BASIS™ Screws and Hooks are intended for posterior, non-cervical fixation for the following indications: spinal stenosis; spondylolisthesis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); trauma (i.e., fracture or dislocation); pseudarthrosis; tumor; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar, or anterior cervical system, BASIS components are intended for the following indications: (1) spinal stenosis, (2) spondylolisthesis, (3) spinal deformities (i.e., scoliosis, and/or lordosis), (4) fracture, (5) pseudarthrosis, (6) tumor resection, and/or (7) failed previous fusion.

Device Description

The BASIS™ Spinal System consists of a variety of shapes and sizes of hooks, screws and rods as well as ancillary instrument sets. The BASIS™ implant components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

BASIS™ hooks are intended for posterior use only.

The BASIS™ Spinal System implant components are made from medical grade titanium and titanium alloy.

AI/ML Overview

This document is a 510(k) premarket notification for the BASIS™ Spinal System, which seeks to demonstrate substantial equivalence to previously cleared devices. It is not a study that proves the device meets specific acceptance criteria through performance evaluation. Therefore, most of the requested information regarding acceptance criteria and study design is not present in this document.

Here's what can be extracted based on the provided text:

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

This document does not contain acceptance criteria related to device performance (e.g., accuracy, sensitivity, specificity) or reported performance metrics. It's a regulatory submission focused on substantial equivalence based on product description and indications for use.

2. Sample sized 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 510(k) submission, which typically relies on comparisons to predicate devices and engineering/bench testing, not clinical performance studies with test sets in the manner of an AI/diagnostic device.

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)

Not applicable. No ground truth establishment for a test set is described.

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

Not applicable. No adjudication method 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 spinal implant system, not a diagnostic AI device.

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

Not applicable. This is a medical device (spinal implant), not a standalone algorithm.

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

Not applicable. The concept of "ground truth" in the context of diagnostic or AI performance evaluation is not relevant to this 510(k) submission. The "truth" in this context refers to the safety and effectiveness of the device as established through comparison to legally marketed predicate devices and adherence to regulatory standards for medical implants.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device; therefore, there is no training set mentioned.

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

Not applicable. As there is no training set, there's no ground truth for it.

Summary of what the document does provide:

Device Name: BASIS™ Spinal System
Manufacturer: Medtronic Sofamor Danek, Inc. USA
Regulatory Status: 510(k) premarket notification (K050484), determined substantially equivalent (May 4, 2005)
Predicate Devices: CD HORIZON® Spinal System screws, hooks and Rods (K042025, K020709 and K981676)
Indications for Use (Key "Acceptance Criteria" in the context of 510(k) for equivalence): These are the conditions for which the device is intended to be used, and they must be substantially equivalent to the predicate device.
- BASIS™ Screws and Hooks (posterior, non-cervical fixation): spinal stenosis; spondylolisthesis; curvatures (scoliosis, kyphosis, lordosis); trauma (fracture or dislocation); pseudarthrosis; tumor; and/or failed previous fusion.
- BASIS™ Components (except hooks, as anterolateral thoracic/lumbar, or anterior cervical system): spinal stenosis, spondylolisthesis, spinal deformities (scoliosis, kyphosis, lordosis), fracture, pseudarthrosis, tumor resection, and/or failed previous fusion.
Materials: Medical grade titanium and titanium alloy.

The "study that proves the device meets the acceptance criteria" in the context of a 510(k) is the demonstration of substantial equivalence to predicate devices, not a separate clinical performance study with specific metrics like sensitivity or specificity. The entire submission acts as the "proof" that it meets the regulatory "acceptance criteria" for market clearance.

Summary

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MAY - 4 2005

BASISTM Spinal System Summary of Safety and Effectiveness April 2005

Medtronic Sofamor Danek, Inc. USA Company: I. 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
Richard W. Treharne, PhD Contact: Senior Vice President Regulatory Affairs
Proposed Proprietary Trade Name: BASIS™ Spinal System II.
Classification Name(s)/Product Code(s): III. Classification Name: Spinal Interlaminal Fixation Orthosis, Pedicle Screw Spinal System, Spinal Intervertebral Body Fixation Orthosis (per 21 CFR Sections 888.3050, 888.3060, and 888.3070) Product Codes: KWP, KWQ, MNH, and MNI

IV. Product Description

BASIS™ hooks are intended for posterior use only.

The BASIS™ Spinal System implant components are made from medical grade titanium and titanium alloy. No warranties express, or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. See the MSD Catalog for further information about warranties and limitations of liability. Never use stainless steel and titanium implant components in the same construct.

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Indications V.

BASIS™ Screws and Hooks

The BASIS™ Spinal System is intended for posterior, non-cervical fixation for the following indications: spinal stenosis; spondylolisthesis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); trauma (i.e., fracture or dislocation); pseudarthrosis; tumor; and/or failed previous fusion.

Substantial Equivalence VI.

Documentation was provided which demonstrated the BASIS™ Spinal System to be substantially equivalent to the following systems: CD HORIZON® Spinal System screws, hooks and Rods (K042025, K020709 and K981676).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

Public Health Service

MAY - 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Richard W. Treharne, PhD Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132

Re: K050484

Trade/Device Name: BASIS™ Spinal System Regulation Number: 21 CFR 888.3070, 888.3060, 888.3050 Regulation Name: Pedicle screw spinal system, Spinal interlaminal fixation orthosis, Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MNI, KWQ, KWP, MNH Dated: February 22, 2005

Received: February 25, 2005

Dear Dr. Treharne:

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. 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

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Page 2 – Mr. Richard W. Treharne

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with and w yourse finding of substantial equivalence of your device to a legally premation in the 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 If you desire specific acrioliance at (240) 276-0120 . Also, please note the regulation entitled, connact the Ories of Compunition in (21 the Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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/cdrl/industry/support/index.html.

Sincerely yours,

Hypt Rlwdn

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1 April 2005

510(k) Number (K050484):

BASIS™ Spinal System Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use

BASIS™ Screws and Hooks

Dribit - berews and Hooks are intended for posterior, non-cervical fixation for the following indications: spinal stenosis; spondylolisthesis; curvatures (i.e., scoliosis, the following indications: spinal stenesse, are -----------------------------------------------------------------------------------------------------------------------------and/or failed previous fusion.

BASIS™ Components

Except for hooks, when used as an anterolateral thoracic/lumbar, BASIS™ components Except for the following indications: (1) spinal stenosis, (2) spondylolisthesis, (3) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (4) fracture, (5) pseudarthrosis, (6) tumor resection, and/or (7) failed previous fusion.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

Hytl Rurdes
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.