Spondylolisthesis Spinal Fixation Device System, 87MNH the intended use and indications for use are:
The HAIDER-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 fusion 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.
Pedicle Screw Spinal System, (Class II uses) 87MNI the intended use and indications for use are:
The HAIDER-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 pseudarthrosis)

Device Description

The new 5.5mm screw will be used in all UCR Spinal System applications where a smaller screw would be of benefit. Therefore, the mechanical properties and fatigue performance are important. The remainder of the UCR Spinal System components will remain unchanged. Other than the major and minor diameter of the cancellous portion of the shaft and threads, the new 5.5mm screws are similar to the existing screws. Spinal rod attachment method are the same as cleared previously.

The new 8.0mm Spinal Screws expand the options for screw insertion by providing an alternative to the smaller 6, 6.5 or 7.0mm pedicle screws of the available UCR Spinal System. This new screw diameter allows the surgeon to insert screws in cases where the spine deformity or the large size of the pedicle makes use of smaller diameter screws less desirable. The larger diameter of the 8.0mm Spinal Screws permits the surgeon to address the needs of an expanded patient population.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the UCR Spinal System, specifically focusing on new 5.5mm and 8.0mm spinal screws. This document addresses the substantial equivalence of these new components to previously cleared devices.

Based on the provided information, the device is a pedicle screw Spinal System, which falls under Class II uses. The "studies" conducted are non-clinical bench tests focused on mechanical and fatigue performance to ensure the new screws meet established standards and are equivalent to the predicate device.

Here's an analysis of the requested information:

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

Acceptance Criteria (Standard/Guidance)	Reported Device Performance
ASTM F-1717-96 guidance document	Both the 5.5mm and 8.0mm pedicular screws carry clinically useful loads out to the five-million cycle asymptotic endurance limit.
Compliance with material standards	Not explicitly detailed, but implied by "Titanium alloy" and "Identical" material comparison to predicate.
Compliance with mechanical testing standard	"Mechanical and fatigue testing were carried out" in accordance with ASTM F-1717-96.
Compliance with biocompatibility standard	Not explicitly detailed but is a general control for such devices.
Compliance with specified labeling requirements	Not explicitly detailed but is a general control for such devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document does not specify the exact number of samples tested for the mechanical and fatigue testing. It only states "Samples were tested".
Data Provenance: The data provenance is from non-clinical bench testing. The testing was conducted by SEASPINE, INC. The country of origin of the data would be the USA, where SEASPINE, INC. is located. It is prospective in the sense that the testing was performed specifically for this 510(k) submission, not gathered retrospectively from patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is a non-clinical mechanical testing study, not a clinical study involving diagnosis or interpretation by medical experts. Therefore:

Number of experts: Not applicable.
Qualifications of experts: Not applicable.

The "ground truth" here is the performance under defined mechanical engineering standards, which is established by the test methods themselves and interpreted by engineers.

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

Since this is a non-clinical mechanical test, an adjudication method for human interpretation is not applicable. The results are quantifiable mechanical measurements.

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

MRMC Study: No, an MRMC study was not done. This submission is for a medical device (spinal screws), not an AI/software device that assists human readers.
Effect Size: Not applicable.

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

Standalone Performance: No, a standalone performance study in the context of an algorithm or AI was not done. This is a physical medical device.

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

The ground truth used for this premarket notification is based on engineering standards and mechanical performance metrics. Specifically, the ability of the screws to "carry clinically useful loads out to the five-million cycle asymptotic endurance limit" as defined by the ASTM F-1717-96 guidance document.

8. The sample size for the training set

This is a non-clinical mechanical testing study for a physical device. There is no "training set" in the context of machine learning or AI. The tests are designed to validate the physical properties against established standards.

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

As there is no training set, this question is not applicable. The "ground truth" for the device's performance is established by the specified mechanical testing methods and standards (e.g., ASTM F-1717-96).

Summary

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K021623 1/3

SEP 1 0 2002

Summary of Safety and Effectiveness InformationPremarket Notification, Section 510(k)	SEASPINE, INC.
	AUGUST 23, 2002

Regulatory Authority: Safe Medical Devices Act of 1990, 21 CFR 807.92

1. Device Name:
-----------------	--

Trade Name:	UCR Spinal System
Common Name(s):	pedicle screw
Classification Name(s):	Pedicle Screw Spinal System (Class II Uses)

2. Establishment Name & Registration Number:

Name: SEASPINE, INC. Number:

3. Classification:

§ 888.3070 - Spondylolisthesis Spinal Fixation Device System § 888.3070 - Pedicle Screw Spinal System (Class II Uses)

Device Class:	Class II for the requested indications
Classification Panel:	Orthopaedic and Rehabilitation Devices Panel
Product Code(s):	MNH, MNI, respectively

4. Equivalent Predicate Device:

The 5.5mm Spinal Screws may be directly contrasted with the larger diameter cleared spinal screws of UCR Spinal System, K983353. Other than the reduced major screw diameter, the new Spinal Screws are essentially the same as the cleared spinal screws in the existing UCR Spinal System. The basic design, dimensional tolerances, materials and intended use are identical.

