The UCR Spinal System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The intended use and indications when used as a Pedicle Screw Spinal System are:
The UCR Spinal System is a pedicle screw system 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 or deformities of the thoracic, lumbar, and sacral spine:
degenerative spondylolisthesis with objective evidence of neurological impairment,
fracture,
dislocation,
scoliosis,
kyphosis,
spinal tumor, and
failed previous fusion (pseudoarthrosis).
The indications for use as a Hook Spinal System are limited to T1-L5 and are:
degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history ad radiographic),
spinal stenosis,
spondylolisthesis,
spinal deformities (scoliosis, kyphosis, and/or lordosis),
fracture,
pseudarthosis,
tumor resection, and/or
failed previous fusion.

Device Description

The UCR Spinal System cross links and their components include variable and fixed cross links, fixed cross link bars, link bars, rounded links, screws, coupler, and an instrument. The variable cross links will be available in sizes ranging from 23 to 75mm and the fixed cross links and fixed cross link bars in sizes between 20 and 36mm. The product is supplied "NON-STERILE" and must be sterilized prior to use.

AI/ML Overview

The provided text is a 510(k) summary for the UCR Spinal System, specifically focusing on its cross links. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving device efficacy through clinical trials with defined acceptance criteria and statistical performance metrics. Therefore, many of the requested categories related to clinical studies, ground truth establishment, expert adjudication, and comparative effectiveness are not applicable or not detailed in this document.

However, I can extract the information relevant to acceptance criteria in the context of a 510(k) (i.e., comparison to the predicate device) and provide available details about the comparative study conducted.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

In a 510(k) submission like this, "acceptance criteria" for substantial equivalence are generally met by demonstrating that the new device has the same technological characteristics, intended use, and indications for use as a legally marketed predicate device, or that any differences do not raise new questions of safety or effectiveness. Mechanical testing is typically performed to demonstrate equivalent performance.

Feature / Acceptance Criterion (for Substantial Equivalence)	Predicate Device Performance / Characteristic	UCR Spinal System Cross Link Reported Performance / Characteristic	Substantially Equivalent?
Intended Use (Overall design & function)	See Instructions for Use	Identical	Yes
Indications for Use	See Instructions for Use	Identical	Yes
Design and Scientific Technology	Titanium cross bar which clamps onto spinal rods to reduce the chance of movement to aid fusion. Uses a 3mm manual hex driver to lock the device.	Identical	Yes
Sizes	60, 70, 80 mm	See prints (with additional sizes beyond predicate)	Yes, with additional sizes
Material	Titanium alloy	Identical	Yes
Sterile	Non-sterile	Identical	Yes
Mechanical Strength	Similar	See test results (implicitly "Similar" as per "Substantially Equivalent" column)	Yes

Note: The "acceptance criteria" here are defined by the predicate device's characteristics and the requirement for "substantial equivalence." The "reported device performance" is the comparison against those characteristics.

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

The document refers to mechanical strength testing ("See test results"), but does not specify the sample size (number of devices tested) for these mechanical tests, nor does it provide data provenance (e.g., country of origin, retrospective/prospective nature) for any specific testing data. Mechanical testing in a 510(k) is typically conducted in a lab environment.

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

This information is not applicable to this 510(k) submission. No clinical study with expert-established ground truth is described or referenced. The "ground truth" for a 510(k) for a device like this relies on engineering principles and comparison to the predicate device's established performance.

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

Not applicable. No expert adjudication process for a test set is 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

Not applicable. This is a medical device for spinal fixation, not an AI-assisted diagnostic or imaging device. No MRMC study was conducted or is relevant to this submission.

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

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

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

For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is primarily based on:

The established intended use and indications for use of the predicate device.
The design, material, and dimensional specifications of the predicate device.
Mechanical engineering principles and testing standards to ensure that the new device's mechanical strength is comparable to the predicate.

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

Not applicable, as there is no training set.

Summary

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K032739

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UCR Spinal System

SPECIAL 510(K) SUMMARY

Pursuant to 510(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and in accordance with 21 CFR § 807.92.

