The Spectrum Spine Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Spectrum Spine Laminoplasty Plating System holds the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.

Device Description

The Spectrum Spine Laminoplasty Plating System is comprised of various sized, pre-bent plates that are designed to fit the anatomy of the vertebral arch (i.e., between the pedicle and spinous process). The plates have screw holes located at both ends of the plate to allow for attachment to the bone. The screws intended for use with the plates are available in a variety of lengths and diameter and are designed to match the anatomical requirements.

AI/ML Overview

The provided text describes the Spectrum Spine Laminoplasty Plating System and its performance data for a 510(k) submission. However, it does not contain specific acceptance criteria, reported device performance in those terms (apart from passing certain ASTM standards), or details about a study that would address most of the requested information.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and mechanical testing according to established ASTM standards. It does not describe a clinical study or a study comparing the device's performance against specific, quantifiable acceptance criteria in a clinical context.

Therefore, for many of your requested points, the information is not available in the provided text.

Here is the information that can be extracted or deduced from the provided text, and where the information is not available, it is stated as such:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Performance:
Static Axial Pullout (screws per ASTM F543-07)	Tested and met the standard (implied, as conclusion states substantial equivalence)
Static Four-Point Bend (system per ASTM F2193-02)	Tested and met the standard (implied, as conclusion states substantial equivalence)
Dynamic Four-Point Bend (system per ASTM F2193-02)	Tested and met the standard (implied, as conclusion states substantial equivalence)
Material Composition:
Plates and screws manufactured from titanium alloy (ASTM F136)	Manufactured from titanium alloy (ASTM F136)
Indications for Use:
Intended for use in lower cervical and upper thoracic spine (C3-T3) after laminoplasty to hold allograft and prevent expulsion/impingement on spinal cord.	Indicated for use in lower cervical and upper thoracic spine (C3-T3) after laminoplasty to hold or buttress allograft and prevent expulsion/impingement on spinal cord.
Technical Characteristics:
No new technical characteristics compared to predicate devices.	No new technical characteristics introduced.

Note on "Reported Device Performance": The document states that the device "was tested" according to specific ASTM standards and that the data "lead to the conclusion that Spectrum Spine Laminoplasty Plating System is substantially equivalent to the predicate devices." This implicitly means the device met the requirements of these tests, but the specific numerical results or thresholds (acceptance criteria) for those tests are not detailed in this summary.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified. The testing described is mechanical (physical hardware testing), not clinical or involving human subjects/cases in the traditional sense of a "test set" for performance evaluation.
Data Provenance: The "performance data" refers to mechanical testing.
- Country of origin: Not specified, but likely performed in a certified lab in the USA, given the FDA submission.
- Retrospective or Prospective: Not applicable, as this refers to mechanical bench testing, not clinical data collection.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The "ground truth" for this device's performance evaluation is based on established engineering standards (ASTM F543-07 and ASTM F2193-02) and material specifications (ASTM F136), not expert consensus from clinical cases. There's no mention of experts establishing a ground truth in the context of device performance as one would for an AI/diagnostic device.

4. Adjudication Method for the Test Set

Not applicable. This concept typically applies to clinical studies where expert reviewers independently assess cases and then reconcile discrepancies. The reported testing is mechanical bench testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is not relevant for this type of mechanical implant device. This type of study is typically performed for diagnostic or AI-assisted interpretation devices.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a mechanical surgical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

Engineering Standards and Material Specifications: The ground truth for evaluating the device's safety and effectiveness for a 510(k) submission is based on adherence to established ASTM standards for mechanical properties (e.g., strength, durability) and material composition (titanium alloy as per ASTM F136), demonstrating substantial equivalence to previously marketed devices.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical surgical implant. There is no training set in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable. See point 8.

Summary

{0}------------------------------------------------

5. 510(K) Summary

Submitter's Name:	Spectrum Spine IP Holdings, LLC
Submitter's Address:	3045 Paces Lake CourtAtlanta, GA 30339
Submitter's Telephone:	(404) 550-1335
Contact Name:	Dr. James Robinson
Date Summary was Prepared:	01 August 2012
Trade or Proprietary Name:	Spectrum Spine Laminoplasty Plating System
Common or Usual Name:	Orthosis, Spine, Plate, Laminoplasty, Metal
Classification:	Class II per 21 CFR §888.3050
Product Codes:	NQW
Classification Panel:	Orthopedic and Rehabilitation Devices Panel
Predicate Devices:	Synthes Arch™ Fixation System (AFS) (K032534)Medtronic™ Centerpiece™ Plate Fixation System (K050082)

Description of the Device Subject to Premarket Notification:

INDICATIONS FOR USE

TECHNICAL CHARACTERISTICS

The Spectrum Spine Laminoplasty Plating System plates and screws are manufactured from titanium alloy (ASTM F136), similar to the referenced predicate devices. No new technical characteristics are being introduced with this product.

PERFORMANCE DATA

The Spectrum Spine Laminoplasty Plating System screws were tested in static axial pullout per ASTM F543-07 Standard Specification and Test Methods for Metallic Medical Bone Screws. The system was also tested in static and dynamic four-point bend per ASTM F2193-02 Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System.

{1}------------------------------------------------

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that Spectrum Spine Laminoplasty Plating System is substantially equivalent to the predicate devices.

. . . .

and the control of the county of

. . . . .

: 1. 1. 1. 1. 1.

Spectrum Spine Laminoplasty System

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human profiles or abstract shapes, creating a sense of unity and connection.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Letter dated: February 7, 2013

Spectrum Spine IP Holdings, LLC % Empirical Testing Corporation Ms. Meredith May 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K122822

Trade/Device Name: Spectrum Spine Laminoplasty Plating System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: NQW Dated: January 14, 2013 Received: January 16, 2013

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. Iisting 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

{3}------------------------------------------------

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 go to http://www.fda.gov/AboutFDA/CentersOffices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

4. Indications for Use Statement

Device Name: Spectrum Spine Laminoplasty Plating System

The Spectrum Spine Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3-T3)' after a laminoplasty has been performed. The Spectrum Spine Laminoplasty Plating System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.

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)

Ronald P. Jean -S

(Division Sign-off) Division of Orthopedic Devices 510(k) Number: K122822

Spectrum Spine Laminoplasty System

Page 17 of 141

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.