The MSD CABLE REDUCTION SYSTEM screws and hooks are only intended for use in the thoracic and lumbar spine. The system provides an alternative to sublaminar and intraspinous process wiring for trauma applications. Another application is the use of the MSD CABLE REDUCTION SYSTEM for instrumentation involved in the correction of scoliotic, kyphotic, and lordotic deformities. The system may also be used with other spinal implants such as the MSD Unit Rod, the ATLAS™ CABLE System or the Luque Rod, or wherever "wiring" may help secure the attachment of other implants.

Device Description

The MSD CABLE REDUCTION SYSTEM is a temporary implant for the use in orthopaedic surgery. The system is intended to help provide temporary stabilization, augment the development of solid bony fusion and/or aid in the repair of bone fractures. The system consists of a multi-stranded cable and ancillary components used in several different configurations. The MSD CABLE REDUCTION SYSTEM implant components are made of medical grade stainless steel described by ASTM Standard F-138 or ISO 5832-1 or ISO 5832-9. Alternatively, the system may be made out of titanium alloy or titanium, as described in ASTM F-136 or ISO 5832-3 for the surgical grade titanium alloy and ASTM F 67 or ISO 5832-2 for pure titanium. The MSD CABLE REDUCTION SYSTEM may be sold sterile or non-sterile.

AI/ML Overview

This document is a 510(k) summary for the Medtronic Sofamor Danek CABLE REDUCTION SYSTEM, approved in 2003. It primarily details the device's description, indications for use, and a declaration of substantial equivalence to a predicate device.

Crucially, this document does not include information about acceptance criteria or a study demonstrating the device meets those criteria in the context of device performance metrics or clinical outcomes.

Instead, the "acceptance criteria" here refers to the FDA's regulatory acceptance, which is based on demonstrating substantial equivalence to a legally marketed predicate device. The "study" that "proves" the device meets these "acceptance criteria" is the 510(k) submission itself, which primarily focuses on demonstrating that the new device is as safe and effective as the predicate, often through material comparisons, design similarities, and sometimes mechanical testing to show performance parity, rather than clinical efficacy studies with human subjects.

Therefore, I cannot fill in the requested table and sections regarding device performance, sample sizes, ground truth, or MRMC studies because the provided text does not contain that level of detail for this type of medical device submission. The 510(k) process for devices like spinal fixation systems typically relies heavily on demonstrating substantial equivalence to a predicate device that is already on the market, rather than requiring new clinical efficacy trials for every new iteration.

Here's what I can extract and what is explicitly missing:

Acceptance Criteria and Device Performance (Based on "Substantial Equivalence")

Acceptance Criteria Category	Reported Device Performance (as demonstrated by substantial equivalence)
Safety and Effectiveness	Equivalent to the predicate ATLAS™ CABLE System in terms of intended use, materials, and design principles. The 510(k) process implicitly accepts that if the device is substantially equivalent to a legally marketed device, it is also safe and effective for its indicated uses.
Indications for Use	Matches the predicate device: temporary stabilization in orthopaedic surgery, augment bony fusion, aid in fracture repair. Specifically for thoracic and lumbar spine, as an alternative to sublaminar/intraspinous process wiring for trauma, correction of scoliotic, kyphotic, and lordotic deformities, and with other spinal implants.
Material Composition	Medical grade stainless steel (ASTM F-138 or ISO 5832-1/5832-9) or titanium/titanium alloy (ASTM F-136, ISO 5832-3, ASTM F 67, ISO 5832-2). This is presumably equivalent to the predicate or within accepted material standards for such devices.
Device Design	Consists of multi-stranded cable and ancillary components, used in various configurations (implied to be similar or functionally equivalent to predicate).
Sterilization Status	May be sold sterile or non-sterile (implies equivalence to predicate's options or standard practice).

