The SSP Vertebral Body Replacement is a complete or partial vertebral body replacement device intended for use in the thoracolumbar spine (T1 - L5) to provide anterior and middle column support after removal or resection of a damaged, collapsed, or unstable vertebral body due to tumor or trauma (e.g., fracture).

The SSP Vertebral Body Replacement is intended to be used with the Specialty Spine Products Pedicle Screw System or with supplemental internal fixation systems cleared for the conditions listed above, and is intended to be used with bone graft. It is designed to provide anterior column support even in the absence of fusion for a prolonged period.

Device Description

The SSP Vertebral Body Replacement is a hollow cylinder available in either 12 mm or 14 mm diameter, with height ranging from 7 mm to 13 mm in 1 mm increments. The various sizes of these implants accommodate individual patient anatomy and pathology. Wall thickness is approximately 1.5 mm. The wall of the device features an open architecture consisting of one or two rows of circumferential holes (depending on height). The ends are notched circumferentially to form a row of "teeth" along the superior and inferior margins.

AI/ML Overview

This 510(k) submission for the SSP Vertebral Body Replacement describes a mechanical device, not an AI/ML-driven device or diagnostic tool. Therefore, the typical acceptance criteria and study designs associated with AI performance (like sensitivity, specificity, AUC, MRMC studies, standalone performance, etc.) are not applicable to this document.

The "acceptance criteria" for this type of medical device primarily revolve around mechanical safety and efficacy demonstrating substantial equivalence to predicate devices, as determined through a combination of:

Mechanical Testing: To ensure the device can withstand the physiological loads and stresses it will experience in the human body.
Biocompatibility Testing: To ensure the materials used are safe for implantation.
Design and Material Equivalence: Comparison to legally marketed predicate devices.
Clinical Justification/Indications for Use: Alignment with established medical practice and predicate device usage.

Based on the provided document, here's an attempt to address the prompts by reinterpreting them for a mechanical device submission where applicable, and explicitly stating when information is not present or relevant:

Acceptance Criteria and Study to Prove the Device Meets Acceptance Criteria for SSP Verteral Body Replacement

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance/Evidence from Submission
Material & Design Equivalence	The device is described as a hollow cylinder available in 12mm or 14mm diameter, with heights from 7mm to 13mm. Wall thickness is ~1.5mm, with an open architecture (circumferential holes) and notched ends ("teeth"). This design is compared to predicate devices for substantial equivalence.
Intended Use Equivalence	Intended for use in thoracolumbar spine (T1-L5) for anterior/middle column support after removal/resection of damaged/collapsed/unstable vertebral body due to tumor or trauma. To be used with pedicle screw system/supplemental fixation and bone graft. This aligns with predicate devices.
Predicate Device Substantial Equivalence	Demonstrated equivalence to SynMesh Spacer System (K003275), Blackstone Surgical Titanium Mesh System (K030744), and Blackstone Surgical Titanium Mesh System Angled End Rings (K032700).
Mechanical Performance (e.g., strength, stability)	Implicitly demonstrated through equivalence to legally marketed predicate devices, which would have undergone mechanical testing. Specific test data and acceptance thresholds are not provided in this summary but would be part of the full 510(k) submission.
Biocompatibility	Implicitly demonstrated through equivalence to predicate devices and use of medically accepted materials. Specific test data is not provided in this summary.
Labeling Requirements	Complies with general controls provisions of the Act, including labeling (21 CFR Part 801).
Quality System Compliance (Good Manufacturing Practice)	Falls under the quality systems (QS) regulation (21 CFR Part 820).
Annual Registration/Listing	Specialty Spine Products will submit Establishment Registration to FDA prior to marketing.

Note: This 510(k) summary does not contain detailed mechanical test results or biocompatibility data. For mechanical devices, proving "substantial equivalence" to legally marketed predicate devices (which have already met safety and effectiveness standards, including mechanical performance) often forms the primary basis for "acceptance." The FDA's letter states the device "is substantially equivalent...to legally marketed predicate devices."

Regarding the remaining questions, which are highly specific to AI/ML device evaluations:

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. This is a mechanical implant, not an AI/ML diagnostic or predictive device that uses test sets of data.
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 context of AI/ML diagnostic performance is not relevant for this mechanical device. The "ground truth" for this device would be its mechanical integrity and biocompatibility, typically established through laboratory testing and material science principles, or clinical outcomes for predicate devices, not expert image review.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set for AI/ML performance is involved.
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. An MRMC study is designed for AI-assisted diagnostic tasks, not for evaluating a spinal implant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. There is no algorithm or AI component in this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the AI/ML context. For this device, "ground truth" is established through engineering principles, material standards, and clinical experience with predicate devices. This includes demonstrating appropriate mechanical strength, fatigue resistance (not detailed in this summary, but would be expected in the full submission), and biological compatibility.
8. The sample size for the training set: Not applicable. This device does not involve machine learning; therefore, there is no training set.
9. How the ground truth for the training set was established: Not applicable. As above, no training set.

Summary

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SSP Vertebral Body Replacement

510(k) Summary

DEC 26 2006

Specialty Spine Products SSP Vertebral Body Replacement

ADMINISTRATIVE INFORMATION

Manufacturer Name:	Specialty Spine Products, LLC
	4121 Tigris Way
	Riverside, CA 92503
	Telephone 1 (951) 687-2808
	Fax 1 (951) 734-7594
Official Contact:	Angela Carlson
Representative/Consultant:	Floyd G. Larson
	PaxMed International, LLC
	11234 El Camino Real, Suite 200
	San Diego, CA 92130
	Telephone 1 (858) 792-1235
	FAX 1 (858) 792-1236

DEVICE NAME

Classification Name:	Spinal intervertebral body fixation orthosis
Trade/Proprietary Name:	SSP Vertebral Body Replacement
Common Name:	Spinal vertebral body replacement device

ESTABLISHMENT REGISTRATION NUMBER

Specialty Spine Products will submit Establishment Registration to FDA prior to marketing the SSP Vertebral Body Replacement.

DEVICE CLASSIFICATION

Spinal vertebral body replacement devices are classified as Class II devices (21 CFR 888.3060). The product code for Spinal intervertebral body fixation orthosis is MQP. This device classification is reviewed by the Orthopedic Branch.

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INTENDED USE

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED PRODUCT

Specialty Spine Products, LLC has submitted information to demonstrate that, for the purposes of FDA's regulation of medical devices, the SSP Vertebral Body Replacement is substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to preamendment devices: the SynMesh Spacer System (K003275) from Synthes, the Blackstone Surgical Titanium Mesh System (K030744) from Blackstone Medical, and the Blackstone Surgical Titanium Mesh System Angled End Rings (K032700), also from Blackstone Medical.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Specialty Spine Products, LLC % Mr. Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130

DEC 9 6 2006

Re: K061578

Trade/Device Name: SSP Vertebral Body Replacement Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: June 5, 2006 Received: June 7, 2006

Dear Mr. Larson:

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. Floyd G. Larson

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) 276-0120. 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,

Houbare Bueckup

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): K061578

Device Name: SSP Vertebral Body Replacement

Indications for Use:

The SSP Vertebral Body Replacement is a complete or partial vertebral body replacement device intended for use in the thoracolumbar spine (T1 -- L5) to provide anterior and middle column support after removal or resection of a damaged, collapsed, or unstable vertebral body due to tumor or trauma (e.g., fracture).

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

-The-Counter Use
(CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Bruchun
(Division Sign-Off)(Division Sign-Off) Division of General, Restorative, and Neurological Devices

K061578 Rev 061222 Page 1 of 10

510(k) Number K061578

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.