(324 days)
The Adapt™ is an AC powered, automated adaptometer (biophotometer), intended to measure the time for retinal adaptation after exposure to an adapting light.
The AdaptTM is an AC-powered, automated, adaptometer (biophotometer).
Here's an analysis of the provided 510(k) summary regarding the Acceptance Criteria and Study to prove device performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Agreement with Predicate Device: High correlation in dark adaptation speed (rod-cone break and rod intercept parameters). | Agreement Study: Dark adaptation speed parameters found to be "highly correlated" between Adapt™ and the predicate device. |
| Precision/Reproducibility: Consistent dark adaptation speed measurements over time. | Precision Study: Dark adaptation speeds for the Adapt™ were "highly correlated" between the first and second visits for both parameters. |
| Precision comparable to Predicate Device: The precision of the new device should not be worse than the predicate. | Precision Study: The precision of the Adapt™ was "comparable to the predicate." |
| Meet Product Specifications and Performance Requirements: (General criteria for verification testing) | Verification Testing: Demonstrated that the device met product specifications and performance requirements for various subsystems (Flash, Stimulus, Fixation Light, etc.). |
Important Note: The provided 510(k) summary does not explicitly state quantitative acceptance criteria (e.g., "correlation coefficient > 0.9"). The criteria are described qualitatively as "highly correlated" and "comparable."
2. Sample Size Used for the Test Set and Data Provenance
- Agreement Study: 12 adults with a range of eye health status. Data provenance is not explicitly stated (e.g., country of origin) but is implied to be prospective for the purpose of the study.
- Precision Study:
- 14 adults with normal retinal health.
- 8 patients with age-related macular degeneration (AMD).
- Separate group of 6 normal adults (for predicate comparison).
- Data provenance is not explicitly stated but is implied to be prospective for the purpose of the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the 510(k) summary. The device measures an objective physiological parameter (retinal adaptation time), so the "ground truth" would likely be derived from the device measurements themselves or comparison to a gold-standard device, not from expert interpretation of images or clinical assessments.
4. Adjudication Method for the Test Set
This information is not applicable as the device is for objective measurement of retinal adaptation, not for diagnostic interpretation requiring human adjudication of findings. Therefore, no adjudication method (like 2+1 or 3+1) would be relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study was not done. This device is an automated adaptometer and does not involve human readers interpreting images or data where AI assistance would be a factor. It directly measures a physiological response.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies described (Agreement Study and Precision Study) demonstrate the standalone performance of the Adapt™ device. It takes measurements directly without human interpretation as part of its core function, other than operation of the device and subject engagement.
7. The Type of Ground Truth Used
The "ground truth" for the performance studies appears to be the measurements obtained from the predicate device (Goldmann-Weekers adaptometer) for the Agreement Study. For the Precision Study, the ground truth for reproducibility is the repeatability of the Adapt™'s own measurements and comparison to the repeatability of the predicate device. It's a comparative performance study against an established method.
8. The Sample Size for the Training Set
This information is not provided and is likely not applicable in the traditional sense of a machine learning-based device that requires a distinct "training set." The Adapt™ is described as an "AC-powered, automated adaptometer (biophotometer)" controlled by software, implying a rule-based or algorithm-driven system rather than a deep learning model that learns from large datasets. Its performance is validated through verification and clinical performance testing.
9. How the Ground Truth for the Training Set Was Established
As noted above, a distinct "training set" with established ground truth as understood in machine learning is not described or implied for this device. The device's operation is based on established biophysical principles of dark adaptation and implemented through software control. Verification and validation testing ensure the software correctly implements these principles and meets product specifications.
