InFill™ is indicated for intervertebral body fusion of the spine in skeletally mature patients. InFill™ is designed for use with autogenous bone graft to facilitate fusion. InFill™ is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill™ is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

Device Description

The InFill™ intervertebral body fusion device is a radiolucent implantable device manufactured from PEEK and tantalum (marker material). The implant is available in various sizes to suit the individual pathology and anatomical conditions of the patient. The InFill™ intervertebral body fusion device is provided sterile, for single use only.

AI/ML Overview

The provided text describes the InFill™ Intervertebral Body Fusion Device, its intended use, and the regulatory pathway. However, it does not contain information about a study proving the device meets acceptance criteria in the way a diagnostic AI device would.

This document is a 510(k) summary for a medical implant (spinal fusion device), not a diagnostic AI/ML system. The "performance data" section refers to mechanical and material testing to ensure the device's physical integrity and equivalence to predicate devices, not clinical efficacy or diagnostic accuracy.

Therefore, many of the requested categories in your prompt (e.g., sample size for test set, data provenance, ground truth, experts, MRMC studies, standalone performance, training set details) are not applicable to this type of device and are not present in the provided text.

Here's an analysis based on the information that is available, and an explanation of why other requested information is absent:

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

For this device type, acceptance criteria are generally related to mechanical and material properties, demonstrating that the device is as safe and effective as previously cleared predicate devices. The document states:

Acceptance Criteria (Type of Test)	Reported Device Performance (Implied)
Static/dynamic compression	Completed successfully, demonstrating substantial equivalence to predicate devices (per ASTM F2077).
Static subsidence	Completed successfully, demonstrating substantial equivalence to predicate devices (per ASTM F2267).
Expulsion	Completed successfully, demonstrating substantial equivalence to predicate devices.
Biocompatibility	(Implied by use of PEEK and tantalum, materials common to predicate devices accepted for implantation – not explicitly detailed in summary but required.)

Explanation: The document explicitly states that "All necessary performance testing, has been completed for the InFill™ intervertebral body fusion device including static/dynamic compression (ASTM F2077), static subsidence (ASTM F2267) and expulsion. to assure substantial equivalence to the predicate devices." The acceptance criteria for these tests would be defined in the standards themselves and by comparison to the predicate devices. The reported performance is that the device met these criteria, thus assuring substantial equivalence. Specific numerical performance values are not typically included in a 510(k) summary for this kind of mechanical device but would be in the full submission.

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

Not applicable. This device is a passive implantable medical device, not a diagnostic or AI system that processes data from a "test set" of patient cases, images, or records. The "test set" for this device would refer to the physical units of the device subjected to mechanical testing. The number of physical units tested is not specified in this summary.

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. Ground truth, in the context of diagnostic performance, is not relevant here. The "ground truth" for mechanical testing is established by engineering standards and comparison to predicate devices, not expert human interpretation.

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

Not applicable. Adjudication methods are typically used in clinical trial settings or for establishing ground truth in diagnostic studies.

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. MRMC studies are used to evaluate the diagnostic performance of systems, often AI-powered ones, by comparing human readers' performance with and without assistance. This is a physical implant, not a diagnostic tool.

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

Not applicable. The device is a physical implant; there is no "algorithm" to run in a standalone fashion.

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

For the mechanical performance, the "ground truth" is adherence to established ASTM standards (F2077, F2267) and demonstrating equivalence to predicate devices which have been previously cleared based on similar standards. It does not involve expert clinical consensus, pathology, or outcomes data in the sense of a diagnostic device.

8. The sample size for the training set

Not applicable. This device is not an AI/ML system that requires a "training set."

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

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

Summary regarding the device and its compliance:

The InFill™ Intervertebral Body Fusion Device is a Class II medical device, which achieved 510(k) clearance by demonstrating "substantial equivalence" to predicate devices (NuVasive CoRoent System, K071795; Globus Medical Patriot Transcontinental LLIF Spacer K093242). This means that its intended use, principle of operation, technological characteristics, and safety/effectiveness profiles were found to be similar enough to already-marketed devices. The "study" mentioned refers to mechanical and material performance testing (static/dynamic compression, static subsidence, expulsion) conducted according to established ASTM standards (F2077, F2267). The device met these engineering performance criteria, allowing it to be deemed substantially equivalent.

Summary

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Section 6

510(k) Summary

6. 510(k) Summarv

This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

APPLICANT:	Pinnacle Spine Group, LLC
DATE PREPARED:	February 21, 2011
CONTACT PERSON:	Rebecca K Pine1601 Elm Street, Suite 300Dallas, TX 75201Phone: 760.809.5178Fax: 760.290.3216
TRADE NAME:	InFill™ Intervertebral Body Fusion Device
COMMON NAME:	Spinal Implant
CLASSIFICATIONNAME:	Intervertebral Body Fusion Device
DEVICECLASSIFICATION:	Class II
REGULATIONNUMBER	888.3080 (product code:MAX)
PREDICATE DEVICES:	NuVasive CoRoent System, K071795Globus Medical Patriot Transcontinental LLIF SpacerK093242

Substantially Equivalent To:

The InFill™ intervertebral body fusion device is substantially equivalent in intended use, principal of operation and technological characteristics to the NuVasive CoRoent System and the Globus Medical Patriot Transcontinental LLIF Spacer.

Description of the Device Subject to Premarket Notification:

The InFill™ intervertebral body fusion device is provided sterile, for single use only.

Indication for Use:

APR 1 8 2011

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spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar devices are to be used in patients who have had at least six months of non-operative treatment. InFill™ is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine.

Technical Characteristics:

The InFill™ intervertebral body fusion device has similar physical and technical characteristics to the predicate devices.

Performance Data:

All necessary performance testing, has been completed for the InFill™ intervertebral body fusion device including static/dynamic compression (ASTM F2077), static subsidence (ASTM F2267) and expulsion. to assure substantial equivalence to the predicate devices.

Basis for Determination of Substantial Equivalence:

Upon reviewing the performance data provided in this submission and comparing intended use, design, materials, principle of operation and overall technological characteristics, the InFill™ intervertebral body fusion device is determined by Pinnacle Spine Group, LLC, to be substantially equivalent to existing legally marketed devices.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus. The seal is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Pinnacle Spine Group, LLC % Ms. Rebecca K. Pine 1601 Elm Street, Suite 300 Dallas, Texas 75201

APR 1 8 201

Re: K103729

Trade/Device Name: InFill" Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 12, 2011 Received: April 13, 2011

Dear Ms. Pine:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Rebecca K. Pine

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.

lf 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

AS vs. rh
fer

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

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: InFill™ Intervertebral Body Fusion Device

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X
(Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

510(k) Number	K103729
Page	of

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.