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510(k) Data Aggregation
(213 days)
The Visibly Digital Acuity Product (VDAP) is a web-based, self-quided software application intended for use by adults, ages 22 to 40, who have the capability to perform a self-test at home, to aid in the evaluation of visual acuity with or without correction. The software allows users to view and respond to displayed optotypes and uses the responses to categorize a patient's visual acuity into one of two categories, with an individual output for each eye:
- . TRUE - visual acuity that is consistent with normal vision
- FALSE visual acuity that is not consistent with normal vision .
The Visibly Digital Acuity Product recommendations are intended to be supportive recommendations that will be used by an eye care provider, along with the patient's medical history and profile, prior corrective evewear prescriptions, and subjective vision data. The Visibly Digital Acuity Product does not provide screening or diagnosis of eye health or other disease, nor is it intended to replace an in-person eye exam.
The Visibly Digital Acuity Product is a web-based, software application intended for use by adults, at home, to aid in the evaluation of visual acuity with or without correction. The standalone software application allows the user to interface with the software via a web browser on two internet-enabled devices:
- A computer screen (the Display) which displays optotypes. O
- A touchscreen mobile device (the Remote) which operates as a remote control and o interface for the user to respond to prompts related to the optotypes appearing on the Display while standing 10 feet away.
The software allows users to view and respond to displayed optotypes and uses the responses to categorize a user's vision acuity into one of two buckets: (1) TRUE - visual acuity that is consistent with normal vision (2) FALSE - visual acuity that is not consistent with normal vision.
Here's a breakdown of the acceptance criteria and the study proving the Visibly Digital Acuity Product (VDAP) meets them, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the primary and secondary endpoints described in the "Performance Data" section. There aren't explicit numeric acceptance criteria stated for all metrics (e.g., sensitivity, specificity), but a performance goal is given for reproducibility.
| Metric (Endpoint) | Acceptance Criteria/Performance Goal | Reported Device Performance (Pooled Study Eye and Non-Study Eye) |
|---|---|---|
| Primary Agreement Endpoints | ||
| Positive Predictive Value (PPV) | Not explicitly stated, implied to be high for substantial equivalence | 95.8% (95% CI: 93.6% - 97.6%) |
| Negative Predictive Value (NPV) | Not explicitly stated, implied to be high for substantial equivalence | 49.1% (95% CI: 40.0% - 58.1%) |
| Sensitivity | Not explicitly stated, implied to be high for substantial equivalence | 85.5% (95% CI: 81.9% - 88.9%) |
| Specificity | Not explicitly stated, implied to be high for substantial equivalence | 78.8% (95% CI: 69.1% - 87.6%) |
| Primary Reproducibility Endpoint | ||
| Reproducibility (Proportion of study eyes with matching VDAP VA classifications for two VDAP tests) | Performance goal of 75% | 89.3% (95% CI: 85.9% - 92.6%) (p-value < 0.0001 vs 75%) |
| Secondary Agreement Endpoint | ||
| Subject Level Agreement (Proportion of subjects with matching VDAP and ETDRS classifications for both eyes) | Not explicitly stated, implied to be high for substantial equivalence | 75.9% (95% CI: 71.3% - 80.5%) |
| Secondary Reproducibility Endpoint | ||
| Subject Level Reproducibility (Proportion of subjects with matching VDAP VA Classifications for the two VDAP tests for both eyes) | Not explicitly stated, implied to be high for substantial equivalence | 82.8% (95% CI: 78.7% - 86.9%) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: n=329 subjects participated in the prospective, multi-center clinical study.
- Data Provenance: The study was "prospective, multi-center." The document doesn't specify the country of origin of the data. It's unclear if the "multi-center" refers to multiple locations within the US or internationally.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth for the test set was established using an "ETDRS Visual Acuity (VA) Lane Test." This is a standardized clinical method for assessing visual acuity, typically performed by trained eye care professionals (e.g., ophthalmologists, optometrists, or trained technicians). The document does not explicitly state the number of experts or their specific qualifications (e.g., 10 years of experience) who performed the ETDRS VA Lane Tests. However, given it's a clinical study comparing to a gold standard, it's implied that qualified personnel administered the ETDRS tests.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing the ETDRS ground truth or resolving discrepancies in readings. The ETDRS VA Lane Test is a direct measurement, so typically, it doesn't require an adjudication process in the same way an AI-assisted diagnosis might.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described in the provided text. The study compared the VDAP's performance to an ETDRS VA Lane Test, which serves as a clinical reference standard, not a comparative effectiveness study of human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
Yes, the primary clinical study evaluates the standalone performance of the VDAP. The VDAP is described as a "web-based, self-guided software application" that categorizes a user's vision. The study directly compares the VDAP's classification output ("TRUE - visual acuity that is consistent with normal vision" or "FALSE - visual acuity that is not consistent with normal vision") to the ETDRS VA Lane Test. The device itself (the software) performs the classification without human intervention based on user responses.
7. The Type of Ground Truth Used
The ground truth used was the ETDRS Visual Acuity (VA) Lane Test. This is a well-established and highly standardized clinical measurement of visual acuity, widely considered the gold standard in clinical research.
8. The Sample Size for the Training Set
The document does not provide any information about the sample size used for the training set of the Visibly Digital Acuity Product. The clinical study described (n=329) is explicitly referred to as a "Performance Data" study, which usually implies it's a validation or test set, not a training set.
9. How the Ground Truth for the Training Set Was Established
Since the document does not mention the training set, it also does not provide information on how the ground truth for any training set was established.
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