(247 days)
The Cetus Laser System is indicated for use in phacofragmentation of the cataractous crystalline lens.
The Cetus system is a 1064nm. pulsed, Nd: YAG Q-switched laser system used together with a sterile, single use laser probe and a Phaco machine. The system console has a digital touch screen and it is used in conjunction with the Cetus probe and a Phacoemulsification machine in the operating room. The probe converts the laser light energy into acoustic energy which is used to perform the fragmentation of the the crystalline lens and has integrated aspiration and irrigation functions.
The provided text is a 510(k) summary for the Cetus System, a laser system for phacofragmentation of cataractous crystalline lenses. It focuses on demonstrating substantial equivalence to a predicate device through comparison of technical specifications and non-clinical performance data.
However, the document does not contain information related to acceptance criteria, clinical studies, or performance metrics in the way your prompt describes for AI/medical device performance evaluation. Such information would typically include:
- Acceptance Criteria for Device Performance: Specific numerical thresholds for metrics like accuracy, sensitivity, specificity, etc.
- Reported Device Performance: Actual results from tests against these criteria.
- Sample Sizes, Data Provenance, Ground Truth: For clinical or simulated clinical studies demonstrating performance.
- Expert Review/Adjudication: Details on how ground truth was established, especially in diagnostic/imaging devices.
- MRMC or Standalone Studies: Type of clinical efficacy study.
Therefore, based solely on the provided text, I cannot complete the table or answer the questions related to clinical performance, acceptance criteria, or studies proving the device meets them because this information is not present.
The document explicitly states: "Clinical Performance Data: None".
The "performance data" referred to in the document is non-clinical and focuses on compliance with various safety, sterilization, packaging, and risk management standards, rather than the device's clinical efficacy or output performance as measured by typical diagnostic/treatment metrics.
Here's what I can extract from the provided text relevant to the device and its testing, but it does not address your specific request for acceptance criteria and clinical performance study details:
1. Table of Acceptance Criteria and Reported Device Performance:
- None provided for clinical performance. The document only lists non-clinical compliance standards.
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. No clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. No clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. No clinical test set.
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:
- No. The document explicitly states "Clinical Performance Data: None." This device is a surgical tool, not an AI diagnostic tool, so an MRMC study is not relevant in the context of this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. The document explicitly states "Clinical Performance Data: None."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable / Not provided. No clinical test set.
8. The sample size for the training set:
- Not applicable / Not provided. No training set for an AI algorithm is mentioned as this is a physical medical device.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. No training set for an AI algorithm is mentioned.
Summary of Non-Clinical Performance Data from the document:
The device's safety and effectiveness were demonstrated through compliance with various non-clinical standards:
- Electrical Safety: AAMI ANSI ES60601-1:2005(R) 2012 and A1:2012
- Laser Safety: IEC 60825-1:2007
- Electromagnetic Compatibility: IEC 60601-1-2:2007
- Sterilization: DIN EN ISO 11135-1:2014
- Packaging Integrity: ASTM F1886/ F1886M-09:2013
- Accelerated Ageing of Sterile Barrier: ASTM F1980-07:2011
- Sterile Packaging: DIN EN 868-5:2009
- Microbial Ranking of Porous Packaging Materials: ASTM F1608-00:2009
- Biological Evaluation of EO Residuals: DIN ISO 10993-7:2009
- Risk Management: ISO 14971: 2007 + Am 2010
The document concludes based on these non-clinical tests that the Cetus system is "as safe and effective as the predicate device."
§ 886.4150 Vitreous aspiration and cutting instrument.
(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.