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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The ReForm Pedicle Screw 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: trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis) spinal tumor; pseudloarthrosis; and failed previous fusion.

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, and cross 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

Here's an analysis of the provided text regarding the acceptance criteria and study for the ReForm Pedicle Screw System:

Based on the provided 510(k) summary, the device is a ReForm Pedicle Screw System, which is a medical device and not an AI/ML-based diagnostic or imaging device. Therefore, the questions related to AI/ML specific performance evaluation metrics, ground truth establishment for AI/ML models, and training/test set sample sizes in the context of AI/ML are not applicable.

The document describes a traditional medical device submission focusing on substantial equivalence to predicate devices, primarily through engineering analysis.

Description of Acceptance Criteria and Study:

The "acceptance criteria" for this device, in the context of a 510(k) submission, are met by demonstrating substantial equivalence to legally marketed predicate devices. The primary method used to prove this is through performance evaluation based on engineering analysis.

Essentially, the device is "accepted" if it can show that its technological characteristics and performance are comparable to (or do not represent a worst-case scenario compared to) already cleared devices with the same intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied for 510(k) Equivalence)	Reported Device Performance
Mechanical Performance: Device components (pedicle screws, rods, cross-connectors, locking cap screws) must meet established mechanical and material standards for spinal fixation.	Engineering analysis was performed to show that the subject devices are substantially equivalent to the predicate devices and do not represent a new worst-case.Components are made from medical grade stainless steel, cobalt chromium alloys, titanium or titanium alloy described by standards such as ASTM F138, ASTM F1537, ISO 5832-12, ASTM F136 or ISO 5832-3.
Biocompatibility: Materials used must be biocompatible for implantation.	Materials are standard medical grade alloys (stainless steel, cobalt chromium, titanium/titanium alloy), implying accepted biocompatibility that is equivalent to predicate devices.
Fit and Function: New designs and sizes (specifically additional cross connectors) must integrate properly and maintain the intended function of the system.	The purpose of the submission is to make modifications by adding "an additional design and sizes of cross connectors." The engineering analysis confirms these modifications "do not substantially differ from the legally marketed predicate devices."
Intended Use: The device must perform effectively for its stated indications.	The intended use and technological features of the modifications/additions "do not substantially differ from the legally marketed predicate devices." The device is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for a range of spinal instabilities and deformities, consistent with the predicates.

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

Sample Size: Not applicable in the traditional sense of a clinical or imaging study. The "test set" here refers to the specific modifications (additional design and sizes of cross connectors) and existing components that underwent engineering analysis. The number of physical units or designs tested is not specified but would typically involve a sufficient number to validate mechanical properties.
Data Provenance: Not applicable. The "data" comes from engineering tests and material specifications, not from patient data or clinical trials.

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)

This is not applicable for this type of device submission. There is no "ground truth" established by medical experts for a test set in a clinical or diagnostic context. The ground truth for mechanical performance relies on established engineering principles, material science, and regulatory standards. Experts involved would be engineers and material scientists conducting the tests and analyses. Their qualifications are not specified in this document.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or reader studies where human interpretation or diagnostic accuracy is being assessed. This submission focuses on engineering equivalence.

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

Not applicable. This is not an AI/ML device, nor is it a diagnostic tool where human readers' performance with/without AI assistance would be relevant.

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

Not applicable. This is not an algorithm or an AI/ML device.

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

The "ground truth" in this context refers to established engineering standards, material specifications, and the mechanical performance of the predicate devices. The new device's components are evaluated against these validated benchmarks.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable. Since there is no training set, the establishment of its ground truth is irrelevant.

Summary

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JUL 2 4 2013

5.510(K) SUMMARY

Submitter's Name:	Spinal USA
Submitter's Address:	2050 Executive DrivePearl, MS 39208
Submitter's Telephone:	601-420-4244
Authorized Contact Name:	Meredith May, Authorized Contact Person
Contact's Telephone:	719-337-7579
Date Summary wasPrepared:	30-Apr-13
Trade or Proprietary Name:	ReForm Pedicle Screw System
Common or Usual Name:	Orthosis, Spinal Pedicle FixationOrthosis, Spondylolisthesis Spinal FixationOrthosis , Spinal Interlaminal Fixation
Classification:	Class II per 21 CFR §888.3070 and §888.3050
Product Codes:	MNIMNH
Classification Panel:	Orthopedic and Rehabilitation Devices Panel
Predicate Devices:	Spinal USA PSS System (ReForm Pedicle ScrewSystem), K121172, K092128, K090033, K073240,K071438Biomet 5.5 Polaris Spinal System K091067

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

CHANGE FROM PREDICATE:

The purpose of this submission is to make modifications to the components of the PSS System (ReForm Pedicle Screw System) cleared in K121172, K092128, K090033, K073240, and K071438. The standard construct is modified by the addition of an additional design and sizes of cross connectors.

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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, K 121172. K092128, K090033, K073240, and K071438) and the Biomet 5.5 Polaris Spinal System (K091067). 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.

INDICATIONS FOR USE

The ReForm Pedicle Screw System is also intended for non-cervical pedicle screw fixation for the following indications: severe spondylolisthesis (grades 3and 4of 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: trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis) spinal tumor; pseudloarthrosis; and failed previous fusion.

PERFORMANCE EVALUATION

Engineering analysis was performed to show that the subject devices are substantially equivalent to the predicate devices and do not represent a new worst-case.

CONCLUSION

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

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Public Health Service

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

July 24, 2013

Spinal USA % Empirical Testing Corporation Ms. Meredith May 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K131343

Trade/Device Name: ReForm Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH Dated: May 22, 2013 Received: May 28, 2013

Dear Ms. May:

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 Mcdical Device Amendments, or 10 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 docs 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 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.

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Page 2 - Ms. Mercdith May

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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/dcfault.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 Small Manufacturers. International and Consumer Assistance 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 yours.

Erin I. Keith

For

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. INDICATIONS FOR USE STATEMENT

Device Name: ReForm Pedicle Screw System

Prescription Use _____________________________________________________________________________________________________________________________________________________________ Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODE)

Ronald P. Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K131343

ReForm Pedicle Screw System Cross Connectors Line Extension

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.