(129 days)
The Laminar Flow Phacoemulsification Needles (Tips) are used to break up (emulsify) the nucleus of a cataractous lens and remove the remaining nuclear fragments.
Phacoemulsification (Phaco) is a technique used during cataract surgery to emulsify and extract a cataractous lens from the eye with an ultrasonic handpiece. The ultrasonic handpiece is connected to and powered by a phacoemulsification system, which is identified in 21 CFR 886.4670 as "an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract."
The fragmentation needle - also referred to as a phaco tip - referenced in the aforementioned definition is the focus of this 510(k) premarket notification. Phaco tips vibrate at an ultrasonic frequency and emulsify a cataract when connected to an ultrasonic phacoemulsification handpiece. The fragmented tissue can then be aspirated and removed through the lumen of the tip. During a surgical procedure, irrigation solution, typically Balanced Salt Solution (BSS), used to irrigate the eye also passes through the hollow opening of the phaco tip.
The subject of this 510(k) premarket notification is for the Phacoemulsification Tips (Phaco Tips) that are additions to the family of Laminar Flow Phacoemulsification Tips, of which there are two proposed designs: a straight tip and a curved tip. Both Phaco Tip models will be marketed as single-use devices, will be compatible with all currently marketed AMO ultrasonic handpieces, and will be made of the same surgical grade titanium as the predicate device; the AMO Profinesse III Needle cleared under the AMO Profinesse III Handpiece 510(k), K951462.
The provided text is a 510(k) summary for a medical device called "Laminar Flow Phaco Tips." This document focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a study to prove the device meets specific acceptance criteria in the way one might for a novel AI algorithm or a diagnostic test.
Therefore, many of the requested points regarding acceptance criteria, sample sizes for test/training sets, expert adjudication, MRMC studies, and standalone performance are not applicable in this context. The 510(k) summary is designed to show that the new device is as safe and effective as a previously cleared device, not to establish novel performance metrics against a reference standard.
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly defined in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity) with numeric thresholds in the provided text. The overall "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to a predicate device.
- Reported Device Performance: The document states that performance testing was conducted to demonstrate equivalence. It generally claims the device performs equivalently to the predicate device in terms of safety and effectiveness.
| Criteria Type | Description from text | Reported Performance |
|---|---|---|
| Overall | Substantial equivalence to the legally marketed predicate device (AMO Profinesse III Needle, K951462) in terms of safety and effectiveness. | "Performance testing was conducted to demonstrate that the Phaco Tips perform equivalently to the predicate device with respect to safety and effectiveness." |
| Functional | Equivalent function and performance to the predicate device. This includes mechanism of action, technological features, materials, intended use, claims, clinical applications, patient population, and method of operation. | "Functional validation testing... all demonstrate that the proposed device, the Phaco Tips, are substantially equivalent in their function and performance to the legally marketed predicate device..." The "technological characteristics... are identical to those of the legally marketed predicate device... The mechanism of action and technological features... are the same as the predicate device..." |
| Biocompatibility | Assessment to ensure the device is biocompatible and safe for human contact. | "Biocompatibility assessments all demonstrate that the proposed device... are substantially equivalent..." |
| Sterilization | Assessment of sterilization efficacy. | "Sterilization... all demonstrate that the proposed device... are substantially equivalent..." |
| Packaging | Assessment of packaging integrity and maintenance of sterility. | "Packaging... all demonstrate that the proposed device... are substantially equivalent..." |
| Animal Studies | To demonstrate that the tips perform well with various AMO phacoemulsification systems and handpieces and pose no additional risks, and are safe and effective. | "Both studies demonstrate that the tips perform well with various AMO phacoemulsification systems and handpieces and pose no additional risks. The results of the animal studies also indicate that the Phaco Tips are safe and effective." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document mentions "Non-clinical animal studies" but does not specify the sample size (number of animals or eyes) used in these studies.
- The data provenance (country of origin, retrospective/prospective) is not mentioned.
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)
- Not applicable. This is not a study assessing diagnostic accuracy of an algorithm against expert consensus. The "ground truth" for this type of submission is typically derived from established engineering standards, material properties, and biological responses in animal models, showing equivalence to a known safe and effective (predicate) device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No expert adjudication method is described as this is not a diagnostic device or AI algorithm evaluation.
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 is a physical medical device (phaco tip), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this context is based on the performance and safety profile of the legally marketed predicate device (AMO Profinesse III Needle, K951462). The goal is to show the new device meets the same performance and safety characteristics.
- Evidence supporting this includes "functional validation testing, sterilization, packaging, and biocompatibility assessments," and "Non-clinical animal studies."
8. The sample size for the training set
- Not applicable. This is not an AI algorithm.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI algorithm.
§ 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.