(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.
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510(k) Summary for K130165
| Submitter: | Advanced Planimetric Services, LLC | |
|---|---|---|
| Address: | 610 Boulevard, Elmwood Park, New Jersey 07407 | |
| Telephone: | 646-220-1745 | |
| Contact Person: | Dr. Martin Wendelken | |
| Date of Summary: | 28- August- 2013 | AUG 30 2013 |
| Trade Name: | PictZar® | |
| Common Name: | Wound measurement and documentation software | |
| Classification Name: | Surgical camera and accessories (21CFR878.4160) | |
| Class : | Class I (general controls) | |
| Predicate Devices: | Verg Videometer (Verg Incorporated) | |
| Visitrak (Smith & Nephew) | ||
| Silhouette (Aranz Medical Ltd.) | ||
| Device Description: | PictZar® is digital planimetry software used for the measurement and tracking | |
| Indications for Use: | PictZar is indicated for wound measurement and documentationand can be used on all external wound types. | |
| Intended Use: | The intended use of PictZar® planimetry software is to measure anddocument the progression of external wounds over time. This systemis a computer software application. The system is a non-contact methodof wound measurement. | |
| Comparison toPredicates: | PictZar® is substantially equivalent to the predicate devices in thecomparison of the indications for use, the intended use, how it isused relating to workflow using current principals and technology.Measurements made PictZar® are equal to or more accuate than thosemade with the predicate devices. The differences do not raise anyquestions of safety and effectiveness over the predicate devices. |
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Advanced Planimetric Services, LLC Dr. Martin E. Wendelken President 610 Boulevard Elmwood Park, New Jersey 07407
August 30, 2013
Rc: K130165
Trade/Device Name: PictZar® Digital Planimetry Software Application Regulation Number: 21 CFR 878.4160 Regulation Name: Surgical camera and accessories Regulatory Class: Class I Product Code: FXN Dated: May 27, 2013 Received: June 05, 2013
Dear Dr. Wendelken:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the cnclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
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Page 2 - Dr. Martin E. Wendelken
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
FOR
Peter D. Rumm -S
Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: K130165
Device Name: PictZar® Digital Planimetry Software and Documentation System
Indications For Use:
PictZar® planimetry software is indicated for wound measurement and documentation and can be used on all external wound types.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Prescription Use | X |
|---|---|
| OR | |
| Over-The-Counter Use | |
| (Per 21 CFR 801.109) |
(Optional Format 1-2-96)
Neil R Ogden: 2013.08.30 12:49:15 -04'00'
(Division Sign-Off) for MXM ·
Division of Surgical Devices
510(k) Number_K130165
§ 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.