The Abacus™ Spacer System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-L5. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radios. These DDD patients may have up to Grade I spondylolisthesis at the involved level(s). The Abacus™ Spacer System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device.

Device Description

The Abacus™ Spacer System is an intervertebral body fusion device manufactured from PEEK-OPTIMA (ASTM F2026) with tantalum markers (ASTM F560) and a plasmasprayed commercially pure titanium coating (ASTM F1580). The Abacus™ Spacer System is available in a variety of shapes and sizes to accommodate variations in anatomy. The Abacus™ Spacer System is a rectangular-shaped device with the titanium coating on both the superior and inferior surfaces. The device also incorporates an internal cavity that allows for the placement of autograft material.

AI/ML Overview

Here's a breakdown of the requested information based on the provided document:

The provided document describes a 510(k) submission for the Abacus™ Spacer System, focusing on the addition of a commercially pure titanium coating. It's important to note that a 510(k) submission typically aims to demonstrate substantial equivalence to a predicate device, rather than proving a device meets specific "acceptance criteria" in the same way a diagnostic test might. The "acceptance criteria" in this context refer to the performance standards and tests required to show this substantial equivalence for the modified device.

1. Table of Acceptance Criteria and Reported Device Performance

For intervertebral body fusion devices, particularly when a coating is introduced, the "acceptance criteria" are generally based on relevant ASTM standards and demonstrate that the modified device performs comparably to or better than the predicate device under various mechanical and material tests. The reported device performance is indicated by the completion of these tests.

Acceptance Criteria (Test Performed)	Reported Device Performance (Outcome)
Coating Characterization
Coating Microstructure (ASTM F1854)	Performed as indicated
Shear Fatigue Testing (ASTM F1160)	Performed as indicated
Static Shear Testing (ASTM F1044)	Performed as indicated
Tensile Testing (ASTM F1147)	Performed as indicated
Abrasion Testing (ASTM F1978)	Performed as indicated
Device Performance
Static Axial Compression (ASTM F2077)	Performed to demonstrate substantial equivalence to predicate
Static & Dynamic Compression Shear (ASTM F2077)	Performed to demonstrate substantial equivalence to predicate
Wear Debris Analysis (ASTM F1877)	Performed to demonstrate substantial equivalence to predicate

Note: The document states that these tests were "performed" and led to the conclusion of "substantial equivalence," implying that the results met the expected performance characteristics for the chosen predicate devices and relevant standards. Specific numerical values for the performance are not included in this summary.

Regarding the sections that are not applicable to this type of device submission:

Since this is a 510(k) submission for an orthopedic implant and not an AI/diagnostic device, many of the requested categories (2-9, relating to AI, human readers, ground truth for image analysis, etc.) are not applicable or cannot be extracted from this document. The focus of this submission is on the material and mechanical performance of the physical device.

Specifically, the following are not applicable or cannot be determined from the provided text:

2. Sample size used for the test set and the data provenance: This refers to clinical data for diagnostic performance, which is not provided for this device. The "test set" pertains to the physical device samples used for the mechanical tests, but their number and provenance are not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe a study involving expert review for diagnostic ground truth.
4. Adjudication method for the test set: Not applicable.
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 for an AI/diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a physical implant's mechanical testing. The "ground truth" for mechanical properties is typically the measured physical performance against engineering standards.
8. The sample size for the training set: Not applicable. There is no "training set" in the context of mechanical device testing.
9. How the ground truth for the training set was established: Not applicable.

Summary

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

October 23, 2014

Spine Wave Incorporated Ms. Roaida R. Johnson Regulatory Affairs Manager Three Enterprise Drive, Suite 210 Shelton, Connecticut 06484

Re: K142101

Trade/Device Name: Abacus™ Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: July 31, 2014 Received: August 1, 2014

Dear Ms. Johnson:

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. Roaida R. Johnson

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" (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 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.

Ronald P. Jean –S for

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

K142101 Page 1 of 1

510(k) Number (if known)

K142101

Device Name Abacus™ Spacer System

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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SPINE WAVE

510(k) Summary Abacus™ Spacer System

1. Submitter Information

Submitter:	Spine Wave, Inc.
Address:	Three Enterprise DriveSuite 210Shelton, CT 06484
Telephone:	203-712-1839
Telefax:	203-944-9493
Contact:	Roaida R. Johnson
Date Prepared:	October 1, 2014

2. Device Information

Trade Name:	Abacus™ Spacer System
Common Name:	Intervertebral Body Fusion Device
Classification:	Class II (special controls) per 21 CFR 888.3080
Classification Name:	Intervertebral Fusion Device with Bone Graft, Lumbar
Product Code:	MAX

3. Purpose of Submission

The purpose of this submission is to gain clearance to add a commercially pure titanium coating to the Abacus™ Spacer System.

4. Predicate Device Information

The Abacus™ Spacer System described in this submission is substantially equivalent to the following predicates:

Primary Predicate Device	Manufacturer	510(k) No.
Abacus™ Spacer System	Spine Wave, Inc.	K140007

Additional Predicate Device	Manufacturer	510(k) No.
CapStone PTC™ Spinal Systems	Medtronic Sofamor Danek	K133205

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5. Device Description

6. Intended Use

The Abacus™ Spacer System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L2-L5. Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Abacus™ Spacer System is to be used with autogenous bone graft and with supplemental fixation. Patients should have at least six (6) months of nonoperative treatment prior to treatment with an intervertebral body fusion device.

7. Comparison of Technological Characteristics

The substantial equivalence of the Abacus™ Spacer System to the predicates is shown by similarity in intended use, indications for use, materials and performance.

8. Performance Data

The following tests were performed for characterization of the commercially pure titanium coating:

Coating Microstructure (ASTM F1854) .
. Shear Fatigue Testing (ASTM F1160)
Static Shear Testing (ASTM F1044) ●
Tensile Testing (ASTM F1147) .
. Abrasion Testing (ASTM F1978)

The following tests were performed to demonstrate the substantial equivalence of the Abacus™ Spacer System to its predicate:

Static axial compression (per ASTM F2077)
Static and dynamic compression shear (per ASTM F2077)
Wear debris analysis (ASTM F1877) .

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9. Conclusion

Based on the indications for use, technological characteristics, performance testing and
comparison to the predicates, the Abacus™ Spacer System has been shown to be substantially equivalent to the predicate devices identified in this submission, and does not present any new issues of safety or effectiveness.

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.