When used as a cervical intervertebral fusion device, the K7C™ spacers are indicated for use at one level in the cervical spine, from C2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with autogenous bone graft and with supplemental fixation systems cleared for use in the cervical spine.

Device Description

The K7C™ Spacer is a collection of radiolucent interbody devices having a keystone-shaped cross-section. The superior and inferior surfaces are open with parallel serrations to facilitate implant stability. The implants are available in an assortment of height, length, width and anteroposterior angulation combinations to accommodate a variety of anatomic requirements.

AI/ML Overview

The provided text describes a medical device, the K7C™ Spacer, and its mechanical testing for a 510(k) submission. However, it does not contain the specific information requested about acceptance criteria for device performance in the format of a table, nor does it detail a clinical study with human subjects, ground truth establishment, or expert involvement as outlined in the request.

Therefore, many of the requested elements cannot be extracted directly from the provided text.

Here's an analysis based on the available information:

1. Table of acceptance criteria and the reported device performance:

The document states: "Mechanical testing of the worst case K7C™ spacer was performed according to ASTM F2077 and included static and dynamic compression and static and dynamic torsion. The subsidence properties were evaluated according to ASTM F2267. The mechanical test results demonstrate that the K7C™ Spacers perform as well as or better than the predicate devices."

This indicates that the acceptance criteria were likely defined by the performance of the predicate devices in these specific ASTM standards (ASTM F2077 and ASTM F2267). The reported device performance is stated as "perform as well as or better than the predicate devices."

Acceptance Criteria (Inferred)	Reported Device Performance
Performance equivalent to or better than predicate devices in:	Performed as well as or better than predicate devices in:
- Static compression (ASTM F2077)	- Static compression (ASTM F2077)
- Dynamic compression (ASTM F2077)	- Dynamic compression (ASTM F2077)
- Static torsion (ASTM F2077)	- Static torsion (ASTM F2077)
- Dynamic torsion (ASTM F2077)	- Dynamic torsion (ASTM F2077)
- Subsidence properties (ASTM F2267)	- Subsidence properties (ASTM F2267)

2. Sample sized used for the test set and the data provenance:

The document mentions "mechanical testing of the worst case K7C™ spacer." This suggests a limited sample size, likely a few units chosen to represent the most challenging design. It does not provide an exact number. The data provenance is from mechanical testing, not human subjects, and is likely conducted in a laboratory setting (prospective testing of manufactured devices). No country of origin for this specific testing data is mentioned, but the sponsor is in Henderson, NV, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the study described is mechanical testing of a medical device, not a study involving human diagnosis or interpretation where expert ground truth would be established.

4. Adjudication method for the test set:

This information is not applicable for mechanical testing.

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:

This information is not applicable. The document describes mechanical testing of an intervertebral fusion device, not an AI-powered diagnostic tool requiring MRMC studies.

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

This information is not applicable. The device is a physical implant, not an algorithm.

7. The type of ground truth used:

For mechanical testing, the "ground truth" would be the objective physical measurements obtained according to the specified ASTM standards. These standards themselves establish the methodology for determining the performance characteristics.

8. The sample size for the training set:

This information is not applicable. There is no "training set" as this is mechanical testing of a physical device, not a machine learning model.

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

This information is not applicable as there is no training set mentioned or implied.

Summary

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510(k) Summary 8.

Date:	31 October 2012
Sponsor:	K7 LLC54 Moonrise WayHenderson, NV 89074Phone: 817.219.4441Facsimile: 817.326.5524JAN 0 4 2013
Contact Person:	Michael D. Smith, Manager
Trade Names:	K7C™ Spacer
Device Classification	Class II
Classification Name:	Intervertebral fusion device with bone graft, cervical
Regulation:	888.3080
Device ProductCode:	ODP
Device Description:	The K7C™ Spacer is a collection of radiolucent interbody deviceshaving a keystone-shaped cross-section. The superior and inferiorsurfaces are open with parallel serrations to facilitate implantstability. The implants are available in an assortment of height,length, width and anteroposterior angulation combinations toaccommodate a variety of anatomic requirements.
Intended Use:	When used as a cervical intervertebral fusion device, the K7Cspacers are indicated for use at one level in the cervical spine, fromC2-T1, in skeletally mature patients who have had six weeks of non-operative treatment for the treatment of degenerative disc disease(DDD) with up to Grade 1 spondylolisthesis. DDD is defined as neckpain of discogenic origin with degeneration of the disc confirmed byhistory and radiographic studies. The device is intended for use withautogenous bone graft and with supplemental fixation systemscleared for use in the cervical spine.
Materials:	K7C™ spacers are manufactured from polyetheretherketone (PEEK)per ASTM F2026 (VESTAKEEP® i4 R, Evonik PolymersTechnologies GmbH). Integral marker pins are manufactured fromtantalum according to ASTM F560.
Predicate Devices:	Eminent Spine (K090064)CenterPulse Spine-Tech (P980048)MC+ (K043479 and K091088)K2M, Inc. (K082698, K101302 and K103169)
TechnologicalCharacteristics:	The K7C™ Spacers possess the same technological characteristicsas the predicate devices. These include:• intended use (as described above),• basic design (hollow column),• material (polymer), and• sizes (widths, lengths and heights are within the range(s)offered by the predicate systems).

Spacers is the same as previously cleared devices.

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Performance Data:

Mechanical testing of the worst case K7C™ spacer was performed according to ASTM F2077 and included static and dynamic compression and static and dynamic torsion. The subsidence properties were evaluated according to ASTM F2267. The mechanical test results demonstrate that the K7C™ Spacers perform as well as or better than the predicate devices. Hence these devices are as safe and as effective as the predicates.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure embracing or being protected by a wing-like shape.

Public Health Service

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

January 4, 2013

K7, LLC % BackRoads Consulting, Incorporated Karen Warden, Ph.D. Representative/Consultant P.O. Box 566 Chesterland. Ohio 44026

Re: K123388

Trade/Device Name: K7CTM Spacer Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: October 31, 2012 Received: November 2, 2012

Dear Dr. Warden:

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. Iisting 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

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Page 2 - Karen Warden, Ph.D.

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 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 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.

Image /page/3/Picture/7 description: The image shows the name "Erin DKeith" in a stylized font. The letters are bold and black, with a unique design that makes them stand out. The name appears to be a logo or a signature, possibly for a business or individual. The font is modern and eye-catching.

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

Enclosure

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7. Indications for Use Statement

510(k) Number: K123388

Device Name: K7C™ Spacer

Indications for Use:

Prescription Use X (Per 21 CFR 801.109) OR

Over-the-Counter Use_____________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/4/Picture/11 description: The image shows the text "Colin O'Neill" in a stylized font. The letters "i", "O", and "N" are designed with geometric patterns and lines, giving them a unique and modern look. The rest of the letters are in a more standard, bold font, providing a contrast to the stylized characters. The overall design is eye-catching and memorable.

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K123388

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.