Search Results
Found 1 results
510(k) Data Aggregation
(148 days)
Zeiss Retina Workplace, K170638
The Afina software is intended for importing, processing and displaying of retinal images and for the measurement of autofluorescence in the superior field (a circular 50-degree field of view at 20 degrees above fixation) of the retina. Afina is indicated for use only with images collected with validated ophthalmic cameras.
Afina is software that transforms a set of field-identical autofluorescent (AF) images captured with a fundus camera into a single enhanced image with improved quality characteristics. It identifies and quantifies AF findings over the retinal AF background within the derived image.
Afina supports licensed healthcare professionals in importing, processing and displaying of retinal images and for the measurement of autofluorescence in the superior field of the retina.
Functionally, Afina imports a set of at least 8 AF images taken of the superior field of the retina (also referred to as a DICOM study), combines them in order to enhance image quality, and then identifies pixels and areas of contiquous pixels (spots) that exhibit autofluorescence that is brighter than the retinal AF background. Once identified, these pixels are quantified as both a count of spots and an overall sum of pixels. These data are consolidated into a single-field patient report that presents images of the field with AF findings identified and spot and pixel counts quantified.
The information provided is not a standard document that details acceptance criteria and the results of a study to prove they are met. Instead, it is an FDA 510(k) summary for a medical device (Afina). While it discusses performance data and a clinical study, it does not present acceptance criteria in a quantitative, tabular format with direct comparison to reported performance values.
However, I can extract and infer information to construct a response that addresses the requested points as much as possible, interpreting "acceptance criteria" through the lens of the performed repeatability and reproducibility study.
Here's an attempt to structure the answer based on the provided text:
Acceptance Criteria and Device Performance Study for Afina
The Afina software is intended for importing, processing, and displaying retinal images and for the measurement of autofluorescence in the superior field of the retina. The study aimed to evaluate the repeatability and reproducibility of the Afina autofluorescence measurement for both Pixel Count and Spot Count.
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary does not explicitly state quantitative "acceptance criteria" as pass/fail thresholds for specific performance metrics. Instead, it characterizes the variability of the measurements. From the study conclusion, the device is deemed "fit for its purpose as a measurement tool" based on the observed variability. Therefore, the reported performance values themselves become the characterized "accepted" performance for this device.
| Metric | Acceptance Criteria (Implicitly from Study Conclusion) | Reported Device Performance |
|---|---|---|
| Spot Count Precision | The device should demonstrate characterized repeatability and reproducibility for Spot Count measurements, indicating it is fit for purpose as a measurement tool. | Repeatability SD: 52.4 |
| Repeatability %CV: 11.6% | ||
| Reproducibility SD: 89.9 | ||
| Reproducibility %CV: 19.9% | ||
| (Across all Camera/Operator Combinations) | ||
| Pixel Count Precision | The device should demonstrate characterized repeatability and reproducibility for Pixel Count measurements, indicating it is fit for purpose as a measurement tool. | Repeatability %CV: 8.7% |
| Reproducibility %CV: 14.4% | ||
| (Across all Camera/Operator Combinations. Note: Repeatability SD is variable and not explicitly reported in summary table.) | ||
| Safety | No adverse events, serious adverse events, or anticipated adverse device effects should be reported during the study. | No safety events reported. |
| Software Functionality | Software functions as intended and is functionally equivalent to the predicate device, with differences in technological characteristics not raising new safety/effectiveness questions. | "Verification and validation activities met their acceptance criteria successfully per test plan and proved that the product, Afina, meets its requirements and intended use." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Test Set: 32 eligible subjects were screened, consented, and enrolled. Of these, 25 eyes had Afina qualified run data (194 completed measurements across various camera/operator combinations).
- Data Provenance: The study was conducted prospectively between April 21, 2017, and August 25, 2017. The country of origin of the data is not explicitly stated, but typically 510(k) submissions for US market clearance involve studies conducted in the US or in compliance with international guidelines recognized by the FDA. Given the FDA submission, it's highly likely to be US data or internationally recognized clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The provided text describes a repeatability and reproducibility study for a measurement tool. This type of study primarily assesses the consistency of the device's output, rather than its accuracy against a "ground truth" established by experts for classification or diagnosis. Therefore, there is no mention of experts establishing a ground truth for individual cases in the test set, as the study focuses on the precision of the quantitative measurements (Pixel Count and Spot Count) rather than diagnostic accuracy.
4. Adjudication Method for the Test Set
As the study focused on quantitative measurement precision rather than expert-derived ground truth for classification, an adjudication method for a test set (e.g., 2+1, 3+1) is not applicable and therefore not mentioned.
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 reported. The study focused on the repeatability and reproducibility of the device's measurements, not on its impact on human reader performance.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done
Yes, the clinical study evaluating repeatability and reproducibility was effectively a standalone performance study of the Afina algorithm's measurements. While operators collected the images, the analysis of Pixel Count and Spot Count is performed by the Afina software. The results characterize the intrinsic variability of the device's measurement functionality.
7. The Type of Ground Truth Used
The study did not use a "ground truth" in the sense of an independent gold standard for diagnosis (e.g., pathology, outcomes data, expert consensus). Instead, the study measured the repeatability and reproducibility of the device's intrinsic measurements (autofluorescence Pixel Count and Spot Count). The study design intended to demonstrate that the device provides consistent measurements under varying conditions (same operators/cameras vs. different operators/cameras).
8. The Sample Size for the Training Set
The document does not provide information about the sample size used for the training set of the Afina software's algorithms. The clinical performance data presented refers to a validation study (test set), not a training set.
9. How the Ground Truth for the Training Set was Established
Since information regarding the training set's sample size is not provided, the method for establishing ground truth for the training set is also not discussed in this 510(k) summary.
Ask a specific question about this device
Page 1 of 1