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

Device Description

The HAIDER-UCR Spinal System is a pedicle screw system. The system components include Titanium Pedicle screws, Pedicle Screw Components (Set Screw, Washer, Cap, Housing), Screw Sub-Assembly, Crosslink (Cross Link Nut, Cross Link Hook, Cross-link Bar), 5.5 mm Titanium Rods, and Accessories (Hex 3mm Screw Driver, Hex 4mm Screw Driver). The system is made from titanium alloy (6Al, 4V, Ti).

AI/ML Overview

The provided text describes a medical device, the HAIDER-UCR Spinal System, and its regulatory submission (510(k)) to the FDA. It details device characteristics, indications for use, materials, and testing summarized in comparison to a predicate device.

However, the document is a 510(k) Pre-market Notification, which is a submission to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. This type of submission primarily focuses on comparing the new device to an existing one for safety and effectiveness, rather than providing a detailed study proving the new device meets specific, quantitative acceptance criteria through clinical trials or extensive standalone performance studies in the way you might expect for a novel AI/software medical device.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, AI efficacy studies, ground truth establishment) are not applicable or not present in this type of regulatory document for this specific device. The HAIDER-UCR Spinal System is a mechanical implant, and its performance is evaluated through material specifications, mechanical testing, and comparison to an established predicate.

Here's an attempt to answer based on the provided text, indicating where information is not available or not relevant to this type of device submission:

Acceptance Criteria and Device Performance Study (HAIDER-UCR Spinal System)

The HAIDER-UCR Spinal System is a pedicle screw spinal system. Its acceptance criteria are primarily based on demonstrating substantial equivalence to a legally marketed predicate device (Synergy™ Spinal System, K974749) and compliance with relevant material and mechanical testing standards.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are largely defined by demonstrating equivalence to the predicate device and meeting specified engineering standards. The "reported device performance" in this context refers to the results of static and fatigue mechanical testing.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Mechanical Testing	Static Testing: Compliance with ASTM F-1717-96 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model (Static and Fatigue)". Specifically, performance in compression bending, tension bending, and torsion of a typical system configuration. (Implied acceptance: performance equal to or better than predicate, or meeting established safety limits for such devices). Fatigue Testing: Compliance with ASTM F-1717-96. Establishment of an S/N (stress-number of cycles) curve with run-out points. (Implied acceptance: ability to withstand a specified number of load cycles without failure, equivalent to or better than predicate, or meeting established safety limits).	Static Testing: "Static tests of compression bending, tension bending and torsion of a typical system configuration indicated design performance was met. All samples were tested according to ASTM F-1717-96, the pedicle screw spinal system guideline." Fatigue Testing: "Samples subjected to cyclic fatigue testing also performed according to expectations. Seven constructs were tested and an S/N curve established. At least two run out points exceeded 5,000,000 load cycles."
Materials	Compliance with quality and composition standards for Titanium alloy or 6Al, 4V, Ti titanium alloy. (Implied acceptance: meeting ISO or ASTM material specifications, and being the "SAME" material as the predicate).	"The system is made from a well known metallic alloy commonly known as titanium alloy or 6Al, 4V, Ti titanium alloy. This material meets or exceeds the quality and composition standards listed in the table below [table not legible for specific values, but indicates compliance]." Comparison Table: "Materials: Titanium alloy" and "Synergy™ Spinal System: SAME" (indicating equivalence).
Indications for Use	Equivalence in indications for use to the predicate device.	The device "has been determined... substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976...". Comparison Table: "Indications for Use: SAME" as Synergy™ Spinal System.
Sterility	Supplied "NON-STERILE" with a recommended sterilization process (high-temperature steam) that will achieve a Sterility Assurance Level (SAL) of at least 10⁻⁶.	"The HAIDER-UCR Spinal System is supplied 'NON-STERILE' and must be sterilized prior to use. The recommended sterilization process is high temperature sterilization. The recommended sterilization cycle will produce a Sterility Assurance Level (SAL) of at least 10⁶. The validated cycle is: Method: Steam Cycle: Gravity Temperature: 270°F (125°C) Exposure Time: 15 minutes." Comparison Table: "Sterile: Supplied Non-sterile Autoclave processed by end user" and "Synergy™ Spinal System: SAME".
Design / Components	Equivalence in design (Rod, sacral screw, pedicle screw & cross-link system) and sizes (rods, pedicular screws) to the predicate device.	Comparison Table: "Design: Rod, sacral screw, pedicle screw & cross link system" and "Synergy™ Spinal System: SAME". "Sizes: Rods: 5.5mm dia. X 40-305mm length Pedicular screws 7.0mm 35mm, 40mm, 45mm" and "Synergy™ Spinal System: EQUIVALENT".
Regulatory Compliance	Compliance with general controls and special controls (material standards, mechanical testing standard, biocompatibility standard, specified labeling requirements) for pedicle screw spinal systems.	The FDA's 510(k) clearance indicates compliance: "You may, therefore, market the device, subject to the general control provisions of the Act... If your device is classified... into... class II (Special Controls)... it may be subject to such additional controls." The document lists special controls that apply and states IAME, INC. meets appropriate general controls.

