The Exactech Acapella One Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Exactech Acapella One Cervical Spacer System is to be used with autogenous bone graft and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach.

Device Description

The Acapella One Cervical Spacer System is an anterior cervical interbody device consisting of a PEEK (polyetheretherkeytone) implant cage with tantalum radiographic markers and two titanium alloy internal anchors. It is intended for use as an interbody fusion device and is offered in a variety of heights, footprints, and lordotic angles to accommodate varying anatomical conditions. The device features a chamber intended to be filled with autogenous bone graft material. The Acapella One Cervical Spacer System is intended to be used with supplemental fixation (i.e., an anterior cervical plate). Acapella One Cervical Spacer System implants are composed of PEEK Optima Grade LT1, Ti-6Al-4V, and tantalum. The body of the implant is composed of PEEK Optima Grade LT1 (ASTM 2026). The PEEK Optima Grade LT1 used in Acapella implants is manufactured using the same processes used to manufacture Exactech Octane-A implants (K082270). The material used to construct the anchors is titanium alloy Ti-6AI-4V per ASTM F136, which has a long history of safe and effective use in orthopedic implants. The radiographic markers are composed of tantalum per ASTM F560, which also has a long history of safe and effective use in orthopedic implants. The Acapella One Cervical Spacer System is accompanied by a complete instrumentation system to assist the surgeon in the implantation of the device.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called the Exactech® Acapella™ One Cervical Spacer System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving independent effectiveness through extensive clinical studies with acceptance criteria for device performance. Therefore, the information typically requested in your prompt (e.g., acceptance criteria for a diagnostic device, details of a study proving a device meets these criteria, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, and ground truth establishment methods) is not present in this document.

The document describes material and mechanical testing to demonstrate substantial equivalence, not clinical performance against predefined acceptance criteria for a diagnostic or AI-driven device.

Here's an breakdown based on the information that is available in the document:

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

No specific acceptance criteria are listed in the typical sense of a diagnostic or AI device (e.g., sensitivity, specificity, AUC).
The "performance" is demonstrated through non-clinical mechanical testing, showing the device functions as intended and is substantially equivalent to predicate devices.
The tests performed are: Static Compression, Static Compression Shear, Static Torsion, Subsidence (Anchors Deployed and Not Deployed), Expulsion (Anchors Deployed and Not Deployed), Dynamic Compression, Dynamic Compression Shear, Dynamic Torsion, and Wear. The document states these tests "demonstrated equivalent performance to cited predicates under the same test conditions," but does not provide numerical results or specific acceptance thresholds for these tests within this summary. The standards referenced (e.g., F2077, F22674, F1877) would contain the details of the test methodologies and potentially acceptance criteria, but these are not reproduced in the 510(k) summary.

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 document describes mechanical, non-clinical testing of a physical implant device, not a study involving human data or a test set in the context of an AI/diagnostic device.

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. See point 2.

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

Not applicable. See point 2.

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

No. This is not a diagnostic device or an AI-assisted device.

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

No. This is not an algorithm or AI device.

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

Not applicable in the AI/diagnostic sense. The "ground truth" for this device's evaluation is its mechanical performance against established ASTM standards and equivalence to predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device requiring a training set.

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

Not applicable. See point 8.

In summary, the provided document is a 510(k) submission for a non-active, implantable medical device. Its purpose is to demonstrate "substantial equivalence" to existing legally marketed devices, primarily through engineering and biocompatibility considerations, rather than clinical performance data against specific acceptance criteria relevant to AI or diagnostic tools.

Summary

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K132582- Page 1 of 3

Exactech® Acapella™ One Cervical Spacer System Traditional 510(k)

510(k) Summary

Company:	Exactech, Inc2320 NW 66th CourtGainesville, FL 32653
Date:	February 10, 2014
Contact Person:	Patrick HughesSenior Regulatory Affairs SpecialistPhone: (352) 327-4762Fax: (352) 378-2617
Proprietary Name:	Exactech® Acapella® One Cervical Spacer System
Common Name:	Interbody Spacer
Classification Name:	21 CFR 888.3080Intervertebral Fusion Device with Integrated Fixation,CervicalClass II
Product Code:	OVE

Legally Marketed Devices to Which Substantial Equivalence Is Claimed

K103655 Octane-C Interbody Fusion System .
K082801 US Spine Phantom Plus Cage ●
KI 13559 LDR ROI-C Cervical Cage Implant Lordotic .
K082270 Octane-A Interbody Fusion System (material composition only) .

