SATELLITE SPINAL SYSTEM by MEDTRONIC SOFAMOR DANEK

The SATELLITE™ Spinal System is intended to be inserted between the vertebral bodies into the disc space from L3 to S1 to help provide stabilization and to help promote intervertebral body fusion. This internal fixation device is intended for, and designed solely for holding bone parts in alignment while they heal. The SATELLITE™ Spinal System is intended to be used with bone graft.

Device Description

The SATELLITE™ Spinal System consists of cobalt chrome spheres, which may be implanted from L3-S1 to provide temporary stabilization in order to help promote fusion.

AI/ML Overview

This device, the SATELLITE™ Spinal System (K051320), received 510(k) clearance in 2005. It's important to note that the provided documentation states this device is a "preamendment device" and was found substantially equivalent to a legally recognized preamendment device (the Harmon Spinal Sphere). This means that its acceptance criteria and the "study" that proves it meets them are fundamentally different from what would be expected for a novel device undergoing a PMA (Premarket Approval) process under current regulations.

The core of its "acceptance" is substantial equivalence to a predicate device that was on the market before the 1976 Medical Device Amendments. Therefore, the information requested about specific performance metrics, sample sizes, expert ground truth, etc., in the context of a prospective study for a novel device does not apply in the same way to this 510(k) clearance.

Here's an attempt to answer the questions based on the provided document, highlighting where the typical interpretation of these questions doesn't fit a preamendment predicate equivalence pathway:

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

For a 510(k) clearance based on substantial equivalence to a preamendment device, the "acceptance criteria" are primarily established by the characteristics and intended use of the predicate device. The "reported device performance" is demonstrating that the new device shares similar characteristics and performs as safely and effectively as the predicate for its intended use, based on documentation and engineering principles rather than a detailed clinical performance study against specific quantitative criteria.

Acceptance Criteria (Inferred from Predicate Equivalence)	Reported Device Performance (as per 510(k) Summary)
Intended Use: Temporary stabilization to promote intervertebral body fusion (L3-S1).	Indication for Use: "The SATELLITE™ Spinal System is intended to be inserted between the vertebral bodies into the disc space from L3 to S1 to help provide stabilization and to help promote intervertebral body fusion. This internal fixation device is intended for, and designed solely for holding bone parts in alignment while they heal. The SATELLITE™ Spinal System is intended to be used with bone graft." (Identical to predicate's intended use in function).
Design/Materials: Spinal spheres made of suitable biocompatible material for intervertebral fusion.	"The SATELLITE™ Spinal System consists of cobalt chrome spheres..." (Implies material similarity or equivalence in performance to predicate).
Mechanism of Action: Provides internal fixation for bone alignment during healing.	"...designed solely for holding bone parts in alignment while they heal." (Consistent with predicate's mechanism).
Safety & Effectiveness: Comparable to the predicate device.	"Documentation was provided which demonstrated the SATELLITE™ Spinal System to be substantially equivalent to a legally recognized preamendment device, namely the Harmon Spinal Sphere manufactured by the Austenal Company of New York, NY." (The "performance" is demonstrated through this equivalence statement).

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

This information is not applicable in the context of a 510(k) clearance based on substantial equivalence to a preamendment device like the SATELLITE™ Spinal System. There was no "test set" in the sense of a clinical study with a specified sample size. The clearance was based on comparison to an already marketed predicate, not new clinical data demonstrating specific performance metrics against a defined acceptance criteria.

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 information is not applicable. There was no "test set" requiring ground truth establishment by experts for performance evaluation in a clinical study. The FDA's review for substantial equivalence focuses on comparing the new device's design, materials, and intended use to the predicate.

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

This information is not applicable for the reasons stated above.

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

This information is not applicable. The SATELLITE™ Spinal System is a physical implant, not an AI or imaging device. Therefore, no MRMC study, AI assistance, or human reader improvement analysis would be relevant or performed.

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

This information is not applicable as the device is a physical implant, not an algorithm.

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

This information is not applicable in the context of establishing performance for this 510(k) clearance. The "ground truth" for the clearance was essentially the FDA's acceptance that the predicate device (Harmon Spinal Sphere) was legally marketed and considered safe and effective for its intended use, and that the SATELLITE™ Spinal System was sufficiently similar.

8. The sample size for the training set

This information is not applicable. There was no "training set" as this device is a physical implant and not an algorithm requiring machine learning.

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

This information is not applicable as there was no training set.

Summary

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A final rule classifying spinal spheres for use in intervertebral fusion procedures, a preamendments, unclassified device type, into class III (premarket approval), was published on March 30, 2023. See here: https://www.federalregister.gov/documents/2023/03/30/2023-06566/medical-devices-orthopedic-devices-classification-of-spinalspheres-for-use-in-intervertebral-fusion. Concurrently, FDA published a final order to require the filing of a premarket approval application (PMA) for spinal spheres for use in intervertebral fusion procedures. See here: https://www.federalregister.gov/documents/2023/03/30/2023-06565/effective-date-of-requirement-for-premarket-approvalapplications-for-spinal-spheres-for-use-in.

Please refer to the aforementioned final rule and final order for current regulatory requirements for this device type.

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SATELLITE™ SPINAL SYSTEM 510(k) Summary - K051320 August 2005

I.	Company:	Medtronic Sofamor Danek1800 Pyramid PlaceMemphis, TN 38132(901) 396-3133	SEP - 9 2005
	Contact:	Richard W. TreharneSr. Vice President, Regulatory Affairs

Proprietary Trade Name: SATELLITE™ Spinal System II.
Classification Name: Spinal Device III.
Regulation Number: Preamendment Device IV.

Product Description V.

The SATELLITE™ Spinal System consists of cobalt chrome spheres, which may be implanted from L3-S1 to provide temporary stabilization in order to help promote fusion.

Indications VII

Substantial Equivalence VIII

Documentation was provided which demonstrated the SATELLITE™ Spinal System to be substantially equivalent to a legally recognized preamendment device, namely the Harmon Spinal Sphere manufactured by the Austenal Company of New York, NY.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 9 2005

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

Re: K051320

Trade/Device Name: SATELLITE Spinal System Regulation Number: Pre-amendment Regulatory Class: Unclassified Product Code: NVR Dated: May 18, 2005 Received: May 20, 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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must be prominently displayed in all labeling, including pouch, box and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name:

The safety and effectiveness of this device for use in motion sparing, non-fusion procedures has not been established.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

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

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

If you desire specific information about the application of other labeling requirements to your device (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" (21 CFR 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/industry/support/index.html.

Sincerely yours,

Donna-Bea Tillman, Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K051320

Device Name: SATELLITE™ Spinal System

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)

Mark A. Wilkerson

Division Sign-Off) Division of General, Restorative and Neurological Device

510(k) Number K051321

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Regulation Number and Section

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