(22 days)
The SOVEREIGN® High Vacuum Pack is indicated for use with the SOVEREIGN® phacoemulsification machine. The SOVEREIGN® High Vacuum pack includes a filter protected flow restriction orifice used during cataract surgery to minimize vacuum surges in the aspiration line. The SOVEREIGN® Compact High Vacuum Pack is indicated for use with the SOVEREIGN® Compact phacoemulsification machine. The SOVEREIGN® Compact High Vacuum pack includes a filter protected flow restriction orifice used during cataract surgery to minimize vacuum surges in the aspiration line.
The SOVEREIGN® High Vacuum Pack and the SOVEREIGN® Compact High Vacuum Pack are accessory kits indicated for use with the SOVEREIGN® phacoemulsification machine and the SOVEREIGN® Compact phacoemulsification machine, respectively, to perform an irrigation/aspiration (I/A) procedure or a phacoemulsification procedure during cataract surgery. The tubing assembly component of the kit incorporates a flow restriction feature for preventing/neutralizing post occlusion surge following an occlusion break at the distal end of a phaco tip. The materials, basic scientific concepts, physical properties and intended use of the device kits are similar to those of the identified predicate devices.
The provided text describes a 510(k) summary for the SOVEREIGN® High Vacuum Pack and SOVEREIGN® Compact High Vacuum Pack, which are accessory kits for phacoemulsification machines used in cataract surgery. The summary focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed study with acceptance criteria and performance metrics in the typical sense of a diagnostic medical device.
However, based on the information provided, we can infer some "acceptance criteria" and the nature of the "study" conducted for this type of submission. The primary goal was to prove substantial equivalence to existing legally marketed devices.
Here's an interpretation of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance |
|---|---|
| Equivalence in Intended Use: Device performs irrigation/aspiration or phacoemulsification during cataract surgery, minimizes vacuum surges. | The SOVEREIGN® High Vacuum Pack and SOVEREIGN® Compact High Vacuum Pack are indicated for use with the respective SOVEREIGN® phacoemulsification machines to perform irrigation/aspiration or phacoemulsification during cataract surgery. They include a filter protected flow restriction orifice to minimize vacuum surges in the aspiration line, similar to predicate devices. |
| Equivalence in Technological Characteristics: Materials, method of sterilization, mode of operation. | "The technological characteristics of the SOVEREIGN® High Vacuum Pack were compared to those of the predicate devices and were found to be equivalent with respect to the materials, method of sterilization, intended use, and mode of operation." |
| Equivalence in Performance Characteristics (Nonclinical): Flow resistance and chamber maintenance. | "Bench testing was conducted which verified that the performance characteristics (flow resistance and chamber maintenance) associated with the SOVEREIGN® High Vacuum Pack were equivalent to that of the predicate devices." |
| Safety and Effectiveness: No new questions of safety or effectiveness. | "AMO® has demonstrated through its evaluation of the SOVEREIGN® High Vacuum Pack that the device is equivalent to the predicate devices with respect to intended use, technological characteristics, and safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a "sample size" in the context of clinical patient data. The evaluation was primarily bench testing. For bench testing, the sample size would refer to the number of units tested. This information is not provided in the document.
- Data Provenance: The data provenance is nonclinical bench testing. The country of origin for the testing is not explicitly stated. It is considered retrospective in the sense that it compares performance to established predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. This was bench testing, not an expert-driven clinical evaluation requiring ground truth establishment in that manner.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Bench tests typically involve direct measurement and comparison to predefined engineering specifications or predicate device performance, not expert adjudication in the clinical sense.
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
- MRMC Study: No, an MRMC study was not done. This device is a surgical accessory, not an AI-powered diagnostic tool.
- Effect Size of AI Improvement: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. This device is a physical accessory used with a phacoemulsification machine, hence inherently "human-in-the-loop" in its application during surgery. No standalone algorithm performance was assessed.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for the bench testing was derived from established performance characteristics of the predicate devices (e.g., their known flow resistance and chamber maintenance capabilities). This is a form of engineering specification/benchmark comparison, rather than expert consensus, pathology, or outcomes data in a clinical trial.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The device design and verification were based on engineering principles and comparisons to existing predicate designs.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable, as there was no training set in the context of machine learning.
§ 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.