The Response 5.5/6.0 Spine System is intended for immobilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Response 5.5/6.0 Spine System implants are indicated as an adjunct to treat adolescent idiopathic scoliosis. The Response 5.5/6.0 Spine System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Device Description

The Response 5.5/6.0 Spine System consists of longitudinal members (rods), anchors (hooks and screws), interconnection components (rod-to-rod and anchor-to-rod connectors) and fasteners in a variety of sizes to accommodate differing anatomic requirements.

No accessories are offered with the system.

AI/ML Overview

The provided document is a 510(k) Pre-Market Notification for a medical device called the "Response 5.5/6.0 Spine System." This document focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical testing and a review of material biocompatibility. It is not a study proving the device meets acceptance criteria related to AI or algorithmic performance, as the device itself is a physical spinal implant system, not a software algorithm.

Therefore, the requested information about AI/algorithmic performance, sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types and establishment are not applicable to this document. These questions are designed for evaluating AI/software as a medical device (SaMD), which this spinal system is not.

However, I can extract information regarding the device's mechanical acceptance criteria and the study (testing) performed to meet them.

Here's the relevant information paraphrased from the document:

1. Table of Acceptance Criteria and Reported Device Performance (Mechanical Testing)

The document states that the acceptance criteria for all mechanical tests were pre-determined. While the specific numerical acceptance values are not provided in this summary, the document explicitly states:

Acceptance Criteria Type	Reported Device Performance
Mechanical Performance	The subject devices met the pre-determined acceptance criteria for all tests, including Axial Grip, Axial Torsion, Flexion Extension Static Testing, Flexion Extension Fatigue, Construct Static Compression Bending, Construct Static Torsion, and Construct Compression Bending Fatigue.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated in terms of number of implants tested, but testing was performed on "subject devices" as per ASTM F1717 and ASTM F1798.
Data Provenance: Not applicable in the context of clinical data provenance (e.g., country of origin, retrospective/prospective clinical study) as this refers to mechanical performance testing of the device itself, not clinical data from patients. The testing was conducted by OrthoPediatrics Corp.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as there is no "ground truth" established by human experts for mechanical testing of a physical medical device in the way it would be for an AI algorithm evaluating medical images. The "ground truth" for mechanical testing is defined by the standardized test methods (ASTM F1717 and ASTM F1798) and their associated performance specifications.

4. Adjudication method for the test set

This question is not applicable for mechanical testing. Performance is evaluated against objective, pre-defined engineering standards established by ASTM.

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

This question is not applicable. This is a physical spinal implant, not an AI software.

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

This question is not applicable. This is a physical spinal implant, not an AI software.

7. The type of ground truth used

For mechanical performance: The "ground truth" (or standard of performance) is defined by the requirements of the recognized industry standards: ASTM F1717 - "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model" and ASTM F1798 - "Standard Guide to Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants."

8. The sample size for the training set

This question is not applicable. There is no "training set" for a physical medical device. The design, materials, and manufacturing processes are developed based on engineering principles and prior knowledge, not machine learning training.

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

This question is not applicable for the same reasons as above.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center of the logo is an abstract symbol of a human figure, represented by three overlapping profiles.

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

May 22, 2015

OrthoPediatrics Corporation Mr. Mark Fox Vice President, Regulatory Affairs 2850 Frontier Drive Warsaw, Indiana 46582

Re: K150600

Trade/Device Name: Response 5.5/6.0 Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, KWP, MNH, MNI Dated: May 8, 2015 Received: May 11, 2015

Dear Mr. Fox:

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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Page 2 - Mr. Mark Fox

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

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Indications for Use

510(k) Number (if known) K150600

Device Name Response 5.5/6.0 Spine System

Indications for Use (Describe)

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

Prescription Use (Rx) (21 CFR 801 Subpart D)
Over-The-Counter Use (OTC)

|X | Prescription Use (Part 21 CFR 801 Subpart D)

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

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OrthoPediatrics Corp. Response 5.5/6.0 Spine System