Device Description

Acapella One Cervical Spacer System implants are composed of PEEK Optima Grade LT1, Ti-6Al-4V, and tantalum. The body of the implant is composed of PEEK Optima Grade LT1 (ASTM 2026). The PEEK Optima Grade LT1 used in Acapella implants is manufactured using the same processes used to manufacture Exactech Octane-A implants (K082270).

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Exactech® Acapella™ One Cervical Spacer System Traditional 510(k)

The material used to construct the anchors is titanium alloy Ti-6AI-4V per ASTM F136, which has a long history of safe and effective use in orthopedic implants.

The radiographic markers are composed of tantalum per ASTM F560, which also has a long history of safe and effective use in orthopedic implants.

The Acapella One Cervical Spacer System is accompanied by a complete instrumentation system to assist the surgeon in the implantation of the device.

Indications for Use

Summary of Technological Characteristics

The rationale for substantial equivalence is based on consideration of the following device characteristics:

. Indications for Use
The proposed Acapella One Cervical Spacer System and predicate LDR ROI-C have similar indications for use statements.
Materials . Both proposed Acapella One Cervical Spacer System and predicate LDR ROI-C devices are composed of similar biocompatible materials conforming to recognized industry standards for permanent implants.
Design Features/Functions . Proposed Acapella One Cervical Spacer System and cited predicate devices share similar basic design features and functions.
Dimensions . Proposed Acapella One Cervical Spacer System devices are dimensionally similar to cited predicate devices.
. Sterilization Proposed Acapella One Cervical Spacer System devices and cited predicate devices are provided sterile for single use only.
. Performance specifications

Mechanical testing confirmed Acapella One Cervical Spacer System devices demonstrated equivalent performance to cited predicates under the same test conditions.

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Exactech® Acapella™ One Cervical Spacer System Traditional 510(k)

Non-Clinical Testing

The following tests were performed to demonstrate Acapella One Cervical Spacer System devices function as intended and are substantially equivalent to cited predicates:

Table 1: Acapella One Testing

Test	Standard
Static Compression	F2077
Static Compression Shear	F2077
Static Torsion	F2077
Static Torsion	F2077
Subsidence - Anchors Deployed	F22674
Subsidence - Anchors Not Deployed	F22674
Expulsion - Anchors Deployed	N/A
Expulsion - Anchors Not Deployed	N/A
Dynamic Compression	F2077
Dynamic Compression Shear	F2077
Dynamic Torsion	F2077
Wear	F1877

Substantial Equivalence Conclusion

The proposed Acapella One Cervical Spacer System has the same intended use, similar Indications for Use, the same technological characteristics, and the same principles of operation as the Exactech Octane-C, US Spine Phantom Plus, and LDR ROI-C Cervical Cage systems. In addition, proposed Acapella One implants are made from the same materials as predicate Exactech Octane-A devices. Information provided in this submission shows the proposed Acapella One Cervical Spacer System is substantially equivalent to the cited predicates.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the HHS logo, which is a stylized caduceus-like symbol with three wavy lines, representing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the logo.

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

February 12, 2014

Exactech, Incorporated Mr. Patrick Hughes Senior Regulatory Affairs Specialist 2320 Northwest 66th Court Gainesville, Florida 32653

Re: K132582

Trade/Device Name: Exactech® Acapella® One Cervical Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: January 14, 2014 Received: January 15, 2014

Dear Mr. Hughes,

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 - Mr. Patrick Hughes

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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,

Vincent訂@evlin -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K132582

Device Name

Exactech® Acapella® One Cervical Spacer System

Indications for Use (Describe)

The Exactech Acapella One Cervical Spacer System is interior cervical interbody fusion procedures in skeletally mature patients with degenerative disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of nonoperative treatment. The Exactech Acapella One Cervical Spacer System is to be used with autogenous bone graft and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach.

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

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

FORM FDA 3881 (1/14)

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

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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.