In addition, when used as a pedicle screw fixation system, the NFix Fusion System is intended for skeletally mature with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 and below), with removal of the implants after the attainment of solid fusion.

Device Description

The NFix Fusion System consists of four or more pedicle screws and two NFix solid rods in a symmetric, bilateral arrangement. The pedicle screws are placed axially in the pedicles with two screws in the cephalad position and two screws in the caudad position. The NFix solid rods are secured in the heads of the pedicle screws so that fixed stabilization is provided between the cephalad and caudad vertebrae. Crosslinks can be used if additional stabilization is necessary.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the NFix Fusion System, a spinal implant. However, it does not contain the detailed information necessary to complete a table of acceptance criteria and reported device performance, nor does it describe a study that proves the device meets specific acceptance criteria in the way described in your request.

The document primarily focuses on establishing substantial equivalence to a predicate device (Moss Miami Spinal System) based on similar intended use, design, and mechanical performance characteristics. It provides the following information that relates to your request, but many specific details are missing:

Device Description: The NFix Fusion System consists of four or more pedicle screws and two solid rods for posterior, noncervical, pedicle fixation.
Indications for Use: Detailed for acute and chronic instabilities/deformities and severe spondylolisthesis.
Summary of Testing: States that the technological characteristics are similar to the predicate device due to similarities in intended use, design, and mechanical performance characteristics. This implies that some form of testing was done to demonstrate these similarities, but the specific acceptance criteria and detailed results are not provided in this summary.

Therefore, many parts of your request regarding acceptance criteria, study details, sample sizes, ground truth establishment, and MRMC studies cannot be answered from the provided text.

Here's a breakdown of what can and cannot be addressed:

Table of acceptance criteria and the reported device performance:
- Cannot be created. The document states "Establishment of similarities is based upon similarities of intended use, design and mechanical performance characteristics." This suggests that the acceptance criteria would be related to meeting certain mechanical performance thresholds comparable to the predicate device, but the specific criteria (e.g., torsion strength, pull-out strength, fatigue life) and the numerical results are not reported here.
Sample size used for the test set and the data provenance:
- Not provided. The document does not detail any specific test sets, sample sizes, or data provenance. The summary of testing refers to general "technological characteristics" and "mechanical performance characteristics" but not a clinical test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. This type of information is usually relevant for studies involving diagnostic or prognostic devices where expert interpretation forms the ground truth. For a spinal implant, ground truth would typically be related to mechanical properties or surgical outcomes, not expert interpretation of outputs. No such expert panel is mentioned.
Adjudication method for the test set:
- Not applicable/Not provided. Similar to point 3, adjudication methods are usually for interpretive tasks, which are not detailed here for this device.
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/Not provided. The device is a spinal implant, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is not relevant to this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. The device is a physical pedicle screw and rod system, not a software algorithm.
The type of ground truth used:
- Inferred based on device type, but not explicitly stated. For a spinal implant, the "ground truth" for mechanical performance would be established through industry standard mechanical testing (e.g., ISO, ASTM standards) to measure properties like fatigue, static compression, or pull-out strength. For clinical outcomes, it would be patient outcomes data. The document only mentions "mechanical performance characteristics" were assessed for similarity to the predicate.
The sample size for the training set:
- Not applicable/Not provided. As this is a physical medical device and not a machine learning model, the concept of a "training set" in the context of AI/ML is not applicable.
How the ground truth for the training set was established:
- Not applicable/Not provided. (See point 8)

In summary, the provided 510(k) summary focuses on demonstrating substantial equivalence through a comparison of design and intended use, and generally mentions "mechanical performance characteristics" without detailing the specific tests, acceptance criteria, or results that would directly answer your questions about study design and performance metrics.

Summary

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KØS3623

JUL 1 2 2006

Section 1 -510(k) Summary

SUBMITTED ON BEHALF OF:

Telephone: Fax:

bv:

Telephone: Fax:

CONTACT PERSON:

DATE PREPARED:

TRADE NAME: COMMON NAME: CLASSIFICATION NAME

REGULATION Regulatory Class Device Panel and Product Code: N Spine, Inc. 6244 Ferris Square, Suite B San Diego, CA 92121-3239 (858) 452-1266 (858) 452-7994

Elaine Duncan, M.S.M.E., RAC President, Paladin Medical, Inc. PO Box 560 Stillwater, MN 55082 715-549-6035 715-549-5380

Elaine Duncan

December 16, 2005

NFix Fusion System Spinal System. Fusion Posterior Spinal Fusion System with solid rod and pedicle screws 21 CFR 888.3070 Class 2 Orthopedic Panel - Product Code: MNH

SUBSTANTIALLY EQUIVALENT TO:

Moss Miami Spinal System

DESCRIPTION of the DEVICE:

INDICATIONS FOR USE:

The NFix Fusion System is intended for posterior, noncervical, pedicle fixation in order 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, including degenerative spondylolisthesis with blyective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). In addition, when used as a periodic screw fixation system, the NFix Fusion System is intended for skeletally mature patients with severe sponding the sis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous brone graft having implants attached to the lumbar and sacral spine (L3 and below), with removal of the implants after the attainment of solid fusion.

SUMMARY OF TESTING:

The technological characteristics of the NFix Fusion System are similar to the Moss Miami Spinal System, manufactured by DePuy Inc. Establishment of similarities is based upon similarities of intended use, design and mechanical performance characteristics.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which features three human figures connected by flowing lines. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 2 2006

N-Spine, Inc. % Paladin Medical, Inc. Ms. Elaine Duncan President PO Box 560 Stillwater, Minnesota 55082

Re: K053623

Trade/Device Name: NFix Fusion System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH Dated: May 30, 2006 Received: May 31, 2006

Dear Ms. Duncan:

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. Elaine Duncan

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 vours,

Loubare Mueller

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):

Device Name: NFix Fusion System

Indications For Use:

NFix Indications for Use:

Prescription Use _ x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Soubaca Buchard fr mxm

Division of General. Restorative. and Neurological Devices

Page 1 of 1

510(k) Number K053623

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.