The Reform Pedicle Screw System is 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

The Reform Pedicle Screw System is also indicated for pedicle screw fixation for the treatment of 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. The Reform Pedicle Screw System is also intended for non-cervical pedicle screw fixation (T1-S1/ilium) for the following indications: degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); spinal tumor; pseudoarthrosis; and failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Reform Pedicle Screw System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Reform Pedicle Screw System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Device Description

The Reform System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, cross-connectors, locking cap screws, hooks, domino connectors, and lateral offset connectors. All of the components are available in a variety of sizes to match more closely to the patient's anatomy. All components are made from medical grade stainless steel, cobalt chromium alloys, titanium or titanium alloy described by such standards as ASTM F138, ASTM F1537, ISO 5832-12, ASTM F136 or ISO 5832-3.

AI/ML Overview

This document is a 510(k) premarket notification for the Reform Pedicle Screw System and does not provide acceptance criteria and detailed study data for a device's performance against specific metrics. Instead, it focuses on demonstrating substantial equivalence to previously cleared predicate devices.

Therefore, many of the requested sections regarding detailed acceptance criteria, specific performance tables, sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies cannot be answered from the provided text. This document is a regulatory submission, not a research paper detailing the performance of an AI/ML-based medical device.

However, I can extract information related to the device itself and the general nature of the evidence provided for substantial equivalence, as well as highlight what information is missing.

The device in question is the "Reform Pedicle Screw System," a spinal implant, not an AI/ML diagnostic or measurement device. The "performance data" mentioned refers to mechanical engineering analysis to demonstrate substantial equivalence, not clinical performance metrics in the way AI models are evaluated.

Here's an analysis based on the provided text, addressing the points where information is available and noting where it is absent for AI/ML device evaluation:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as pass/fail metrics for a specific performance study in the way an AI algorithm would have. The "acceptance" in this context is regulatory clearance based on substantial equivalence.
Reported Device Performance: No specific numerical performance metrics (e.g., sensitivity, specificity, accuracy, precision) are reported for this device in the provided document. The performance is implied by its "substantial equivalence" to predicate devices, meaning it performs similarly in its mechanical function.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This document describes a mechanical device (pedicle screw system), not a software or AI device that would have a "test set" in the context of clinical data. The "tests" mentioned are mechanical analyses. The document does not specify details about these mechanical tests such as the number of devices tested or their origin, beyond stating "Analysis was performed."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As this is a mechanical spinal implant, there is no "ground truth" to be established by experts in the context of diagnostic accuracy. "Ground truth" for this device would relate to its physical properties, biocompatibility, and mechanical strength, typically evaluated through engineering standards and testing, not expert clinical interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No expert adjudication is described as the device is not based on interpreting clinical images or data that would require such a process.

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 a hardware device (pedicle screw system), not an AI-assisted diagnostic or treatment planning tool. Therefore, an MRMC study related to AI assistance is not applicable and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a physical spinal implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable in the AI/ML sense. For a physical device like a pedicle screw system, "ground truth" generally refers to adherence to established engineering standards (e.g., ASTM, ISO for materials and mechanical properties) and proven clinical performance of predicate devices. The document implies reliance on these standards and the known safety and efficacy of the predicate devices for achieving substantial equivalence.

8. The sample size for the training set

Not applicable. This is a mechanical device, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. (See point 8)

Summary of what the document does describe (relevant to substantial equivalence):

The document K143248 describes the Reform Pedicle Screw System and its submission for 510(k) clearance by Precision Spine, Incorporated.

Device Description:
The Reform System is a top-loading, multiple component, posterior spinal fixation system consisting of pedicle screws, rods, cross-connectors, locking cap screws, hooks, domino connectors, and lateral offset connectors. Components are made from medical-grade stainless steel, cobalt chromium alloys, titanium, or titanium alloy conforming to standards like ASTM F138, ASTM F1537, ISO 5832-12, ASTM F136 or ISO 5832-3. The implants are provided non-sterile with instructions for sterilization.

Change from Predicate:
The primary purpose of this specific 510(k) submission (K143248) is to:

Make modifications to the indications for use.
Add additional sizes to the already cleared PSS (Reform Pedicle Screw System) devices (referenced by K131343, K130279, K121172, K092128, K090033, K073240, and K071438).

Technological Characteristics for Substantial Equivalence:
The document states that the intended use and technological features of the modifications/additions do not substantially differ from the legally marketed predicate devices.
Specifically, the following characteristics are identical between the subject and predicates:

Materials of manufacture
Structural support mechanism
Sterilization

Predicate Devices:

Primary: PSS System (Reform Pedicle Screw System) from Precision Spine (Spinal USA) - multiple 510(k) numbers listed.
Additional: Polaris Spinal System from Biomet Spine - K133746, K131615.

