(76 days)
The Tenon Medical Catamaran Sacroiliac Joint Fixation System) is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
The Tenon Medical Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) was developed as a less invasive alternative to traditional open posterior surqical SIJ fusion. The Tenon Medical Catamaran Sacroillac Joint Fixation System (CAT SIJ Fixation System) includes the Catamaran SIJ Implant and associated surgical instruments: an Access Set, a Drill/Delivery and an Accessory Set and an Extraction Set. The titanium implant consists of two hollow barrels connected by a bridge. During the procedure, autologous bone graft material is placed in the barrel of the implant to facilitate stabilization. The Catamaran SIJ Implant is available in two (2) different barrel diameters (7.5mm and 10mm) and two implant lengths (30mm and 40mm) for a total of four sizing options to fit patient anatomy. The Catamaran SIJ Implant is intended for single-use only. The implants and associated components are provided clean and non-sterile and designed for routine steam sterilization prior to use.
This document describes the Tenon Medical Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System). It is a medical device for sacroiliac joint fusion. The information provided outlines the regulatory submission, but does not detail a study that defines acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or effect size, as would be typical for an AI/ML or diagnostic device.
Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices through performance testing related to the device's physical and mechanical properties.
Here's an analysis based on the provided text, addressing your points where possible, and noting when information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide acceptance criteria in the form of specific performance metrics (e.g., accuracy, sensitivity, specificity) for a clinical study or an AI/ML model. Instead, it states that "Performance testing, including biocompatibility, chemical characterization, mechanical static and dynamic shear testing, pull-out, cadaver and instrumentation testing was submitted to support the overall functionality and usability of the Tenon Medical Catamaran Sacroiliac Joint Fixation System."
Therefore, a table of acceptance criteria and reported device performance, as you've requested for a typical AI/ML or diagnostic device evaluation, cannot be extracted from this text. The "performance data" here refers to engineering and biocompatibility tests, not clinical efficacy or diagnostic performance.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The document refers to "performance testing" which includes mechanical and cadaver testing, but does not specify sample sizes for these tests or characterize them as "test sets" in the context of clinical or AI/ML evaluations. There is no mention of country of origin or whether data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided. The document describes a medical device for surgical fixation, not a diagnostic or AI/ML system that would typically require expert-established ground truth on a test set.
4. Adjudication Method
This information is not provided. As above, adjudication methods are typical for expert review in clinical or AI/ML studies, which is not the focus of this device's performance data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not provided. The device is a surgical implant, not a diagnostic tool that human readers would use in conjunction with AI. Therefore, an MRMC study related to AI assistance for human readers is not applicable to this device and is not mentioned.
6. Standalone (Algorithm Only) Performance Study
This information is not provided. The device is a physical implant, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and not mentioned.
7. Type of Ground Truth Used
The concept of "ground truth" as typically applied to diagnostic or AI/ML studies (e.g., expert consensus, pathology, outcome data) is not applicable or stated for the performance testing mentioned for this surgical implant. The "performance data" refers to engineering and biocompatibility tests, which would have their own established standards and reference methods for evaluation.
8. Sample Size for the Training Set
This information is not provided. This device is a physical implant, not an AI/ML model, so the concept of a "training set" is not relevant.
9. How Ground Truth for the Training Set Was Established
This information is not provided. As the device is not an AI/ML model, there is no training set or associated ground truth establishment.
Summary of what the document does provide regarding device evaluation:
The document is a 510(k) premarket notification letter for a Class II surgical implant (Catamaran Sacroiliac Joint Fixation System). The primary method of demonstrating its suitability for market is through substantial equivalence to existing predicate devices.
The "Performance Data" section indicates that the following types of testing were submitted:
- Biocompatibility: To ensure the implant is safe for interaction with biological tissues.
- Chemical Characterization: To understand the material composition.
- Mechanical Static and Dynamic Shear Testing: To evaluate the implant's strength and fatigue resistance under various loads.
- Pull-Out Testing: To assess the implant's resistance to being dislodged from bone.
- Cadaver Testing: Likely to evaluate surgical technique, implant placement, and initial stability in a simulated anatomical environment.
- Instrumentation Testing: To ensure the surgical tools function as intended.
