The Dogbone ACFS is indicated for trauma, deformity (lordosis and kyphosis), pseudoarthrosis, previously failed cervical spine fusion, tumor, degenerative disk disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.), and spinal canal stenosis.

The Dogbone ACFS is indicated for stabilizing the spine from C2 to C7. Unicortical or bicortical fixation from the anterior face of the vertebral bodies may be employed using either the variable angle or fixed angle screws. This product may be employed as an internal fixation device during the time interval required for arthrodesis.

Device Description

The Dogbone ACFS is a titanium alloy anterior cervical plate fixation system. Plates are pre-contoured in two planes, and come in a variety of lengths. Screws arc available in two diameters, several lengths, and two different styles; fixed angle and variable angle. Fixed angle screws are used to build a rigid fixation construct. Variable angle screws are used to build a non-rigid construct. Hybrid constructs combining elements of fixed and variable angle screws may be built also. Eight locking tingers circumferentially disposed around the rim of each screw hole engage the screw heads to provide mechanical resistance against screw back-out.

AI/ML Overview

The provided text describes a medical device called the "Dogbone ACFS," a spinal intervertebral body fixation orthosis. However, the document is a 510(k) summary for regulatory clearance and does not contain information about acceptance criteria, a study demonstrating the device meets those criteria, or any of the detailed data provenance, expert involvement, or statistical analyses typically associated with such studies for AI/software-as-a-medical-device (SaMD) products.

The "Performance Data" section specifically states: "Non-clinical: Static and fatigue cantilever axial compression testing was performed. Properties of stiffness, strength, and fatigue life were characterized. Static torsion was also examined." This indicates engineering performance testing for a mechanical device, not a study evaluating an algorithm's performance.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be answered:

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

Cannot be provided. The document describes non-clinical engineering tests (stiffness, strength, fatigue life, static torsion) but does not define specific "acceptance criteria" (e.g., minimum stiffness values, maximum fatigue cycles) or quantitative "reported device performance" against those criteria. It only states that these properties were "characterized."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. This information is relevant for studies involving data-driven algorithms (like AI/ML). The document describes mechanical testing, not a study involving a test set of data.

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)

Cannot be provided. This is relevant for studies involving human interpretation or labeling of data for ground truth. The device is a physical implant, and its performance is assessed via mechanical testing, not expert consensus on data.

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

Cannot be provided. This is relevant for resolving discrepancies in expert labeling of ground truth in data-driven studies.

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

Cannot be provided. This type of study is specific to AI/software that assists human readers/clinicians, which is not what the Dogbone ACFS is.

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

Cannot be provided. This is relevant for AI-only devices. The Dogbone ACFS is a physical medical implant.

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

Cannot be provided. No "ground truth" in the context of data labeling is mentioned. For mechanical devices, testing against engineering standards or established physical properties would be the equivalent.

8. The sample size for the training set

Cannot be provided. No training set exists for this physical device.

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

Cannot be provided. No training set or associated ground truth is relevant here.

Summary of available information from the document that relates to performance:

The document describes non-clinical performance data for a physical spinal implant.

Type of tests performed:
- Static cantilever axial compression testing
- Fatigue cantilever axial compression testing
- Static torsion testing
Properties characterized:
- Stiffness
- Strength
- Fatigue life
Study proving device meets acceptance criteria:
- No specific "study" in the sense of a clinical trial or AI performance validation is described. The "Performance Data" section indicates that these mechanical tests were performed and properties characterized. The implication for regulatory clearance (510(k)) is that these tests demonstrated the device's performance is substantially equivalent to a predicate device (Synthes (USA) Titanium Locking Plate System (TILPS) (K970048)) and meets general safety and effectiveness requirements for its intended use. The 510(k) summary does not detail the specific test results or the acceptance criteria established for these mechanical properties.

Summary

{0}------------------------------------------------

FEB

510(k) Summary

Dogbone ACFS

510 (k) Summary

Company: Theken Surgical 1100 Nola Avenue Barberton, Ohio 44203
Trade Name: Dogbone ACFS

Classification: KWG 888.3060, Spinal Intervertebral Body Fixation Orthosis. Class II.

The Dogbone ACFS is a titanium alloy anterior cervical plate fixation system. Description: Plates are pre-contoured in two planes, and come in a variety of lengths. Screws arc available in two diameters, several lengths, and two different styles; fixed angle and variable angle. Fixed angle screws are used to build a rigid fixation construct. Variable angle screws are used to build a non-rigid construct. Hybrid constructs combining elements of fixed and variable angle screws may be built also. Eight locking tingers circumferentially disposed around the rim of each screw hole engage the screw heads to provide mechanical resistance against screw back-out.

Performance Data:

Non-clinical:

Static and fatigue cantilever axial compression testing was performed. Properties of stiffness, strength, and fatigue life were characterized. Static torsion was also examined.

Intended Use;

The Dogbone ACFS is indicated for:

The Dogbone ACFS is indicated for trauma, deformity (lordosis and kyphosis). oseudoarthrosis, previously failed cervical soine fusion, tumor, degenerative disk disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.), and spinal canal stenosis.

Substantial Equivalence:

Synthes (USA) Titanium Locking Plate System (TILPS) (K970048)

{1}------------------------------------------------

Public Health Service

FEB 4 2000 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Lukas Eisermann Director, Regulatory Affairs Theken Surgical 1100 Nola Avenue Barberton, Ohio 44203

Re: K994383 Trade Name: Dogbone ACFS Regulatory Class: II Product Code: KWQ Dated: December 27, 1999 Received: December 28, 1999

Dear Mr. Eisermann:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

{2}------------------------------------------------

Page 2 - Mr. Lukas Eisermann

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Neil K.P. Ogden

James E. Dillard II Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

610/k) Number K994383

510 {k} Number {if known):

Device Name: Dogbone ACFS

1. Indications for Use:
  The Dogbone ACFS is indicated for trauma, deformity (lordosis and kyphosis), pseudoarthrosis, previously failed cervical spine fusion, tumor, degenerative disk disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.), and spinal canal stenosis.

The Dogbone ACFS is indicated for stabilizing the spine from C2 to C7. Unicontical or bicortical fixation from the anterior face of the vertebral bodies may be employed using either the variable angle or fixed angle screws. This product may be employed as an internal fixation device during the time interval required for arthrodesis.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1/2/96)

DRO for JZD

(Division Sign-Off) Division of General Restorative Devices 994393 510(k) Number

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.