(90 days)
The EyeFeel™ Ophthalmic warmer is a hot disposable pack for the application of localized heat therapy in cases of chronic inflammatory and cystic conditions of the eye lids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye, and chalazia.
The EyeFeel Ophthalmic Warmer is a simple device for application of heat therapy to the eye. It is shaped as a kind of "mask" to fit over the eyes, and consists of layers of synthetic paper, which surround a "sac" containing an iron powder mixture. Oxidation of the iron powder mixture generates heat.
Here's a breakdown of the acceptance criteria and study information for the EyeFeel™ Ophthalmic Warmer, based on the provided document:
Acceptance Criteria and Device Performance
The document doesn't explicitly state "acceptance criteria" in the traditional sense of a predetermined threshold that the device must meet. Instead, it presents performance data from a study and concludes that the device is "substantially equivalent to its claimed predicates under conditions of intended use." The P values for the clinical outcomes (0.028) suggest statistical significance, implying the observed improvements are unlikely due to chance.
However, we can infer the "acceptance criteria" were implied by the chosen clinical endpoints and the statistically significant improvement shown in these metrics.
Table of Acceptance Criteria (Inferred) and Reported Device Performance:
| Metric | Inferred Acceptance Criteria (e.g., significant improvement) | Reported Device Performance (Mean +/- SD) | P-Value |
|---|---|---|---|
| Tear Evaporation Rate (10-7g cm-2 sec-1) | Significant decrease in rate | Prior: 6.6 +/- 0.97 | |
| Following: 4.7 +/- 1.5 | 0.028 | ||
| BUT (seconds) | Significant increase in time | Prior: 3.0 +/- 2.1 | |
| Following: 11.0 +/- 2.7 | 0.028 | ||
| MG Lipid Expressibility Score | Significant decrease in score (indicating improvement) | Prior: 2.2 +/- 0.41 | |
| Following: 1.0 +/- 0.0 | 0.028 | ||
| Eyelid Temperature Increase | Safe and effective temperature increase for therapeutic effect | Upper Eyelid: 34.4 to 40.0 °C (Δ 5.6 °C Avg.) | |
| Lower Eyelid: 34.2 to 40.4 °C (Δ 6.2 °C Avg.) | N/A | ||
| Corneal Temperature Increase | Safe temperature increase (not exceeding harmful levels) | 34.0 to 37.7 °C (Δ 3.7 °C Avg.) | N/A |
Study Information
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Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Six patients with non-inflamed obstructive MGD for efficacy testing. Three patients with healthy eyes for safety testing.
- Data Provenance: Not explicitly stated (e.g., country of origin, specific institution, retrospective/prospective). However, the language "Six patients... tested the EyeFeel Product" suggests a prospective clinical observation or trial.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- The document does not mention the use of experts to establish ground truth for the test set. The measurements (tear evaporation, BUT, MG lipid expressibility) are objective clinical assessments. The MG lipid expressibility score, while potentially involving a subjective grading, is based on a defined scale (Grade 0-3). It does not specify who performed these assessments or their qualifications.
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Adjudication Method for the Test Set:
- Not applicable/Not mentioned. The study involved objective measurements and a subjective scoring system without an explicit mention of adjudication by multiple parties for the test set.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This study focuses on the device's direct impact on physiological parameters and clinical scores, not on human reader performance with or without AI assistance.
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Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
- Not applicable. The EyeFeel™ Ophthalmic Warmer is a physical device, not an algorithm or AI product. The study evaluates the device's direct therapeutic effect.
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Type of Ground Truth Used:
- The "ground truth" for the efficacy study was established through objective physiological measurements (tear evaporation rate, tear breakup time) and a clinical scoring system (meibomian gland lipid expressibility score) assessed by investigators. For the safety study, it involved direct temperature measurements of the eyelids and cornea.
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Sample Size for the Training Set:
- Not applicable. The EyeFeel™ Ophthalmic Warmer is not an AI/ML algorithm requiring a training set.
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How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this device.
§ 890.5710 Hot or cold disposable pack.
(a)
Identification. A hot or cold disposable pack is a device intended for medical purposes that consists of a sealed plastic bag incorporating chemicals that, upon activation, provides hot or cold therapy for body surfaces.(b)
Classification. Class I (general controls). Except when intended for use on infants, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 890.9.