510(K) Summary

I.	Submitter	OrthoPediatrics Corp.2850 Frontier DriveWarsaw, IN 46582(574) 268-6379
	Contact	Mark FoxVice President, Regulatory Affairs
	Date Prepared	March 6, 2015
II.	Device
	Name of Device	Response 5.5/6.0 Spine System
	Classification Name	Pedicle Screw Spinal System (bone screws, rods, &hooks) adolescent idiopathic scoliosis, SpinalInterlaminal Fixation Orthosis, Orthosisspondylolisthesis spinal fixation, Orthosis, Spinal pediclefixation, Orthosis, spinal pedicle fixation, fordegenerative disc disease and Pedicle Screw SpinalSystem (21 CFR 888.3070 and 888.3050)
	Classification	Class III; 21 CFR 888.3070 and 21 CFR 888.3050
	Product Codes	NKB, OSH, MNH, MNI, KWP
III.	Predicates	K130655 - OrthoPediatrics Response Spine - (PRIMARY)K091445 – Medtronic CD Horizon Spine SystemK120291 – OrthoPediatrics OP Spine System
		None of the above predicates have been subject to adesign-related recall. No reference device was used inthis submission.
	Product Description	The Response 5.5/6.0 Spine System consists oflongitudinal members (rods), anchors (hooks andscrews), interconnection components (rod-to-rod andanchor-to-rod connectors) and fasteners in a variety ofsizes to accommodate differing anatomic requirements.
		No accessories are offered with the system.

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IV. Indications For Use The Response 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, noncervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Response 5.5/6.0 Spine System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Response 5.5/6.0 Spine System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

V. Comparison of Technological Characteristics

The fundamental scientific principles and technological characteristics, including the intended use, material, general design, and sizes of the device are the same as, or similar to, the predicate devices.

This subject system is an expansion of the previously cleared predicate "Response Spine System" (K130655). At a high level, the subject and predicate devices are based on the following same technological elements:

Implanted into the patient ●
. Used with rods, hooks, cross-links, and other instrumentation to build a construct
The subject devices are intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and /or sacral spine

VI. Performance Data

The following performance data are provided in support of the substantial equivalence determination.

Mechanical Testing

In accordance with, Guidance for Industry and FDA Staff - Spinal System 510(k)'s, OrthoPediatrics Corp. has evaluated the subject devices to demonstrate substantial equivalence to the predicate devices.

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Design verification testing was completed in accordance with ASTM F1717 -Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, and ASTM F1798 – "Standard Guide to Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants. The tests completed were:

Axial Grip .
. - Axial Torsion
- Flexion Extension Static Testing
Flexion Extension Fatigue ●
- Construct Static Compression Bending
. - Construct Static Torsion
- Construct Compression Bending Fatigue

The subject devices met the pre-determined acceptance criteria for all tests.

Biocompatibility

Response 5.5/6.0 Spine System implants are comprised of the same medical grade metals (i.e., Titanium Alloy (Ti-6A1-4V-ELI) per ASTM F136, commercially pure titanium (ASTM F67), and CoCr (ASTM F1537-08)) and have the same type of body contact as other permanently implantable, (>30 days) contact duration, commercially available spinal system components. Response 5.5/6.0 Spine System instruments are comprised of the same material (medical grade stainless Steel) as other commercially available instruments and have patient contact for a transient duration (limited (< 24 hours) contact). These materials have well- characterized levels of biological response and a long history of successful clinical application in implantable and transient use with spinal systems in humans. Furthermore, these materials are identical to the predicate systems, Response Spine System (K130655), OP Spine System (K120291), CD Horizon Spine System (K091445) in formulation, processing, and sterilization and no other chemicals have been added. Biocompatibility met per Flow Chart for the Selection of Toxicity Tests for 510(K)s per FDA Guidance #G95-1 "Use of International Standard IS0-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing", May 1, 1995. Therefore, biocompatibility testing is not required.

VII. Conclusions

A risk analysis was completed and design verification testing was completed in accordance with ASTM F1717 and ASTM F1798. Based on the test results and additional supporting information provided in this pre-market notification, the subject devices demonstrated substantial equivalence to the legally marketed 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.