The INTREPID™ Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via a laparoscopic or an open anterior approach. The INTREPID™ interbody device is intended to be used with the three titanium alloy screws which accompany the implant. If the physician chooses to use less than three, or none of the provided screws, then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability.

Device Description

The INTREPID™ Spinal System is a stand-alone intervertebral body fusion device, which consists of an anatomically shaped vertebral body spacer designed with a selfdistracting nose. The spacer is equipped with three holes which allow for the placement of internal fixation screws. The screws are inserted through the cage and help provide stabilization and back-out resistance. The INTREPID™ spacer is manufactured from medical grade polyetheretherketone (PEEK), while the screws are manufactured from titanium alloy.

AI/ML Overview

This document, K080083, is a 510(k) summary for the INTREPID™ Spinal System. It focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a detailed study that proves the device meets specific acceptance criteria with quantifiable performance metrics.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not present in this type of regulatory submission. 510(k)s primarily rely on showing that a new device is as safe and effective as a legally marketed predicate device, often through mechanical testing and comparison of design features and indications for use.

Here's a breakdown of what can be extracted based on the provided text, and where information is inherently missing for a 510(k) submission:

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

Acceptance Criteria: Not explicitly stated as quantifiable performance metrics with specific thresholds in this submission. For 510(k) devices, acceptance criteria are generally met by demonstrating substantial equivalence to predicate devices, often through mechanical testing. The implied acceptance criteria are that the device meets the performance characteristics (e.g., strength, durability, biocompatibility) necessary to be considered equivalent to the predicate devices.
Reported Device Performance: The document only states that "mechanical test results was provided which demonstrated that the subject INTREPID™ Spinal System is substantially equivalent to the SynFIX-LR Spacer (K072253...)." Specific numerical performance data from these mechanical tests are not included in this summary.

Acceptance Criteria (Implied for 510(k))	Reported Device Performance
Mechanical integrity and strength for spinal fusion.	Demonstrated substantial equivalence to predicate devices through mechanical test results. (Specific metrics not provided).
Biocompatibility.	Implied through selection of medical-grade PEEK and titanium alloy, consistent with predicate devices.
Design features and indications for use comparable to predicate devices.	Device description and indications for use are provided and compared to predicate devices for substantial equivalence.

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

Sample Size: Not specified in the summary. For mechanical tests, the "sample size" would refer to the number of devices tested, which is not provided.
Data Provenance: Not specified. Mechanical testing data would typically be generated in a lab setting rather than from patient data.

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. For a 510(k) for a spinal implant, "ground truth" typically involves mechanical testing standards and comparison to predicate devices, not human expert interpretation of a clinical test set. No clinical experts or a "ground truth" derived from them were used in the context of this 510(k) summary.

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

Not Applicable. There is no "test set" of clinical cases requiring adjudication by experts.

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 hardware implant (spinal system), not an AI/software device involving human readers or AI assistance.

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

Not Applicable. This is a hardware implant, not an algorithm.

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

The "ground truth" for this 510(k) is the established safety and efficacy profile of the predicate devices, as determined by their prior FDA clearance/approval. The INTREPID™ Spinal System aims to demonstrate equivalence to these established devices through mechanical testing and design comparison.

8. The sample size for the training set

Not Applicable. This is a hardware implant, not a machine learning algorithm that requires a training set.

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

Not Applicable. As above, no training set for a machine learning algorithm is involved.

In summary: K080083 is a 510(k) premarket notification for a new medical device. The primary method for gaining clearance is demonstrating "substantial equivalence" to previously cleared predicate devices. This typically involves:

Performance Testing: Usually mechanical and material testing to show the new device performs comparably to predicates. Specific results are often summarized but not fully detailed in the public 510(k) summary.
Comparison of Indications for Use and Design Features: Ensuring the new device's intended use and fundamental design are similar to predicates.
Biocompatibility Assessment: Confirming materials are safe for human use, often by referring to existing data on similar materials in predicate devices.

The detailed "study" information (sample sizes, expert consensus, MRMC studies) you've requested is characteristic of clinical trials or AI/software evaluations, which are generally not part of a standard 510(k) submission for a non-active implant unless specific clinical data is deemed necessary by the FDA.

Summary

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INTREPIDTM Spinal System 510(k) Summary March 2008 - K080083

APR 1 0 2008

Medtronic Sofamor Danek Company: l. 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
Contact: Lee Grant Senior Project Specialist, Regulatory Affairs

Proprietary Trade Name: INTREPID™ Spinal System II.

Classification Name/Product Code: Intervertebral Body Fusion Device (21 CFR III. 888.3080)
Product Code: MAX IV.

Product Description V.

V. Indications

The INTREPID™ interbody device is intended to be used with the three titanium alloy screws which accompany the implant. If the physician chooses to use less than three, or none of the provided screws, then additional supplemental fixation, which has been cleared by the FDA for use in the lumbar spine, must be used to augment stability.

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K080083

VI. Substantial Equivalence

Documentation, including mechanical test results was provided which demonstrated that the subject INTREPID™ Spinal System is substantially equivalent to the SynFIX-LR Spacer (K072253, SE 10/12/07, Synthes Spine), the LT-CAGE® Peek Lumbar Tapered Fusion Device (P970015, Medtronic Sofamor Danek, Approved 9/10/03), the BAK® Cage (P950002, Zimmer Spine, Approved 7/8/03), the RAY® Threaded Fusion Cage (P950019, Stryker, Approved 9/4/03), the Lumbar I/F Cage (P960025, DePuy, Approved 3/4/05) and the PARAMOUNT Intervertebral Body Fusion Device (K072120, Innovative Spinal Technologies, SE 10/11/07).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is depicted in a simple, black and white design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 0 2008

Medtronic Sofamor Danek % Mr. Lee Grant Senior Project Specialist, Regulatory Affairs 1800 Pyramid Place Memphis, TN 38132

Re: K080083

Trade/Device Name: INTREDPID™ Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: January 8, 2008 Received: January 11, 2008

Dear Mr. Grant:

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 - Mr. Lec Grant

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Millerson

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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510(k) Number (if known): K080083

Device Name: INTREPID™ Spinal System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) 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)

Nul he Qgl formxm

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

AND/OR

510(k) Number K080083

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.