The Valeo™ Pedicle Screw System is intended for noncervical pedicle fixation and noncervical nonpedicle fixation as an adjunct to fusion for the following acute and chronic instabilities or deformities for the T1-S1 vertebrae in skeletally mature patients: 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 Valeo™ Pedicle Screw System comprises non-sterile, single use, titanium alloy components for creating a posterior spinal implant construct. The system attaches to the spine through a component system comprising screws, rods, connectors, and set screws. The system is designed to stabilize the spine during the fusion process. The Valeo Pedicle Screw System is fabricated from wrought Ti-6A1-4V (ISO 5832-3).

AI/ML Overview

The provided text is a 510(k) summary for the Valeo™ Pedicle Screw System. This document primarily focuses on demonstrating substantial equivalence to predicate devices for a mechanical medical implant, not a diagnostic AI device. Therefore, many of the requested categories about acceptance criteria, study design for AI algorithms, and expert involvement are not applicable or cannot be extracted from this type of regulatory filing.

Here's an analysis based on the information available:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria in terms of device performance metrics (e.g., accuracy, sensitivity, specificity) as would be seen for a diagnostic device. Instead, acceptance for this type of device is based on substantial equivalence to legally marketed predicate devices, primarily demonstrated through mechanical testing and material characterization to ensure performance characteristics are similar and meet recognized standards.

Acceptance Criteria (Implied for a Mechanical Implant)	Reported Device Performance (Implied from "Performance Standards")
Mechanical strength and fatigue resistance (e.g., per ASTM standards for spinal implants)	Testing performed indicates the Valeo™ Pedicle Screw System is substantially equivalent to predicate devices.
Biocompatibility of materials (Ti-6A1-4V)	The system is fabricated from wrought Ti-6A1-4V (ISO 5832-3), a commonly used and biocompatible material for implants.
Design equivalence to predicate devices	"The Valeo™ Pedicle Screw System was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used."

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

This information is not applicable and not provided in the document. The "test set" for a mechanical implant typically refers to specimens subjected to mechanical testing, not a dataset for an AI algorithm. Therefore, details about data provenance (country, retrospective/prospective) are not relevant here.

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 information is not applicable and not provided. "Ground truth" in the context of an AI device usually refers to expert-validated labels for a dataset. For a mechanical implant, "ground truth" relates to the physical and mechanical properties of the device, established through standardized testing procedures, not expert consensus on medical images or diagnoses.

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

This information is not applicable and not provided. Adjudication methods are relevant for resolving discrepancies in expert labeling of data for AI algorithms. For a mechanical implant, testing results are typically evaluated against pre-defined engineering standards, not through adjudications of expert opinions.

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

An MRMC study is not applicable and not mentioned. This type of study is specifically designed for assessing the impact of AI on human reader performance in diagnostic tasks. The Valeo™ Pedicle Screw System is a physical implant, not an AI diagnostic tool.

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

A standalone performance study for an algorithm is not applicable and not mentioned. The device is a mechanical implant and does not involve an algorithm with standalone performance.

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

The "ground truth" for this device is based on engineering standards and material specifications. This includes:

Mechanical testing results: Demonstrating strength, fatigue life, and other mechanical properties meet relevant ASTM or ISO standards for spinal implants.
Material properties: Confirmation that the Ti-6A1-4V material conforms to ISO 5832-3 standards.
Design and functional equivalence: Comparison of the device's design and intended function to legally marketed predicate devices.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" for a mechanical implant.

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

This information is not applicable and not provided. As there is no training set for a mechanical implant, the method for establishing its ground truth is irrelevant.

Summary

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K073430

6. 510(k) Summary

Contact:	Mr. Justin EggletonMusculoskeletal Clinical & Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005202.552.5800
Device Trade Name:	Valeo™ Pedicle Screw System
Manufacturer:	Amedica Corp.615 Arapeen Drive, Suite 302Salt Lake City, UT 84108
Common Name:	Pedicle screw spinal system
Classification:	21 CFR §888.3070
Class:	III
Product Code:	NKB, MNH, MNI
JAN 29 2006

Indications For Use:

Device Description:

Predicate Device(s):

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The Valeo™ Pedicle Screw System was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials used. The cited references include:

Jemo Spine Delta™ Spinal Fixation System (K071857) .
U&I Optima™ Spinal System (K031585) .
DePuy Expedium Spine System (K070387) .
Medtronic Sofamor Danek TSRH® Spinal System (K072317) .
. Zimmer ST360® Spinal Fixation System (K072183)
. Theken Spine Coral™ Spinal System (K070962)
DePuy Spine VIPER Spine System (K071860) .
Vertebron PSSTM Pedicle Screw System (K071376) .
Custom Spine ISSYS LP Spinal Fixation System (K070281) .
EBI® Array® Spinal System (K062685) .
Globus Medical REVERE™ Stabilization System (K061202) .
Amedica ValeoTM Pedicle Screw System (K072022) .

Performance Standards:

Testing performed indicates the Valeo™ Pedicle Screw System is substantially equivalent to predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three abstract human figures in profile, arranged in a cascading manner. The figures are black and are set against a white background. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.

Public Health Service

JAN 2 9 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Amedica Corporation % Musculoskeletal Clinical Regulatory Advisers, LLC Mr. Justin Eggleton 1331 H Street Northwest, 12th Floor Washington, DC 20005

Re: K073430

Trade/Device Name: Valeo™ Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, MNI, MNH Dated: December 5, 2007 Received: December 6, 2007

Dear Mr. Eggleton:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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 - Mr. Justin Eggleton

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark H. Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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5. Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Valeo™ Pedicle Screw System

マ Prescription Use (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carbare Buelm

Division of General, Restorative, and Neurological Devices

510(k) Number K073430

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.