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

Sample size for test set:
- For mechanical testing (ASTM F-1717-96): "Seven constructs were tested" for cyclic fatigue. The number of samples for static tests (compression bending, tension bending, torsion) is not explicitly stated, but it mentions "All samples were tested." In the context of ASTM F1717, typically a minimum of 6 samples per test condition are recommended.
Data provenance: The data is generated from in vitro mechanical testing performed by the manufacturer, INTERNATIONAL ADVANCED MEDICAL ENTERPRISES, INC. The country of origin for the data is implicitly the USA, where the company and the FDA are located. The testing is prospective in the sense that it was conducted specifically to support this regulatory submission, rather than being collected retrospectively from a pre-existing dataset.

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

Not Applicable. This is a mechanical implant device. The "ground truth" for its performance is established through adherence to engineering standards (ASTM F-1717-96) measuring physical properties, not by expert interpretation of clinical data or images.

4. Adjudication method for the test set

Not Applicable. As per point 3, there is no expert interpretation or "ground truth" in the sense of clinical assessment requiring adjudication. The compliance is assessed by comparing measured mechanical properties against standard requirements.

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 not an AI/software medical device. No human-in-the-loop studies or AI assistance are relevant.

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

Not Applicable. This is not an AI/software medical device.

7. The type of ground truth used

Engineering Standards and Predicate Device Equivalence: The "ground truth" is defined by the requirements of recognized engineering standards (e.g., ASTM F-1717-96) for mechanical performance and the established performance and safety profile of the legally marketed predicate device (Synergy™ Spinal System). For materials, it's compliance with material composition standards.

8. The sample size for the training set

Not Applicable. This is not an AI/software medical device for which a "training set" in the machine learning sense would be used. The design and manufacturing processes are informed by established engineering principles and prior knowledge from the predicate device and similar implants.

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

Not Applicable. As per point 8, there is no "training set" in this context. The "truth" for developing such a device relies on decades of biomedical engineering research, material science, surgical experience, and regulatory guidance for spinal implants.

Summary

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

APR 1 4 2000

CALL COLORIO COLLEGION COLLEGION CARDED THE TOUR WAS FORcome to consistence in controllation and consistences and the management commens process and est a manus commendent commendent commendent commendent commendent commendent com.CARRARIELE BALKE BREAK ULAR IS SPICE SITEREARCERILAT AREAS... Anche managaganaaaaa attitutation as actua-lillanteel. .















a consisted to the country of the count of the commended to the are all of the a de time of the call of the call of the call of the call of the call of the call of the call o

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

1. Device Name:

HAIDER-UCR Spinal System

Common Name(s): Pedicle screw spine system

Classification Name(s): Pedicle Screw Spinal System

2. Establishment Information:

Name:	INTERNATIONAL ADVANCED MEDICAL ENTERPRISES, INC
Number:	9033791
Address:	5360 Preserve Parkway, S
	909.682.9616 - 909.682.9620 - fax
	Greenwood Village, CO 80121

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 Codels): MNH. MNI respectively

Equivalent Predicate Device: 4.

Synergy™ Spinal System: K974749, Cross Medical Products, Inc. (now Interpore Cross International).

5. Device Description:

Indications for Use: when used as a 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.

