(175 days)
NovaVision™ is intended for the diagnosis and improvement of visual functions in patients with impaired vision that may result from trauma, stroke, inflammation, surgical removal of brain tumors or brain surgery, and may also be used to improve visual function in patients with amblyopia.
NovaVision™ consists of two computer software programs: (1) one intended for health care professionals - for the precise diagnosis of patients' visual deficiencies, the development of patient-specific therapy programs, and the analysis of results of patient therapy (NovaVision™ Diagnosis Software and Training Program); and (2) one intended for patients - therapeutic software for use by patients in their homes to train and improve impaired visual functions (NovaVision™-Therapy).
The NovaVision Model 2.0 (K023623) is a diagnostic and therapeutic device intended for the diagnosis and improvement of visual functions. This response summarizes the available information regarding its acceptance criteria and supporting studies.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state quantitative acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy, or a specific threshold for improvement). Instead, it relies on demonstrating substantial equivalence to predicate devices (DynaVision 2000 and AA-1 System for the Treatment of Amblyopia) based on similar intended use, target population, functionality, and demonstrated safety and effectiveness in clinical studies.
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance |
|---|---|
| Diagnosis of patients' visual deficiencies: Equivalent ability to collect and interpret diagnostic information concerning visual deficits. | "Two clinical studies have confirmed the effectiveness and reliability of NovaVision™ Diagnosis Software and Training Program in diagnosing patients' visual deficiencies..." |
| Improvement of visual functions: Equivalent ability to improve impaired visual functions. | "...and five clinical studies have confirmed the safety and effectiveness of patient use of NovaVision™-Therapy to improve visual functions." |
| Safety and Effectiveness: No new questions of safety and effectiveness compared to predicate devices. | "NovaVision™ has been demonstrated to be as safe and effective as the Dynavision 2000." |
| Amblyopia treatment: Correlates with improvement of vision in patients with amblyopia. | "Moreover, reference to a third-party clinical study strongly correlates with the capabilities of NovaVision™-Therapy to improve the vision of patients with amblyopia." |
2. Sample Sizes and Data Provenance
The provided document does not specify the exact sample sizes used for the test sets in the various clinical studies. It also does not explicitly state the country of origin or whether the studies were retrospective or prospective.
3. Number and Qualifications of Experts for Ground Truth
The document does not provide details on the number or qualifications of experts used to establish ground truth for the test sets.
4. Adjudication Method
The document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for establishing ground truth in the test sets.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided information does not mention a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance, nor does it specify any effect size for such a study.
6. Standalone (Algorithm Only) Performance Study
The document indicates that NovaVision™ consists of "two computer software programs," implying a software-only component for diagnosis and therapy. The statement "Two clinical studies have confirmed the effectiveness and reliability of NovaVision™ Diagnosis Software and Training Program in diagnosing patients' visual deficiencies" and "five clinical studies have confirmed the safety and effectiveness of patient use of NovaVision™-Therapy to improve visual functions" suggests that studies were conducted to assess the performance of the software. However, it does not explicitly differentiate between standalone (algorithm only) performance studies and human-in-the-loop studies. Given the nature of the device (presenting visual stimuli and interpreting patient responses), it is likely that the "device performance" inherently involves the algorithm's capability.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). However, for a device intended for "diagnosis and improvement of visual functions," ground truth would likely involve:
- For diagnosis: Clinical assessments of visual deficiencies by healthcare professionals (e.g., ophthalmologists or neurologists), potentially using established diagnostic criteria or other validated tests.
- For improvement: Objective measures of visual function (e.g., visual field tests, visual acuity) before and after therapy, or patient-reported outcomes, as assessed by healthcare professionals.
8. Sample Size for the Training Set
The document does not provide information regarding the sample size used for the training set. The 510(k) summary focuses on clinical performance data rather than detailing the machine learning model development process.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established.
§ 886.1605 Perimeter.
(a)
Identification. A perimeter is an AC-powered or manual device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.