When used as a posterior, noncervical pedicle screw system, the VertiFlex™ Spinal Screw System is 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 of the thoracic, lumbar, and sacral spine:

Degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies;
Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra; .
Degenerative spondylolisthesis; .
Trauma (i.e., fracture or dislocation); .
. Spinal stenosis;
Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); ●
Tumor: .
Pseudoarthrosis; and/or .
Failed previous fusion. .

Device Description

The VertiFlex™ Spinal Screw System is a posterior, non-cervical instrumentation system consisting of both pedicle screws and rigid connecting rods. Screws are of polyaxial or monoaxial (fixed) top-loading design, are composed of titanium alloy, and are available in a range of diameters and lengths to accommodate physiological requirements. The rods are composed of titanium, and are available in both straight and curved (pre-lordosed) styles, and in a range of lengths to accommodate both single-level and multiple levels procedures. The System may be implanted by either conventional surgical methods, or via minimally-invasive/percutaneous techniques. Manual instrumentation for implantation of the System is available for both conventional and minimally-invasive procedures. Screws, rods, and instruments are offered non-sterile.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the "VertiFlex™ Spinal Screw System." It describes the device, its intended use, and substantial equivalence to predicate devices, but it does not contain acceptance criteria or a study proving the device meets those criteria, especially in the context of an AI/algorithm-based device as implied by your detailed questions.

This 510(k) pertains to a physical implantable device (pedicle screws) and its regulatory review for market clearance based on substantial equivalence to existing devices, not an AI or software as a medical device (SaMD). Therefore, many of your specific questions related to AI/algorithm performance metrics, training sets, expert ground truth, MRMC studies, and standalone performance are not applicable to the information contained in this document.

Here's an analysis based on the provided text, highlighting what is present and what is absent:

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

Not Applicable / Not Provided. The document does not define specific performance acceptance criteria in terms of quantitative metrics for a device (like sensitivity, specificity, accuracy, etc.) nor does it report performance against such criteria. This is a physical implant device, and its performance is assessed via non-clinical tests (mechanical/material properties) and comparison to predicate devices, not AI performance metrics.

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

Not Applicable / Not Provided. No "test set" in the context of an algorithm's performance is mentioned. The document refers to "non-clinical tests" in accordance with standards like ASTM F1717-04 for spinal implant constructs in a vertebrectomy model. This implies mechanical testing of the physical device, not data analysis on a patient dataset. Therefore, there's no information on sample size for an algorithm test set, data provenance, or whether it was retrospective/prospective.

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)

Not Applicable / Not Provided. As there is no algorithm requiring a "ground truth" to be established for a test set, there is no mention of experts or their qualifications in this context. The "truth" for a mechanical implant typically comes from engineering standards and physical measurements.

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

Not Applicable / Not Provided. An adjudication method is used when multiple human readers disagree on ground truth. Since no human readers or ground truth establishment for a test set are mentioned, no adjudication method is applicable or described.

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

No, not done. The document explicitly states: "No clinical testing was conducted to support this submission." Therefore, no MRMC study, AI assistance, or effect size is reported.

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

No, not done. This device is a physical medical implant, not an algorithm. Standalone algorithm performance is not applicable.

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

Not Applicable. For this physical device, "ground truth" would relate to its material properties and mechanical performance meeting engineering specifications and standards (e.g., ASTM F1717-04), rather than clinical outcomes or diagnostic accuracy. The document focuses on demonstrating "substantial equivalence" of the device's design, materials, and performance to predicate pedicle screw systems through non-clinical tests.

8. The sample size for the training set

Not Applicable / Not Provided. There is no algorithm, and thus no training set or associated sample size for training data.

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

Not Applicable / Not Provided. No training set means no method for establishing its ground truth is described.

Summary of what the document does provide regarding device performance:

The document states that non-clinical tests, including those conducted in accordance with recognized standards like ASTM F1717-04, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, "have demonstrated the substantial equivalence of the subject device to commercially-available predicate devices in terms of performance."

This implies a comparison of the mechanical and structural performance of the VertiFlex™ Spinal Screw System against the performance of predicate devices, adhering to industry-accepted testing standards. The "acceptance criteria" here are effectively met by demonstrating that the VertiFlex™ system performs comparably to the predicate devices under these standardized non-clinical tests. However, the exact numerical results or specific pass/fail thresholds from these tests are not detailed in this summary.