When used as a 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:

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

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

The system components include:

Component	Catalog Number	Level of Use
Titanium Pedicle screw7.0mm dia., Assembled7.0mm X 35mm7.0mm X 40mm7.0mm X 45 mm	40-3540-4040-45	T-10 to SacrumT-10 to SacrumT-10 to Sacrum
Pedicle Screw ComponentsSet ScrewWasherCapHousing	60-1060-1560-2060-25	T-10 to SacrumT-10 to SacrumT-10 to SacrumT-10 to Sacrum
Screw Sub-Assembly7.0mm X 35mm7.0mm X 40mm7.0mm X 45 mm	60-3560-4060-45	T-10 to SacrumT-10 to SacrumT-10 to Sacrum
CrosslinkCross Link NutCross Link HookCross-link Bar-60mmCross-link Bar-70mmCross-link Bar-80mm	505570-6070-7070-80	L-1 to L-5L-1 to L-5L-1 to L-5L-1 to L-5L-1 to L-5
5.5 mm Titanium Rods5.5mm X 305mm	95	T-10 to Sacrum
AccessoriesHex 3mm Screw DriverHex 4mm Screw Driver	300400

Materials: The system is made from a well known metallic alloy commonly known as titanium alloy or 6Al, 4V, Ti titanium alloy. This material meets or exceeds the quality and composition standards listed in the table below:

	Specificant of the controllation of the commended to come of the come of the moreand and of the program and the comments of the country of the may be the country of the country of the country of the country of the country of the country of the county of t
GAL AVTIMapley Labor	A CTAI CASCC-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	------------------------------------------------------------------------------------------------------------------------------------------------------------------------------No. of Children of Children of Childrenubod UDI1AM------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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

Testing Summary: Static and fatigue testing were conducted. Static tests of compression bending, tension bending and torsion of a typical system configuration indicated design performance was met. All samples were tested according to ASTM F-1717-96, the pedicle screw spinal system quideline. Samples subjected to cyclic fatigue testing also performed according to expectations. Seven constructs were tested and an S/N curve established. At least two run out points exceeded 5.000.000 load cycles.

7. Company Contact:

Todd L. Ackarman Requiatory Affairs IAME, INC.

8. Submission Correspondent:

Mr. David W. Schlerf Buckman Company, Inc. 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 and qualification procedures, Quality Systems Regulations, ISO materials standards and ISO 9000 series quality regulations.

IAME, INC. also meets appropriate general controls authorized under Sections 501, 502, 510, 516, 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. Storage, Packaging & Sterilization Information:

The HAIDER-UCR Spinal System is supplied "NON-STERILE" and must be sterilized prior to use.

The recommended sterilization process is high temperature sterilization. The recommended sterilization cycle will produce a Sterility Assurance Level (SAL) of at least 10°

The validated cycle is:

Method: Steam Cycle: Gravity Temperature: 270°F (125°C) Exposure Time: 15 minutes

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

All packages containing implants or instruments should be intact upon receipt. If the package or product is damaged, the product should not be used and should be returned. Product must be handled, stored and opened in such a way that it is protected from inadvertent damage or contamination. When used, the product must be placed into use following cleaning, sterilization and accepted surgical sterile technique.

FEATURE	HAIDER-UCR Spinal System	Synergy™ Spinal System	SE?
Indications forUse:	degenerative spondylolisthesis with objective evidence ofneurological impairment,fracture,dislocation,scoliosis,kyphosis,spinal tumor, andfailed previous fusion pseudarthrosis).	SAME	YES
Materials:	Titanium alloy	SAME	YES
Design:	Rod, sacral screw, pedicle screw & cross link system	SAME	YES
Sterile:	Supplied Non-sterileAutoclave processed by end user	SAME	YES
Sizes:	Rods: 5.5mm dia. X 40-305mm lengthPedicular screws 7.0mm 35mm, 40mm, 45mm	EQUIVALENT	YES
Manufacturer:	IAME, Inc.	Interpore/Cross	YES
Product Code:	MNH, MNI	SAME	YES
K - Number:	Pending	K974749	YES

12. Summary Comparison Table:

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

Image /page/4/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 4 2000

Mr. David W. Schlerf Buckman Company, Inc. c/o IAME, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, California 94523-3389

Re: K993503 Trade Name: HAIDER-UCR Spinal System Regulatory Class: II Product Code: MNH and MNI Dated: January 10, 2000 Received: February 24, 2000

Dear Mr. Schlerf:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

{5}------------------------------------------------

Page 2 - Mr. David W. Schlerf

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 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 your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Danne R. Vochner.

1 Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Page 1 of 1

X 493503 510(k) Number :_______________________________________________________________________________________________________________________________________________________________

Device Name(s): HAIDER-UCR Spinal System

Intended Use Statement(s):

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.
1. 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 with objective evidence of neurological ● spondylolisthesis 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)

Dmns D. Lochner.

(Division Sig -Off) Division of Ceneral Restorative Devices 510(k) Number_K99350 Z

X Prescription Use _ (Per 21 CFR 801.109)

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

UCR.DOC

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.