therapeutic efficacy.
Information NOT available from the provided text:
- A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on comparison to predicates by intended use and technology, and compliance with general safety standards.
- Sample size used for the test set and the data provenance: Not applicable in the context of demonstrating substantial equivalence for this type of device based on the provided text. There is no mention of a "test set" for clinical performance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; no ground truth establishment for a clinical test set is described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This device is an arthroscope, not an AI-assisted diagnostic tool.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable; this is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
Summary of available information related to "Performance" (as per the document):
| Performance Aspect | Description |
|---|---|
| Acceptance Criteria (Implicit) | Substantial Equivalence to predicate devices (K082293, K043395, K072879) in terms of intended use, indications for use, fundamental technology, and operating principles. Compliance with international standards for safety and biocompatibility. |
| Reported Device Performance | - Intended Use/Indications: Same as predicate devices. |
- Basic Technology/Operating Principles: Same as predicate devices.
- Compliance with Standards: Complies with international standards for EMC, Medical Device Electrical Safety, and Biocompatibility. |
| Study Type/Evidence | Comparison to predicate devices (K082293, K043395, K072879) and demonstration of compliance with relevant international safety/engineering standards. |
| Sample Size (for clinical performance) | Not applicable; no clinical performance study referenced in the provided text. |
| Data Provenance | Not applicable for clinical performance. |
| Experts for Ground Truth | Not applicable. |
| Adjudication Method | Not applicable. |
| MRMC Study | No. |
| Standalone Performance | No. |
| Ground Truth Type | Not applicable. |
| Training Set Sample Size | Not applicable. |
| Training Set Ground Truth Method | 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.