(142 days)
The AquaLase® Capsule Wash Tip is indicated to assist in the removal of residual cortical material and lens epithelial cells.
The AquaLase® Capsule Wash Tip is a sterile, single-use product. It is an accessory to the AquaLase® Handpiece (K980292), which produces the heated intraocular irrigating solution (Balanced Salt Solution or equivalent fluid) that washes the capsular surface. The AquaLase® Capsule Wash Tip and the AquaLase® Handpiece are accessories to the INFINITI® Vision System (K021566). The AquaLase® Capsule Wash Tip utilizes existing packaging configurations and has the same shelf life as existing AquaLase® tips.
To use the AquaLase® Capsule Wash Tip as intended, no modification to the existing INFINITI® System is required.
The document describes the acceptance criteria and performance testing for the AquaLase® Capsule Wash Tip, an accessory to a phacoemulsification device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Description | Reported Device Performance |
|---|---|
| Nozzle and Tube Retention (Minimum Retention Strength) | Tips passed the minimum retention strength. |
| Passive Flow (Requirements) | Tips passed the passive flow requirements. |
| Wrench/Tip Detachment (Force) | Tips passed the wrench/tip detachment force. |
| Fluid Output Profile (Collimated Requirement) | Tips passed the fluid output profile requirement of being collimated. |
| Handpiece Compatibility (Requirement) | Tips passed the handpiece compatibility requirement. |
| Irrigation Free Flow (Minimum Rate) | Tips passed the minimum irrigation free flow rate requirement. |
| Injection Fluid Active Flow (Average Pulse Flow Rate) | Tips passed the injection fluid active flow. |
| Injection Pulse Volume (Maximum) | Tips passed the maximum injection pulse volume requirement. |
| Pulse Fluid Exit Temperature (Maximum) | Tips passed the maximum temperature requirement. |
| Leakage (Leak-free during use) | Tips passed the requirement to remain leak free during use. |
| Particulates (Metallic Particulate Requirements) | Tips passed the metallic particulate requirements. |
| Endurance (Injection Fluid Active Flow & Leakage) | Tips passed the endurance requirement for Injection Fluid Active Flow and the endurance requirement for Leakage |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a distinct "test set" in terms of a clinical study with human patients. The performance testing appears to be primarily non-clinical bench testing of the device itself. Therefore, sample sizes would refer to the number of tips or tests conducted on the device components. This information (e.g., number of tips tested for each criterion) is not provided in the summary.
Data provenance is not explicitly stated as country of origin, but given the submission is to the FDA, it's implied that the testing was conducted to meet US regulatory requirements. The testing is retrospective in the sense that it's conducted on the manufactured device prior to market introduction, but not in the context of analyzing previously collected patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not applicable as the "ground truth" for the non-clinical performance testing of this medical device is based on predefined engineering specifications, regulatory standards, and comparison to predicate devices, not on expert consensus from clinical cases. There is no mention of experts establishing ground truth for the device's functional performance.
4. Adjudication Method for the Test Set:
This information is not applicable as the testing described is objective, non-clinical performance testing against pre-defined specifications. There is no mention of subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document focuses on the non-clinical performance of the device itself and its equivalence to predicate devices, not on the clinical effectiveness or improvement of human readers with or without AI assistance. The device is a surgical accessory, not an AI software.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
This question is not applicable as the device is a physical surgical accessory (Capsule Wash Tip), not an algorithm or AI software. There is no "algorithm only" performance to evaluate.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance testing is based on:
- Engineering specifications and requirements: Such as minimum retention strength, passive flow requirements, collimation of fluid output profile, maximum temperature, and leak-free operation.
- Regulatory standards: Adherence to standards like ISO 10993 (biocompatibility) and ISO 11135-1 (sterilization).
- Comparison to predicate devices: "Salient tip performance characteristics such as fluid output volume and fluid output temperature are analogous to the 1.1mm Liquefaction Tip."
8. The Sample Size for the Training Set:
This information is not applicable. The device is a physical medical device, not an AI or software algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no "training set" for this type of medical device.
§ 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.