(220 days)
The Atalia Titanium Surgical Mesh is indicated for use in the thoraco-lumbar spine (T1-LS), in cases where one vertebral body has been structurally compromised either by tumor or trauma. The objective is the restoration of anterior column support through introduction of a corpectomy construct in tandem with bone graft to ultimately realize spinal fusion. The Atalia Titanium Surgical Mesh is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and/or lumbar spine.
The Atalia Titanium Surgical Mesh is a round-patterned, surgical mesh device. The body is manufactured from TI-6AL-4V ELI Alloy conforming to ASTM F 136. Because of the construction, the angle and the length of the mesh can be reduced incrementally to adjust it to individually anstomical conditions. The Atalia Surgical Mesh System is sold non-sterile.
The provided text is a 510(k) summary for the Atalia Titanium Surgical Mesh, a spinal implant. It details the device's description, indications for use, and a summary of testing. However, it does not contain the specific information requested about acceptance criteria, detailed study results proving a device meets those criteria, expert details, or training/test set specifics for an AI/ML device.
This document describes a medical device clearance for a physical surgical mesh, not a software-driven AI/ML diagnostic tool. Therefore, many of the questions related to AI/ML device evaluation metrics (e.g., sample size for test set, data provenance, ground truth establishment by experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to the information provided in this 510(k) summary.
The "SUMMARY of TESTING" section states: "The Atalia Titanium Mesh (U.S. Spinal Technologies) was tested in accordance with ASTM F2077." This indicates a biomaterial and mechanical performance test for spinal implants, not a clinical study or AI/ML performance evaluation.
To answer your request based on the provided text, I can only state what is directly available:
1. A table of acceptance criteria and the reported device performance:
The document mentions testing was done in accordance with ASTM F2077. This ASTM standard defines mechanical test methods for spinal implants. However, the specific acceptance criteria (e.g., minimum compression strength, fatigue life) from ASTM F2077 and the reported performance of the Atalia Titanium Surgical Mesh against those specific criteria are not provided in this 510(k) summary. The summary only states that it was tested in accordance with the standard.
| Acceptance Criteria (from ASTM F2077) | Reported Device Performance |
|---|---|
| Not specified in document | Not specified in document |
Regarding the other points, as the device is a physical surgical mesh and not an AI/ML diagnostic device, most of the requested information is not applicable to this 510(k) submission.
- 2. Sample sized used for the test set and the data provenance: Not applicable for a physical device mechanical test.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device performance typically refers to physical measurements and engineering specifications, not expert interpretation of medical data.
- 4. Adjudication method (e.g. 2+1, 3+1, none) 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, as this is not an AI/ML device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a physical device like this, the "ground truth" for mechanical testing would be the physical properties and performance measured according to the ASTM F2077 standard. The document does not detail these specific measurements.
- 8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
- 9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.
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FEB - 7 7005
041798
510(k) Summary
Submitted on behalf of:
U.S. Spinal Technologies, Inc. 3600 FAU Blvd. Ste 101 Boca Raton, FL 33431, USA Telephone: 561-367-7463 Fax: 561-367-9627
by:
Elaine Duncan, M.S.M.E., RAC President, Paladin Medical, Inc. PO Box 560 Stillwater, MN 55082 Telephone: 715-549-6035 Fax: 715-549-5380
CONTACT PERSON:
Elaine Duncan
| DATE PREPARED: | January 27, 2005 |
|---|---|
| TRADE NAME: | Atalia Titanium Surgical Mesh |
| COMMON NAME: | vertebral body replacement |
SUBSTANTIALLY EQUIVALENT TO:
The Atalia Titanium Surgical Mesh is substantially equivalent to various features and performance characteristics to the Osteotech VBR (K003155), the Depuy Acromed Surgical Titanium Mesh (K003043) and the Blackstone Surgical Mesh System (K030744) as detailed in the submission.
DESCRIPTION of the DEVICE:
The Atalia Titanium Surgical Mesh is a round-patterned, surgical mesh device. The body is manufactured from TI-6AL-4V ELI Alloy conforming to ASTM F 136. Because of the construction, the angle and the length of the mesh can be reduced incrementally to adjust it to individually anstomical conditions. The Atalia Surgical Mesh System is sold non-sterile.
INDICATIONS FOR USE:
The Atalia Titanium Surgical Mesh is indicated for use in the thoraco-lumbar spine (TI-LS), in cases where one vertebral body has been structurally compromised either by turnor or trauma. The objective is the restoration of anterior column support through introduction of a corpectomy construct in tandem is the graft to ultimately realize spinal fusion. The Atalia Titanium Surgical Mesh is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and/or lumbar spine.
SUMMARY of TESTING:
The Atalia Titanium Mesh (U.S. Spinal Technologies) was tested in accordance with ASTM F2077.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an emblem of a stylized bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 7 2005
U.S. Spinal Technologies, Inc. c/o Ms. Elaine Duncan, M.S.M.E., RAC President Paladin Medical, Inc. P.O. Box 560 Stillwater, Minnesota 55082
Re: K041798
Trade/Device Name: Atalia Titanium Surgical Mesh Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: December 10, 2004 Received: January 21, 2005
Dear Ms. Duncan:
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 for abounded or 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). 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 898. In addition, ITDA 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); good manufacturing practice requirements as set 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.
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Page 2 - Ms. Elaine Duncan, M.S.M.E., RAC
This letter will allow you to begin marketing your device as described in your Section 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Millerman
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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Indications for Use
PRODUCT NAME: Atkin Titanin Surgical Mask
510(k) Number (if known): 1041798
The Atalia Titanium Surgical Mesh is indicated for use in the thoraco-lumbar spine (T1-LS), in cases where one vertebral body has been structurally compromised either by tumor or trauma. The objective is the restoration of anterior column support through introduction of a corpectomy construct in tandem with bone graft to ultimately realize spinal fusion. The Atalia Titanium Surgical Mesh is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and/or lumbar spine.
Prescription Use AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Exaluation (ODE
for
(Division Sign-Off)
Division of General, Restorative,
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Neurological Devices
10(k) Number K041798
§ 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.