{0}------------------------------------------------
. 510(k): K100954
510(k) Summary
FEB 2 5 2011
| Submitter: | Apeliotus Vision Science, Inc.1456 N. Morningside Drive, NEAtlanta, Georgia 30306 |
|---|---|
| Contact Person: | John G. Edwards, CEOApeliotus Vision Science, Inc.1456 N. Morningside Drive, NEAtlanta, Georgia 30306Phone: 404-875-9561Email: jedwards@apeliotus.com |
| Date Prepared: | February 18, 2011 |
| Trade Name: | AdaptTM |
| Classification: | 886.1050 |
| Product Codes: | HJW |
| Predicate Device: | Goldmann-Weekers adaptometer |
| Device Description: | The AdaptTM is an AC-powered, automated, adaptometer(biophotometer). |
| Intended Use: | The AdaptTM is an AC powered, automated adaptometer (biophotometer)intended to measure the time for retinal adaptation after exposure to anadapting light. |
| Comparison ofTechnologicalCharacteristics: | The AdaptTM is technologically substantially equivalent to the predicatein being AC-powered and having a similar design with photobleach lightand stimulus light to evaluate dark adaptation. The AdaptTM differs fromthe predicate primarily in that it is controlled by software. |
| Verification &Validation TestingTesting: | Verification testing was conducted on the following subsystems: Flash,Stimulus, Fixation Light, Patient Input & Patient Management, InfraredCamera, Refractive Correction, and Chin Rest. Softwareverification/validation was conducted and computer control andintegration was verified. Calibration & Alignment were verified.Testing demonstrated that the device met product specifications andperformance requirements. Validation testing, including conducting darkadaptation testing on subjects, was also conducted.All results met final requirements and demonstrate substantialequivalence to the predicate device. |
| ClinicalPerformanceTesting: | An Agreement Study was conducted comparing the AdaptTM against thepredicate with 12 adults having a range of eye health status. Darkadaptation speed as characterized by both the rod-cone break and the rodintercept parameters was found to be highly correlated between the twoinstruments.A Precision Study was conducted among 14 adults with normal retinalhealth and 8 patients with age-related macular degeneration (AMD).Each participant was tested twice separated by two weeks. Darkadaptation speed was characterized using both the rod-cone break and rodintercept parameters. For comparison, similar measurements were madeon a separate group of 6 normal adults using the predicate. Darkadaptation speeds for the AdaptTM were highly correlated between thefirst and second visits for both parameters, and the precision of theAdaptTM was comparable to the predicate. |
| Conclusion: | By comparison of design features and by testing the AdaptTM, weconclude it is substantially equivalent to the predicate device. |
{1}------------------------------------------------
510(k) Summary (Continued)
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Apeliotus Vision Science, Inc. c/o Mr. John G. Edwards Chief Executive Officer 1456 N. Morningside Drive, NE Atlanta, GA 30306
FEB 2 5 20:1 .
Re: K100954
Trade/Device Name: Adapt™ Regulation Number: 21 CFR 886.1050 Regulation Name: Adaptometer (biophotometer) Regulatory Class: I Exempt Product Code: OUM Dated: February 18, 2011 Received: February 22, 2011
Dear Mr. Edwards:
We have reviewed your premarket notification submission and have found this device to be exempt from the premarket notification requirements of the Federal Food, Drug, and Cosmetic Act (Act). Therefore, you may immediately begin marketing this device as described in your premarket notification.
The final classification regulation for your device appears in Title 21 of the Code of Federal Regulations (CFR) 21 CFR 886.1050. We suggest that you review this regulation since it may grant other exemptions from certain general controls of the Act. Your device classification regulation name, regulatory class, and product code are shown above. When listing your device with the Food and Drug Administration, please use this product code.
In the future, new but substantially equivalent devices which fall within the above classification regulation name and meet the classification criteria may be marketed without sending a premarket notification submission to the Food and Drug Administration. We suggest, however, that you review 21 CFR Section 886.9 to determine whether or not your new device (s) meets the limitations of exemption from Section 510(k) of the Act.
{3}------------------------------------------------
Page 2 - Mr. John G. Edwards
If you have any questions regarding this letter, please contact Daryl Kaufman at (301) 796-6620 or the Division of Small Manufacturers, International and Consumer Assistance at its toll free number (800) 638-2041 or (301) 796-7100, or at its Internet address ''http://www.fda.gov/cdrh/dsmamain.html.''
Sincerely yours,
Kesia Alexander
Malviña B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
{4}------------------------------------------------
Indications for Use Statement
510(k) Number: K100954
Device Name: AdaptTM
Indications For Use:
The Adapt™ is an AC powered, automated adaptometer (biophotometer), intended to measure the time for retinal adaptation after exposure to an adapting light.
Prescription Use X - AND/OR: (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear Nose and Throat Devices
510(k) Number K10954
§ 886.1050 Adaptometer (biophotometer).
(a)
Identification. An adaptometer (biophotometer) is an AC-powered device that provides a stimulating light source which has various controlled intensities intended to measure the time required for retinal adaptation (regeneration of the visual purple) and the minimum light threshold.(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.