(87 days)
The Surgical Theater, LLC SNAP is intended for use as a software interface and image segmentation system for the transfer of imaging information from a CT or MR medical scanner to an output file. It is also intended for use in simulating and evaluating surgical treatment options both pre-operatively and intra- operatively with validated systems as identified in the device labeling.
The SNAP is software based medical image management system. It is intended for use as a software interface and image segmentation system for the transfer of imaging information from a CT or MR medical scanner to an output file. It is also intended for use in simulating and evaluating surgical treatment options both pre-operatively and intraoperatively with validated systems as identified in the device labeling. The SNAP system is based on the Surgical Theater Surgery Rehearsal Platform (SRP) image management system. The SNAP utilizes the same identical software as the SRP to create 3D models of patient data from 2D scan slices. This provides the user with ability to input, display, color, and manipulate the 2D scan slices via a 3D representation. The SNAP system enhances the SRP's capability by adding additional input and allowing the surgeon to connect to an external Image Guided System and Navigation systems (in general: "IGS"; for example Brainlab Kolibri or Brainlab Curve), and to see the incoming navigation data in the SNAP monitor. The incoming navigation data is then displayed to the surgeon inside the generated 3D model, so the surgeon gets a 3D representation of his surgery navigation session.
The provided document K140819 for the Surgical Navigation Advanced Platform (SNAP) does not contain a specific table of acceptance criteria with numerical performance targets or a detailed study report demonstrating how these criteria were met. Instead, it states that "Verification and validation results confirm that the SNAP Software meets its' performance requirements."
However, based on the information provided, we can infer the acceptance criteria for the device's functionality and its proven performance:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Basic Functionality | Ability to reconstruct a 3D model of patient anatomy from 2D medical images (DICOM dataset). | The SNAP system "reconstructs a 3D model of a specific patient's anatomy" from 2D DICOM datasets. It "utilizes the same identical software as the SRP to create 3D models of patient data from 2D scan slices." |
| Visualization & Manipulation | Capability to input, display, color, and manipulate the 2D scan slices via a 3D representation, including image tools like rotation, scaling, and coloring. | The SNAP "provides the user with ability to input, display, color, and manipulate the 2D scan slices via a 3D representation" and has "Image tools such as rotation, scaling and coloring." This functionality is identical to the predicate SRP device. |
| External Device Connectivity | Capability of connecting to an external Surgical Navigation system (e.g., Brainlab Kolibri or Brainlab Curve) and processing incoming navigation data. | The SNAP allows the surgeon to "connect to an external Image Guided System and Navigation systems," "see the incoming navigation data in the SNAP monitor," and displays this data "in a 3D fashion inside the SNAP 3D model." It was specifically "tested with the Brainlab Kolibri 2 and Brainlab Curve systems." |
| Navigation Data Display | Display of incoming navigation data (e.g., pointer position and orientation) from an external navigation system within the generated 3D model. | The SNAP "displays the same navigation data (Pointer position and orientation), as it is received from the external navigation system, in a 3D fashion inside the SNAP 3D model of the anatomy." |
| Intra-operative Use | Functionality and safety for use in the Operating Room (OR) during surgery. (This is a key differentiating feature from the predicate SRP). | The SNAP is "also intended to be used in the OR during surgery." This implies it met safety and performance requirements for this environment. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 Standard for Electromagnetic Interference and Susceptibility. | The SNAP System "was tested to and meets the requirements of IEC 60601-1-2 Standard for Electromagnetic Interference and Susceptibility." |
| Overall Performance | Software performs as intended and meets its performance requirements, being substantially equivalent to the predicate SRP device for shared functionalities, and effectively extending its use to intra-operative navigation. | "Verification and validation results confirm that the SNAP Software meets its' performance requirements." The device is considered "substantially equivalent" to the SRP for its core functions, with additional intra-operative capabilities. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document states that the SNAP was "validated by two neurosurgeons based on historical DIOCM cases (of patients' cases who had their surgeries done in the past)." The specific number of DICOM cases used is not mentioned in the provided text.
- Data Provenance: The data used consisted of "historical DIOCM cases (of patients' cases who had their surgeries done in the past)." This indicates the data was retrospective. The country of origin is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Two neurosurgeons were used for validation.
