The Precision Spine Reform® POCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine from T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Precision Spine Reform® POCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

Device Description

The Reform® POCT System is a posterior spinal fixation system intended for fusion of the Occipital, Cervical, and Thoracic regions of the spine (Occiput-T3). The system consists of a variety of rods, occipital plates, occipital screws, polyaxial screws, cross-connectors, lateral offset, domino connectors, and hooks to achieve an implant construct that closely matches patient anatomy. The Reform POCT System implants are fabricated from titanium, titanium alloy, or cobalt chromium alloys as described by standards such as ASTM F136, ASTM F1537, or ISO 5832-3. Implants made from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium may be used together, however, should not be used with stainless steel. The system also includes the instruments necessary for inserting and securing the implants. The components are supplied clean and "NON-STERILE". All implants are single use only and should not be reused under any circumstances.

AI/ML Overview

Based on the provided K172495 document for the Precision Spine Reform® POCT System, here's a description of the acceptance criteria and the study that proves the device meets them:

Important Note: The provided document is a 510(k) summary for a spinal fixation system, which is a medical implant. The "acceptance criteria" and "study" described in this document refer to mechanical and material performance testing for substantial equivalence against predicate devices, not a clinical study involving human patients or an AI algorithm’s performance. Therefore, many of the typical questions for an AI/ML device (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies) are not applicable to this type of device submission and thus cannot be answered from the provided text.

Acceptance Criteria and Device Performance for Precision Spine Reform® POCT System (K172495)

The acceptance criteria for the Reform® POCT System are not explicitly listed with numerical targets in the document. Instead, the study's goal was to demonstrate substantial equivalence to legally marketed predicate devices based on technological characteristics and mechanical performance. The implicit acceptance criterion is that the device's mechanical performance is "substantially equivalent" to the specified predicate devices.

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance:

Feature/Test Mode	Acceptance Criteria (Implicit)	Reported Device Performance
Material	Compatible with standards (ASTM F136, ASTM F1537, ISO 5832-3) and similar to predicates.	Fabricated from titanium, titanium alloy, or cobalt chromium alloys as described by these standards, similar to predicates.
Sterility	Non-sterile, single-use only, similar to predicates.	Supplied clean and "NON-STERILE." Single use only. Similar to predicates.
Indications for Use	Similar to predicate devices listed in Table 5-1.	Stated indications for use are similar to those of predicates K162300, K151755, and K153631.
Principles of Operation	Similar to predicate devices.	Similar to predicate devices.
Dynamic Axial Compression (per ASTM F2706)	Strength is substantially equivalent to legally marketed predicate devices.	Tested, and results show "strength... is substantially equivalent to legally marketed predicate devices."
Dynamic Torsion (per ASTM F2706)	Strength is substantially equivalent to legally marketed predicate devices.	Tested, and results show "strength... is substantially equivalent to legally marketed predicate devices."

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

Sample Size: The document does not specify the exact number of devices or constructs tested for dynamic axial compression and dynamic torsion. It only states that "The Reform® POCT System has been tested in the following test modes." For mechanical testing, this typically involves a sufficient number of samples to generate statistically meaningful data for comparison.
Data Provenance: The testing was "non-clinical testing" and was conducted to support the 510(k) submission. The document does not provide details on the location of the testing facility (e.g., country of origin), nor does it describe data as retrospective or prospective (as this terminology applies to clinical studies, not mechanical bench testing).

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

Not Applicable. This is a mechanical device, not an AI/ML diagnostic tool. Ground truth in this context is established by standardized mechanical testing protocols (e.g., ASTM F2706) and the physical properties and performance of the device itself compared to predicate devices, not by expert interpretation of images or data.

4. Adjudication Method for the Test Set:

Not Applicable. As this is mechanical bench testing, there is no "adjudication method" in the sense of multiple human experts reviewing results. The results are quantitative measurements obtained through standardized test methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. This type of study is relevant to diagnostic devices and AI algorithms where human readers interpret medical images or data. It is not applicable to a spinal implant system like the Reform® POCT System, which is evaluated based on its mechanical and material properties.

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

No. This is not an AI algorithm. Its performance is tested as a standalone mechanical device.

7. The Type of Ground Truth Used:

The ground truth for this device's performance is established through standardized mechanical engineering tests (e.g., ASTM F2706 for dynamic axial compression and dynamic torsion) performed on the device components and constructs. The performance is then compared to the known performance of predicate devices or to established industry standards to demonstrate "substantial equivalence."

8. The Sample Size for the Training Set:

Not Applicable. This is not an AI/ML device that uses a "training set."

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

Not Applicable. There is no training set for this type of device.

Summary

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April 11, 2018

Precision Spine, Inc. % Meredith L. May, MS, RAC Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K172495

Trade/Device Name: Reform® POCT System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: March 8, 2018 Received: March 15, 2018

Dear Ms. May:

We have reviewed vour 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 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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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.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ronald P. Jean -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 SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017
Indications for Use	See PRA Statement on last page.

510(k) Number ( if known )	K172495
Device Name	Reform® POCT System
Indications for Use (Describe)
The Precision Spine Reform® POCT System is intended to provide immobilization andstabilization of spinal segments as an adjunct to fusion for the following acute and chronicinstabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spinefrom T1-T3: traumatic spinal fractures and/or traumatic dislocations; instability or deformity;failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; anddegenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or armpain of discogenic origin as confirmed by radiographic studies, and degenerative disease of thefacets with instability. The Precision Spine Reform® POCT System is also intended torestore the integrity of the spinal column even in the absence of fusion for a limited timeperiod in patients with advanced stage tumors involving the cervical spine in whom lifeexpectancy is of insufficient duration to permit achievement of fusion.
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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Submitter's Name:	Precision Spine, Inc.
Submitter's Address:	2050 Executive DrivePearl, MS 39208
Submitter's Telephone:	601.420.4244
Contact Person:	Meredith L. May, MS, RACEmpirical Consulting719.291.6874
Date Summary was Prepared:	16 August 2017
Trade or Proprietary Name:	Reform® POCT System
Common or Usual Name:	Orthosis, Cervical Spinal Pedicle FixationAppliance, Fixation, Spinal Interlaminal
Classification:	Unclassified
Product Code:	NKG, KWP

510(K) SUMMARY

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

TECHNOLOGICAL CHARACTERISTICS

The subject and predicate devices are considered substantially equivalent as they are similar or identical in material, indications for use, sterility, and size offerings.

INDICATIONS FOR USE

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integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The indications for use for the Reform® POCT System is similar to that of the predicate devices listed in Table 5-1.

510k Number	Trade or Proprietary or ModelName	Manufacturer	PredicateType
K162300	Reform® POCT System	Precision Spine, Inc.	Primary
K151755	OASYS® System	Stryker	Additional
K153631	Virage®	Zimmer Spine	Additional

Table 5-1: Predicate Devices

TECHNOLOGICAL CHARACTERISTICS

The following technological characteristics are similar between the subject and predicate devices:

Indications for Use ●
Principles of operation ●
Materials
Sterility

PERFORMANCE DATA

The Reform® POCT System has been tested in the following test modes:

Dynamic axial compression per ASTM F2706 ●
Dynamic torsion per ASTM F2706

The results of this non-clinical testing show that the strength of the Reform® POCT System is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Reform® POCT System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 888.3075 Posterior cervical screw system.

(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.