(113 days)
This device assists in the removal of cataracts by softening, emulsifying and aspirating the cataract
The Liquefracture device is designed to assist ophthalmic surgeons in the removal of cateractous lenses (cataracts) for the purpose of restoration of impaired sight due to the formation of a cataract. The Liquefracture device combines the prefreatment and emulsification functions. It will be packaged into a handpiece used directly by the surgeon within the sterile field. The handpiece will be driven by a Ophthalmic Surgery system containing irrigation and aspiration functions as currently provided in cataract surgery equipment. In addition, a low power DC power source will be included in the Ophthalmic Surgery system to control the fluid heating function of the handpiece. A user interface will also be provided by the Ophthalmic Surgery system, which is placed external to the sterile environment (field) just as in most cataract surgery equipment.
The provided text describes a 510(k) premarket notification for the Alcon Cataract Liquefracture Device. The submission aims to establish substantial equivalence to predicate devices, not necessarily to meet specific, pre-defined acceptance criteria in a quantitative sense as might be found in a clinical trial for a novel device. Instead, the submission focuses on demonstrating that the new device is "as safe and effective" as existing, legally marketed devices.
Therefore, the requested information elements related to specific acceptance criteria and the study proving the device meets them might not be directly available in the format you expect for a statistically powered clinical trial with clear thresholds for success. The provided 510(k) summary focuses on demonstrating equivalence through comparison of technological characteristics and performance data to predicate devices.
However, I can extract and infer information based on the 510(k) document to answer as many of your points as possible:
1. Table of Acceptance Criteria and Reported Device Performance
As a 510(k) submission, explicit "acceptance criteria" for a novel performance threshold are not present. Instead, the "acceptance criteria" are implicitly demonstrating that the device is substantially equivalent in safety and effectiveness to predicate devices. The "reported device performance" is compared against the performance of these predicate devices in key areas.
| Acceptance Criterion (Implicit for 510(k) Equivalence) | Reported Device Performance |
|---|---|
| Safety: Anterior chamber temperature rise comparable to U/S phacoemulsification | Reported to be comparable to U/S phacoemulsification. (Specific numerical data not provided in this summary.) |
| Safety: Histological impact of hot BSS pulses in vivo comparable to U/S phacoemulsification | Reported to be comparable to U/S phacoemulsification. (Specific histological findings not provided in this summary.) |
| Effectiveness: Efficiency of cataract aspiration comparable to U/S phacoemulsification | Reported to be comparable to U/S phacoemulsification. (Specific quantitative measures of efficiency not provided in this summary.) |
| Overall Equivalence: Device is as safe and effective as predicate devices. | The testing and calculations provided in the Premarket Notification show the device to be as safe and effective in the removal of cataracts as the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The summary does not specify the sample size for any test set or in vivo studies.
The data provenance is implied to be from Alcon Laboratories, Inc., likely conducted in the USA (given the submission to the FDA).
It is not explicitly stated whether the studies were retrospective or prospective. Due to the nature of product development and safety/performance testing, it's generally expected that such tests (especially in vivo histology) would be prospectively designed experiments.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The summary does not mention a panel of experts used to establish "ground truth" in the context of diagnostic accuracy, as this device is a surgical tool, not a diagnostic aid. The evaluation of histological impact would involve expert pathologists, but the number and specific qualifications are not detailed in this summary.
4. Adjudication Method
Not applicable as there is no diagnostic ground truth or expert panel adjudication described for this type of device submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study is not mentioned in the summary. This type of study is typically associated with diagnostic imaging devices where human reader performance is a key metric. This device is a surgical instrument. Effects on human readers/surgeons are not described in terms of AI assistance.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
The concept of "standalone (algorithm only)" performance is not applicable to this device. The Alcon Cataract Liquefracture Device is a physical surgical handpiece operated by a human surgeon. It does not operate as an algorithm in a standalone capacity.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the objective measurements and histological analyses collected during the performance and safety testing.
- Physiological measurements: Anterior chamber temperature rise.
- Histology: In vivo impact of hot BSS pulses (presumably assessed by expert pathologists).
- Performance metrics: Efficiency of cataract aspiration. These are compared directly to the performance of predicate devices.
8. The Sample Size for the Training Set
Not applicable. This device is a physical surgical tool and does not involve AI or machine learning algorithms that require a "training set" in the computational sense. The "training set" concept is irrelevant here.
9. How the Ground Truth for the Training Set was Established
Not applicable for the reasons stated in point 8.
§ 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.