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510(k) Data Aggregation
(87 days)
EYE IRRIGATOR MODEL #2020
The Eye Irrigator, Ocular Irrigating System, is indicated for use as an eyeirrigating device. It is designed especially for post-traumatic injury, chemical exposure and burns, permitting irrigation of the eye and under the upper eyelid, with sterile saline.
The Eye-Deal Eye Inigator, an ocular irrigator, consists of a plastic irrigation tube that works like a shower-head to irrigate continuously from under the upper eye-lid. The device is held in place with the lower speculum wire resting within the lower lid. The frame of the irrigator can be applied using adhesive tape provided, to the cheek of the patient, to stabilize the irrigator during the procedure. The device is designed to provide approximately 20 minutes of irigation using a standard saline bag.
The provided text describes a 510(k) submission for the "Eye-Deal Eye Irrigator" and a preliminary study conducted to support its substantial equivalence. However, it does not explicitly define acceptance criteria in a quantitative manner or present a rigorous study designed to prove the device meets such criteria. Instead, the study aims to demonstrate substantial equivalence to a predicate device.
Here's an analysis based on the provided text, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not define explicit, quantitative acceptance criteria in the way you might expect for a typical performance study (e.g., "device must achieve 90% sensitivity"). Instead, the 'acceptance' is based on demonstrating substantial equivalence to the predicate device, the Morgan Lens. The reported performance is qualitative for the most part.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Efficacy of Irrigation (compared to predicate) | "The Eye Irrigator was efficient in clearance of fluorescein, an indicator dye commonly used as an indicating dye." (Compared favorably to the Morgan Lens, although the study was too small for statistical significance, the trend was clear.) |
| Patient Tolerance (compared to predicate) | "The Eye Irrigator was well tolerated by the patient." (Compared favorably to the Morgan Lens, although the study was too small for statistical significance, the trend was clear.) |
| Ease of Insertion/Use by Emergency Care Provider (compared to predicate) | "easy to use by the technician." (Compared favorably to the Morgan Lens, although the study was too small for statistical significance, the trend was clear.) |
| Material Biocompatibility | "materials passed the required assays" for surface devices/mucosal membrane/short-term ocular membrane contact, in accordance with ISO 10993-1. Materials were pre-qualified as medical or food grade. |
| Sterilization Efficacy | "Validation of the sterilization process... showed that the ethylene oxide gas cycle will reproducibly provide a sterility assurance level of 10-6 for processes meeting the specified cycle parameters." (according to ANSVAAMI/ISO 11135-1994). Note: This is a process validation, not direct device performance in a clinical setting but crucial for safety. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "Six patients and 12 total eyes" were compared.
- Data Provenance: Not explicitly stated, but clinical studies are generally conducted in the country of origin of the submitter unless otherwise specified. Given the company is based in Wisconsin, USA, and the correspondent in Minnesota, USA, it is highly probable the data is from the USA. The study was prospective as it involved actual comparison in patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The study does not describe establishing a "ground truth" using experts in the clinical sense (e.g., diagnosis verification). Instead, it compares the physical performace of two devices in terms of fluorescein clearance, patient tolerance, and ease of use. The "technicians" or "emergency care providers" who inserted the device would be the evaluators of "ease of insertion," and the patients provided feedback on "tolerance."
4. Adjudication Method for the Test Set
Not applicable in the typical sense. The study was a direct comparison of device performance parameters (fluorescein clearance, tolerance, ease of use) between the Eye Irrigator and the Morgan Lens, rather than a diagnostic performance study requiring adjudication of expert interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is a medical device (physical irrigator), not an AI 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.
7. The Type of Ground Truth Used
For the clinical comparison, the "ground truth" was the direct observation of fluorescein clearance by an observer (likely a clinician), patient self-reported tolerance, and clinician assessment of ease of use. This is essentially an observational outcome comparison.
For the material and sterilization aspects:
- Materials: Laboratory testing against ISO 10993-1 standards (biocompatibility assays).
- Sterilization: Process validation based on physical/biological indicators to achieve a Sterility Assurance Level (SAL) of 10-6.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/machine learning algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
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