The Transom™ is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Device Description

The Transom™ Cervical Plate System consists of a variety of bone plates and screws. Fixation is achieved by inserting bone screws through the openings in the plate into the vertebral bodies of the cervical spine. The Transom™ Plates include locking pins that cover the heads of the bone screws to reduce the potential for screw back-out. The locking pins come preassembled to the plate. Associated instruments are available to facilitate the implantation of the device. The Transom™ Cervical Plate System implant components are made from titanium alloy such as described by ASTM F136.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the Transom™ Cervical Plate System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets new acceptance criteria through extensive clinical studies. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth for an AI/CADe device is not applicable to this document.

Here's a breakdown based on the information provided and what is typically expected from a 510(k) submission for a spinal implant:

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

Acceptance Criteria (Mechanical Testing):
- The acceptance criteria for a 510(k) for a spinal implant typically involve demonstrating that the new device performs at least as well as or better than the predicate device in specific mechanical tests. The document states the Transom™ was tested for:
  - Static axial compression bending per modified ASTM F1717-13
  - Static torsion per modified ASTM F1717-13
  - Dynamic axial compression bending fatigue per modified ASTM F1717-13
- The implicit acceptance criterion is that the new device's performance in these tests is comparable to or exceeds that of the predicate devices (Tempus™ Cervical Plate System, Orthofix Anterior Cervical Plating System) to ensure it is "sufficient for its intended use" and "substantially equivalent." Specific numerical acceptance thresholds are not provided in this summary but would be part of the full submission.
Reported Device Performance:
- The document states: "The results of this non-clinical testing show that the strength of the Transom™ is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
- Specific quantitative results (e.g., maximum load, fatigue cycles to failure) are not included in this summary. These would be detailed in the full performance data section of the 510(k) submission.

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 in the context of this document. This document describes mechanical (non-clinical) testing of a physical implant, not a study involving human data or an AI algorithm. The "test set" here refers to physical samples of the device and predicate devices used in laboratory testing. The sample size would be the number of physical implants tested for each condition, which is not specified in this summary. Data provenance for mechanical testing is generally about the testing facility and methodology rather than patient origin.

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

Not Applicable. Ground truth, in the sense of expert consensus on patient data (e.g., radiology reads, pathology), is not relevant for this type of mechanical device testing. The "ground truth" for mechanical testing is established by standardized testing protocols (e.g., ASTM F1717-13) and precise measurement instruments.

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

Not Applicable. Adjudication methods are typically used to resolve discrepancies among human readers or experts when establishing ground truth for clinical data. This is not pertinent to mechanical 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. MRMC studies are clinical studies, often used for diagnostic imaging devices or AI-assisted diagnostic tools. This submission is for a physical spinal implant and does not involve human readers interpreting images, nor does it concern AI.

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

Not Applicable. This device is a physical implant, not an algorithm.

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

Mechanical Testing Results against Predicate Performance: The "ground truth" for this submission is the performance of the predicate devices as established through historical mechanical testing and clinical use, and the new device's conformity to relevant ASTM standards. The comparison is against established benchmarks for similar spinal implants' mechanical properties.

8. The sample size for the training set

Not Applicable. "Training set" refers to data used to train an AI algorithm. This device is a physical implant, not an AI system.

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

Not Applicable. As above, no AI training set is involved.

Summary of what is provided from the perspective of a 510(k) for a physical device:

The document emphasizes that the Transom™ Cervical Plate System shares "nearly identical technological characteristics" with its predicate devices, including:

Indications for Use
Materials of manufacture (titanium alloy conforming to ASTM F136)
Sterilization method
Structural support mechanism

The key "study" mentioned is the non-clinical mechanical testing (static axial compression bending, static torsion, dynamic axial compression bending fatigue) performed according to modified ASTM F1717-13. The conclusion is that these tests demonstrate the strength of the Transom™ is "sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." The predicates are listed as the Tempus™ Cervical Plate System (K131374, K120515) from Neurostructures, Inc. and various Anterior Cervical Plating System models from Orthofix (K974885, K012184, K030595, K050892, K100614).

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 features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized depiction of three human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth and unity.

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

November 18, 2014

Neurostructures, Incorporated % Ms. Meredith Mav Senior Manager Empirical Testing Corporation 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K142060

Trade/Device Name: Transom™ Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: October 13, 2014 Received: October 20, 2014

Dear Ms. May:

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 - Ms. Meredith May

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" (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. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES	Form Approved: OMB No. 0910-0120
Food and Drug Administration	Expiration Date: December 31, 2013
Indications for Use	See PRA Statement on last page.
510(k) Number (if known)	K142060
Device Name	Transom™ Cervical Plate System
Indications for Use (Describe)	The Transom™ is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
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)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (9/13)	PSC Publishing Services (301) 443-6740 EF

Neurostructures, Inc. Transom™ Cervical Plate System

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510(K) SUMMARY

Submitter's Name:	Neurostructures, Inc.
Submitter's Address:	16 Technology Dr. Suite 165Irvine, CA 92618
Submitter's Telephone:	800.352.6103
Contact Person:	Meredith L. May, MSEmpirical Testing Corp.719.337.7579
Date Summary was Prepared:	17-Oct-2014
Trade or Proprietary Name:	Transom™ Cervical Plate System
Common or Usual Name:	Spinal intervertebral body fixation orthosis
Classification:	Class II per 21 CFR §888.3060 Device Classification
Product Code:	KWQ
Classification Panel:	Orthopedic

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

The indications for use for the Transom™ is the same as the Tempus™ Cervical Plate System (K120515, K131374).

TECHNOLOGICAL CHARACTERISTICS

Transom™ Cervical Plate System is made from titanium alloy that conforms to ASTM F136. Titanium alloy has a successful history of use in the spinal implant industry and use of it in these devices does not introduce any previously unaccepted patient risks. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise

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any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:

. Indications for Use
Materials of manufacture ●
Sterilization method ●
Structural support mechanism .

510k Number	Trade or Proprietary or Model Name	Manufacturer
K131374	Tempus™ Cervical Plate System(Primary Predicate)	Neurostructures, Inc.
K120515	Tempus™ Cervical Plate System	Neurostructures, Inc.
K974885, K012184,K030595, K050892, K100614	Anterior Cervical Plating System	Orthofix

Table 5-1 Predicate Devices

PERFORMANCE DATA

The Transom™ has been tested in the following test modes:

Static axial compression bending per modified ASTM F1717-13 ●
Static torsion per modified ASTM F1717-13 ●
Dynamic axial compression bending fatigue per modified ASTM F1717-13 .

The results of this non-clinical testing show that the strength of the Transom™ 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 Transom™ Cervical Plate 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.