(53 days)
The Sovereign™ Cataract Extraction System is a phacofragmentation system for use with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract. The Sovereign™ Cataract Extraction System is designed to provide the surgical capabilities desired by the Anterior Segment/Cataract Surgeon for use in the cataract extraction.
The Sovereign™ Cataract Extraction System is a phaccemulsification 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. The Sovereign™ Cataract Extraction System is a modification of a previous device and is substantially equivalent to the predicate devices listed above.
The provided Premarket Notification 510(k) Summary for the Sovereign™ Cataract Extraction System describes non-clinical performance testing rather than a clinical study with acceptance criteria in the format typically associated with AI/ML device evaluations. This submission precedes the widespread use of such technologies in medical devices.
Therefore, the information you requested about acceptance criteria, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details for AI/ML devices is not applicable or extractable from this document.
However, I can extract the information relevant to the performance testing that was conducted as described in the document.
Acceptance Criteria and Device Performance (Based on "Brief summary of nonclinical tests and results"):
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Phacoemulsification performance comparable to predicate device | Performance in an in vivo model system was comparable to the predicate with respect to phacoemulsification. |
| Irrigation performance comparable to predicate device | Performance in an in vivo model system was comparable to the predicate with respect to irrigation. |
| Diathermy performance comparable to predicate device | Performance in an in vivo model system was comparable to the predicate with respect to diathermy. |
| Vitrectomy performance comparable to predicate device | Performance in an in vivo model system was comparable to the predicate with respect to vitrectomy. |
| Fluidics performance comparable to predicate device | Performance in an in vivo model system was comparable to the predicate with respect to fluidics. |
| Reusable tubing sets (OPO55) durability | Reusable tubing sets (OPO55) qualified through cleaning, sterilization, and durability studies for up to 20 uses when reprocessed in accordance with the Directions for Use provided. |
| Overall function and intended use | The overall function and intended use of the modified device are substantially equivalent to the predicate devices. The results of these tests indicate that Sovereign™ Cataract Extraction System performs equivalent to the predicate devices. |
Additional Information (Not Applicable/Not Provided in the Document for AI/ML specific criteria):
- Sample size used for the test set and the data provenance: Not applicable. The document mentions "in vivo model system" but does not specify sample sizes or data provenance in the context of clinical test sets. This was likely bench and animal testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML models (e.g., expert consensus on images or pathology) is not relevant to this type of device and testing.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 system, not an AI diagnostic or assistance tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical system that requires a human operator (ophthalmic surgeon).
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" here is the performance of the predicate devices against which the Sovereign™ system's performance was compared in non-clinical settings (e.g., "in vivo model system"). The document implies that the established functionality and performance characteristics of the predicate devices served as the standard for comparison.
- The sample size for the training set: Not applicable. This device does not use an AI/ML algorithm that requires a training set.
- How the ground truth for the training set was established: Not applicable.
Summary of the Study:
The study referenced in the 510(k) summary is a "performance testing" of the Sovereign™ Cataract Extraction System. This testing was non-clinical and involved comparisons to predicate devices (other AMO® cataract extraction devices). The primary purpose was to demonstrate "substantial equivalence" to previously cleared devices rather than to meet specific statistical performance metrics against a clinical ground truth as would be required for an AI/ML diagnostic system. The testing covered functional aspects like phacoemulsification, irrigation, diathermy, vitrectomy, and fluidics in an "in vivo model system," as well as durability studies for reusable components.
§ 886.4360 Ocular surgery irrigation device.
(a)
Identification. An ocular surgery irrigation device is a device intended to be suspended over the ocular area during ophthalmic surgery to deliver continuous, controlled irrigation to the surgical field.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.