(57 days)
The ALTES™ Buttress Plating System is intended for anterior intravertebral body screw fixation/attachment to the L1-S1 spine over one vertebral body extending onto the adjacent interverbral space. Due to variations in the anatomy, the plate is designed for applications caudal to the bifurcation of the great vessels. Specifically, the device is intended for stabilization and buttressing of bone graft over one motion segment following anterior structural reconstruction for degenerative disc disease (DDD). DDD is defined as follows: back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies.
The ALTES™ Anterior Buttress Plating System consists of plates and screws. The plate is shaped to conform to the anatomy of the anterior spine. The system features two screws which engage the vertebral body and prevent rotation. A unique locking mechanism of the screw prevents the plate and screws from releasing. The plates are available in three sizes: 20mm, 25mm. and 30mm. The screws are available in two diameters: 4.5mm and 5.0mm, and two lengths: 15mm and 20mm. The components of the ALTES™ Anterior Buttress Plating System are manufactured from titanium alloy and have a smooth anodized color-coded finish.
The Altiva ALTES™ Buttress Plating System is a medical device designed for anterior intravertebral body screw fixation/attachment to the L1-S1 spine. The 510(k) submission (K061482) describes the device and its intended use, and indicates that performance data were submitted to characterize the system. However, the provided text does not include specific acceptance criteria or a detailed study description with performance metrics, sample sizes, or ground truth establishment.
The document is a 510(k) summary and the FDA's substantial equivalence letter, which confirms that the device is substantially equivalent to legally marketed predicate devices. This typically means that the device has similar technological characteristics and is as safe and effective as the predicate device(s). While performance data were submitted, the specifics of those data, including the acceptance criteria, study design, and results, are not contained within the provided excerpts.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or MRMC studies, as this information is not present in the provided text.
Here's how I would present the information based on the provided text, highlighting what is missing:
Acceptance Criteria and Device Performance Study
The provided 510(k) summary for the Altiva ALTES™ Buttress Plating System states that "Performance data were submitted to characterize the ALTES™ Anterior Buttress Plating System." However, the specific acceptance criteria for this performance data and the detailed results of the study are not included in the provided document. The document primarily focuses on the device description, intended use, and the FDA's determination of substantial equivalence.
Therefore, I am unable to populate the table of acceptance criteria and reported device performance or answer the detailed questions regarding the study.
Information not available in the provided text:
- Specific quantitative acceptance criteria (e.g., tensile strength, fatigue life, screw pull-out force thresholds).
- Reported device performance values against these criteria.
- Detailed study design (e.g., type of tests conducted, methodologies).
- Sample sizes for test sets (e.g., number of implants tested).
- Data provenance (e.g., in-vitro, in-vivo, country of origin).
- Any information regarding expert involvement in ground truth establishment or adjudication.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
- Standalone performance details.
- Type of ground truth used (e.g., expert consensus, pathology, outcomes data), as applicable to a clinical study (which isn't detailed here).
- Sample size for any training set (if an AI/ML component were involved, which is not indicated).
- How ground truth for any training set was established.
General understanding from the document:
The 510(k) process relies on demonstrating "substantial equivalence" to a legally marketed predicate device. This typically involves showing that the new device is as safe and effective as the predicate, often through comparisons of design, materials, and performance data (e.g., mechanical testing, biocompatibility). The FDA's substantial equivalence letter confirms that Altiva Corporation provided sufficient information to meet this requirement for the ALTES™ Buttress Plating System. However, the specifics of that "performance data" are not elaborated in the public summary.
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Altiva ALTESTM Buttress Plating System 510(k) Application
SIOF 2
PREMARKET NOTIFICATION 510(K) SUMMARY
JUL 26 2005 Company: Altiva Corporation 9800 Suite i, Southern Pines Blvd Charlotte, NC 28273 Telephone: 704/409-1754 Fax: 704/409-1771 Company Contact: John Kapitan, Director Product Development, RA/QA Date: May 24, 2006 Trade Name: ALTES™ Buttress Plating System Common Name Anterior Lumbar Buttress System Orthopedics, 888.3060, Class II Classification: KWQ
FDA Product Code :
Device Description:
The ALTES™ Anterior Buttress Plating System consists of plates and screws. The plate is shaped to conform to the anatomy of the anterior spine. The system features two screws which engage the vertebral body and prevent rotation. A unique locking mechanism of the screw prevents the plate and screws from releasing. The plates are available in three sizes: 20mm, 25mm. and 30mm. The screws are available in two diameters: 4.5mm and 5.0mm, and two lengths: 15mm and 20mm. The components of the ALTES™ Anterior Buttress Plating System are manufactured from titanium alloy and have a smooth anodized color-coded finish.
Intended Use:
The ALTES Anterior Buttress Plating System is intended for anterior intravertebral body screw fixation/attachment to the L1-S1 spine over one vertebral body extending onto the adjacent interverbral space. Due to variations in the anatomy, the plate is designed for applications caudal to the bifurcation of the great vessels. Specifically, the device is intended for stabilization and buttressing of bone graft over one following motion segment anterior structural reconstruction for degenerative disc disease (DDD). DDD is defined as follows: back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies.
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Predicate Device:
Predicate device information is included.
Performance Data: Performance data were submitted to characterize the ALTES™ Anterior Buttress Plating System.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, in the center. Encircling the caduceus is the text "U.S. Department of Health and Human Services" arranged in a circular pattern.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 26 2006
Altiva Corporation % Mr. John Kapitan Director, RA/QA 9800 Southern Pines Blvd., Suite I Charlotte, NC 28273
Re: K061482
Trade/Device Name: Altiva ALTES™ Buttress Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: May 24, 2006 Received: May 30, 2006
Dear Mr. Kapitan:
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 markcted 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.
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, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination docs 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 - Mr. John Kapitan
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) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Herbert Lemoncito
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Altiva ALTES™ Buttress Plating System
Indications for Use:
The ALTES™ Buttress Plating System is intended for anterior intravertebral body screw fixation/attachment to the L1-S1 spine over one vertebral body extending onto the adjacent interverbral space. Due to variations in the anatomy, the plate is designed for applications caudal to the bifurcation of the great vessels. Specifically, the device is intended for stabilization and buttressing of bone graft over one motion segment following anterior structural reconstruction for degenerative disc disease (DDD), DDD is defined as follows: back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies.
Prescription Use x or
Over-The-Counter Use
(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 Evaluation (ODE)
Division of General, Restorative, and Neurological Devices
510(k) Numb
§ 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.