(57 days)
The S-scan Temporomandibular Coil is to be used in MR imaging of the temporomandibular joint.
S-scan is a Magnetic Resonance (MR) system that produces transverse, sagittal and coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip, imaging of the temporomandibular joint and imaging the cervical spine and the lumbar spine sections as portions of the spinal column. S-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (TI), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.
S-scan is a Magnetic Resonance (MR) system, which produces images of the internal structures of the patient's limbs and joints.
This 510(k) is to add the Temporomandibular coil. This is a single channel surface receiving coil, shaped for suitability to the areas under examination and designed to be matched to the patient's temporomandibular joint; the coil is also morphologically adapted to the examined area to obtain a good Signal-to-Noise Ratio.
The provided text is a 510(k) summary for a medical device (a Temporomandibular coil for an S-scan MRI system) and does not describe a study with acceptance criteria and reported device performance in the way a diagnostic AI/ML device submission would. Instead, it focuses on demonstrating "substantial equivalence" of the new coil to existing, legally marketed predicate devices.
Therefore, many of the typical acceptance criteria and study details for an AI/ML device will not be found in this document. The "performance data" section explicitly states "Non-clinical testing of the S-scan system with the addition of the Temporomandibular Coil demonstrated that it met performance requirements and is as safe and effective as the predicate devices." This implies engineering and safety testing, not a clinical study to assess diagnostic accuracy or the impact of AI.
I will fill in the requested information as much as possible based on the provided text, and explicitly state when the information is not available due to the nature of this type of submission.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for an MRI coil, the acceptance criteria are not in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity) for an AI/ML algorithm. Instead, the "performance requirements" would typically relate to the coil's physical properties, image quality metrics (e.g., Signal-to-Noise Ratio), and safety (e.g., heating, electromagnetic compatibility) when integrated with the existing S-scan MRI system. The document does not provide specific numerical acceptance criteria or reported values for these engineering performance requirements.
The core "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Implied) |
|---|---|
| Safety: Meets relevant safety standards for MRI coils and systems. | Demonstrated safe. |
| Effectiveness: Capable of producing diagnostically useful MR images of the temporomandibular joint. | Demonstrated effective; provides diagnostically useful information when interpreted by a medical expert. |
| Technical Characteristics: Similar technological characteristics (e.g., single channel surface receiving coil, designed for temporomandibular joint, optimized SNR, integration with S-scan system). | Substantially equivalent to predicate devices in technological characteristics. |
| Image Quality: Capable of obtaining a good Signal-to-Noise Ratio (SNR). | Designed to obtain a good Signal-to-Noise Ratio. |
| Intended Use: Consistent with the intended use of the S-scan system and specific to temporomandibular joint imaging. | Meets intended use for imaging the temporomandibular joint. |
2. Sample size used for the test set and the data provenance
This information is not provided because the submission describes non-clinical testing for an MRI coil, not a clinical study involving patient data for an AI/ML algorithm. "Non-clinical testing" typically involves engineering bench tests and phantom studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of diagnostic accuracy, is not established for this type of submission. The device's "effectiveness" is tied to its ability to produce images that a "medical expert trained in the use of MR equipment" can interpret, rather than an algorithm making a diagnosis.
4. Adjudication method for the test set
Not applicable, as there is no clinical test set for diagnostic accuracy requiring ground truth adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This K110373 submission is for an MRI coil, not an AI/ML device, and therefore no MRMC study or AI assistance comparison was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is an MRI coil, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this device, "performance" relates to the technical specifications and image quality necessary for a medical expert to make a diagnosis, not the diagnostic accuracy of an algorithm against a specific ground truth.
8. The sample size for the training set
Not applicable. This is for an MRI coil, not an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable. This is for an MRI coil, not an AI/ML algorithm.
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K110373
APR - 6 2011
510(k) Summary Temporomandibular coil 15 Esaute, S.p.A.
510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a).
Submitter Information
Donatella Ragghianti Esaote S.p.A. Via Siffredi 58 Genova 16153 Italy
| Contact Person: | Allison Scott, RAC |
|---|---|
| Phone: | (317) 569-9500 x 106 |
| Facsimile: | (317) 569-9520 |
| ascott@ansongroup.com | |
| Date: | February 7, 2011 |
| Trade Name: | Temporomandibular Coil 15 |
| Common Name: | Coil, Magnetic Resonance, Specialty |
| Classification Name(s): | Magnetic resonance diagnostic device |
| Classification Number: | 90MOS |
Predicate Device(s)
| Tradename | Common name | Class | Product code | Manufacturer | K number |
|---|---|---|---|---|---|
| S-scan | System, nuclearmagnetic resonanceimaging | II | LNH | Esaote S.p.A. | K080968 |
| MagnetomAvanto 1.5 TLoop coil | Coil, MagneticResonance, Specialty | II | MOS | SIEMENS AGMEDICALSOLUTIONS | K070629 |
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510(k) Summary Temporomandibular coil 15 Esaote, S.p.A.
Device Description
S-scan is a Magnetic Resonance (MR) system, which produces images of the internal structures of the patient's limbs and joints.
This 510(k) is to add the Temporomandibular coil. This is a single channel surface receiving coil, shaped for suitability to the areas under examination and designed to be matched to the patient's temporomandibular joint; the coil is also morphologically adapted to the examined area to obtain a good Signal-to-Noise Ratio.
Intended Use(s)
S-scan is a Magnetic Resonance (MR) system that produces transverse, sagittal and coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip, imaging of the temporomandibular joint and imaging the cervical spine and the lumbar spine sections as portions of the spinal column.
S-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (T1), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.
Technological Characteristics
The technological characteristics of the S-scan system with the addition of the Temporomandibular Coil, reflected in this Traditional 510(k), are substantially equivalent to those of the predicate devices.
Performance Data
Non-clinical testing of the S-scan system with the addition of the Temporomandibular Coil demonstrated that it met performance requirements and is as safe and effective as the predicate devices.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is in a sans-serif font.
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
Esaote, S.p.A. % Ms. Allison Scott, RAC Official Correspondent The Anson Group 11460 N Meridian St., Ste 150 CARMEL IN 46032
APR - 6 2011
Re: K110373
Trade/Device Name: Temporomandibular coil 15 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: February 7, 2011 Received: February 8, 2011
Dear Ms. Scott:
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 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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,
Mary Pastel
Mary S. Pastel, Sc.D. 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
510(k) Number (if known):
Device Name: Temporomandibular coil 15
Indications for Use:
The S-scan Temporomandibular Coil is to be used in MR imaging of the temporomandibular joint.
S-scan is a Magnetic Resonance (MR) system that produces transverse, sagittal and coronal and oblique cross-section images of the limbs, joints and spinal column. It is intended for imaging portions of the upper limb, including the hand, wrist, forearm, elbow, arm and shoulder, imaging portions of the lower limb, including the foot, ankle, calf, knee, thigh and hip, imaging of the temporomandibular joint and imaging the cervical spine and the lumbar spine sections as portions of the spinal column. S-scan images correspond to the spatial distribution of protons (hydrogen nuclei) that determine magnetic resonance properties and are dependent on the MR parameters, including spin-lattice relaxation time (TI), spin-spin relaxation time (T2), nuclei density, flow velocity and "chemical shift". When interpreted by a medical expert trained in the use of MR equipment, the images can provide diagnostically useful information.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary Stoll
Page 1 of 1
Division of Radiological Office of In Vitro
510K K110323
TemporomandIbular Coil 510(k)
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.