Performance Data (for Substantial Equivalence):
"Analysis was performed to show that the subject devices are substantially equivalent to the predicate devices and do not require additional mechanical testing." This implies that the engineering and material specifications of the new sizes and modifications were compared against the established mechanical performance of the predicate devices. This type of "performance data" is typically bench testing and material characterization to ensure the new components meet the safety and efficacy profiles of the established devices.

Conclusion:
The overall technology characteristics and mechanical engineering analysis led to the conclusion that the Reform Pedicle Screw System is substantially equivalent to the predicate device. This conclusion is a regulatory determination, not a clinical performance metric.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 19, 2014

Precision Spine, Incorporated % Mr. Kenneth C. Maxwell II Empirical Consulting, LLC 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K143248

Trade/Device Name: Reform Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, MNI, MNH, KWP Dated: November 6, 2014 Received: November 14, 2014

Dear Mr. Maxwell:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Vincent J. Devlin -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
510(k) Number (if known)	K143248
Device Name	Reform Pedicle Screw System
Indications for Use (Describe)
The Reform Pedicle Screw System is 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).
The Reform Pedicle Screw System is also indicated for pedicle screw fixation for the treatment of 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. The Reform Pedicle Screw System is also intended for non-cervical pedicle screw fixation (T1-S1/ilium) for the following indications: degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); spinal tumor; pseudoarthrosis; and failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Reform Pedicle Screw System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Reform Pedicle Screw System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
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)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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5.510(K) SUMMARY

Submitter's Name:	Precision Spine
Submitter's Address:	2050 Executive DrivePearl, MS 39208
Submitter's Telephone:	973-455-7150
Contact Person:	Kenneth C Maxwell IIEmpirical Consulting LLC904.392.7576
Date Summary was Prepared:	15-Dec-14
Trade or Proprietary Name:	Reform Pedicle Screw System
Common or Usual Name:	Orthosis, Spinal Pedicle FixationOrthosis, Spondylolisthesis Spinal FixationOrthosis, Spinal Pedicle Fixation, For Degenerative Disc DiseaseAppliance, Fixation, Spinal Interlaminal
Classification:	Class III per 21 CFR §888.3070, 888.3050
Product Code:	MNI, MNH, NKB, KWP, OSH
Classification Panel:	87 Orthopedic Panel

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

CHANGE FROM PREDICATE:

The purpose of this submission is to make modifications to the indications for use for and add additional sizes to the PSS System (Reform Pedicle Screw System) cleared in K131343, K130279, K121172, K092128, K090033, K073240, and K071438.

INDICATIONS FOR USE

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Pedicle Screw System is also intended for non-cervical pedicle screw fixation (T1-S1/ilium) for the following indications: degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis); spinal tumor; pseudoarthrosis; and failed previous fusion.

TECHNOLOGICAL CHARACTERISTICS

The intended use and technological features of the modifications/additions to the components of the PSS System (Reform Pedicle Screw System) do not substantially differ from the legally marketed predicate devices, which are the PSS System (Reform Pedicle Screw System, K131343, K130279, K121172, K092128, K090033, K073240, and K071438) and the Biomet Polaris Spinal System (K133746, K131615). The predicate devices and the subject additions to the PSS (Reform) system are designed for posterior stabilization to provide immobilization and stabilization of spinal segments as an adjunct to fusion.

Reform Pedicle Screw System is manufactured from medical grade stainless steel, cobalt chromium alloys, titanium or titanium alloy described by such standards as ASTM F138, ASTM F1537, ISO 5832-12, ASTM F136 or ISO 5832-3.. The implants are provided non-sterile with instructions for sterilization. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:

Materials of manufacture
Structural support mechanism ●
. Sterilization

Table 5-1 Predicate Devices

510k Number	Trade or Proprietary orModel Name	Manufacturer	Primary orAdditional
K131343, K130279, K121172,K092128, K090033, K073240,and K071438	PSS System (ReformPedicle Screw System)	Precision Spine(Spinal USA)	Primary
K133746, K131615	Polaris Spinal System	Biomet Spine	Additional

Performance Data

Analysis was performed to show that the subject devices are substantially equivalent to the predicate devices and do not require additional mechanical testing.

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CONCLUSION

The overall technology characteristics and mechanical engineering analysis lead to the conclusion that the Reform Pedicle Screw System is substantially equivalent to the predicate device.

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.