Missing Information (Not Present in the Provided 510(k) Summary)

The following information regarding a detailed study with specific performance metrics is not available in the provided text. The 510(k) summary focuses on regulatory approval via substantial equivalence rather than a detailed performance study with quantifiable metrics as typically seen for AI/diagnostic devices.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of 510(k) submission which relies on substantial equivalence rather than clinical study data. Any 'testing' would likely be mechanical bench testing, not clinical human data.
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. "Ground truth" for this device would refer to its mechanical properties or ability to fulfill its function, likely assessed through engineering tests, not expert consensus on images or outcomes.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 device is a surgical implant, not an AI diagnostic tool or imaging system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Ground truth for a device like this would typically involve mechanical testing (e.g., tensile strength, fatigue testing, pull-out strength) and potentially animal studies, which are not detailed here. Clinical outcomes data or pathology results from human trials are not described in this summary as a basis for equivalence.
The sample size for the training set: Not applicable. This device is not an AI model.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission demonstrating "substantial equivalence" of a medical device (a surgical cable system) to a previously approved predicate device. It does not contain the kind of detailed performance study data you would typically find for an AI/diagnostic device or a device requiring new clinical efficacy trials.

Summary

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JUN - 6 2003

Medtronic Sofamor Danek CABLE REDUCTION SYSTEM 510(k) Summary (K030816) May 2003

Medtronic Sofamor Danek USA, Inc. I. Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133

Proposed Proprietary Trade Name: II.

MSD CABLE REDUCTION SYSTEM

Regulation Numbers: 888.3050 and 888.3010

Regulation Names: Bone Fixation Cerclage, Spinal Interlaminal Fixation Orthosis

Codes: KWP, JDQ

Description III.

The system consists of a multi-stranded cable and ancillary components used in several different configurations. The MSD CABLE REDUCTION SYSTEM implant components are made of medical grade stainless steel described by ASTM Standard F-138 or ISO 5832-1 or ISO 5832-9. Alternatively, the system may be made out of titanium alloy or titanium, as described in ASTM F-136 or ISO 5832-3 for the surgical grade titanium alloy and ASTM F 67 or ISO 5832-2 for pure titanium. The MSD CABLE REDUCTION SYSTEM may be sold sterile or non-sterile.

IV. Indications for Use:

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spinal implants such as the MSD Unit Rod, the ATLAS™ CABLE System or the Luque Rod, or wherever "wiring" may help secure the attachment of other implants.

Substantial Equivalence: V.

The subject MSD CABLE REDUCTION SYSTEM components were declared substantially equivalent to the predicate ATLAS™ CABLE System components manufactured by Medtronic Sofamor Danek.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human profile, represented by three curved lines that suggest a face looking to the right. The logo is rendered in black and white.

Public Health Service

JUN - 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. Richard Treharne, Ph.D. Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis. Tennessee 38132

Re: K030816

Trade Name: MSD Cable Reduction System Regulation Number: 21 CFR 888.3050, 888.3010 Regulation Name: Spinal interlaminal fixation orthosis, Bone fixation cerclage Regulatory Class: II Product Code: KWP, JDQ Dated: April 21, 2003 Received: April 22, 2003

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.

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Page 2 - Dr. Richard Treharne, Ph.D.

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

O 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

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510(k) Number (if known): ____K030816

Device Name: _ _ _____________________________________________________________________________________________________________________________________________________________

The MSD CABLE REDUCTION SYSTEM screws and hooks are only intended for use in the thoracic and lumbar spine. The system provides an alternative to sublaminar and intraspinous process wiring for trauma applications. Another application is the use of the MSD CABLE REDUCTION SYSTEM for instrumentation involved in the correction of scoliotic, and lordotic deformities. The system may also be used with other spinal implants such as the MSD Unit Rod, the ATLAS™ CABLE System or the Luque Rod, or wherever "wiring" may help secure the attachment of other implants.

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

Concurrence of CDRH, Office of Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) (Optional 1-2-96)

Over-the-counter Use - -

Muriam C. Provost

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

510(k) Number K030816

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.