(60 days)
The Storz MicroFlow Plus, MicroFlow Plus Angled, and Standard Angled Phacoemulsification Needles are accessories to a phacoemulsification handpiece, intended for use in the ultrasonic surgical removal of the cataractous crystalline lens.
A phaco needle is the cylindrical, metal tip which is connected to the distal end of a phaco handpiece. The needle is the component of a phaco system which, as driven by the ultrasonic handpiece, contacts and fragments the crystalline lens. Irrigation fluid flows between the external surface of the needle and the internal surface of an irrigation sleeve and into the eye. The emulsified lens material and irrigant are aspirated from the eye through the lumen of the phaco needle.
The provided document is a 510(k) summary for Storz MicroFlow Plus, Storz MicroFlow Plus Angled, and Storz Standard Angled Phacoemulsification Needles. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving that a device meets specific acceptance criteria through a clinical study. Therefore, the document does not contain information about acceptance criteria, a specific study proving the device meets them, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established in the context of a clinical performance study.
Instead, the document focuses on demonstrating substantial equivalence based on device characteristics, intended use, and materials compared to several predicate devices.
Here's a breakdown of why the requested information cannot be fully provided from this document:
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A table of acceptance criteria and the reported device performance: This document does not establish new acceptance criteria. It compares the device's characteristics to those of predicate devices to establish substantial equivalence. The tables provided (on pages 2 and 3) are "Substantial Equivalence Charts" comparing device characteristics, not performance against pre-defined acceptance criteria.
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Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set or clinical data is presented for this 510(k) submission.
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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): No ground truth established by experts is mentioned as this is not a study assessing diagnostic or clinical performance.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as there is no test set or clinical study.
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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. The device is a phacoemulsification needle, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. The device is a surgical instrument, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as no ground truth was established for a performance study.
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The sample size for the training set: Not applicable as there's no machine learning algorithm involved requiring a training set.
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How the ground truth for the training set was established: Not applicable as there's no machine learning algorithm involved requiring a training set.
Summary based on the document:
The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. The "study" referenced in the prompt (if considering the 510(k) process as a form of "study" for regulatory clearance) is a comparison of device characteristics to existing, legally marketed devices.
Table of Acceptance Criteria and Reported Device Performance (as inferred from the Substantial Equivalence Charts):
While not framed as "acceptance criteria" in the traditional sense of a clinical trial, the tables compare characteristics of the new devices to predicates. The "acceptance criteria" in this context are implicitly that the new devices share similar fundamental technological characteristics and intended use with the predicate devices, thereby demonstrating safety and effectiveness.
| Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (Storz MicroFlow Plus, MicroFlow Plus Angled, Standard Angled Needles) |
|---|---|---|
| Intended Use | Accessory to phaco handpiece used in lens removal (K954340, K952259, K943102, K946176) | Accessory to phaco handpiece used in lens removal |
| Materials | Ti-6Al-4V (for Storz MicroFlow, MicroSeal, Standard); Titanium (alloy unknown for Surgin High-Efficiency) | Ti-6Al-4V |
| Needle I.D. | Ranging from 0.020 to 0.026 inches (depending on specific predicate) | MicroFlow Plus/Angled: 0.024 inches |
| Standard Angled: 0.036 inches | ||
| Needle O.D. | Ranging from 0.036 to 0.046 inches (depending on specific predicate) | MicroFlow Plus/Angled: 0.046 inches |
| Standard Angled: 0.042 inches | ||
| Recommended Surgical Incision Size (mm) | Ranging from 2.5 to 2.8 mm, or unspecified (3.2 mm typical) (depending on specific predicate) | MicroFlow Plus/Angled: 2.8 mm |
| Standard Angled: Unspecified (3.2 mm typical) | ||
| Number of Uses Recommended | Ranging from 5 to 10, or unknown/unspecified (depending on specific predicate) | MicroFlow Plus/Angled: 10 |
| Standard Angled: Unspecified | ||
| Angled Shaft | Yes or No, depending on specific predicate device and model variant | MicroFlow Plus: No |
| MicroFlow Plus Angled: Yes | ||
| Standard Angled: Yes | ||
| Model Variations | Needle tip bevel angle; Degree angled shaft (depending on specific predicate) | Needle tip bevel angle (MicroFlow Plus, MicroFlow Plus Angled, Standard Angled) |
Study to Prove Acceptance Criteria:
The "study" is implicitly the submission of the comparison charts and other descriptive information to the FDA, which then determined substantial equivalence. No separate, formal clinical study or performance study is detailed in this 510(k) summary as proof against quantitative acceptance criteria for the new devices. The FDA's letter (pages 4-5) confirms the determination of substantial equivalence.
§ 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.