APCLO PEDICLE SCREW SYSTEMS by ATLAS SPINE INC.

The Apelo™ Pedicle Screw System is intended for noncervical pedicle fixation 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, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.

Device Description

The subject of this submission is the design of Fixed Length Cross Connectors for the Apelo" Pedicle Screw System and additional smaller sizes, 20mm through and including 42mm. The Atlas Spine Fixed Length Cross Connectors will provide surgeons additional smaller sizes from which to choose based on the patients' anatomies. The Atlas Spine Fixed Length Cross Connectors will be manufactured from medical grade titanium alloy, Ti-6AI-4V (ELI), in accordance with ASTM F-136.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the Atlas Spine Pedicle Screw System. This document is a regulatory submission for a medical device that demonstrates substantial equivalence to a legally marketed predicate device. The information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is typically associated with studies evaluating the performance of AI/ML-driven diagnostic or prognostic devices, or software as a medical device (SaMD).

This 510(k) submission, however, is for a physical orthopedic implant (pedicle screw system), not a diagnostic or AI-enabled device. Therefore, the detailed performance metrics and study design elements requested in the prompt are not applicable to this type of submission.

Here's why the information cannot be provided from this document:

Device Type: This is a physical orthopedic implant (pedicle screw system), not a diagnostic device or a software product requiring AI performance evaluation.
Regulatory Pathway: A 510(k) for such devices primarily focuses on demonstrating "substantial equivalence" to a predicate device in terms of intended use, design, materials, and functional characteristics (e.g., mechanical testing, biocompatibility). It does not typically involve clinical performance studies in the way an AI/ML device would, especially not with "acceptance criteria" related to sensitivity, specificity, or other diagnostic performance metrics.
Missing Information: The document does not contain any information regarding:
- Acceptance criteria for diagnostic or prognostic performance.
- Reported device performance in terms of diagnostic accuracy.
- Sample sizes for test sets (as there isn't a "test set" in the context of AI performance).
- Data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types (pathology, outcomes data, expert consensus).
- Training set size or how ground truth for a training set would be established, as these terms are irrelevant to a physical implant's 510(k).

The document explicitly states the basis for substantial equivalence:

Same indications for use
Same operating principle
Same raw materials
Similar manufacturing environments
Same packaging configurations
Same sterilization process
Implanted using the same surgical techniques and similar equipment types

The conclusion explicitly states "This conclusion is based on the devices' similarities in indications for use, design, function, materials and mechanical function." This indicates the focus is on engineering and material equivalence, not clinical diagnostic performance.

Therefore, I cannot provide the requested table and study details as they are not relevant to or present in the provided 510(k) document for the Atlas Spine Pedicle Screw System.

Summary

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Atlas Spine, Inc. Special 510(k) Premarket Notification: Atlas Spine Pedicle Screw System ンドレート > < < ( < > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > >

510(k) SUMMARY

Manufacturer:	Atlas Spine, Inc.
Address:	1555 Jupiter Park Drive, Suite #4Jupiter, FL 33458
Telephone:	561-741-1108
Fax:	561-741-1870
Establishment Reg. No.	3003855635
Official Correspondent:	Thomas G. Smith
Title:	Manager, Regulatory Affairs & Quality Assurance
Telephone:	561-354-4318
Date Prepared:	September 19, 2011
Device ClassificationName:	Spinal pedicle fixation orthosis
Trade/Proprietary Name:	Apelo™ Pedicle Screw System
Common Name:	Pedicle screw spinal system
Classification:	Class III per 21 CFR §888.3070
Product Code:	MNI, MNH, and NKB
Classification Panel:	Orthopedic and Rehabilitation Devices Panel
Predicate Devices:	Apelo™ Pedicle Screw SystemAtlas Spine, Inc.K072426, K110842Coral™ Spinal System

Theken Spine, LLC K041592, K081414

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K112759 Atlas Spine, Inc. Special 510(k) Premarket Notification: Atlas Spine Pedicle Screw System ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Intended Use:

The Apelo" Pedicle Screw System is intended for noncervical pedicle fixation in skeletally mature patients as an adjunct to fosion 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, and/or lordosis); tumor; pseudarthrosis; and failed previous fusion.

Device Description:

Equivalence to Marketed Product

Atlas Spine, Inc. has submitted information to demonstrate that, for the purpose of FDA's regulation of medical devices, the Atlas Spine Fixed Length Cross Connectors is substantially equivalent in the intended use, design, materials and functional characteristics compared to the predicate devices.

The subject device similarities include:

· The same indications for use
· The same operating principle
· The same raw materials
· Similar manufacturing environments
· The same packaging configurations
· The same sterilization process
· Implanted using the same surgical techniques and similar equipment types

Conclusion

Provided documentation demonstrates that the Atlas Spine Fixed Length Cross Connectors is substantially equivalent to the aforementioned predicate devices. This conclusion is based on the devices' similarities in indications for use, design, function, materials and mechanical function.

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

Atlas Spine, Inc. % Mr. Thomas Smith Manager, Regulatory Affairs & Quality Assurance 1555 Jupiter Park Drive, Suite 4 Jupiter, Florida 33458

OCT 1 8 2011

Re: K112759

Trade/Device Name: Apelo Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: September 19, 2011 Received: September 22, 2011

Dear Mr. Smith:

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 contractly and warranties. We remind you; however, that device labeling must be truthful and not mislery]

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

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Page 2 - Mr. Thomas Smith

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Apelo™ Pedicle Screw System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Posted November 13, 2003)

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number_ K112759

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.