(86 days)
The Synergist™ Power Pack is intended for use in cataract surgery or other ophthalmic surgical procedures where precision surgical tissue removal is required.
The Synergist™ Power Pack is an accessory device that operates in conjunction with currently marketed Phaco Emulsifier Aspirator Systems used in ophthalmic surgery. The Synergist™ replaces the ultrasonic handpiece of the host console. As such, it is intended for use in cataract surgery or other ophthalmic surgical procedures where precision surgical tissue removal is required. The Synergist™ delivers two distinct surgical capabilities: 1) load compensating ultrasonic handpiece power, and 2) Tmesis™ multifunction handpiece capability.
The Synergist™ Power Pack consists of:
Power Pack Console
Connector Cables
Tmesis™ multi-function handpiece,
Adjunct Footswitch
Ultra Tip™ Pack in various configurations
The Synergist™ Power Pack utilizes the programmable features of the Phaco Emulsifier host console but contains no software or firmware. It is controlled by the amplified signal of the host console by measuring the handpiece output of the host console and establishing that exact power level to the connected handpiece. Displayed power levels and energy summations on the host console are precisely maintained by the Synergist™. The Power Pack neither provides or utilizes power from the host console.
This document describes a medical device, the Synergist™ Power Pack, and claims substantial equivalence to a predicate device, the Phacotron™ Gold Multifunction Ultrasonic (Tmesis™) Handpiece. The provided text is a K960414 510(k) summary. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting de novo clinical studies with detailed acceptance criteria and performance data for the novel device itself.
Therefore, many of the requested elements for describing standalone device performance and a comparative effectiveness study involving AI with human readers are not applicable or extractable from this specific type of regulatory submission. The information below reflects what can be inferred or directly extracted from the provided text, indicating where information is not present.
1. Table of Acceptance Criteria and Reported Device Performance
No explicit "acceptance criteria" for the Synergist™ Power Pack as a standalone device's performance are provided in terms of specific metrics like accuracy, sensitivity, or specificity, nor are there reported performance statistics for these. The document focuses on demonstrating substantial equivalence to the predicate device's operational characteristics and intended use.
The comparison table provided in the 510(k) focuses on technological characteristics for substantial equivalence:
| Characteristic | Synergist™ Power Pack | Phacotron™ Gold Multifunction Handpiece | Performance Statement (as presented in 510(k)) |
|---|---|---|---|
| Intended use | Cataract/ophthalmic surgery | Cataract/ophthalmic surgery | Equivalent |
| Operating principle | Equivalent to US handpiece impedance matched | Equivalent to US handpiece impedance matched | Equivalent |
| Control mechanism | Console controlled via standard footswitch | Console controlled via standard footswitch | Equivalent |
| Physical form | External module | Internal module | Difference in form, but not functionality or safety. |
| Power supply | Independent power supply | Phaco console power supply | Difference in power source, but not functionality or safety. |
| Operating frequency | 40kHz | 40kHz | Equivalent |
| Materials | Standard materials used in Phaco Emulsifier Aspirator consoles and handpieces | Standard materials used in Phaco Emulsifier Aspirator consoles and handpieces | Equivalent |
2. Sample size used for the test set and the data provenance
- Not Applicable. The 510(k) submission does not describe a "test set" of data or patients to evaluate the Synergist™ Power Pack's performance in a clinical study with specific metrics. The substantial equivalence claim is based on comparing the device's technical specifications and intended use to an existing predicate device.
- The document implies that the device operates "in conjunction with currently marketed Phaco Emulsifier Aspirator Systems" and "replaces the ultrasonic handpiece of the host console," suggesting its performance is tied to the established safety and efficacy of the host systems and the predicate handpiece.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. As no specific clinical "test set" or evaluation requiring ground truth establishment for the Synergist™ Power Pack's performance is described, this information is not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical test set or adjudication method is described.
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. This device is a surgical accessory (a phacofragmentation system component), not an AI-assisted diagnostic or decision-support tool for human "readers." The concept of "human readers improve with AI vs without AI assistance" does not apply to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical surgical accessory. It does not perform "algorithm only" functions in the sense of an AI or software-based medical device. Its operation is inherently "human-in-the-loop" as it is controlled by a surgeon via a footswitch and integrates with an existing Phaco Emulsifier host console.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. As no specific clinical test set requiring ground truth is detailed for the Synergist™ Power Pack, this information is not provided. The "ground truth" for this type of submission is the demonstrated safety and effectiveness of the predicate device and the assertion that the new device is substantially equivalent in terms of technology, intended use, and performance characteristics.
8. The sample size for the training set
- Not Applicable. This device is a physical surgical instrument accessory. It does not utilize machine learning or AI models, and therefore does not have a "training set" in that context.
9. How the ground truth for the training set was established
- Not Applicable. As stated above, there is no "training set" for this type of 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.