(90 days)
This device is used by an ophthalmic surgeon to extend the irrigation/aspiration syringe by use of the tubing extension set away from the cannula allowing better control of irrigation/aspiration during the ophthalmic surgical procedure. This also allows the surgeons assistant to perform the irrigation/aspiration process if needed.
The Hurricane Medical tubing extension set consists of a length of silicone tubing with huer taper hubs (one male and one female) attached to both ends.
The provided text describes a medical device, the "Tubing Extension Set" by Hurricane Medical, and its regulatory clearance as substantially equivalent to existing devices. However, it does not include information about acceptance criteria or a study proving the device meets specific performance criteria in the way one would typically describe for a software-based medical device (e.g., an AI algorithm).
The document is a 510(k) premarket notification summary and an FDA clearance letter. It focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a detailed performance study with quantitative acceptance criteria for a novel device.
Therefore, for almost all the requested information, the answer will be "Not applicable" or "Information not provided in the given text."
Here's a breakdown of why based on your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitely stated as quantitative performance criteria. The submission focuses on demonstrating substantial equivalence to predicate devices for its intended use. | Device reported to be composed of "medical grade" silicone tubing meeting "USP class VI test for plastics." |
| Luer hub fittings have a "6% taper to assure proper fit to syringes and other medical devices." | |
| Sterilization process ensures "at least a 10⁻⁶ sterility assurance level (SAL)." | |
| The device "allows free movement of the aspiration/irrigation syringe" and "provides a greater level of control during aspiration/irrigation." (These are descriptive statements, not quantitative performance metrics). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Information not provided. This document does not describe a clinical or performance study with a "test set" in the context of an AI/algorithm-driven device. The "study" mentioned is a review of existing literature and the physical properties of the device components.
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 / Information not provided. No "ground truth" was established by experts for a test set in the context of this 510(k) submission. Reference is made to historical uses described by "Emery et. al." and "Jaffe et. al." in ophthalmic surgery literature.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Information not provided. No test set or adjudication method 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 / Information not provided. This device is a physical tubing extension set, not an AI algorithm. Therefore, an MRMC study related to AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Information not provided. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Information not provided. The "truth" in this submission relies on established surgical practices using similar tubing, the physical and material properties of the tubing, and sterility validation for a physical product. Not a "ground truth" as typically defined for AI performance studies.
8. The sample size for the training set
- Not applicable / Information not provided. This is a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable / Information not provided. This is a physical medical device.
§ 886.4150 Vitreous aspiration and cutting instrument.
(a)
Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.(b)
Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.