The Solitaire Anterior Spinal System is indicated for vertebral body replacement and intervertebral fusion. When used for vertebral body replacement, the Solitaire Anterior Spinal System is indicated for use in the thoracolumbar spine (i.e., T10 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Solitaire System is also indicated for treating fractures of the thoracic and lumbar spine. The Solitaire System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.

As an intervertebral body fusion device designed for use with autograft, the Solitaire Anterior Spinal System is indicated for stand-alone intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to S1 in patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

Device Description

The components of the Solitaire™ Anterior Spinal System are comprised of Titanium alloy and are inserted into the intervertebral body space of the lumbosacral spine with bone graft material. The system consists of a spacer with radiographic markers and three bone screws.

AI/ML Overview

The provided text is a 510(k) summary for the Solitaire™ Anterior Spinal System, which is a medical device. This type of document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

It describes the device and its intended use, but it does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for an AI/CADe device.

Here's why and what information is available (or not available) based on your request:

Device Type: This is a physical implantable device (intervertebral body fusion device), not an AI/CADe (Computer-Aided Detection/Diagnosis) software device. Therefore, the types of "acceptance criteria" and "studies" for this device are fundamentally different from what you would expect for an AI algorithm. Its "performance" is related to its mechanical and biological compatibility, not diagnostic accuracy or image interpretation.
Safety and Effectiveness: For this type of device, "acceptance criteria" generally refer to demonstrating substantial equivalence to a predicate device in terms of material, design, sizing, indications for use, technological characteristics, and principles of operation, without introducing new issues of safety or effectiveness. The "study" proving this is often a comparison to the predicate device and possibly mechanical testing, but not typically a clinical trial in the sense of comparing diagnostic accuracy or clinical outcomes directly in a multi-reader, multi-case study as you described for AI devices.

Given this context, I will address each point of your request based on the limited applicability to this type of device and the information present in the document.

Here's the breakdown of the information based on your request:

A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implicit for a 510(k) for a physical device): The primary acceptance criterion for a 510(k) submission like this is to demonstrate "substantial equivalence" to a legally marketed predicate device such that the new device does not raise new questions of safety or effectiveness. This is achieved by showing similar intended use, indications, technological characteristics (materials, design, sizing), and principles of operation.
Reported Device Performance: The document does not provide quantitative "performance" metrics in the way an AI algorithm's sensitivity/specificity would be reported. Instead, it states: "The Solitaire™ Anterior Spinal System is substantially equivalent to its predicate devices with respect to intended use and indications, technological characteristics, and principles of operation and do not present any new issues of safety or effectiveness."

Acceptance Criteria (for 510(k) Substantial Equivalence)	Reported Device Performance (as stated in the 510(k) Summary)
Intended Use is similar to predicate.	Substantially equivalent to predicate in intended use.
Indications for Use are similar to predicate.	Substantially equivalent to predicate in indications.
Technological characteristics (material, design, sizing) are similar to predicate.	Technological characteristics are the same as, or similar to, the predicate devices.
Principles of operation are similar to predicate.	Substantially equivalent to predicate in principles of operation.
Device does not raise new issues of safety or effectiveness.	Does not present any new issues of safety or effectiveness.
Restore biomechanical integrity for a prolonged period (for vertebral body replacement).	Designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.

Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This document does not describe a "test set" or "data provenance" in the context of an AI algorithm study. For a physical implant, "testing" typically involves mechanical tests, biocompatibility tests, and sometimes animal studies, but clinical data for 510(k)s often isn't required if substantial equivalence can be shown otherwise. No such clinical "test set" information is provided here.
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 to the provided document. There is no mention of a "test set" requiring ground truth established by experts.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable to the provided document.
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
- No MRMC study was done, as this is a physical implant, not an AI device aimed at assisting human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable; this is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the context of an AI study. For this device, "ground truth" would relate to successful implantation, fusion, biomechanical stability, and clinical outcomes for the patient, which are not detailed as specific "ground truths" in this 510(k) summary.
The sample size for the training set
- Not applicable; this is not an AI algorithm.
How the ground truth for the training set was established
- Not applicable; this is not an AI algorithm.

In summary, the provided document is a 510(k) premarket notification for a physical medical device (spinal implant). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance metrics based on clinical trial data or AI algorithm validation studies.

Summary

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JUL - 2 2008

K 081501 (pg. 1 of 2)

Page 1 of 1

Image /page/0/Picture/3 description: The image shows the logo for Biomet Spine. The word "BIOMET" is in large, bold, sans-serif font, with each letter connected to the others. Below the word "BIOMET" is the word "SPINE" in a smaller, sans-serif font. The logo is black and white.

510(k) Summar

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.

Preparation Date:	June 27, 2008
Applicant/Sponsor:	Biomet Spine100 Interpace ParkwayParsippany, NJ 07054
Contact Person:	Vivian KellyPhone: 973-299-9300 x2214Fax: 973-257-0232
Trade name:	Solitaire™ Anterior Spinal System
Common Name:	Intervertebral Body Fusion Device, Vertebral BodyReplacement Device
Classification Name:	Intervertebral Body Fusion Device, 21 CFR 888.3080; SpinalIntervertebral Body Fixation Orthosis, 21 CFR 888.3060
Device Panel /Product Code:	Orthopedic MAX, MQP

Device Description:

Indications for Use:

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Summary of Technologies:

The technological characteristics (material, design and sizing) of the Solitaire™ Anterior Spinal System are the same as, or similar to, the predicate devices.

Substantial Equivalence:

The Solitaire™ Anterior Spinal System is substantially equivalent to its predicate devices with respect to intended use and indications, technological characteristics, and principles of operation and o not present any new issues of safety or effectiveness. An example of another predicate intervertebral body fusion device distributed for the similar indications include the InterPlate™ Interbody Fusion Device by RBB Spins, LLC (KC71922) while the Solital is neerior Spinal System from Interpres Cross In and States of the Spins of Statistian
Editor of Article Collect of the Solitates. Solitaire " Anterior Spinal System is substantially equivalent for its intended use to other spaces currently on the market.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the perimeter of the circle.

SEP 1 2 2011

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Biomet Spine % Ms. Vivian Kelly, MS, RAC Regulatory Affairs Project Manager 100 Interpace Parkway Parsippany, NJ 07054

Re: K081501

Trade/Device Name: Solitaire™ Anterior Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MOP Dated: May 27, 2008 Received: May 29, 2008

Dear Ms. Kelly:

This letter corrects our substantially equivalent letter of July 2, 2008.

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 (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 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

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,
Mark A. Mulkeman

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known): K081501

Device Name: Solitaire™ Anterior Spinal System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number 14081501
Page 1 of 1

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.