The Neurostructures Belvedere™ Lateral Plating System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracolumbar (T1-L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of disco genic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery.

Device Description

The Belvedere™ Lateral Plating System provides an assortment of thoracic and thoracolumbar plates and screws. The plates and screws provided are manufactured from titanium alloy 6AL-4V-ELI per ASTM F-136. Multiple variations of the screws are provided in lengths of 20-70mm and diameters of 5.0-6.5mm. The plates are provided in lengths of 36-132mm.

AI/ML Overview

The provided document is a 510(k) premarket notification from the FDA for a medical device called the "Belvedere™ Lateral Plating System." This type of document focuses on establishing substantial equivalence to a predicate device, primarily through mechanical performance testing for spinal implants, rather than clinical studies on patient outcomes or AI performance.

Therefore, many of the requested categories related to AI performance, clinical study design, and ground truth establishment are not applicable.

Here's the information that can be extracted from the document:

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

The document states that the device was tested according to ASTM F1717-14 standards, and the results show that "the strength of the Belvedere™ Lateral Plating System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."

The document does not explicitly state specific numerical acceptance criteria for each test (e.g., minimum bending strength in Nm) nor does it provide the numerical reported device performance values. It only provides a qualitative conclusion of sufficiency and equivalence. To get these specific numbers, one would typically need to refer to the full test reports submitted to the FDA, which are not provided here.

Test Mode (per ASTM F1717-14)	Acceptance Criteria (Implicit)	Reported Device Performance (Summary)
Static axial compression bending	Sufficient for intended use and substantially equivalent to predicate devices (Implied by FDA clearance and 510(k) summary)	Strength is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices. (Specific values not provided)
Static torsion	Sufficient for intended use and substantially equivalent to predicate devices (Implied by FDA clearance and 510(k) summary)	Strength is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices. (Specific values not provided)
Static tension	Sufficient for intended use and substantially equivalent to predicate devices (Implied by FDA clearance and 510(k) summary)	Strength is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices. (Specific values not provided)
Dynamic axial compression bending	Sufficient for intended use and substantially equivalent to predicate devices (Implied by FDA clearance and 510(k) summary)	Strength is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices. (Specific values not provided)

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

Sample Size: Not specified in this summary. Mechanical tests typically involve a sample size of components according to ASTM standards, but the exact number of plates and screws tested is not disclosed.
Data Provenance: The tests are "non-clinical testing," meaning they were conducted in a laboratory setting on the device components, not on human or animal subjects. The data provenance is mechanical testing conducted by the manufacturer or a contracted lab. Neither country of origin of data nor retrospective/prospective is applicable in this context.

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

Not applicable. This is a mechanical device performance study, not a study requiring expert clinical review to establish ground truth. The "ground truth" for these tests would be the measured physical properties of the materials and constructs themselves according to standardized testing protocols.

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

Not applicable. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, not for mechanical laboratory testing.

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

Not applicable. This document describes a physical medical device (spinal plating system), not an AI diagnostic or assistive tool.

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

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

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

Not applicable. The "ground truth" for mechanical performance is the objective measurement of physical properties (e.g., strength, stiffness, fatigue life) as defined by the ASTM F1717-14 standard.

8. The sample size for the training set

Not applicable. There is no training set mentioned as this is not an AI/machine learning device.

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

Not applicable. No training set exists for this type of device.

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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other.

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

July 15, 2016

Neurostructures, Incorporation % Mr. Kenneth Maxwell II Regulatory and Quality Specialist Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K153097

Trade/Device Name: Belvedere™ Lateral Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: June 9, 2016 Received: June 10, 2016

Dear Mr. Maxwell:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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/ResourcesforYou/Industry/default.htm. 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 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 yours,

Mark N. Melkerson -S

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) K153097

Device Name Belvedere™ Lateral Plating System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Submitter's Name:	Neurostructures, Inc.
Submitter's Address:	16 Technology Dr. Suite 165Irvine, CA 92618
Submitter's Telephone:	800.352.6103
Contact Person:	Kenneth C. Maxwell IIEmpirical Consulting LLC719.291.6874
Date Summary was Prepared:	11 July 2016
Trade or Proprietary Name:	Belvedere™ Lateral Plating System
Common or Usual Name:	Appliance, Fixation, Spinal Intervertebral Body
Classification:	Class II per 21 CFR §888.3060
Product Code:	KWQ
Classification Panel:	Division of Orthopedic Devices

510(K) SUMMARY

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

The NeuroStructures Belvedere™ Lateral Plating System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (T) - L5) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of disco genic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, lordosis, spinal stenosis, or a failed previous spine surgery.

The indications for use for the Belvedere™ Lateral Plating System are similar to that of predicate devices listed in Table 5-1 Predicate Devices.

TECHNOLOGICAL CHARACTERISTICS

The Belvedere™ Lateral Plating System and the predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:

Indications for Use
Materials of manufacture
Principles of operation o

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510kNumber	Trade or Proprietary or Model Name	Manufacturer	Type
K020244	Thoracolumbar Spine Locking Plate (TSLP)System	Synthes	Primary
K133194	Black/Red Diamond Rattlesnake LumbarPlating System	Eminent Spine	Additional
K143230	Palladian™ Lumbar Pedicle Screw System	Neurostructures, Inc.	Reference

Table 5-1 Predicate Devices

PERFORMANCE DATA

The Belvedere™ Lateral Plating System has been tested in the following test modes:

Static axial compression bending per ASTM F1717-14 ●
Static torsion per ASTM F1717-14 .
Static tension per ASTM F1717-14 .
Dynamic axial compression bending per ASTM F1717-14 ●

The results of this non-clinical testing show that the strength of the Belvedere™ Lateral Plating System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Belvedere™ Lateral Plating System is substantially equivalent to the predicate device.

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.