(17 days)
The Dignity™ Ophthalmic Surgical System is a Phacofragmentation device intended for use in cataract surgery to emulsify, and extract the cataract.
The Dignity™ Ophthalmic Surgical System is used by ophthalmic surgeons to perform cataract surgery. The system utilizes accessories connected to the console to perform the cataract surgery.
This document describes a 510(k) premarket notification for the Dignity™ Ophthalmic Surgical System, a phacofragmentation unit used in cataract surgery. The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices for Phacoemulsification, Irrigation/Aspiration, Diathermy, and Vitrectomy in an in vitro model. This implies that the Dignity™ Ophthalmic Surgical System should perform similarly to the predicate devices in these functional areas within a controlled laboratory setting. | The performance tests conducted on the Dignity™ Ophthalmic Surgical System in an in vitro model demonstrated that it was substantially equivalent to the predicate devices with respect to Phacoemulsification, Irrigation/Aspiration, Diathermy and Vitrectomy. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not specify a numerical sample size for the test set. It mentions "Performance tests were conducted," implying a set of tests were performed, but not the quantity of tests or specific materials used.
- Data Provenance: The study was an in vitro model. This means the testing was conducted in a controlled laboratory environment, likely using simulated cataract materials or experimental setups, rather than on live subjects or human tissues. No country of origin is explicitly stated for the testing itself, but the submission is for the US FDA. The study is non-clinical.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This information is not applicable as the study was an in vitro performance test, not a study involving human interpretation or clinical data where expert ground truth would be established. The "ground truth" here is the measured performance against defined engineering or functional specifications, benchmarked against predicate devices.
4. Adjudication Method for the Test Set
- This information is not applicable for an in vitro performance test. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in studies involving human interpretation (e.g., image reading) or complex clinical endpoints.
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, an MRMC comparative effectiveness study was not done. The device described is a surgical instrument (phacofragmentation unit), not an AI-assisted diagnostic or interpretation tool for human readers. Therefore, there's no mention of human readers or AI assistance in this context.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- This question is not directly applicable in the AI-sense. The "device" itself (the Dignity™ Ophthalmic Surgical System) performs its function (phacofragmentation, etc.) without human "in-the-loop" once the surgeon initiates and controls it. However, this is a mechanical/electronic device, not an "algorithm" in the AI sense. The performance tests were of the device's functional capabilities (Phacoemulsification, Irrigation/Aspiration, Diathermy, and Vitrectomy) in an in vitro setting, which can be considered "standalone" in that it measures the device's inherent performance.
7. The Type of Ground Truth Used
- The ground truth in this non-clinical study was the performance of the predicate devices, against which the Dignity™ Ophthalmic Surgical System was compared to establish substantial equivalence. The specific metrics for Phacoemulsification, Irrigation/Aspiration, Diathermy, and Vitrectomy (e.g., efficiency, flow rates, temperature control) would have been measured for both the new device and the predicates to demonstrate comparable function.
8. The Sample Size for the Training Set
- Not applicable. This submission describes a medical device clearance based on substantial equivalence through in vitro performance testing against predicate devices. There is no mention or implication of a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for one. The "ground truth" for the device's functional testing was its performance relative to established predicate devices.
§ 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.