The Blustone Synergy lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of non-operative therapy. Additionally, the Blustone Synergy lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The Blustone Sysergy lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

Blustone Synergy cervical implants (Slate):

The Blustone Synergy cervical (Slate) implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiguous levels from C2 to T1. These patients should be skeletally mature and have had six weeks of non-operative treatment. The Blustone Synergy cervical implants are also to be used with supplemental fixation.

Device Description

The Blustone Synergy Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of:

Blustone Synergy cervical interbody fusion device(s), which may be implanted as a single 1) device via an anterior approach.
1. Blustone Synegy lumbar interbody fusion device(s), which may be implanted
- bi-laterally in pairs via a posterior (PLIF) approach;
- as a single device via a transverse (T-PLIF) approach;
- as a single device via a lateral (LLIF) approach;
- as a single device via a transforaminal (TLIF) approach

The Blustone Synergy System implant components are made of polyether ether ketone (Zeniva ZA-500 PEEK) that conforms to ASTM F2026. Additionally, the devices contain tantalum markers (ASTM F560) to assist the surgeon with proper placement of the device. The System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899.

AI/ML Overview

This FDA 510(k) K171893 document describes the Blustone Synergy Interbody Fusion System, which includes both lumbar and cervical implants. However, it does not contain information about formal acceptance criteria, device performance metrics (like accuracy, sensitivity, specificity, etc.), or a study evaluating such performance for a device that fits the description of an AI/ML medical device.

The document is a premarket notification for an intervertebral body fusion device made of PEEK material, intended to be implanted surgically. The non-clinical testing mentioned focuses on mechanical performance of the physical implant itself (e.g., static and dynamic compression, torsion, subsidence, expulsion) to demonstrate structural integrity and safety. These tests are standard for physical implantable medical devices.

Therefore, I cannot fulfill the request to provide information based on the typical acceptance criteria and study design for an AI/ML device because this document does not pertain to such a device. The questions you've asked (about sample size, data provenance, experts, MRMC studies, standalone performance, ground truth establishment) are relevant to AI/ML device performance evaluation, but this document describes a traditional medical device (an implant).

To directly answer your request based on the provided document, the following points can be made regarding the physical implant's evaluation, though they don't align with an AI/ML context:

Table of acceptance criteria and reported device performance: This document does not provide a table with quantitative acceptance criteria for device performance in terms of clinical outcomes or diagnostic accuracy. Instead, it discusses mechanical testing standards. The "reported device performance" is essentially that the device performed equivalently to predicates in these mechanical tests.

Acceptance Criteria (e.g., Mechanical Standard)	Reported Device Performance (as compared to predicates)
ASTM F2077-14 (Static & Dynamic Compression)	Met, equivalent to predicates
ASTM F2077-14 (Static & Dynamic Torsion)	Met, equivalent to predicates
ASTM F2267-04(2011) (Subsidence)	Met, equivalent to predicates
ASTM Draft Standard F-04.25.02.02 (Expulsion)	Met, equivalent to predicates

Sample size used for the test set and the data provenance: Not applicable in the context of AI/ML device evaluation. The "test set" here refers to the physical devices subjected to mechanical testing. The document does not specify the number of individual implants tested for each mechanical test, nor does it refer to "data provenance" in the sense of patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context would relate to the mechanical properties being measured, which are determined by physical tests and engineering standards, not expert clinical consensus.
Adjudication method: Not applicable. Adjudication is relevant for interpreting ambiguous or challenging cases in diagnostic AI, not for mechanical testing of an implant.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study: No. This type of study is for evaluating human interpretation with and without AI assistance, which is not relevant for a physical interbody fusion device.
Standalone performance (algorithm only without human-in-the-loop performance): Not applicable. This device is a physical implant, not an algorithm.
The type of ground truth used: For the mechanical tests, the "ground truth" would be the engineered specifications and the results obtained from standardized mechanical testing equipment. It's not expert consensus, pathology, or outcomes data in the AI/ML sense.
The sample size for the training set: Not applicable. There is no training set mentioned, as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable.

In conclusion, the provided FDA document pertains to a physical interbody fusion device and details mechanical testing to establish substantial equivalence, not the performance of an AI/ML diagnostic or assistive device.