Summary

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JAN 1 2 2007

Page 1 of 2
K062670

510(k) SUMMARY 5.0

In accordance with Title 21 Code of Federal Regulations (21 CFR), Part 807, and in particular, §807.92, the following 510(k) summary is provided for the VertiFlex™ Spinal Screw System:

5.1 Submitted By:

VertiFlex™, Incorporated 1954 Kellogg Avenue, Suite 100 Carlsbad, California 92008

Contact: Steve Reitzler, Vice President of Regulatory & Quality Assurance

Date Prepared: September 5, 2006

5.2 Device Name

Trade or Proprietary Name: VertiFlex™ Spinal Screw System Common or Usual Name: Pedicle Screw System Pedicle Screw Spinal System Classification Name: Classification Regulation: 21 CFR, §888.3070 Product Codes: MNH, MNI, NKB

5.3 Predicate Devices

The subject device is substantially equivalent, in whole or in part, to the following commercially available predicate devices:

UCR Spinal System (Seaspine; K043232) VIPERTM Spine System (DePuy; K061520) Xia® Spinal System (Stryker; K060979) Click X® Svstem (Synthes: K031175) ST360TM Spinal Fixation System (Zimmer; K041925) CD HORIZON® Spinal System (Medtronic Sofamor Danek: K043343) PathFinder™ Spinal System (Spinal Concepts; K030625)

5.4 Device Description

The VertiFlex™ Spinal Screw System is a posterior, non-cervical instrumentation system consisting of both pedicle screws and rigid connecting rods. Screws are of polyaxial or monoaxial (fixed) top-loading design, are composed of titanium alloy, and are available in a range of diameters and lengths to accommodate physiological requirements. The rods are composed of titanium, and are available in both straight and curved (pre-lordosed) styles, and in a range of lengths to accommodate both single-level and multiple levels procedures. The System may be implanted by either conventional surgical methods, or via minimallyinvasive/percutaneous techniques. Manual instrumentation for implantation of the System is available for both conventional and minimally-invasive procedures. Screws, rods, and instruments are offered non-sterile.

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Page 2 of 2 KO62670

5.5 Intended Use

The subject device is indicated for use as follows:

Degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies:
Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra; .
Degenerative spondylolisthesis; .
Trauma (i.e., fracture or dislocation); .
. Spinal stenosis;
Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); ●
Tumor: .
Pseudoarthrosis; and/or .
Failed previous fusion. .

5.6 Comparison to Predicate Devices

Testing and comparisons of design characteristics and features have established that the subject VertiFlex™ Spinal Screw System is substantially equivalent in design, materials of composition, indications, performance, and other features, to other predicate pedicle screw spinal systems commercially available in the U.S.

5.7 Summary of Non-Clinical Tests

Non-clinical tests, including those conducted in accordance with such recognized standards as ASTM F1717-04, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model, have demonstrated the substantial equivalence of the subject device to commercially-available predicate devices in terms of performance.

5.8 Summary of Clinical Tests

No clinical testing was conducted to support this submission.

5.9 Conclusions

The results of all testing and comparison demonstrated the substantial equivalence of the subject device to the identified predicate devices.

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Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with a double helix representing DNA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

VertiFlex™, Incorporated % Mr. Steve Reitzler Vice President, Regulatory Affairs and Quality Assurance 1954 Kellogg Avenue, Suite 100 Carlsbad, California 92008

JAN 1 2 2007

Re: K062670

Trade/Device Name: VertiFlex™ Spinal Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI, Dated: September 5, 2006 Received: September 7, 2006

Dear Mr. Reitzler:

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. Steve Reitzler

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 Office of Compliance at (240) 276-0210 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Barbara Buehum

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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Indications for Use

510(k) Number (if known): K062670

Device Name: VertiFlex™ Spinal Screw System

Indications for Use:

When used as a posterior, noncervical pedicle screw system, the VertiFlex™Spinal Screw System is 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 of the thoracic, lumbar, and sacral spine:

Degenerative disc disease (DDD) as defined by back pain of discogenic origin . with degeneration of the disc confirmed by patient history and radiographic studies;
Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra; .
Degenerative spondylolisthesis; .
Trauma (i.e., fracture or dislocation); .
. Spinal stenosis:
Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis); .
. Tumor;
Pseudoarthrosis; and/or .
Failed previous fusion.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PI.EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

(Division Sign-C Division of General, Restorative, and Neurological Devices

510(k) Number K062670

Regulation Number and Section

N/A