(28 days)
The Sight Sciences Viscoelastic Injector is a manually operated device for delivery of small amounts of viscoelastic fluid, for example Healon™ or HealonGV™ from Abbott Medical Optics (AMO), Amvisc™ from Bausch & Lomb, or PROVISC™ from Alcon, during ophthalmic surgery.
The Sight Sciences Viscoelastic Injector is a sterile, single use, manually operated instrument used by ophthalmologists to deliver small amounts of viscoelastic into the eye during ophthalmic surgery. The Viscoelastic Injector 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 Sight Sciences Viscoelastic Injector dispenses fluid on the principle of exchanging volumes much like a syringe. The handheld instrument includes a cannula, injection tube, 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 (00 or OS) using either hand.
The provided text does not contain detailed acceptance criteria or a study proving the device meets those criteria in the typical format for medical device performance studies (e.g., sensitivity, specificity, accuracy for diagnostic devices, or specific numerical targets for functional performance).
The document is a 510(k) summary for a "Viscoelastic Injector," indicating it's a submission for regulatory clearance in the US, asserting substantial equivalence to a predicate device. The information provided is primarily for regulatory purposes and highlights manufacturing, design, and general performance testing rather than a clinical efficacy study with detailed metrics and statistical analysis.
Based on the available text, here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Viscoelastic injector dispensing performance | "performs as intended" |
| Intrinsic strength of the materials | "performs as intended" |
| Load to which the Sight Science Viscoelastic Injector would be subjected during intended use | "performs as intended" |
| Equivalence to the predicate device | "functionally equivalent to the predicate device" |
| Meeting all product design requirements and applicable standards | "meets all product design requirements and applicable standards" |
| Safety and effectiveness | "is safe and effective" |
Missing Information: Specific, quantifiable acceptance criteria (e.g., "dispenses fluid within +/- X% of target volume," "material strength exceeds Y MPa," "withstands Z N of force") are not provided. The reported performance is general and qualitative ("performs as intended," "functionally equivalent").
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: Not specified. The document states "performance testing was conducted," but no number of devices tested or the amount of data collected (e.g., number of injections, duration of tests) is given.
- Data Provenance: Not specified, but given the nature of a 510(k) submission for a manufacturing and design modification, it's highly likely this was retrospective testing performed on manufactured devices in an engineering lab setting, rather than human-centric prospective studies. The country of origin for the data is not mentioned but can be inferred to be within the US or by the manufacturer, Sight Sciences, Inc., based in California.
3. Number of Experts and Qualifications for Ground Truth:
- Not applicable for this type of device and study. The "ground truth" for a mechanical device like a viscoelastic injector typically refers to engineering specifications, material properties, and functional output (e.g., volume dispensed, pressure exerted). It doesn't involve clinical "experts" establishing a ground truth in the same way as a diagnostic imaging device. The testing would be against established engineering standards and validated measurement techniques.
4. Adjudication Method for the Test Set:
- Not applicable. Adjudication methods (2+1, 3+1, etc.) are used in clinical studies where human interpretation of data (e.g., medical images) requires consensus. This device's performance testing would involve objective measurements against engineering specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No comparison study mentioned. The document states the device is "manually operated" by ophthalmologists, but there's no mention of a comparative effectiveness study involving human readers (ophthalmologists) with and without the device, or against a different device, to measure improvement in human performance "with AI vs without AI assistance." This device is a tool, not an AI diagnostic assistant.
6. Standalone (Algorithm Only) Performance:
- Not applicable. This device is a manually operated mechanical injector, not an AI algorithm. Its performance is tied directly to its physical function.
7. Type of Ground Truth Used:
- The "ground truth" for this device's performance testing would be based on engineering specifications and validated metrology/measurement standards. For example, the accuracy of dispensed volume would be measured against a known reference standard using calibrated equipment. The material strength would be tested against established mechanical engineering limits. The text broadly refers to "viscoelastic injector dispensing performance, intrinsic strength of the materials, and the load to which the Sight Science Viscoelastic Injector would be subjected during intended use" as the basis for acceptance criteria, implying these engineering and functional benchmarks.
8. Sample Size for the Training Set:
- Not applicable. This is a mechanical device, not an AI system that requires a training set.
9. How Ground Truth for the Training Set was Established:
- Not applicable. As above, no training set for an AI-like system is involved.
§ 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).