The F1 - Modular Pedicle Screw System (F1-MPS) is intended for posterior, noncervical pedicle fixation (T1-S1) 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 (Grade 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurological impairment, spinal stenosis, fracture, dislocation, scoliosis or kyphotic deformities, spinal tumor, Schuermann's disease, and failed previous fusion.

The F1-MPS is intended for posterior, noncervical pedicle fixation (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment.

The F1-MPS is also intended for posterior, non-cervical fixation in pediatric patients indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The device is intended to be used with autograft and/or allograft.

Device Description

The F1-Modular Pedicle Screw System is composed of cannulated and non-cannulated pedicle screws which are designed to accept a 5.5mm rod and are available in various sizes. The components can be rigidly assembled in a variety of constructs, each corresponding to the needs and anatomy of a specific patient. The system is provided in both sterile and non-sterile versions. The system is constructed from Titanium and Titanium alloy (Ti-6Al-4V ELI) per ASTM F136 and F67 or cobalt-chromium-molybdenum per ASTM F1537.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "F1-Modular Pedicle Screw System". It's not a study proving device performance against acceptance criteria in the way you're asking about for an AI/software device. This document is for a mechanical implant, and the "acceptance criteria" and "study" described are for non-clinical mechanical testing to demonstrate substantial equivalence to existing devices.

Therefore, many of your requested points (like sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set size, etc.) are not applicable to this type of medical device submission.

However, I can extract the relevant information regarding the non-clinical performance testing and substantial equivalence.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For this mechanical device, "acceptance criteria" are typically defined by recognized standards such as ASTM F1717 and ASTM F543, and the performance is demonstrated by meeting or exceeding the performance of predicate devices. Specific quantitative acceptance criteria are not provided in this summary, but the conclusion states the device meets or exceeds the performance of predicate devices.

Acceptance Criterion (Standard)	Reported Device Performance (Conclusion)
Static and Dynamic Compression Testing (ASTM F1717)	Meets or exceeds the performance of the predicate devices.
Static Torsion Testing (ASTM F1717)	Meets or exceeds the performance of the predicate devices.
Screw Strength (ASTM F543)	Meets or exceeds the performance of the predicate devices.
Straight and Angled Static Axial Pull-Apart Testing	Meets or exceeds the performance of the predicate devices.

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

Sample Size: Not explicitly stated in this summary. For mechanical testing per ASTM standards, specific sample sizes are prescribed, but the exact number of screws/constructs tested is not given here.
Data Provenance: Not applicable in the context of clinical data. This refers to laboratory-based mechanical testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. Ground truth in this context refers to established mechanical testing standards and the comparison to predicate devices, not expert human interpretation of data for an AI.

4. Adjudication Method for the Test Set

Not applicable. This is mechanical testing against engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is not an AI/diagnostic imaging device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

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

7. The Type of Ground Truth Used

The "ground truth" for this device is based on established ASTM mechanical testing standards (F1717, F543) and the performance of existing, legally marketed predicate devices. The goal is to show substantial equivalence, meaning it performs at least as well as, if not better than, comparable devices already on the market.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" for this type of mechanical device.

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

Not applicable. There is no "training set."

Summary for this specific document related to your request:

This document describes a non-clinical performance testing study for a mechanical pedicle screw system. The purpose of the study was to demonstrate substantial equivalence to existing predicate devices based on recognized ASTM standards for mechanical testing. The "acceptance criteria" are implied by these standards and the performance of the predicate devices, which the subject device was found to meet or exceed. There are no elements related to AI, software performance, human reader studies, or ground truth derived from expert consensus on clinical data.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol depicts a stylized human figure with three faces in profile, representing the department's focus on health and human well-being.

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

March 20, 2015

DeGen Medical % Linda Braddon, Ph.D. Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 Woodstock, Georgia 30188

Re: K142531

Trade/Device Name: F1-Modular Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, MNH, MNI Dated: February 10, 2015 Received: February 11, 2015

Dear Dr. Braddon:

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

{1}------------------------------------------------

Page 2 - Linda Braddon, Ph.D.

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.

