(50 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 eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye, and chalazia.
The EyeFeel Ophthalmic Warmer also may relieve accommodative fatigue and may help recover baseline visual acuity levels after prolonged work on visual display terminals.
The EyeFeel Warmer consists of a front layer, two oval shaped sacks that hold the iron powder mixture, and a back inner layer that is placed on the face. The iron powder mixture consists of iron powder, sodium chloride, filtrated water, powdered activated carbon, granular activated carbon, sodium polyacrylate powder, and exfoliated vermiculite.
The information provided describes the indications for use and technological characteristics of the EyeFeel Ophthalmic Warmer, along with a statement about a clinical study. However, it does not provide specific acceptance criteria or the detailed results of a study designed to meet those criteria in a quantitative manner.
Here's the breakdown of what can be extracted and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified directly in the document. For expanded indications, the device should demonstrate effectiveness in: | "A small clinical study was conducted to assess the effect of the EyeFeel Warmer on periocular accommodation fatigue and visual acuity after prolonged work on visual display terminals." |
| - Relieving accommodative fatigue. | "The results of the study support the expanded indications of the EyeFeel Warmer." |
| - Helping recover baseline visual acuity levels after prolonged work on visual display terminals. |
Explanation: The document states that a clinical study was conducted to "assess the effect" and that its "results...support the expanded indications." However, it does not explicitly define what constitutes "relief," "recovery," or any quantitative threshold for these effects, which would typically be included in acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: "A small clinical study" – specific number not provided.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The phrasing "was conducted" suggests it was a prospective study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not Applicable / Not Provided: The nature of the study (assessing the effect on fatigue and visual acuity) suggests that ground truth would likely be established through objective measurements (e.g., visual acuity charts, objective measures of accommodative response) rather than expert consensus on diagnostic images. Therefore, expert consensus for "ground truth" in the diagnostic sense is not relevant here, and no information about experts is provided for this purpose.
4. Adjudication Method for the Test Set:
- Not Applicable / Not Provided: As the study likely involved objective physiological measurements rather than subjective diagnostic interpretations requiring adjudication, this information is not relevant or provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No: The document describes a "small clinical study" assessing the device's effect, not a comparative effectiveness study comparing human readers with and without AI assistance. The device itself is a physical warmer, not an AI diagnostic tool.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- No: This question is not applicable. The device is a physical warmer and does not involve an algorithm or AI. The study assessed the device's direct therapeutic effect on human subjects.
7. The Type of Ground Truth Used:
- Likely Objective Clinical Measurements: While not explicitly stated, for a study assessing "accommodative fatigue" and "visual acuity," the ground truth would typically be established by:
- Visual Acuity: Standardized visual acuity charts (e.g., Snellen chart, ETDRS chart).
- Accommodative Fatigue: Objective measurements of accommodation (e.g., using an autorefractor, accommodometer, or dynamic retinoscopy before and after prolonged visual display terminal work and after device use).
The document does not detail the specific methods used.
8. The Sample Size for the Training Set:
- Not Applicable / Not Provided: This device is a physical warmer and does not involve a "training set" in the context of machine learning or AI algorithms.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable / Not Provided: This question is not relevant for the described device.
Summary of what is missing in the provided text regarding acceptance criteria and study details:
- Quantitative Acceptance Criteria: No specific numerical thresholds or target values for improvement in visual acuity or reduction in fatigue are stated.
- Detailed Study Protocol: No information on the study design, specific endpoints, measurement methods, statistical analysis plan, or blinding.
- Exact Sample Size: "Small clinical study" is vague.
- Demographics/Baseline Characteristics of the study participants.
- Detailed Results: Only a general statement that "results...support the expanded indications" is provided, without sharing actual data, p-values, confidence intervals, or effect sizes.
§ 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.