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510(k) Data Aggregation
(124 days)
The AMO WHITESTAR Signature Pro Phacoemulsification System is a modular ophthalmic microsurgical system that facilitates anterior segment (i.e., cataract) ophthalmic surgery. The modular design allows the users to configure the system to meet their surgical requirements.
The subject device is the AMO WHITESTAR SIGNATURE PRO Phacoemulsification System, which is an upgrade to the primary predicate device, the AMO WHITESTAR Signature Phacoemulsification System (K111697). Key device components included in this 510(k) submission are the system console, advanced linear (four-button) foot pedal (ALP), and wireless remote control. The system console and wireless remote control of the subject device are substantially equivalent to the console and wireless remote control of the primary predicate device in K111697. The Advanced Linear foot pedal (ALP) used with the subject device is substantially equivalent to the foot pedal used with the secondary predicate device, the COMPACT INTUITIV System, cleared under K133115.
The subject device is classified under 21 CFR 886.4670 as a "phacofragmentation system," described as an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract. Like the primary predicate device in K111697, the subject device is used to perform phacoemulsification by applying ultrasonic energy combined with the mechanical action of a vibrating phaco handpiece to the cataractous lens of the eye. The system performs four basic functions: phacofragmentation, irrigation of fluid, diathermy (bipolar), and vitrectomy.
This document is a 510(k) summary for the AMO WHITESTAR SIGNATURE PRO Phacoemulsification System, not a clinical study report. It states that no clinical studies were deemed necessary to demonstrate safety and effectiveness. Therefore, the document does not contain the information required to answer the prompt directly as it pertains to acceptance criteria and performance data from a clinical study for this medical device.
The document focuses on demonstrating substantial equivalence to existing predicate devices (K111697 and K133115) based on non-clinical testing and technological characteristics.
However, I can extract information related to the non-clinical tests that were performed and the standards met, which serve as a form of "acceptance criteria" for regulatory clearance based on substantial equivalence.
Here's a summary of the non-clinical tests and the "performance" demonstrated by meeting these standards, presented as closely as possible to the requested format, while acknowledging the lack of clinical study data:
Acceptance Criteria and Device Performance (Based on Non-Clinical Testing for Substantial Equivalence)
Since no clinical studies were performed, the "acceptance criteria" here refer to compliance with recognized standards and successful completion of non-clinical design verification and validation testing, ensuring the device performs equivalently to its predicates. The "reported device performance" is its successful demonstration of meeting these standards and functional requirements.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Standard Met | Reported Device Performance / Compliance |
|---|---|---|
| Electromechanical Safety | ANSI/AAMI/ES 60601-1: 2005 (Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance. Amendment 1/Amendment 2) | Device passes acceptance criteria; performs as safely and effectively as the primary predicate. |
| Electromagnetic Compatibility (EMC) | EN/IEC 60601-1-2: 2007 (Medical Electrical Equipment – Part 1-2: General Requirements for Basic Safety and Essential Performance — Collateral Standard: Electromagnetic Compatibility – Requirements and Tests.) | Device passes acceptance criteria; performs as safely and effectively as the primary predicate. |
| High-Frequency Surgical Equipment Safety | EN/IEC 60601-2-2: 2009 (Medical Electrical Equipment – Part 2-2: Particular Requirements for the Basic Safety and Essential Performance of High-Frequency Surgical Equipment and High-Frequency Surgical Accessories.) | Device passes acceptance criteria; performs as safely and effectively as the primary predicate. |
| Software Life Cycle Processes | IEC 62304: 2006 (Medical Device Software – Software Life Cycle Processes.) | Device developed and tested in accordance with "AMO requirements and specifications" which comply with this standard. |
| Usability Engineering | IEC 62366: 2007 (Medical Device – Application of Usability Engineering to Medical Devices) | Device developed and tested in accordance with "AMO requirements and specifications" which comply with this standard. |
| Risk Management | ISO 14971: 2007 (Application of Risk Management to Medical Devices) | Device developed and tested in accordance with "AMO requirements and specifications" which comply with this standard. |
| Functional Equivalence | Performance in phacoemulsification, irrigation/aspiration, diathermy, and vitrectomy modes equivalent to the primary predicate device (K111697). | Passed acceptance criteria; found to perform as safely and effectively as the primary predicate device during these surgical modes. |
| Foot Pedal Equivalence | Performance of the Advanced Linear Foot Pedal (ALP) equivalent to the foot pedal in the secondary predicate device (K133115). | Found to perform as safely and effectively as the secondary predicate device's foot pedal. |
| Manufacturing Quality | Compliance with FDA and ISO quality system requirements prior to commercial release. | Preliminary system validation and verification data demonstrated that functional requirements and system specifications were met. |
Summary Regarding Clinical Study Details:
- 2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data is provided as no clinical studies were performed. The "test set" for non-clinical studies is not specified in terms of sample size or data provenance beyond general compliance with standards.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set.
- 4. Adjudication method for the test set: Not applicable. No clinical test set.
- 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: Not applicable. The device is a phacoemulsification system, not an AI or imaging diagnostic device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm device. Performance was established via engineering and bench testing, demonstrating equivalence to predicates.
- 7. The type of ground truth used: For non-clinical validation, "ground truth" would be defined by engineering specifications, validated test methods, and adherence to recognized standards. The device's performance was compared against these established technical benchmarks and the known performance characteristics of the predicate devices.
- 8. The sample size for the training set: Not applicable. This is not a machine learning device.
- 9. How the ground truth for the training set was established: Not applicable. This is not a machine learning device.
In conclusion, this 510(k) submission relied on non-clinical testing and a demonstration of substantial equivalence to already cleared predicate devices, rather than new clinical studies with defined acceptance criteria and performance metrics for direct patient outcomes.
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