These tests are standard for evaluating the safety and mechanical performance of orthopedic implants, demonstrating that the device is "capable of performing in accordance with its intended use" and "does not raise any new or different questions or concerns of safety or effectiveness as compared to commercially available predicate devices."
The document does not contain the details of a clinical study or an AI/ML model evaluation as implied by the structure of your request.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 13, 2018
Tenon Medical, Inc. % Ms. Jeannie Cecka Regulatory Consultant JGC, LLC 2100 Omega Road, Suite F San Ramon, California 94583
Re: K180818
Trade/Device Name: Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OUR Dated: March 28, 2018 Received: March 29, 2018
Dear Ms. Cecka:
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. 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 CFR Part 807); labeling (21 CFR Part 801); medical device 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);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ronald P. Jean -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180818
Device Name
Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)
Indications for Use (Describe)
The Tenon Medical Catamaran Sacroiliac Joint Fixation System) is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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II. 510(k) Summary
Image /page/3/Picture/2 description: The image shows the logo for Tenon Medical. The logo features a large, stylized letter 'T' in blue, with the words 'TENON' and 'MEDICAL' stacked below it, also in blue. The 'T' is designed with sharp angles and a modern look, while the text is in a simple, sans-serif font.
ADMINISTRATIVE INFORMATION
| Submitter: | Tenon Medical, Inc.2100 Omega Road Suite FSan Ramon, CA 94583Telephone (925) 362-9492 |
|---|---|
| ------------ | --------------------------------------------------------------------------------------------------- |
Official Correspondent:
Jeannie Cecka Regulatory Consultant Telephone (510) 685-6004 Email jmcecka@comcast.net
Date Prepared: March 28, 2018
DEVICE NAME
| Trade Name: | Catamaran Sacroiliac Joint Fixation System (CATSIJ Fixation System) |
|---|---|
| Classification Name: | Sacroiliac Joint Fixation |
| Regulation Description: | Smooth or threaded metallic bone fixation fastener |
| Device Class: | Class II |
| Product Code: | OUR |
| Regulation Number: | 888.3040 |
| Review Panel: | Orthopedic |
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Device Description:
The Tenon Medical Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) was developed as a less invasive alternative to traditional open posterior surqical SIJ fusion. The Tenon Medical Catamaran Sacroillac Joint Fixation System (CAT SIJ Fixation System) includes the Catamaran SIJ Implant and associated surgical instruments: an Access Set, a Drill/Delivery and an Accessory Set and an Extraction Set. The titanium implant consists of two hollow barrels connected by a bridge. During the procedure, autologous bone graft material is placed in the barrel of the implant to facilitate stabilization. The Catamaran SIJ Implant is available in two (2) different barrel diameters (7.5mm and 10mm) and two implant lengths (30mm and 40mm) for a total of four sizing options to fit patient anatomy. The Catamaran SIJ Implant is intended for single-use only. The implants and associated components are provided clean and non-sterile and designed for routine steam sterilization prior to use.
Indications for Use: The Tenon Medical Catamaran Sacroillac Joint Fixation System (CAT SIJ Fixation System) is intended for sacroiliac ioint fusion for conditions including sacroiliac joint disruptions and degenerative sacroillitis.
Performance Data:
Performance testing, including biocompatibility, chemical characterization, mechanical static and dynamic shear testing, pull-out, cadaver and instrumentation testing was submitted to support the overall functionality and usability of the Tenon Medical Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System).
Predicate Devices:
- Medtronic Sofamor Danek Rialto™ SI Fusion System (K161210) o Primary Predicate
- Medtronic Inc. SI-FIX Sacroiliac Joint Fusion System (MSB Sacroiliac . Joint Fusion Device) (K110472)
- Si-Bone iFuse Implant System (K131405) ●
- Synthes 6.5mm Cannulated Screw (K021932) o
Equivalence to Marketed Products:
Tenon Medical Inc. has submitted information to demonstrate that, for the purposes of FDA's requlation of medical devices, the Tenon Medical Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) is substantially equivalent to predicate devices based on a comparison including the following attributes:
- FDA Product Code ●
- Intended Use ●
- Technological Characteristics o
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Conclusions:
In summary, the Tenon Medical Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) is substantially equivalent to predicate devices and is capable of performing in accordance with its intended use. The device does not raise any new or different questions or concerns of safety or effectiveness as compared to commercially available predicate devices.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.