(50 days)
The intended use of the device is emulsification and removal of cataracts, as well as associated procedures such as vitreous aspiration and cutting along with bipolar coagulation.
The Infiniti" is a cataract extraction system used by ophthalmologists during cataract surgery. It is designed for use in anterior segment procedures that require simultaneous lens fragmentation, irrigation and aspiration, as well as ancillary functions such as vitreous aspiration and cutting along with bipolar coagulation. The Infiniti" system is a modification of the Alcon Series 20000 " Legacy " system and is substantially equivalent to the predicate devices listed above.
Here's an analysis of the provided text regarding the Infiniti™ Cataract Extraction System's acceptance criteria and studies:
Summary of Device Acceptance Criteria and Performance Studies
The provided 510(k) summary for the Infiniti™ Cataract Extraction System does not offer specific quantitative acceptance criteria or a detailed clinical study demonstrating the device's performance against such criteria in terms of efficacy on patients. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant safety and biocompatibility standards.
The acceptance criteria here primarily revolve around:
- Compliance with Safety Standards: Meeting established electrical safety and electromagnetic compatibility standards.
- Biocompatibility: Ensuring materials in contact with patients are biologically safe.
- Sterilization and Reprocessing Validation: Confirming the effectiveness of sterilization methods for single-use components and reprocessing instructions for reusable parts.
- Functional Equivalence: Demonstrating that the system's technological characteristics and functional requirements are similar to predicate devices, and that specifications are fulfilled.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance/Study Outcome |
|---|---|---|
| Electrical Safety | IEC 60601-1: 1988 (Medical Electrical Equipment, Part 1 - General Requirements for Safety) | "Safety tests... will demonstrate its compliance with applicable requirements." (Implies successful testing or intent to successfully test before commercial release). |
| IEC 60601-1: A1:1991-11 + A2:1995 -03 (Amendment - Medical Electrical Equipment, Part 1 - General Requirements for Safety) | "Safety tests... will demonstrate its compliance with applicable requirements." | |
| UL 2601-1: 1997 (Medical Electrical Equipment, Part 1 - General Requirements for Safety) | "Safety tests... will demonstrate its compliance with applicable requirements." | |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2: 1993 (Medical electrical equipment Part 1: General Requirements for Safety 2. Collateral Standard: ElectroMagnetic Compatibility - Requirements and tests) | "Safety tests... will demonstrate its compliance with applicable requirements." |
| Biocompatibility | AAMI/ANSI/ISO 10993-1: 1997 (Biological evaluation of medical devices, Part 1: Evaluation and Testing) | "Biocompatibility evaluations... will be performed to the following standards." (Implies successful evaluation or intent to successfully evaluate). |
| AAMI/ANSI/ISO 10993-5: 1999 (Biological evaluation of medical devices, Part 5: Test for cytotoxicity: in vitro methods) | "Biocompatibility evaluations... will be performed to the following standards." | |
| AAMI/ANSI/ISO 10993-7: 1995 (Biological evaluation of medical devices, Part 7: Ethylene oxide sterilization methods) | "Biocompatibility evaluations... will be performed to the following standards." | |
| AAMI/ANSI/ISO 10993-10: 1995 (Biological evaluation of medical devices, Part 10: Tests for irritation and sensitization) | "Biocompatibility evaluations... will be performed to the following standards." | |
| Sterilization Efficacy | AAMI/ISO 11135:1994 (Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization) for single-use consumable products. Validated reprocessing instructions for reusable handpieces (cleaning, sterilization, re-use). | "The Infiniti™ consumable products are provided sterile and intended for single use only. These products will be EtO sterilized and the process will be validated per the standard." "Reusable handpieces are not provided sterile. Validated reprocessing instructions... will be provided in the Directions for Use." |
| Functional Performance / Equivalence | Similar technological characteristics to predicate devices. Functional requirements met and system specifications fulfilled. | "Technological characteristics affecting clinical performance are similar to that of predicate devices previously listed." "Testing will demonstrate that the functional requirements have been met and that the system specifications are fulfilled prior to commercial product release." |
2. Sample Size Used for the Test Set and Data Provenance
- The document does not specify any clinical test set sample size in terms of patient data or a specific number of procedures.
- The studies mentioned are primarily non-clinical (bench testing, biocompatibility, sterilization validation).
- Data Provenance: Not applicable as no clinical test set data is presented. The non-clinical tests would have been performed in a laboratory setting, likely in the US where Alcon Research, Inc. is located. The submission states the device "will be developed and manufactured in compliance with FDA and ISO quality system requirements," indicating the testing environment follows established quality control.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. The submission does not describe a clinical study requiring expert-established ground truth for patient outcomes or diagnostic accuracy. Instead, the "ground truth" for the non-clinical tests comes from adherence to established engineering and medical device standards (e.g., passing specific electrical tests or biocompatibility assays).
4. Adjudication Method for the Test Set
- Not applicable. There is no clinical test set involving human interpretation or outcome assessment that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, an MRMC comparative effectiveness study was not done. This 510(k) submission is for a surgical device, not an imaging or diagnostic aid that would typically involve human reader performance. Its approval is based on substantial equivalence to existing predicate devices for safety and performance characteristics, rather than demonstrating improved human reader performance with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. The "Infiniti™ Cataract Extraction System" is a surgical instrument system, not an AI algorithm. Its performance is evaluated through its physical and functional characteristics and safety profile, not as a standalone AI.
7. The Type of Ground Truth Used
- For the non-clinical studies described, the "ground truth" is defined by compliance with recognized international standards (IEC, UL, ISO, AAMI) for safety, biocompatibility, and manufacturing quality. For functional performance, it's defined by meeting internal system specifications that are deemed equivalent to predicate devices. There is no mention of pathology, expert consensus on patient outcomes, or other clinical ground truth, as this is a device for performing a surgical procedure, not for diagnosis or prediction.
8. The Sample Size for the Training Set
- Not applicable. The Infiniti™ Cataract Extraction System is a physical medical device, not an AI/ML model that requires training data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for an AI/ML model.
§ 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.