(31 days)
The Sight Sciences VISCO360® Viscosurgical System is a manually operated device for delivery of small amounts of viscoelastic fluid, for example HealonGV™ from Abbott Medical Optics (AMO), Amvisc™ from Bausch & Lomb, or PROVISCTM from Alcon, during ophthalmic surgery.
The Sight Sciences VISCO360 Viscosurgical System is a sterile, single use, manually operated instrument used by ophthalmologists to deliver small amounts of viscoelastic into the eye during ophthalmic surgery. The VISCO360 is designed to function with commonly used viscoelastic fluids made commercially available by companies such as Abbott Medical Optics (AMO), Bausch & Lomb, and Alcon. The VISCO360 dispenses fluid on the principle of exchanging volumes much like a syringe. The handheld instrument includes a cannula, microcatheter, internal reservoir, plunger tube and finger wheels. The finger wheels on the handle of the device are used to advance the plunger tube into the viscoelastic fluid reservoir thereby dispensing viscoelastic fluid. The finger wheels are placed on both sides of the handle facilitating viscoelastic delivery in either the left or right eye (OD or OS) using either hand.
Here's a breakdown of the acceptance criteria and study information for the VISCO360® Viscosurgical System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Significant reduction in friction force required to advance the plunger tube into the viscoelastic reservoir, compared to the primary predicate device. | "Testing demonstrated that the modified device passed this functional test." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample size used for the test set during the performance testing. It mentions "Testing demonstrated...", implying a study was conducted, but the number of devices tested is not provided.
The data provenance is not specified. It's likely an in-house engineering or laboratory study, given the nature of the test (friction force). It is a prospective study in the sense that the modified device was specifically tested to assess this characteristic.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of testing (friction force measurement) does not typically involve human expert adjudication for ground truth. It's a quantitative measurement using calibrated instruments. Therefore, human experts were not used to establish the ground truth for this specific performance test.
4. Adjudication Method for the Test Set
Not applicable. As noted above, this was a quantitative engineering measurement, not a subjective assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document describes a performance test related to a mechanical characteristic (friction force) of the device, not an MRMC comparative effectiveness study involving human readers and clinical outcomes or image interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable to the VISCO360® Viscosurgical System, as it is a manually operated medical device, not an AI algorithm.
7. The Type of Ground Truth Used
The ground truth for this specific test was a quantitative measurement of friction force. This would have been established through controlled experimental procedures using appropriate force-measuring equipment.
8. The Sample Size for the Training Set
Not applicable. This device is a mechanical instrument, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, this device does not involve a training set.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).