(263 days)
The Patriot-SI Posterior Implant System is intended for sacroiliac joint fusion including sacroiliac joint disruptions and degenerative sacroiliitis. When the Patriot Implant System (i.e., an "in-line" or "in-line" or "intraarticular" device) is implanted, it must be used with a Spinal Simplicity Liberty-SI Lateral System device (i.e., a "transfixing" device) implanted across the same sacroiliac joint to create a hybrid SI joint fusion construct.
The Patriot-Sl Posterior Implant System is a minimally invasive sacrolliac joint fusion implant that is intended for implantation on a trajectory in line with the joint space (i.e., the device is an in-line or intra-articular implant). The Patriot Implant System device is required to be implanted with the Spinal Simplicity Liberty-Sl Lateral System device implanted across the same sacroiliac joint to create a hybrid SI joint fusion construct for the purpose of stabilizing and fusing the sacroiliac joint. It is available in one size and may be implanted using the designated surgical instruments through a posterior approach into the Sl joint space, fixating on both the sacrum and ilium via external threads. Bone graft materials may be used with the Patriot-Sl Posterior Implant System. The Patriot-SI Posterior Implant System device is manufactured titanium alloy, Ti-6AI-4V-ELI per ASTM F3001 and is offered with or without a hydroxyapatite (HA) coating per ASTM F1185. The Patriot-SI Posterior Implant System device is provided sterile and individually packed.
This document describes a spinal implant device, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, and AI-specific metrics (like MRMC studies or standalone AI performance) is not applicable.
The document is a 510(k) premarket notification for the "Patriot-SI Posterior Implant System," which is a physical medical device for sacroiliac joint fusion. The FDA letter confirms that the device is substantially equivalent to a legally marketed predicate device (NADIA® SI Fusion System, K190580) based on non-clinical mechanical tests and cadaver testing.
Here's a breakdown of the provided information, emphasizing why the AI/ML-specific questions are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a physical implant, "acceptance criteria" and "reported device performance" are based on mechanical properties and safety/effectiveness relative to its predicate, rather than AI model metrics like sensitivity, specificity, or AUC. The document lists the types of non-clinical mechanical tests performed to support substantial equivalence:
| Test Type | Standard/Method | Purpose/Outcome (as implied by context) |
|---|---|---|
| Static Shear Testing | ASTM F3574 | Evaluate resistance to shearing forces. |
| Static and Dynamic Torsion Testing | ASTM F3574 | Assess resistance to twisting forces (static/dynamic). |
| Static Pushout Testing | ASTM F3574 | Determine force required to dislodge the implant. |
| Driving Torque Testing | ASTM F3574 | Measure torque required for implantation. |
| Static and Dynamic Compression-Shear Testing | ASTM F2077 | Evaluate performance under combined compression and shear loads. |
| Cadaver Testing | Not specified | Support surgical approach and implant function. |
The conclusion states that "performance testing provided in this 510(k) application demonstrates that the Patriot SJ Posterior Implant System is capable of performing as intended and is as safe and effective as the legally marketed predicate device." Specific numerical acceptance criteria or performance values are not included in this summary document.
2. Sample Size for Test Set and Data Provenance:
Not applicable, as this is a physical device. Mechanical tests involve test specimens, and cadaver testing involves human cadavers, but these are not "datasets" in the AI/ML sense. Data provenance regarding country of origin or retrospective/prospective is not relevant here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. Ground truth for mechanical testing is derived from engineering principles and standards, and for cadaver testing, it pertains to the anatomical and biomechanical performance, typically evaluated by biomechanical engineers and potentially surgeons. There isn't a "ground truth" established by a panel of medical experts in the way it would be for an AI diagnostic algorithm.
4. Adjudication Method:
Not applicable. This concept pertains to resolving discrepancies in expert labeling or diagnoses for AI training/testing, which is not relevant for a physical implant's mechanical and cadaver testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This type of study assesses the impact of AI on human reader performance for diagnostic tasks. The Patriot-SI system is a surgical implant, not a diagnostic AI.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
Not applicable. There is no algorithm to evaluate in a standalone manner.
7. Type of Ground Truth Used:
For the mechanical tests, the "ground truth" is defined by the requirements of the ASTM standards (F3574 and F2077) and the performance characteristics of the predicate device. For cadaver testing, it relates to the successful implantation and biomechanical stability observed. This is distinct from pathology, expert consensus, or outcomes data used for AI models.
8. Sample Size for the Training Set:
Not applicable. There is no AI model, and therefore no training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there's no training set, there's no ground truth to establish for one.