- Qualifications of Experts: They are identified as "neurosurgeons," implying medical expertise relevant to the device's application. Specific years of experience or other detailed qualifications are not provided.
4. Adjudication method for the test set:
- The document states that the device was "validated by two neurosurgeons." It does not specify an adjudication method (e.g., 2+1, 3+1). It is only mentioned that they performed the validation.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done comparing human reader performance with and without AI assistance (or in this case, SNAP assistance). The SNAP is described as an image management and navigation assistance tool, not an AI diagnostic tool primarily aimed at improving human reader diagnostic performance. The validation focused on the software's functional correctness and suitability for use, particularly the new intra-operative navigation feature. There is no mention of an effect size related to human improvement with assistance.
6. If standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance assessment was conducted in the sense that the software underwent internal "full testing, verification, and validation by Surgical Theater as part of its' own internal design control requirements" to confirm it meets its performance requirements. The subsequent validation by neurosurgeons assessed the usability and correctness of its output for clinical use, but the core functionality and technical performance were first verified in a standalone manner.
7. The type of ground truth used:
- The ground truth was implicitly derived from the "historical DIOCM cases (of patients' cases who had their surgeries done in the past)." This suggests that the ground truth for validating the 3D reconstructions and navigation display was based on the known anatomy and surgical outcomes of these historical cases, likely interpreted by the validating neurosurgeons. It is most akin to expert consensus/clinical data derived from previously treated cases.
8. The sample size for the training set:
- The document does not specify a sample size for a training set. The device is described as software that reconstructs 3D models from DICOM data based on algorithms, rather than a machine-learning model that would typically require a distinct training set. The SNAP system "utilizes the same identical software as the SRP to create 3D models."
9. How the ground truth for the training set was established:
- As the document does not mention a distinct training set in the context of machine learning, there is no information provided on how ground truth for a training set was established. The software's underlying algorithms for 3D reconstruction and visualization likely rely on established medical image processing principles and were developed and refined through engineering and standard software development practices, rather than by training on a labeled dataset in the modern AI sense.
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K140819
Page 1 of 6
Surgical Navigation Advanced Platform
510(K) SUMMARY" AS REQUIRED BY SECTION 807.92(c) Modified May 27, 2014
510(k) Owner's Name, Address, Telephone Number, Fax Number, Contact Person and Date Prepared.
Surgical Theater 781 Beta Drive Mayfield Village, Ohio 44143 Phone: (216) 496-7884 Fax: (216) 916-3806
Contact Person:
Mordechai Avisar CEO/President Surgical Theater, LLC 781 Beta Drive Mayfield Village, Ohio 44143 Phone: (216) 496-7884 Fax: (216) 916-3806 Email: mavisar@surgicaltheater.net
Date Prepared: March 22, 2014
Name of Device
- Trade Name: Surgical Navigation Advanced Platform (SNAP) .
- Common Name: Image Management Software .
- Classification Name: Medical Image Management System Product Code LLC .
Predicate Device
The Surgical Navigation Advanced Platform (SNAP) substantially equivalent to the Surgical Theater, LLC Surgery Rehearsal Platform (K123023).
Device Description:
The SNAP is software based medical image management system. It is intended for use as a software interface and image segmentation system for the transfer of imaging information from a CT or MR medical scanner to an output file. It is also intended for use
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in simulating and evaluating surgical treatment options both pre-operatively and intraoperatively with validated systems as identified in the device labeling.
The SNAP system is based on the Surgical Theater Surgery Rehearsal Platform (SRP) image management system. The SRP was cleared by FDA on February 12, 2013 under 510(k) Accession Number K 123023.
The SNAP utilizes the same identical software as the SRP to create 3D models of patient data from 2D scan slices. This provides the user with ability to input, display, color, and manipulate the 2D scan slices via a 3D representation.
The cleared SRP device interfaces with an input from external 3D mouse device (Omni), which allows the surgeons to navigate the simulated instruments within the said 3D image.
The SNAP system enhances the SRP's capability by adding additional input and allowing the surgeon to connect to an external Image Guided System and Navigation systems (in general: "IGS"; for example Brainlab Kolibri or Brainlab Curve), and to see the incoming navigation data in the SNAP monitor. The incoming navigation data is then displayed to the surgeon inside the generated 3D model, so the surgeon gets a 3D representation of his surgery navigation session.
