(30 days)
The CONMED CrystalView™ Pro Irrigation System is a dual-head pump system intended to provide fluid distention, irrigation, and suction during diagnostic and operative knee, shoulder, hip, and small bone arthroscopic procedures.
The CONMED CrystalView™ Pro Irrigation System is designed to automatically provide and control distention and irrigation of the operative site during arthroscopic procedures. The system consists of a console with two peristaltic pumps and a control valve. It can be used as an inflow only pump or as an inflow and outflow / suction pump, utilizing currently marketed CONMED disposable tubing sets. The set pressure and measured pressure are displayed on the equipment. A USB port allows for easy import and export of Surgeon Presets and System settings to or from the console. The CONMED CrystalView™ Pro Irrigation console is sold non-sterile and must be located in a non-sterile area of the operating suite. The console gets connected to an autoclavable remote control which is a hand-held device, used in the sterile field with the cord connected to the console, that provides the same control functions as the console with the exception of Stand-by and Presets. The remote control gives the user the added advantage of controlling these functions from within the sterile field. Additionally, the system communicates with different existing, marketed accessories like power supply, tubing sets, cables, shaver sensor etc.
This document is a 510(k) Summary of Safety & Effectiveness for the CONMED CrystalView™ Pro Irrigation System, comparing it to a predicate device. This type of document is typically for medical devices that are substantially equivalent to an already legally marketed device, and therefore does not usually contain extensive clinical study data (such as MRMC studies, large training/test sets for AI, or detailed ground truth methodologies) as might be seen for novel devices or AI/ML-driven diagnostics. The focus here is on bench testing and demonstrating equivalence rather than proving clinical performance against a disease gold standard.
Based on the provided text, here is the information requested:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Performance Test) | Reported Device Performance |
|---|---|
| Reliability (console & remote) | Pass |
| Flow & Pressure Performance | Pass |
| Design Verification | Pass |
| Environmental | Pass |
| Electrical Safety (IEC 60601-1-2) | Pass |
| Electromagnetic compatibility (IEC 60601-2-2) | Pass |
| Software development | Pass |
| Packaging | Pass |
| Transportation | Pass |
| User Validation | Pass |
| Packaging & Labeling | Pass |
| Sterilization (remote) | Pass |
| Cleaning & Disinfection | Pass |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily discusses "extensive bench testing" and "design verification and validation testing." There is no mention of a clinical "test set" with patient data. The testing described appears to be laboratory-based engineering and quality assurance testing. Therefore, information on sample size for a test set based on patient data and data provenance is not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. The testing described is against engineering specifications and regulatory standards, not against "ground truth" established by experts for diagnostic performance. "User Validation" is mentioned, which might involve expert users, but no details are given about their number, qualifications, or how they established a ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no traditional "test set" for diagnostic performance described in the document that would require an adjudication method.
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
An MRMC comparative effectiveness study was not done. The device is an irrigation system, not an AI-driven diagnostic tool or an assistive technology for human readers/clinicians in the way an AI algorithm might be.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable. The CONMED CrystalView™ Pro Irrigation System is a physical medical device (a pump system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context refers to the device meeting its own specifications and applicable industry/regulatory standards. This includes:
- Engineering specifications: For flow and pressure performance, reliability, electrical safety, EMC, software functionality, etc.
- Regulatory standards: Such as IEC 60601-1-2 for electrical safety and ISO 14971 for risk management.
- User requirements: Validated through "User Validation."
There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for the performance tests described.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML algorithm.
§ 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.