(73 days)
The AMO®Diplomax™ and AMO®Opsys® consoles are components of phacofragmentation systems designed to provide all the surgical capabilities desired by the Anterior Segment/Cataract Surgeon. Phacofragmentation, also known as phacoemulsification or "phaco," is a cataract removal technique. When utilizing this technique, the surgeon makes a small incision in the eye and breaks up the cataract using ultrasonic vibration delivered by the tip of the handpiece inserted through the incision.
The subject of this 510(k) is the AMO®Diplomax™ and AMO®Opsys® consoles with modified driver controller board, power supply printed circuit board and software. The consoles are part of the phacoemulsification system which is used by ophthalmic surgeons during cataract surgery. Accessories, which are connected to the consoles, aid the surgeon in breaking up and removing the cataract from the patient’s eye.
Acceptance Criteria and Device Performance Study
The information provided describes a 510(k) premarket notification for modified AMO®Diplomax™ and AMO®Opsys® consoles. The study aims to demonstrate substantial equivalence to predicate devices, not necessarily to prove the device meets specific acceptance criteria as would be typical for a novel device. The "acceptance criteria" here are implicitly the performance characteristics of the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for the modified consoles are based on their equivalence to the predicate devices. The study demonstrates that the modified consoles exhibit the "Same" performance or capability as the predicate devices in the listed categories.
| Characteristic | Acceptance Criteria (Predicate Performance) | Reported Device Performance (Modified Consoles) |
|---|---|---|
| Safety Specification | Meets UL 544 | Meets UL 544 |
| Vitrectomy Circuit Output | Same (as predicate) | Same |
| Diathermy Circuitry Output | Same (as predicate) | Same |
| Load Compensation | Yes (present in predicate) | Yes |
| Output Waveforms | Yes (present in predicate) | Yes |
| Phaco Output Energy | Yes (present in predicate) | Yes |
| Continuous Irrigation All Modes | Yes (present in predicate) | Yes |
| CAP VAC | Yes (present in predicate) | Yes |
| U/S I/S | Yes (present in predicate) | Yes |
| Phaco Mode Sound ASP, VAC, U/S | Yes (present in predicate) | Yes |
| Diathermy Sound | Yes (present in predicate) | Yes |
| I/A Sound | Yes (present in predicate) | Yes |
| Self Test | Yes (present in predicate) | Yes |
(Note: "Same" and "Yes" in the reported device performance column indicate that the modified device performs identically to or possesses the same feature as the predicate device, thereby meeting the implicit acceptance criteria of substantial equivalence.)
2. Sample Size and Data Provenance
- Test Set Sample Size: The document does not explicitly state the sample size for the performance testing. It mentions "Performance testing was conducted on the AMO®Diplomax™ console with the Enhanced Driver Board, Power Module PCB and modified software." This implies testing was done on a console, potentially a limited number of consoles, but a specific numerical sample size is not provided.
- Data Provenance: The study was conducted by Allergan, based in Irvine, California, USA. The data is retrospective in the sense that it evaluates modifications to existing devices against their predicate versions. However, the testing itself for the modified device would be prospective at the time of submission. The country of origin for the data is the USA.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This is not a study that involves expert assessment for establishing ground truth, such as in image analysis or diagnosis. The study is a technical performance comparison against predicate devices.
4. Adjudication Method
Not applicable. As noted above, this is a technical performance study, not one requiring expert adjudication of results against a ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is not an MRMC study. It is a technical comparison of an updated medical device against its predicate for substantial equivalence.
6. Standalone Performance Study
Yes, in a way. The performance testing described is of the device itself (the modified consoles) and its components (Enhanced Driver Board, Power Module PCB, modified software). The results indicate that "the Enhanced Driver Board and Power Module PCB are compatible when incorporated into the AMO®Diplomax™ and AMO®Opsys® consoles and will not compromise system performance." This directly assesses the standalone performance of the modified components within the console system. There isn't a "human-in-the-loop" aspect to this performance evaluation described.
7. Type of Ground Truth Used
The "ground truth" for this study is the performance characteristics of the legally marketed predicate devices, specifically the original AMO®Diplomax™ and AMO®Opsys® consoles. The goal is to demonstrate that the modified devices are substantially equivalent to these established, safe, and effective devices.
8. Sample Size for the Training Set
Not applicable. This is not a study involving a "training set" in the context of machine learning or AI. The modifications are to hardware and software components of a physical medical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no "training set" in the AI/ML sense. The ground truth for the comparison is the established performance of the predicate medical 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.