5. Device Description:

Testing Summary:

Mechanical and fatigue testing were carried out. Samples were tested using the ASTM F-1717-96 guidance document. Both the 505mm and the 8.0mm pedicular screws carry clinically useful loads out to the five-million cycle asymptotic endurance limit.

Indications for Use:

Indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion 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. Also 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 the thoracic, lumbar, and sacral spine:

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. degenerative spondylolisthesis with objective evidence of neurological impairment,
. fracture.
dislocation,
. scoliosis,
kyphosis.
l spinal tumor, and
I failed previous fusion (pseudarthrosis)

6. Applicant Name & Address:

SEASPINE, INC. 6276 River Crest Drive Riverside, CA 92507.0754 909.413.0200 (v) 909.653.5680 (f)

7. Company Contact:

Regulatory Affairs 6276 River Crest Drive Riverside, CA 92507.0754 909.413.0200 (v) 909.653.5680 (f)

8. Submission Correspondent:

Mr. David W. Schlerf Buckman Company, LLC. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 - fax

9. Performance Standards:

United States Food and Drug Administration mandated performance standards for this device do not exist. Various voluntary performance standards are utilized. Voluntary standards utilized include ASTM, Standard Operating Procedures, vendor & process certification procedures, Quality Systems Regulations. ISO materials standards and ISO 9000 series quality regulations. SEASPINE, INC. In addition, meets appropriate general controls authorized under Sections 501, 502, 510, 518, 519, and 520 of the Food, Drug, and Cosmetic Act.

10. Special Controls:

Special controls were published in the Federal Register, Vol. 63, No. 143, July 27, 1998 (Orthopedic Devices: Classification and Reclassification of Pedicle Screw Spinal Systems). The following special controls apply to the marketing of this device when used as a posterior pedicle system:

(i) Compliance with material standards,
(ii) Compliance with mechanical testing standard,
(iii) Compliance with biocompatability standard, and
(iv) Compliance with specified labeling requirements.

11. Special Guidance Document Information:

The 510(k) was prepared in accordance with:

"Guidance for Spinal System 510(k)'s," May 7, 1999. l
"The New 510(k) Paradigm, Alternate Approaches to Demonstrating Substantial Equivalence in Premarket 트 Notifications - Final Guidance, March 20, 1998.

12. Storage, Packaging & Sterilization Information:

The UCR Spinal System is supplied "NON-STERILE" and must be sterilized before use. The recommended sterilization process is high temperature sterilization. The recommended sterilization cycle will produce a Sterility Assurance Level (SAL) of at least 10°.

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The validated sterilization cycle is:

Method:	Steam
Cycle:	Gravity
Temperature:	270°F (134°C)
Exposure Time:	30 minutes

13. Summary Comparison Table:

FEATURE	SeaSpine UCR Spinal Screws	UCR Spinal System	SE?
IndicationsforUse:	Indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1vertebra in skeletally mature patients receiving fusion by autogenous bone grafthaving implants attached to the lumbar and sacral spine (L3 to sacrum) with removalof the implants after the attainment of a solid fusion. Also intended to provideimmobilization and stabilization of spinal segments in skeletally mature patients as anadjunct to fusion in the treatment of the following acute and chronic instabilities ordeformities of the thoracic, lumbar, and sacral spine:degenerative spondylolisthesis with objective evidence of neurological impairment,fracture,dislocation,scoliosis.kyphosis,spinal tumor, andfailed previous fusion pseudarthrosis)	Identical	YES
Design:	Cancellous thread pedicle screw, vertebral screws, sacral screws, Polyaxial	SAME	YES
Sterile:	Non-sterile	SAME	YES
Sizes:	5.5 & 8.0mm diameter in 35, 40 and 45mm lengths	EQUIVALENT	YES
Material:	Titanium alloy	Identical	YES
Manufacturer:	SeaSpine, Inc.	IAME, Inc.	YES
Product Code:	MNH, MNI	SAME	YES
K - Number:	K021623	K993503	YES

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is arranged so that "DEPARTMENT OF HEALTH & HUMAN SERVICES" is on the left side of the circle, and "USA" is on the right side.

Public Health Service

SEP 1 0 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SeaSpine, Inc. c/o Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, California 94523

Re: K021623

Trade/Device Name: UCR Spinal System Regulatory Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system, Regulatory Class: II Product Code: MNH, MNI Dated: August 15, 2002 Received: August 16, 2002

Dear Mr. Schlerf:

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.

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. David W. Schlerf

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

A. Salim M. Witta, Ph.D., M.D.

elia 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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Page

K021623 510(k) Number :

Device Name(s):

5.5mm, 8.0mm Spinal Screws and Instruments (Haider UCR Spinal System)

Intended Use(s) of the Device:

1. Spondylolisthesis Spinal Fixation Device System, 87MNH the intended use and indications for use are:
The HAIDER-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 fusion 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.
Pedicle Screw Spinal System, (Class II uses) 87MNI the intended use and indications for use 2. are:
The HAIDER-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 pseudarthrosis)

please do not write below this line - continue on another page if necessary Concurrence of CDRH, Office of Device Evaluation (ODE)

Hipt Qurlse
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number K021623

Prescription Use CFR 801.109) OR

Over-The-Counter Use (Per 21 (Optional format 1-2-96)

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.