(219 days)
PictZar is indicated for wound measurement and documentation and can be used on all external wound types.
PictZar® is digital planimetry software used for the measurement and tracking
The provided text is a 510(k) summary for the PictZar® Digital Planimetry Software Application. It does not contain the detailed study information required to fully answer all aspects of your request, such as specific acceptance criteria and the comprehensive study data. It primarily focuses on equivalence claims to predicate devices and general regulatory information.
However, based on the available information, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state quantitative acceptance criteria for performance metrics (e.g., accuracy thresholds). It broadly claims that "Measurements made PictZar® are equal to or more accurate than those made with the predicate devices." Without the actual study report, specific performance data (e.g., mean accuracy, standard deviation, correlation coefficients) are not provided in this summary.
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accuracy of wound measurement | Not explicitly stated (implied to be "equal to or more accurate than predicate devices") | Not quantitatively reported in this summary, but clinical data was submitted to FDA. |
| Documentation of wound progression | Not explicitly stated | The device performs this function. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature). To obtain this, one would need to review the full submission to the FDA, which would include the detailed clinical study report. The summary states that "Clinical data were obtained to demonstrate that the PictZar® device performed as intended."
3. Number of Experts Used to Establish Ground Truth and Qualifications
The 510(k) summary does not provide information on the number of experts used or their qualifications for establishing ground truth in any test set. This type of detail would typically be found in the clinical study protocol and report.
4. Adjudication Method
The 510(k) summary does not describe any adjudication method (e.g., 2+1, 3+1). This detail would be part of the study design.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The 510(k) summary does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. It focuses on comparing the PictZar® device's accuracy to predicate devices, not on the improvement of human readers with AI assistance.
6. Standalone Performance Study
The 510(k) summary implies a standalone performance study was conducted to demonstrate the device's accuracy, stating "Measurements made PictZar® are equal to or more accurate than those made with the predicate devices. The differences do not raise any questions of safety and effectiveness over the predicate devices." This suggests the algorithm's performance was evaluated independently. However, the details of this study are not provided.
7. Type of Ground Truth Used
The 510(k) summary does not explicitly state the type of ground truth used. Given the nature of wound measurement, it's highly likely that ground truth would be established through a combination of:
- Manual measurements: Precise manual measurements performed by trained clinicians using traditional methods (e.g., rulers, transparent grids) or other validated photographic planimetry tools.
- Expert Consensus: Agreement among multiple qualified experts on the accurate wound boundaries and dimensions.
8. Sample Size for the Training Set
The 510(k) summary does not provide information on the sample size for the training set. This information would be crucial for understanding the robustness of the underlying algorithms, but it is not part of this regulatory summary.
9. How Ground Truth for the Training Set Was Established
The 510(k) summary does not explain how ground truth for the training set was established. Similar to the test set, it would likely involve highly accurate manual measurements or expert annotations.
§ 878.4160 Surgical camera and accessories.
(a)
Identification. A surgical camera and accessories is a device intended to be used to record operative procedures.(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 § 878.9.