The Sypher Spacer System is an intervertebral body fusion system indicated for intervertebral body fusion procedures in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use with autogenous bone graft at one or two contiguous levels of the lumbar spine (from L2 to S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation to facilitate fusion.

Device Description

The Sypher Spacer System implants are cylinder shaped blocks made of PEEK Optima® LT1 (Polyether ether ketone per ASTM F2026), with tantalum alloy radiological position markers (per ASTM F560), titanium alloy self-drilling and self-tapping bone screws (per ASTM F136), and titanium alloy cage lock assemblies (per ASTM F136).

The implants are available in a variety of footprints, heights and lordotic angles. The shape of the Sypher product allows for a larger implant (height and width) to be used allowing for more surface area contact. The Sypher Spacer System is offered in a closed graft space design. The implants incorporate integrated anterior screw holes to allow for medial placement of screws, as well as a titanium alloy cage lock assembly for securing the screws once in place. Additional or other supplemental fixation may be used, as patient needs dictate. The superior and inferior surfaces of the devices have a pattern of teeth to provide increased stability and to prevent movement of the implants. The Sypher Spacer System is intended to be used with autologous bone graft.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Sypher Spacer System, an intervertebral body fusion device. While it mentions performance testing, it does not include detailed acceptance criteria or a study that specifically proves the device meets those criteria in the way you've outlined.

Here's what can be extracted based on the provided text, and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Specific quantitative criteria for intervertebral fusion devices related to clinical outcomes or device durability (e.g., fusion rates, subsidence limits, stability thresholds)	Not explicitly stated in the provided document. The document refers to "sufficient strength for its intended use" without quantifiable acceptance criteria.
Material conformance to standards	PEEK Optima® LT1 conforms to ASTM F2026. Tantalum conforms to ASTM F560. Titanium alloy conforms to ASTM F136.
Mechanical Test Standards	Device was tested according to: - Static axial compression bending per ASTM F2077-11 - Static compressive shear per ASTM F2077-11 - Static subsidence per ASTM F2267-04 and ASTM F2077-11 - Dynamic axial compression per ASTM F2077-11 - Dynamic compressive shear per ASTM F2077-11 - Expulsion per ASTM Draft Standard F-04.25.02.02
Comparative Strength	The device's strength is considered "substantially equivalent to legally marketed predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified. The document only mentions that the device "has been tested" in various modes. It refers to "non-clinical testing," which typically means bench testing or cadaver studies, not human clinical trials.
Data Provenance: The testing is "non-clinical," implying it was conducted in a laboratory setting, likely in the US where the company and consultants are located. It is not clinical data (retrospective or prospective from patients).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Not applicable. This document describes non-clinical, mechanical performance testing of an implantable medical device, not a diagnostic device or a study requiring expert interpretation of results to establish ground truth. The "ground truth" for mechanical testing is typically the adherence of the device's physical properties to engineering standards and comparison to predicate devices, measured by instruments.

4. Adjudication Method for the Test Set

Not applicable. As this is mechanical testing, there is no "adjudication method" in the sense of expert consensus on clinical or imaging readings. The results are quantitative measurements against established engineering standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This type of study (MRMC) is typically done for diagnostic devices where human readers interpret images or other data, and the goal is to assess the impact of an AI tool on reader performance. The Sypher Spacer System is an implantable surgical device, not a diagnostic one, and the reported tests are mechanical performance tests.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

Not applicable. The Sypher Spacer System is a physical intervertebral fusion device, not a software algorithm. Its "performance" is its mechanical integrity and ability to facilitate fusion when implanted, which is assessed through bench testing and, eventually, clinical outcomes (though clinical trial data is not presented here, as this is a 510(k) submission based on substantial equivalence to predicates).

7. Type of Ground Truth Used

For the non-clinical mechanical testing, the "ground truth" is defined by established ASTM (American Society for Testing and Materials) standards for intervertebral body fusion devices, and comparison to the mechanical properties of legally marketed predicate devices. The goal is to demonstrate that the Sypher Spacer System's mechanical characteristics are equivalent or superior to these benchmarks.

8. Sample Size for the Training Set

Not applicable. There is no "training set" in the context of mechanical performance testing of a physical medical device. Training sets are relevant for machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set.

In summary: The provided document is a 510(k) clearance letter and summary for a physical medical device. It focuses on demonstrating substantial equivalence to predicate devices primarily through mechanical (bench) testing, adherence to material standards, and similar indications for use. It does not contain information about clinical trials, diagnostic performance, or AI algorithms, which are the contexts in which many of your questions would typically apply.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of human profiles facing right, suggesting a sense of community and care. The text is arranged in a circular pattern around the symbol.

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

February 19, 2015

Biogennix, LLC % Ms. Meredith May Empirical Consulting 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K141798

Trade/Device Name: Sypher Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVD, MAX Dated: January 21, 2015 Received: January 23, 2015

Dear Ms. May:

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

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Page 2 - Ms. Meredith May

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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 vours.

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) K141798

Device Name Sypher Spacer System

Indications for Use (Describe)

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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5.510(K) SUMMARY

Submitter's Name:	Biogennix, LLC
Submitter's Address:	18011 Sky Park Circle, Suite MIrvine, CA 92614
Submitter's Telephone:	949.253.0994
Contact Person:	Meredith L. May, MSEmpirical Testing Corp.719.337.7579
Date Summary was Prepared:	01-Jul-14
Trade or Proprietary Name:	Sypher Spacer System
Common or Usual Name:	Intervertebral Fusion Device With Bone Graft, Lumbar
Device Classification:	Class II per 21 CFR §888.3080
Product Code:	MAX
Classification Panel:	Division of Orthopedic Devices

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

The Sypher Spacer System is an intervertebral body fusion system indicated for intervertebral body fusion procedures in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use with autogenous bone graft at one or two contiguous levels of the lumbar spine (from L2 to S1) for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation to facilitate fusion.

TECHNOLOGICAL CHARACTERISTICS

Biogennix, LLC Sypher Spacer System

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Sypher Spacer System is made from PEEK Optima® LT1, Tantalum, and Titanium alloy that conforms to ASTM F2026, ASTM F560, and ASTM F136, respectively. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are similar or identical between the subject and predicates:

Intended Use
Materials of manufacture ●
Structural support mechanism ●
Indications for Use ●

Table 5-1 Predicate Devices

510kNumber	Trade or Proprietary or Model Name	Manufacturer	Predicate Type
K120031	Chesapeake® Anterior-LumbarStabilization System	K2M	Primary
K100089	T-PAL Spacer	Synthes	Additional
K103034,K130913	Apache™ Lateral Lumbar InterbodyFusion System	Genesys Spine	Additional

PERFORMANCE DATA

The Sypher Spacer System has been tested in the following test modes:

Static axial compression bending per ASTM F2077-11 ●
o Static compressive shear per ASTM 2077-11
Static subsidence per ASTM F2267-04 and ASTM 2077-11 ●
Dynamic axial compression per ASTM 2077-11
Dynamic compressive shear per ASTM 2077-11 ●
Expulsion per ASTM Draft Standard F-04.25.02.02

The results of this non-clinical testing show that the strength of the Sypher Spacer System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Sypher Spacer 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.