Current navigation systems usually display the navigation data on 2D black and white DICOM imagery within the external navigation system itself. The SNAP displays the same navigation data (Pointer position and orientation), as it is received from the external navigation system, in a 3D fashion inside the SNAP 3D model of the anatomy as it is reconstructed from the original DICOM slices.
Device Function
The SNAP device takes 2D medical images (DICOM dataset) and reconstructs a 3D model of a specific patient's anatomy. Using the existing data segmentation and visualization capabilities of the SRP, the SNAP system allows the surgeon to connect to external navigation systems and display navigation data (i.e. pointer from IGS) inside its own 3D model. This provides surgeons with additional navigation feedback during surgery.
The two main differences between the SRP and the SNAP are the input device being the navigation systems in the SNAP Vs the Omni device in the SRP and the use in the Operating Room of the SNAP Vs the Pre-Operating Room use of the SRP.
Except for these two differences, the SRP and the SNAP are identical. They are made from the same code (software) and are manufactured by the same company (Surgical
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Image /page/2/Picture/0 description: The image shows a logo with the words "SURGICAL THEATER" stacked vertically. Above the text is an abstract graphic. The graphic appears to be a stylized representation of a human head or brain. The logo is simple and uses a sans-serif font.
Theater). They share the same features and performance characteristics utilize the same identical technology and both function in the same identical manner.
The underlying method of connectivity to the external device is the same in the SRP and SNAP; both devices present the external device's movements based on information obtained directly from the external device and it relays on the accuracy of the external device.
Scientific Concepts
The SNAP is based on the concept of transforming stacked medical images (DICOM dataset) to a 3 dimensional model of patient specific anatomy, and applying visualization algorithms and filters on that 3D model, to control its visualization representation to get a better understanding of the case at hand.
Furthermore, the SNAP connectivity to an external IGS (i.e. Navigation System) expands the visual model by displaying the navigation data inside the 3D model.
Significant Physical and Performance Characteristics
Design:
The Surgical Navigation Advanced Platform (SNAP) is a software based device running on "of the shelf" commercial components. The design is based on an advanced, touch screen friendly, Graphical User Interface (GUI) that runs an underlying simulation engine to process the medical data and user inputs, and an image generator software engine that is used to display a high end 3D model of the medical data (DICOM).
The underlying simulation engine includes a navigation connectivity module that allows external IGS systems (i.e. navigation systems) to send navigation data into the SNAP system. to be displayed within its internal 3D model.
Materials:
The Surgical Navigation Advanced Platform is a software based and commercial off the shelf personal computer system (i.e. PC, keyboard, mouse, touchscreen monitor etc.). Materials used in these systems have been used in offices, homes, hospitals and other applications for many years in both medical and non-medical applications, with no adverse effects.
Physical Properties:
The physical properties of the Surgical Navigation Advanced Platform are the same as any software based, and commercial off the shelf personal computer system (i.e. PC, keyboard, mouse, touchscreen monitor etc.).
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Indications for Use:
The Surgical Theater, LLC SNAP is intended for use as a software interface and image segmentation system for the transfer of imaging information from a CT or MR medical scanner to an output file. It is also intended for use in simulating and evaluating surgical treatment options both pre-operatively and intra- operatively with validated systems as identified in the device labeling.
Predicate Device Comparison
The Surgical Theater SNAP is substantially equivalent to the Surgical Theater Surgery Rehearsal Platform (SRP) (K123023).
