(113 days)
The Triton™ Sacroiliac Joint Fixation system is intended for fixation of sacroiliac joint distruptions, and intended for sacroiliac joint fusion for conditions including;
-sacroiliac joint disruptions,
-degenerative sacroiliitis
-to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and
-Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint
The Triton™ Sacroiliac Joint Fixation System is a multiple component system consisting of non-sterile instruments and sterile, cannulated Ø8mm, Ø12mm and Ø14mm Screws offered in multiple lengths. The Triton SI Screws are manufactured from medical-grade titanium alloy (Ti-6Al-4V ELI) per ASTM F3001, Class C. The implants feature 3 fluted channels for bone collection and a tapered proximal tip. The Ø12mm and Ø14mm Screws feature multiple open and porous-filled windows for packing and disbursement of autograft and allograft materials.
This FDA 510(k) summary is for a medical device called the Triton™ Sacroiliac Joint Fixation System. It describes the device, its intended use, and claims substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study that proves the device meets those criteria, as typically understood in the context of AI/ML device performance or clinical outcomes.
The provided document primarily focuses on non-clinical testing for mechanical properties (e.g., static pull-out, torsion, cantilever) to demonstrate the safety and effectiveness of the physical implant by comparing its mechanical characteristics to existing predicate devices.
Therefore, many of the requested categories related to AI/ML device performance, human expert involvement, ground truth, and training data cannot be extracted from this document, as they are not applicable to the type of 510(k) submission described.
Here's a breakdown based on the information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists non-clinical mechanical tests, but doesn't explicitly state acceptance criteria as pass/fail thresholds against specific numerical values. Instead, it implies that the device's performance in these tests was comparable to that of predicate devices, leading to a conclusion of substantial equivalence.
| Acceptance Criterion (Implied) | Reported Device Performance (Implied) |
|---|---|
| Static Pull Out (ASTM F543) | Met (Comparable to predicate devices) |
| Static Torsion (ASTM F543) | Met (Comparable to predicate devices) |
| Static Cantilever (ASTM F2193) | Met (Comparable to predicate devices) |
| Dynamic Cantilever (ASTM F2193) | Met (Comparable to predicate devices) |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The "test set" here refers to physical components of the device undergoing mechanical testing, not a dataset for AI/ML. The provenance would be the materials used in manufacturing the device components for these tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not AI/ML performance testing requiring expert ground truth for classification or prediction. The "ground truth" for mechanical testing is established by standard engineering principles and test methods, often performed by engineers or technicians.
4. Adjudication Method for the Test Set
Not applicable. There is no adjudication in the context of mechanical testing as described here. Results are objectively measured according to the ASTM standards.
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 is not an AI/ML device that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is not an AI/ML device.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical testing is based on established engineering standards and measurements of mechanical properties (e.g., force, torque, displacement) as defined by ASTM standards.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/ML device.
Summary of the Study Proving Device Acceptance Criteria (based on the provided document):
The Triton™ Sacroiliac Joint Fixation System underwent a series of non-clinical mechanical tests to demonstrate its performance and substantial equivalence to legally marketed predicate devices. These tests were conducted according to established ASTM standards:
- Static Pull Out (ASTM F543)
- Static Torsion (ASTM F543)
- Static Cantilever (ASTM F2193)
- Dynamic Cantilever (ASTM F2193)
The document concludes that the "differences in geometry are not significant and would not adversely affect the use of the product. The Triton™ System is substantially equivalent in material, size offerings, classification, anatomical location, manufacturing and sterilization methods, surgical approach, principle of operation, indications for use, and mechanical testing plan." This statement implies that the device successfully met the performance expectations by demonstrating comparable mechanical characteristics to the predicate devices, thereby establishing its safety and effectiveness for its intended use. The "ground truth" for these tests was the objective measurements obtained through adherence to the specified ASTM testing protocols.
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August 31, 2021
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ChoiceSpine, LLC Kim Finch Director of Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37919
Re: K211449
Trade/Device Name: Triton™ Sacroiliac Joint 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: July 29, 2021 Received: July 30, 2021
Dear Kim Finch:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrl-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K211449
Device Name
Triton™ Sacroiliac Joint Fixation system
Indications for Use (Describe)
The Triton™ Sacroiliac Joint Fixation system is intended for fixation of sacroiliac joint distruptions, and intended for sacroiliac joint fusion for conditions including;
-sacroiliac joint disruptions,
-degenerative sacroilititis
-to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and
-Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Date: | July 7, 2021 |
|---|---|
| Sponsor: | ChoiceSpine, LLC400 Erin DriveKnoxville, TN 37919 |
| Phone: | 865-246-3333 |
| Fax: | 865-246-3334 |
| Contact Person: | Kim Finch, Director of Regulatory Affairs |
| Proposed ProprietaryTrade Name: | Triton™ Sacroiliac Joint Fixation System |
| Product Class: | Class II |
| Classification Name: | Triton™ Sacroiliac Joint Fixation System• 21 CFR 888.3040- Smooth or Threaded Metallic Bone Fixation Fastener |
| Device Product Code: | Triton™ Sacroiliac Joint Fixation System• OUR |
| Purpose of Submission: | The purpose of this submission is to gain clearance for the new Triton™ Sacroiliac Joint Fixation System. |
| Device Description: | The Triton™ Sacroiliac Joint Fixation System is a multiple component systemconsisting of non-sterile instruments and sterile, cannulated Ø8mm, Ø12mmand Ø14mm Screws offered in multiple lengths. The Triton SI Screws aremanufactured from medical-grade titanium alloy (Ti-6Al-4V ELI) per ASTMF3001, Class C. The implants feature 3 fluted channels for bone collection anda tapered proximal tip. The Ø12mm and Ø14mm Screws feature multipleopen and porous-filled windows for packing and disbursement of autograftand allograft materials. |
| Indications for Use: | The Triton™ Sacroiliac Joint Fixation System is intended for fixation ofsacroiliac joint disruptions, and intended for sacroiliac joint fusion forconditions including;• sacroiliac joint disruptions• degenerative sacroiliitis• to augment immobilization and stabilization of the sacroiliac joint inskeletally mature patients undergoing sacropelvic fixation as part of alumbar or thoracolumbar fusion and• Acute, non-acute, and non-traumatic fractures involving the sacroiliacjoint. |
| Materials: | The Triton™ Sacroiliac Joint Fixation System implants are composed of atitanium alloy (Ti-6Al- 4V ELI per ASTM F3001, Class C). The systeminstrumentation is made from medical grade stainless steels, aluminum, and |
| Predicate Devices: | Primary Predicate:Orthofix Firebird SI Fusion System (K203138)Additional Predicates:Synthes Ø6.5mm Cannulated Screw (K021932)Zyga Technology, Inc. SImmetry® Sacroiliac Joint Fusion System (K151818)ChoiceSpine Hawkeye VBR System (K171686) |
| Non-clinical Testing: | Static Pull Out per ASTM F543Static Torsion per ASTM F543Static Cantilever per ASTM F2193Dynamic Cantilever per ASTM F2193 |
| Conclusion/Technological Characteristics: | The only difference between the Triton™ Sacroiliac Joint Fixation System andthe predicate devices are device geometry. The differences in geometry arenot significant and would not adversely affect the use of the product. TheTriton™ System is substantially equivalent in material, size offerings,classification, anatomical location, manufacturing and sterilization methods, |
| surgical approach, principle of operation, indications for use, and mechanicaltesting plan. The system components were assessed in accordance with ISO |
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plastics.
10993-1 and found substantially equivalent to the 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.