Summary

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

September 8, 2017

Blustone Synergy % Ms. Lisa Peterson Official Correspondent Bluestone Synergy 5520 Ventana Ct. Pueblo, Colorado 81005

Re: K171893

Trade/Device Name: Blustone Synergy Lumbar Interbody Fusion System Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate) Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX, ODP Dated: June 17, 2017 Received: June 26, 2017

Dear Ms. Peterson:

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

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education (DICE) 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education (DICE) 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.

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K171893

Device Name

Blustone Synergy Lumbar Interbody Fusion (Basalt, Magma, Obsidian), Blustone Synergy Cervical Interbody Fusion System (Slate)

Indications for Use (Describe)

Blustone Synergy lumbar implants (Basalt, Magma, Obsidian):

Blustone Synergy cervical implants (Slate):

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary Blustone Synergy İnterbody Fusion System Premarket Notification

SUBMITTED BY	Blustone Synergy5520 Ventana Ct.Pueblo CO 81005
CONTACT PERSON	Lisa PetersonKaedon Consulting, LLCPhone: 512-507-0746lpeterson@kaedonconsulting.com
DATE PREPARED	September 7, 2017
CLASSIFICATION NAME	Intervertebral Body Fusion Device with Bone Graft, Lumbar(MAX)Intervertebral Body Fusion Device with Bone Graft, Cervical(ODP)
DEVICE CLASS	Class II
REGULATION NUMBER	888.3080 (Product Code MAX)888.3080 (Product Code ODP)
COMMON NAME	Interbody Fusion Device
PROPRIETARY NAME	Blustone Synergy Lumbar Interbody Fusion System (Basalt,Magma, Obsidian)Blustone Synergy Cervical Interbody Fusion System (Slate)
IDENTIFICATION OF PREDICATEDEVICE(S)	Predicate devices include various cleared interbody fusionsystems:
	PrimaryEminent Spine: Eminent Spine Interbody Fusion System(K090064)
	AdditionalDePuy Acromed: Lumbar I/F Cage (P960025)

K2M, Inc: Aleutian System (K133614) and Cascadia System (K162264)
Integrity Spine: Integrity Spine Lumbar Interbody Fusion -System (K151819)

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K171893 Page 2 of 3

DEVICE DESCRIPTION

The Blustone Synergy Interbody Fusion System will be offered in various device configurations based on surgical approach and patient anatomy, and consist of:

Blustone Synergy cervical interbody fusion device(s), which may be implanted as a single 1) device via an anterior approach.
1. Blustone Synegy lumbar interbody fusion device(s), which may be implanted
- bi-laterally in pairs via a posterior (PLIF) approach;
- as a single device via a transverse (T-PLIF) approach;
- as a single device via a lateral (LLIF) approach;
- as a single device via a transforaminal (TLIF) approach

INDICATIONS

Blustone Synergy lumbar implants (Basalt, Magma, Obsidian):

The Blustone Synerqy lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiquous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have six months of non-operative therapy. Additionally, the Blustone Synergy lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The Blustone Synergy lumbar implants are intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

Blustone Synergy cervical implants (Slate):

The Blustone Synerqy cervical (Slate) implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with cervical disc disease (DDD) at one level or two contiquous levels from C2 to T1. These patients should be skeletally mature and have had six weeks of non-operative treatment. The Blustone Synergy cervical implants are also to be used with supplemental fixation.

TECHNOLOGICAL COMPARISON TO PREDICATE(S)

The purpose of this premarket notification is to obtain clearance to market the Blustone Synergy Interbody Fusion System. The Blustone Synergy System implants were compared to the predicate devices identified above, and performance evaluation results, design features, materials and sizes were found to be substantially equivalent to these systems.

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K171893 Page 3 of 3

DISCUSSION OF NON-CLINICAL TESTING

The following non-clinical tests were conducted:

Static and dynamic compression testing, conducted in accordance with ASTM F2077-14 -
-Static and dynamic torsion testing, conducted in accordance with ASTM F2077-14
-Subsidence testing, conducted in accordance with ASTM F2267-04(2011)
-Expulsion testing, conducted in accordance with ASTM Draft Standard F-04.25.02.02

CONCLUSIONS

The subject and predicate device(s) share the same intended use, primary implant design and equivalent material of manufacture. The non-clinical mechanical test results demonstrate that any minor differences do not impact device performance as compared to the predicates and demonstrate that the Blustone Synergy Interbody Fusion System is substantially equivalent to the predicate device.

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.