| Characteristic | Surgical NavigationAdvanced Platform(SNAP) | Surgery RehearsalPlatform | Explanation ofDifferences |
|---|---|---|---|
| 510(k) AccessionNumber | TBD | K123023 | NA |
| Clearance Date | TBD | 2/12/2013 | NA |
| Computer | PC Workstation | PC Workstation | NA |
| Image Sources | CT and MRI | CT and MRI | NA |
| Indications for Use | Software interface andimage segmentationsystem for the transfer ofimaging information fromCT or MR medical scannerto an output file. It is alsointended for use insimulating and evaluatingsurgical treatment optionsboth preoperatively andintraoperatively withinterface to externalnavigation systems withOpenIGTLink Capability. | Software interface andimage segmentationsystem for the transfer ofimaging information fromCT or MR medical scannerto an output file. Pre-operative software forsimulating/evaluationsurgical treatment options. | Unlike the SRP, TheSNAP is also intended tobe used in the OR duringsurgery. |
| Data Transfer Method | CD or USB | CD or USB | NA |
| Preoperative Planning | Yes | Yes | NA |
| Patient Contact | No | No | NA |
| Human Interventionfor Interpretation of | Yes | Yes | NA |
SNAP/SRP Comparative Analysis
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Image /page/4/Picture/0 description: The image shows a logo for Surgical Theater. The logo consists of an abstract image of a head with a surgical cap on top. Below the image, the words "SURGICAL THEATER" are written in a small, sans-serif font, with "SURGICAL" on the first line and "THEATER" on the second line.
Surgical Navigation Advanced Platform
| Characteristic | Surgical NavigationAdvanced Platform(SNAP) | Surgery RehearsalPlatform | Explanation ofDifferences |
|---|---|---|---|
| Images | |||
| Capability of creating3D models of patientdata from 2D scanslices. | Yes | Yes | NA |
| Provides the user withability to input,display, color, andmanipulate the 2Dscan slices via a 3Drepresentation. | Yes | Yes | NA |
| Image tools such asrotation, scaling andcoloring. | Yes | Yes | NA |
| Capability ofconnecting to anexternal SurgicalNavigation system(for example BrainlabKolibri or BrainlabCurve), andprocessing theincoming navigationdata. | Yes | No | Unlike the SRP thatconnected to a 3D mouse(Omni), the SNAP isdesigned to connect via anetwork connection, to anexternal navigationsystem, and display theincoming navigation dataon its own 3D model ofthe DICOM data.The underlying method ofconnectivity to theexternal device is the samein the SRP and SNAP;both devices present theexternal device'smovements based oninformation obtaineddirectly from the externaldevice and it relays on theaccuracy of the externaldevice. |
| Intra-operative Use | Yes | No | Unlike the SRP. TheSNAP is also intended tobe used in the OR duringsurgery. |
| Pre-operative Use | Yes | Yes | NA |
Performance Data: (Non-clinical Testing)
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Image /page/5/Picture/0 description: The image shows a logo with the words "SURGICAL THEATER" stacked vertically. Above the text is a stylized graphic that appears to be an abstract representation of a surgical instrument or tool. The text is in a simple, sans-serif font, and the overall design is minimalist.
The Surgical Theater SNAP Software was fully tested, verified and validated by Surgical Theater as part of its' own internal design control requirements. Furthermore, the SNAP was validated by two neurosurgeons based on historical DIOCM cases (of patients' cases who had their surgeries done in the past). Verification and validation results confirm that the SNAP Software meets its' performance requirements. The SNAP was tested with the Brainlab Kolibri 2 and Brainlab Curve systems which had "Brainlab Cranial Version 2.1" with an active license for the "IGT Link" connectivity module.
The SNAP System was tested to and mects the requirements of IEC 60601-1-2 Standard for Electromagnetic Interference and Susceptibility.
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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center ~ WO66-G60 Silver Spring, MD 20993-0002
June 27, 2014
SURGICAL THEATER, LLC MORDECHAI AVISAR 781 BETA DR. MAYFIELD VILLAGE OH 44143
Re: K140819
Trade/Device Name: Surgical Navigation Advanced Platform Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: 11 Product Code: LLZ Dated: May 28, 2014 Received: May 29, 2014
Dear Mr. Avisar:
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 in 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 (sec above) into cither 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 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041
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Page 2-Mr. Avisar
or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education 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.
l
Sincerely yours,
Sm.h.7.)
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K140819
Device Name Surgical Theater. LLC Surgical Navigation Advanced Platform
Indications for Use (Describe)
The Surgical Theater, LLC SNAP is intended for use as a software interface and image segmentation system for the transfer of imaging information from a CT or MR medical scanner to an output file. It is also intended for use in simulating and evaluating surgical treatment options both pre-operatively with validated systems as identified in the device labeling.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Sm.h.7)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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FORM FDA 3881 (1/14)
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§ 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).