The Swedge™ Pedicle Screw Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities or curvatures (i.e. scoliosis, and/or lordosis), spinal tumor, pseudoarthrosis and failed previous fusion.

The Swedge™ Pedicle Screw Fixation System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: DDD (degenerative disc disease); trauma (i.e. fracture or dislocation); spinal stenosis; deformities (i.e. scoliosis, kyphosis, and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion.

Device Description

The Swedge™ Pedicle Screw Fixation System is an implant device made from a titanium alloy (Ti-6Al-4V-ELI) and Cobalt Chrome. The subject device is to be implanted from the posterior approach. The screws are available as either solid or cannulated in diameters from 4.5mm and in lengths from 25mm – 120 mm. Titanium Alloy and Cobalt Chrome rods are available in 4.75mm – 6.0mm diameters either straight or pre-curved in lengths from 25-600 mm. Transition rods are also included with a tapered diameter from 4.75mm -5.5mm and lengths of 60mm - 600mm. The system also includes locking set screws, cross-links connectors, standard, reduction and Long polyaxial tulip heads along with the associated instrumentation to complete the procedure and implant construct.

AI/ML Overview

Based on the provided text, the document is a 510(k) Premarket Notification for a medical device called the "Swedge™ Pedicle Screw Fixation System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device's performance through extensive clinical studies with specified acceptance criteria and ground truth establishment in the way an AI/ML device would.

Therefore, many of the requested details, particularly those related to a study proving device performance against acceptance criteria for an AI/ML system (like sample size for test sets, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment for training data), are not applicable to this 510(k) submission for a mechanical pedicle screw fixation system.

The "Performance Testing" section in the document describes mechanical testing, which is standard for orthopedic implants, not software or AI.

Here's a breakdown of what can be extracted or inferred from the provided text, and what is explicitly not present or applicable for this type of device:

Acceptance Criteria and Device Performance (for a Mechanical Device)

For a mechanical device like a pedicle screw system, "acceptance criteria" revolve around established industry standards for mechanical performance (e.g., strength, fatigue, static/dynamic resistance). "Device performance" is the result of these mechanical tests.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category/Standard	Reported Device Performance
Static Compression Bending (per ASTM F1717)	Performed (Tested to standard)
Static Torsion (per ASTM F1717)	Performed (Tested to standard)
Dynamic Compression Bending (per ASTM F1717)	Performed (Tested to standard)
Equivalence to Predicate Swedge™ Pedicle Screw Fixation System (K170045)	Concluded to be substantially equivalent based on test results

Note: The document states "Testing shows that the subject Swedge™ Pedicle Screw Fixation System performs equivalent to the predicate Swedge™ Pedicle Screw Fixation System (K170045)." It does not provide specific numerical outcomes of these mechanical tests, but rather a qualitative statement of equivalence to the predicate as the performance conclusion.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified for the mechanical tests. For mechanical testing of medical implants, sample sizes are typically determined by relevant ISO/ASTM standards (e.g., typically n=5 or n=6 for static tests, and larger for fatigue tests, varying by standard and test type). However, the exact number tested is not provided in this public summary.
Data Provenance: Not applicable in the context of "data" as clinical or imaging data. It refers to in vitro mechanical testing performed according to international standards (ASTM F1717). The location of the testing laboratory is not specified.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. This is a mechanical orthopedic implant, not an AI/ML diagnostic or prognostic device that requires human expert review to establish "ground truth" for clinical data.

4. Adjudication Method for the Test Set

Not Applicable. No human interpretation or adjudication of clinical data is involved for this type of mechanical testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not Applicable. MRMC studies are used to evaluate the diagnostic accuracy of AI-assisted systems compared to human readers alone. This is a mechanical device, not an AI system. Therefore, there is no effect size for human readers improving with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not Applicable. This is a mechanical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device is the performance against mechanical testing standards (ASTM F1717) and comparison to the established performance of the legally marketed predicate device. It is not clinical "ground truth" derived from expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

Not Applicable. As a mechanical device, there is no "training set" in the context of machine learning. The design and manufacturing process are informed by engineering principles, material science, and prior predicate device designs for which performance is already established.

9. How the Ground Truth for the Training Set Was Established

Not Applicable. There is no "ground truth" for a training set as this is not an AI/ML device. The design and manufacturing are based on engineering specifications and established material properties and biomechanical principles, validated by mechanical testing against industry standards and comparison to a predicate device.

Summary

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March 23, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Spinal Resources, Inc. % Ms. Christine Scifert Partner MRC Global, LLC 9085 E. Mineral Cir., Suite 110 Centennial. Colorado 80112

Re: K230482

Trade/Device Name: Swedge™ Pedicle Screw Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: February 22, 2023 Received: February 22, 2023

Dear Ms. Scifert:

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/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.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 (QS) 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 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

Enclosure

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Indications for Use

510(k) Number (if known) K230482

Device Name Swedge™ Pedicle Screw Fixation System

Indications for Use (Describe)

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) Summary Swedge™ Pedicle Screw Fixation System Date Prepared: 22 February 2023

Company:	Spinal Resources Inc.5975 N. Federal HighwaySuite 250Fort Lauderdale, FL 33308904-540-9049
Company Contact:	Bernie BedorPresident and Chief Executive Officer904-540-9049BernieBedor@SpinalResourcesInc.com
Official Correspondent:	Christine Scifert – MRC Global, LLCChristine.scifert@askmrcglobal.com901-831-8053
Trade Name:	Swedge™ Pedicle Screw Fixation System
Common Name:	Thoracolumbosacral Pedicle Screw System
Classification:	Class II
Regulation Number:	21 CFR 888.3070 (Thoracolumbosacral pedicle screw system)
Panel:	Orthopedic
Product Code:	NKB

Device Description:

Indications for Use:

The Swedge™ Pedicle Screw Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, deformities

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or curvatures (i.e. scoliosis, kyphosis), spinal tumor, pseudoarthrosis and failed previous fusion.

The Swedge™ Pedicle Screw Fixation System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. It is also intended for the following indications: DDD (degenerative disc disease); trauma (i.e. fracture or dislocation); spinal stenosis; deformities or curvatures (i.e. scoliosis, and/or lordosis), tumor; pseudoarthrosis; and failed previous fusion.

Substantial Equivalence:

The subject Swedge™ Pedicle Screw Fixation System is substantially equivalent to the following predicate devices:

Primary Predicate:

Spinal Resources, Inc., Swedge™ Pedicle Screw Fixation System (K170045) . Secondary Predicate:
Stryker Spine, XIA 4.5 Spinal System (K121342) .

There are insignificant differences between the subject Swedge™ Pedicle Screw Fixation System and the predicates. The Indications for Use and Materials are identical to those for the previously cleared Swedge™ Pedicle Screw System (K170045). The geometry for predicate devices are all inclusive of the subject device. Testing shows that the subject Swedge™ Pedicle Screw Fixation System performs equivalent to the predicate Swedge™ Pedicle Screw Fixation System (K170045). Thus, it can be concluded that the subject does not raise new questions about safety and effectiveness.

Performance Testing:

The following mechanical testing has been performed on the subject Swedge™ Pedicle Screw Fixation System: per ASTM F1717 - Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model - static compression bending, static torsion, and dynamic compression bending.

Conclusion:

Based on the test results and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices.

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.