(305 days)
The PROcedure Rehearsal Studio software is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner to an output file. It is also intended as pre-operative software for simulating/evaluating surgical treatment options.
The Simbionix PROcedure Rehearsal Studio software allows clinicians to create a patient specific 3D anatomical model based on a patient's CT for the purpose of simulating, analyzing and evaluating for preoperative surgical treatment options. Once the 3D segmentation model has been exported to the Simbionix ANGIO Mentor Simulator Practice Environment, the physician can use it to create a library of modules for training and post operative debriefing.
Here's an analysis of the provided text regarding the acceptance criteria and study for the PROcedure Rehearsal Studio™ device, presented in the requested format:
It's important to note that the provided text is a 510(k) summary, which is a regulatory document. These summaries typically focus on demonstrating substantial equivalence to a predicate device rather than providing extensive details on a comprehensive clinical study with specific acceptance criteria and detailed performance metrics. As such, several requested pieces of information are not available in the provided document.
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
Summary: The PROcedure Rehearsal Studio™ device performance was validated through bench tests and phantom studies, demonstrating substantial equivalence to its predicate device, Mimics® by Materiallise N.V. (K073468). The primary claim is substantial equivalence, not a specific performance metric against a predefined numerical acceptance criterion.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (Mimics® K073468) | Device was found substantially equivalent to the Mimics® predicate device based on bench tests and phantom studies. |
| No new safety and/or effectiveness issues raised. | Simbionix Ltd. believes no new safety and/or effectiveness issues are raised. |
Note: The document does not specify quantitative acceptance criteria (e.g., specific accuracy, sensitivity, specificity thresholds) that the device had to meet. The acceptance was based on demonstrating equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not specified. The document only mentions "bench tests and phantom studies."
- Data Provenance: Not specified. "Bench tests and phantom studies" typically imply engineered test scenarios and physical models, not patient data from a specific country or retrospective/prospective collection.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
4. Adjudication Method for the Test Set
- Adjudication Method: Not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No, an MRMC comparative effectiveness study is not mentioned. The validation involves comparison to a predicate device, not human reader performance.
- Effect Size of Human Readers with vs. without AI: Not applicable, as no MRMC study was performed.
6. Standalone Performance Study
- Was a standalone study done? Yes, the device's performance was evaluated independently through "bench tests and phantom studies" in comparison to the predicate device. This implies an algorithm-only (standalone) assessment of the software's ability to perform its intended functions (image segmentation, 3D model creation). The comparison to the predicate device itself is a form of standalone performance evaluation against an established benchmark.
7. Type of Ground Truth Used for the Test Set
- Type of Ground Truth: Implied to be engineered "ground truth" models within "bench tests and phantom studies." This would likely involve phantoms with known anatomical structures and precise measurements against which the device's segmentation and 3D model generation capabilities could be compared. It is not expert consensus, pathology, or outcomes data in the traditional clinical sense.
8. Sample Size for the Training Set
- Sample Size (Training Set): Not mentioned. The document primarily focuses on validation for regulatory clearance, not detailed algorithm development.
9. How Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not mentioned. The document does not provide details on the algorithm's training process or how ground truth for any potential training data was established.
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510(K) SUMMARY [as required by section 807.92(c)] PROcedure Rehearsal Studio™
510(k) Number K_093269
Applicant's Name:
AUG 2 0 2010
Simbionix Ltd. 6 Hamelacha St. Lod, Northern Industrial Zone, 71520 Israel Tel: +972-8-921-1177 Fax: +972-8-921-1188
Contact Person:
Name: Shoshana (Shosh) Friedman Telephone: 704-899-0092 Fax: 704-899-0098 Email: shosh@pushmed.com
Trade Name:
PROcedure Rehearsal Studio™
Classification Name: Regulation Number: Product Code: Classification: Review Panel:
System, Image Processing, Radiological 892.2050 LLZ Class II Radiology
Predicate Devices:
Device Description:
The Simbionix PROcedure Rehearsal Studio software allows clinicians to create a patient specific 3D anatomical model based on a patient's CT for the purpose of simulating, analyzing and evaluating for preoperative surgical treatment options.
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Once the 3D segmentation model has been exported to the Simbionix ANGIO Mentor Simulator Practice Environment, the physician can use it to create a library of modules for training and post operative debriefing..
Intended Use:
The PROcedure Rehearsal Studio software is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner to an output file. It is also intended as pre-operative software for simulating/evaluating surgical treatment options.
Performance Data:
The device performance was validated through bench tests and phantom studies in comparison to the Mimics predicate device and was found substantially equivalent.
Conclusion:
Simbionix Ltd. believes that, based on the information provided in this submission, the PROcedure Rehearsal Studio™ is substantially equivalent to its predicate devices without raising any new safety and/or effectiveness issue.
PROcedure Rehearsal Studio™ · Page 5-4
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Image /page/2/Picture/0 description: The image contains a logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the seal is a stylized emblem featuring three abstract shapes resembling waves or ribbons.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring. MD 20993-0002
Simbionix Ltd. % Ms. Shoshana Friedman President & CEO Push-Med LLC 1914 J N Pease Pl. CHARLOTTE NC 28262
AUG 2 0 2010
Re: K093269
Trade/Device Name: PROcedure Rehearsal StudioTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II. Product Code: LLZ Dated: June 21, 2010 Received: June 23, 2010
Dear Ms. Feiedman:
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 enclosure) 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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 5 00() , rims rete notification. The FDA finding of substantial equivalence of your device to a legally wonarketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.
Sincerely yours.
Donald J. Trump
Donald J. St.Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(k) Number (if known): 长 693269
Device Name:
Indications for Use:
The PROcedure Rehearsal Studio software is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner to an output file. It is also intended as pre-operative software for simulating/evaluating surgical treatment options.
Prescription Use __X (Per 21 CFR 801 Subpart D) AND/OR
Over the Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE ·CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Devie
(Division Sign-Off)
Division of Radiological Devic Office of In Vitro Diagnostic Device Eva
510K K093269
PROcedure Rehearsal Studio™ · Page 4-3
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).