(146 days)
The Milvella Perfect Capsule is intended to be used after phacoemulsification of the natural crystalline lens by providing a method for sealed capsule polishing and irrigation, for the purpose of removing residual cortex and/or epithelial cells.
The Milvella Perfect Capsule is intended for use after phacoemulsification of the natural crystalline lens for the purpose of removing residual cortex and/or epithelial cells, by providing a method for sealed capsule polishing and irrigation.
The Perfect Capsule is a single-use, sterile instrument molded from silicone and designed for use in cataract surgery for the purpose of removing residual cortex and/or epithelial cells after cataract extraction by phacoemulsification. This device provides a method of holding the empty lens capsule and containing irrigation fluid to within the lens capsule after cataract removal, thus reducing the risk of irrigating fluid contacting other ocular structures including the corneal endothelium.
The provided text describes a medical device called the "Milvella Perfect Capsule" and its 510(k) submission for market clearance. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study to prove performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not explicitly available in the provided document.
However, I can extract the information directly available and infer what might be considered "acceptance" based on the regulatory context.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or a dedicated performance study with specific metrics. Instead, the "acceptance criteria" are implied by compliance with established standards and demonstrated "substantial equivalence" to predicate devices. The reported "performance" is a general statement of meeting requirements and performing consistently with intended use.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with Sterilization Standards: ANSI/AAMI/ISO 11137-1994, ANSI/AAMI/ISO 10993 | "The Milvella Perfect Capsule complies with the following standards... STERILIZATION - ANSI/AAMI/ISO 11137-1994... ANSI/AAMI/ISO 10993; Biological Evaluation of Medical Devices-Part 1." (Implied successful sterilization and biocompatibility) |
| Compliance with Shelf-Life and Packaging Integrity Standards: ANSI/AAMI/ISO 11607-1997, AAMI TIR Guidance | "The Milvella Perfect Capsule complies with the following standards... SHELF-LIFE AND PACKAGING INTEGRITY - ANSI/AAMI/ISO 11607-1997... AAMI TIR, Guidance for ANSI/AAMI/ISO 11607-1997..." (Implied successful shelf-life and packaging integrity) |
| Functionality and Safety (General) | "Additionally, performance testing and clinical testing were conducted to establish the functionality and safety of the Perfect Capsule." (No specific metrics or results are provided, only that tests were conducted and it met requirements.) |
| "the Perfect Capsule is safe and effective and performs in a fashion consistent with its intended use as well as the intended use of the predicate device(s)." (General conclusion of meeting requirements) | |
| Substantial Equivalence to Predicate Devices | "Milvella Pty. Ltd. concludes that the Perfect Capsule is substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act." (The core "acceptance" criteria for a 510(k) submission) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "performance testing and clinical testing" but does not provide any details regarding sample size, data provenance, or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not mention the use of experts to establish ground truth for any test set. The evaluation seems to be based on compliance with technical standards and comparison to predicate devices, rather than a diagnostic performance study requiring expert adjudicated ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no external expert adjudication for a test set 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 an accessory to a phacoemulsification device, designed for capsule polishing and irrigation in cataract surgery. It is a physical instrument, not an AI-powered diagnostic or assistive tool, so an MRMC study comparing human readers with and without AI assistance is irrelevant 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 instrument for surgical use, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The document assesses the device's substantial equivalence based on its technological characteristics and compliance with standards, not on a diagnostic test's performance against a specific ground truth.
8. The sample size for the training set
Not applicable. This device is a physical instrument and does not involve AI or machine learning that would require a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this 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.