Submitter Information:	SeaSpine, Inc.Contact: Kirt Stephenson6276 River Crest Drive, Suite ERiverside, CA 92507-0754Phone: 909-656-4850 Fax: 909-656-5530
Company Registration Number:	2032593
Submission Correspondent:	The Regulatory Affairs CompanyContact: Diana Smith727 Park BoulevardSan Diego, CA 92101Phone: 619-251-9132 Fax: 619-696-9883
Date Summary Prepared:	August 18, 2003
Classification Name:	Spondylolisthesis Spinal Fixation DeviceSystem (Class II) – MNH 888-3070Pedicle Screw Spinal System (Class II) –MNI 888-3070Spinal Interlaminal Fracture Orthosis (ClassII) - KWP 88-3050
Common/Usual Name:	Variable and Fixed Cross Link System
Device Trade Name:	UCR Spinal System

The primary device used for comparison in this summary is SeaSpine Inc.'s existing UCR Spinal System cross links (K993503, K021623, and K031381).

(The statements of intended use are identical.) 1. Intended Use:
The intended use and indications when used as a Spondylolisthesis Spinal Fixation Device System are:
The UCR Spinal System is a pedicle screw system indicated for the treatment . of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The intended use and indications when used as a Pedicle Screw Spinal System are:

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UCR Spinal System

The UCR Spinal System is a pedicle screw system 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 or deformities of the thoracic, lumbar, and sacral spine:
degenerative spondylolisthesis with objective evidence of neurological ● impairment,
fracture, .
dislocation, .
scoliosis. .
. kyphosis,
spinal tumor, and .
failed previous fusion (pseudoarthrosis). .

The indications for use as a Hook Spinal System are limited to T1-L5 and are:

degenerative disc disease (as defined by back pain of discogenic origin with . degeneration of the disc confirmed by patient history ad radiographic),
spinal stenosis, ●
spondylolisthesis, ●
spinal deformities (scoliosis, kyphosis, and/or lordosis), ●
fracture, ●
pseudarthosis, ●
tumor resection, and/or ●
failed previous fusion. .

2. Description:

3. Technological Characteristics:

The UCR Spinal System variable and fixed cross links have substantially equivalent technological characteristics to the predicate device. Refer to Table 1 in the following section, entitled Comparison Analysis, for a summation of technological characteristics such as design, dimensional specifications, and material.

4. Comparison Analysis:

The overall design of the UCR Spinal System fixed and variable cross links and their components is essentially the same as that of the predicate device. See Table 1 bon the following page for a comparison of the fixed and variable cross link system and the predicate device.

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PREDICATE DEVICE COMPARISON SUMMARY TABLE
Feature	Variable and Fixed Cross ApprovedLink System	Cross Link	SubstantiallyEquivalent
Intended Use	See Instructions for Use	Identical	Yes
Indications for Use	See Instructions for Use	Identical	Yes
Design and ScientificTechnology	Titanium cross bar whichclamps onto spinal rods toreduce the chance ofmovement to aid fusion.Uses a 3mm manual hexdriver to lock the device.	Identical	Yes
Sizes	See prints	60, 70, 80mm	Yes, withadditional sizes
Material	Titanium alloy	Identical	Yes
Sterile	Non-sterile	Identical	Yes
Mechanical Strength	See test results	Similar	Yes

Table 1: Summary of Design Comparison

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

NOV 2 0 2003

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SeaSpine, Incorporated C/o Ms. Diana Smith The Regulatory Affairs Company 727 Park Boulevard San Diego, California 92101

Re: K032739/S1

Trade/Device Name: UCR Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, MNH Dated: October 15, 2003 Received: October 21, 2003

Dear Ms. Smith:

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 - Ms. Diana Smith

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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. 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 Statement

K632735 510(k) Number (if known):

Device Name: UCR Spinal System

The intended use of the UCR Spinal System variable and fixed cross links remains the same as that of the existing variable and fixed cross links.

The intended use and indications when used as a Spondylolisthesis Spinal Fixation Device System are:

The UCR Spinal System is a pedicle screw system indicated for the treatment . of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.
The intended use and indications when used as a Pedicle Screw Spinal System are:
The UCR Spinal System is a pedicle screw system 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 or deformities of the thoracic, lumbar, and sacral spine:
degenerative spondylolisthesis with objective evidence of neurological . impairment,
fracture, ●
. dislocation,
scoliosis,
. kyphosis,
spinal tumor, and .
failed previous fusion (pseudoarthrosis). ●

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

¥032739 510(k) Numberg Prescription Use V Over=The-Counter-Use · (Per 21 CFR § 801.109)

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when 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 or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.