(89 days)
The Tether™ ACFS is indicated for trauma, deformity (lordosis, kyphosis and scoliosis), pseudoarthrosis, previously failed cervical spine fusion, tumor, scollosis); pocudour.hrools; provised as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.), spondylolisthesis, and spinal stenosis.
The Tether™ ACFS is indicated for temporary stabilization of the spine from C2 to C7 during the time interval required for arthrodesis.
The Tether ACFS is a titanium alloy anterior cervical plate fixation system. The Tether AOTO 13 a titaniam anoy and come in a variety of lengths. Screws Prates are pre-contoured in two planos, and two different styles; fixed and variable in two diametors, cororal rengine are used to build a rigid fixation angle and variable angle screws are used to build a non-rigid construct. Hybrid constructs are possible by combining fixed and variable angle screws. A locking constructs are possible by comemages the plate hole upon entry into the plate and provides a mechanical lock against screw back-out.
The provided 510(k) summary for the Theken Surgical Company's Tether™ ACFS (Anterior Cervical Plate Fixation System) is for a medical device (spinal implant) and does not contain information related to software or AI performance. Therefore, many of the requested fields about AI-specific acceptance criteria, study design, and ground truth establishment cannot be answered from this document.
However, I can extract the general "performance data" provided for this medical device and present it.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-clinical: | |
| Stiffness | Characterized |
| Strength | Characterized |
| Fatigue Life | Characterized |
Explanation: The document states, "Static and fatigue testing was performed. Properties of stiffness, strength, and fatigue life were characterized." This implies that the device met pre-defined acceptance criteria for these mechanical properties, which are standard for spinal implants, allowing it to be considered substantially equivalent to the predicate device. However, the specific quantitative values for these criteria or the test results are not detailed in this summary.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. Testing would have involved a number of manufactured devices or prototypes.
- Data Provenance: Not specified, but generally, such non-clinical performance testing is conducted in a laboratory setting by the manufacturer or a contracted testing facility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is a mechanical device, and "ground truth" for performance is established through engineering and biomechanical testing standards, not expert medical opinion.
4. Adjudication method for the test set
- Not applicable. Performance is based on objective measurements against engineering standards.
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 not an AI/software device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an AI/software device.
7. The type of ground truth used
- Ground Truth: Engineering standards and biomechanical testing protocols for spinal implants (e.g., ASTM standards for static and fatigue testing).
8. The sample size for the training set
- Not applicable. This is not an AI/software device. The concept of a "training set" is not relevant here.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/software device.
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510(k) Summary
MAY 1 6 2001
510 (k) Summary
Tether™ ACFS
Theken Surgical Company: 1100 Nola Avenue Barberton, Ohio 44203
Tether™ ACFS Trade Name:
Classification: KWG 888.3060. Spinal Intervertebral Body Fixation Orthosis. Class II.
The Tether ACFS is a titanium alloy anterior cervical plate fixation system. Description: The Tether AOTO 13 a titaniam anoy and come in a variety of lengths. Screws Prates are pre-contoured in two planos, and two different styles; fixed and variable in two diametors, cororal rengine are used to build a rigid fixation angle and variable angle screws are used to build a non-rigid construct. Hybrid constructs are possible by combining fixed and variable angle screws. A locking constructs are possible by comemages the plate hole upon entry into the plate and provides a mechanical lock against screw back-out.
Performance Data:
Non-clinical:
Static and fatigue testing was performed. Properties of stiffness, strength, and fatique life were characterized.
Intended Use:
The Tether™ ACFS is indicated for:
The Tether™ ACFS is indicated for trauma, deformity (fordosis, kyphosis and the rether - AGT o lo misus reviously failed cervical spine fusion, turnor, Scollosis), "pscudounthrools," providely as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.) spondylolisthesis, and spinal stenosis.
The Tether™ ACFS is indicated for temporary stabilization of the spine from C2 to C7 during the time interval required for arthrodesis.
Substantial Equivalence:
Synthes (USA) Titanium Locking Plate System (TILPS) (K970048)
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines that suggest a person in profile.
MAY 1 6 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Randy Theken President Theken Surgical, LLC 1100 Nola Avenue Barberton. Ohio 44203
Re: K010466
Trade Name: TetherTM ACFS Regulation Number: 888.3060 Regulatory Class: Class II Product Code: KWQ Dated: February 15, 2001 Received: February 16, 2001
Dear Mr. Theken:
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 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.
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.
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Page 2 - Mr. Randy Theken
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,
Rmuklellmpr
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510 (k) Number (if known): KOLO466
Device Name: Tether™ ACFS
-
- Indications for Use:
The Tether™ ACFS is indicated for trauma, deformity (lordosis, kyphosis and scoliosis), pseudoarthrosis, previously failed cervical spine fusion, tumor, scollosis); pocudour.hrools; provised as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.), spondylolisthesis, and spinal stenosis.
- Indications for Use:
The Tether™ ACFS is indicated for temporary stabilization of the spine from C2 to C7 during the time interval required for arthrodesis.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1/2/96)
Muckheeeesa
(Division Sign-Off) (Division Sign of General, Restorative Division of Neurological Devices
510(k) Number 016446
§ 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.