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April 19, 2024
Spinal Simplicity LLC Adam Rogers Vice President of Regulatory and Engineering 6363 College Blvd, Ste 320 Overland Park, Kansas 66211
Re: K232259
Trade/Device Name: Patriot-SI Posterior Implant 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 11, 2024 Received: March 11, 2024
Dear Adam Rogers:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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/cdrh-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,
Colin O'neill -S
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
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Indications for Use
510(k) Number (if known) K232259
Device Name Patriot-SI Posterior Implant System
Indications for Use (Describe)
The Patriot-SI Posterior Implant System is intended for sacroiliac joint fusion including sacroiliac joint disruptions and degenerative sacroiliitis. When the Patriot Implant System (i.e., an "in-line" or "in-line" or "intraarticular" device) is implanted, it must be used with a Spinal Simplicity Liberty-SI Lateral System device (i.e., a "transfixing" device) implanted across the same sacroiliac joint to create a hybrid SI joint fusion construct.
| 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) |
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| 510(k) #: K232259 | 510(k) Summary | Page 1 of 2Prepared on: 2024-03-13 |
|---|---|---|
| ------------------- | ---------------- | ---------------------------------------- |
Contact Details
| Applicant Name | Spinal Simplicity LLC | 21 CFR 807.92(a)(1) |
|---|---|---|
| Applicant Address | 6363 College Blvd Ste 320 Overland Park KS 66211 United States | |
| Applicant Contact Telephone | 913-451-4414 | |
| Applicant Contact | Mr. Adam Rogers | |
| Applicant Contact Email | arogers@spinalsimplicity.com |
Device Name
| Device Trade Name | Patriot-SI Posterior Implant System | 21 CFR 807.92(a)(2) |
|---|---|---|
| Common Name | Smooth or threaded metallic bone fixation fastener | |
| Classification Name | Sacroiliac Joint Fixation | |
| Regulation Number | 888.3040 | |
| Product Code | OUR |
Legally Marketed Predicate Devices
| 21 CFR 807.92(a)(3) | ||
|---|---|---|
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K190580 | NADIA® SI Fusion System | OUR |
Device Description Summary
| 21 CFR 807.92(a)(4) | ||
|---|---|---|
| -- | -- | --------------------- |
The Patriot-Sl Posterior Implant System is a minimally invasive sacrolliac joint fusion implant that is intended for implantation on a trajectory in line with the joint space (i.e., the device is an in-line or intra-articular implant). The Patriot Implant System device is required to be implanted with the Spinal Simplicity Liberty-Sl Lateral System device implanted across the same sacroiliac joint to create a hybrid SI joint fusion construct for the purpose of stabilizing and fusing the sacroiliac joint. It is available in one size and may be implanted using the designated surgical instruments through a posterior approach into the Sl joint space, fixating on both the sacrum and ilium via external threads. Bone graft materials may be used with the Patriot-Sl Posterior Implant System. The Patriot-Sl Posterior Implant System device is manufactured titanium alloy, Ti-6AI-4V-ELI per ASTM F3001 and is offered with or without a hydroxyapatite (HA) coating per ASTM F1185. The Patriot-SI Posterior Implant System device is provided sterile and individually packed.
Intended Use/Indications for Use
The Patriot-Sl Posterior Implant System is intended for sacroiliac joint fusion including sacroiliac joint disruptions and degenerative sacroiliitis. When the Patriot-Sl Posterior Ine., an "in-line" or "intra-articular" device) is implanted, it must be used with a Spinal Simplicity Liberty-Sl Lateral System device (i.e., a "transfixing" device) implanted across the same sacroiliac joint to create a hybrid SI joint fusion construct.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
Indications for Use Comparison
The Patriot-SI Posterior Implant System has the same indications for use as the predicate device.
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Technological Comparison
21 CFR 807.92(a)(6)
The Patriot-SI Posterior Implant System is as safe and effective as the identified predicate device. The Patriot-Sl Posterior Implant System has the same technological characteristics and surgical approach as its predicate device. Performance testing demonstrates that the Patriot-SI Posterior Implant System is substantially equivalent to the predicate device.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Non clinical mechanical tests were performed to support substantial equivalence of the Patriot Implant System. Cadaver testing was also performed to support the Patriot-Sl Posterior Implant System. The following tests were performed:
ASTM F3574 Static Shear Testing ASTM F3574 Static and Dynamic Torsion Testing ASTM F3574 Static Pushout Testing ASTM F3574 Driving Torque Testing ASTM F2077 Static and Dynamic Compression-Shear Testing
Clinical performance testing was not performed for this submission.
Spinal Simplicity concludes that the performance testing provided in this 510(k) application demonstrates that the Patriot SJ Posterior lmplant System is capable of performing as intended and is as safe and effective as the legally marketed predicate device.
§ 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.