(89 days)
The intended use of this device is to assist in the automated phacoemulsification of a natural crystalline lens.
The Series 20000® Legacy® System and its predicate devices use ultrasonic energy to emulsify cataractous lens material and remove it from the eye (phacoemulsification). Electronic energy is generated in the machine, delivered to a handpiece and is finally converted to ultrasonic energy delivered through a hollow titanium needle, or tip. Irrigation fluid is delivered to the eye via the combination of an irrigation sleeve over the handpiece tip. The emulsified lens material is aspirated out of the eye through the center of the handpiece/tip assembly. The handpieces are being routinely used repeatedly in multiple surgical procedures, while the tips marketed by Alcon have been labeled for single-use only. Other predicate devices have been labeled as reusable. The labeling modification which is the subject of this submission is that some of Alcon phacoemulsification tips can be used in up to 20 surgical procedures, provided they are carefully handled and inspected before and after each use.
This document is a 510(k) Pre-Market Notification for a medical device, specifically an Alcon Limited Reuse Ultrasonic Tip. It is not an AI/ML device, so much of the requested information (like AI/ML specific criteria, ground truth, and training sets) is not applicable.
However, I can extract information related to the device's performance claims and supporting evidence described in the document.
1. Table of Acceptance Criteria and the Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable table format as might be expected for modern AI/ML device submissions. Instead, it refers to the performance relative to predicate devices and the absence of certain negative effects after repeated use.
| Acceptance Criteria (Inferred from regulatory requirements and claims) | Reported Device Performance |
|---|---|
| Safety: Performance of tips does not compromise safety during repeated use. | "It has been demonstrated that repeated use of the phacoemulsification tips does not alter performance of the tips as to affect safety..." Specifically, "effects of fatigue, cavitation erosion, and chemical reactions have been shown to have no significant effect on tip performance." |
| Efficacy: Performance of tips during repeated use remains effective for the intended purpose. | "... and efficacy of the device." Specifically, "effects of fatigue, cavitation erosion, and chemical reactions have been shown to have no significant effect on tip performance." The device "utilizes the same technology as the predicate devices." |
| Structural Integrity: Maintains structural integrity after repeated use (e.g., no significant fatigue). | "effects of fatigue... have been shown to have no significant effect on tip performance." The tips are manufactured from a "titanium alloy which exhibits excellent structural... properties making it suitable for repeated use." |
| Material Degradation: No significant cavitation erosion or chemical reactions that degrade performance or safety. | "cavitation erosion, and chemical reactions have been shown to have no significant effect on tip performance." |
| Equivalence to Predicate Devices: Performance is substantially equivalent to legally marketed predicate devices. | "the Alcon Limited Reuse Phacoemulsification Ultrasonic Tip is proven to be substantially equivalent to the predicate devices described in Section 1 (above)." The device "utilizes the same technology as the predicate devices." The predicate devices are listed and are reusable. Alcon's tips are now labeled for 20 uses. |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not provide a specific "sample size" for a test set in the conventional sense of a clinical trial or algorithm validation. The "study" mentioned is more akin to engineering and materials testing to assess the effects of repeated use on the tip's physical properties and performance.
- Sample Size: Not explicitly stated in terms of number of tips or number of uses observed in a "test set." The document generally refers to "repeated use."
- Data Provenance: Not specified (e.g., country of origin). The testing would have been conducted by Alcon Laboratories, Inc.
- Retrospective or Prospective: Unclear, but likely a combination of prospective laboratory testing (e.g., accelerated aging, fatigue testing) and potentially retrospective analysis of predicate device performance or materials science. It's not a clinical study on patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This concept is not directly applicable to this device submission. "Ground truth" in the context of expert consensus is typically for diagnostic interpretation. Here, the "ground truth" relates to the physical and functional integrity of a mechanical device after repeated use. This would be established through:
- Engineers/Material Scientists: Experts in fatigue analysis, material science, and mechanical testing.
- Manufacturing Quality Control: Personnel performing inspections and performance checks.
- Surgeons/Ophthalmologists: Providing input on clinical performance parameters and observations during use.
The document does not detail the specific number or qualifications of these individuals involved in assessing the testing results.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods like 2+1 or 3+1 refer to how discrepant expert interpretations are resolved, which isn't relevant for mechanical device testing results. The "adjudication" would be based on established engineering standards and performance benchmarks.
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:
This is explicitly not applicable. This is a physical ultrasonic tip, not an AI/ML device that assists human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This is explicitly not applicable. This is a physical ultrasonic tip, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance would be derived from:
- Engineering/Material Science Testing Data: Measurements of material degradation (e.g., fatigue cracking, erosion), functional output (e.g., ultrasonic power, tip integrity), and structural analysis.
- Bench Testing: Performance against established specifications and predicate device performance in controlled environments.
- Clinical Performance Observations (indirect): Ensuring no adverse events or performance degradation when used in a surgical context (though direct patient outcomes from a trial are not reported here).
- Regulatory Standards: Adherence to relevant FDA guidance and industry standards for medical device materials and reuse.
8. The Sample Size for the Training Set:
This is explicitly not applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This is explicitly not applicable. As it's not an AI/ML model, there is no "training set" or "ground truth for the training set."
§ 886.4670 Phacofragmentation system.
(a)
Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.(b)
Classification. Class II.