Lori A. Wiggins -S

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

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known)

K142531

Device Name

F1-Modular Pedicle Screw System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

区 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)

{3}------------------------------------------------

510(k) Summary of Safety and Effectiveness

In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the DeGen Medical F1-Modular Pedicle Screw System is provided below.

Date Summary Prepared	March 5, 2015
Manufacturer/Distributor/Sponsor	DeGen Medical1321-C North Cashua DriveFlorence, SC 29501Phone 877-240-7838Fax 843-407-0545
510(k) Contact	Secure BioMed EvaluationsLinda Braddon, Ph.D.7828 Hickory Flat HighwaySuite 120Woodstock, GA 30188770-837-2681LGB@SecureBME.com
Trade Name	F1-Modular Pedicle Screw System
Common Name	Pedicle screw spinal system
Code -Classification	NKB21 CFR 888.3070 : Class IIIMNH, MNI, OSH21 CFR 888.3070 : Class II
Primary Predicate Device	K130646 Medtronic CD Horizon
Reference Devices	K992739 Synthes Click'XK933881, K953915, K982320, K982511, K982011, K983583, K992168,K011182, K030383 DePuy Moss Miami Spinal SystemK950099 Cross Medical Synergy Posterior Spinal SystemK121250 OrthoPediatrics Spine System
Device Description	The F1-Modular Pedicle Screw System is composed of cannulated andnon-cannulated pedicle screws which are designed to accept a 5.5mmrod and are available in various sizes. The components can be rigidlyassembled in a variety of constructs, each corresponding to the needsand anatomy of a specific patient. The system is provided in both sterileand non-sterile versions. The system is constructed from Titanium andTitanium alloy (Ti-6Al-4V ELI) per ASTM F136 and F67 or cobalt-chromium-molybdenum per ASTM F1537.

Indications for Use	The F1 - Modular Pedicle Screw System (F1-MPS) is intended for posterior,noncervical pedicle fixation (T1-S1) to provide immobilization andstabilization of spinal segments in skeletally mature patients as an adjunctto fusion in the treatment of the following acute and chronic instabilities ordeformities of the thoracic, lumbar, and sacral spine: severespondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra, degenerativespondylolisthesis with objective evidence of neurological impairment, spinalstenosis, fracture, dislocation, scoliosis or kyphotic deformities, spinaltumor, Schuermann's disease, and failed previous fusion.
	The F1-MPS is intended for posterior, noncervical pedicle fixation (T1-S1) toprovide immobilization and stabilization of spinal segments in skeletallymature patients as an adjunct to fusion in the treatment of degenerativedisc disease (back pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies) and spondylolisthesis otherthan either severe spondylolisthesis (grades 3 and 4) at L5-S1 ordegenerative spondylolisthesis with objective evidence of neurologicimpairment.
	The F1-MPS is also intended for posterior, non-cervical fixation in pediatricpatients indicated as an adjunct to fusion to treat adolescent idiopathicscoliosis. The device is intended to be used with autograft and/or allograft.
Technological Characteristics	As was established in this submission, the subject F1-Modular Pedicle ScrewSystem is substantially equivalent to other predicate devices cleared by theFDA for commercial distribution in the United States. The subject device wasshown to be substantially equivalent and has the same technologicalcharacteristics to its predicate devices through comparison in areas includingdesign, intended use, material composition, function, and range of sizes.
Non-Clinical PerformanceTesting Conclusion	Non-clinical testing was performed to demonstrate the DeGen Medical F1-Modular Pedicle Screw System is substantially equivalent to other predicatedevices in accordance with "Guidance for Industry and FDA Staff, Guidancefor Spinal System 510(k)s", May 3, 2004. The following tests wereperformed:Static and dynamic compression testing per ASTM F1717●Static torsion testing per ASTM F1717●Screw strength via ASTM F543●Straight and angled static axial pull-apart testing●
	The results of these studies show the subject DeGen Medical F1-ModularPedicle Screw System meets or exceeds the performance of the predicatedevices, and the device was therefore found to be substantially equivalent.
Substantial EquivalenceSummary (Conclusion)	Based on the indications for use, technological characteristics, performancetesting, and comparison to predicate devices, the subject DeGen Medical F1-Modular Pedicle Screw System has been shown to be substantially equivalentto legally marketed predicate devices.

{4}------------------------------------------------

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.