(367 days)
The Transcorp ACIF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. Transcorp ACIF implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation.
The Transcorp Anterior Cervical Intervertebral Fusion (ACIF) System includes various size implants manufactured from implant grade PEEK conforming to ASTM F2026-08. The implant is hollow to allow for autogenous bone graft material. The implant is provided nonsterile.
Here's an analysis of the provided 510(k) summary regarding the Transcorp ACIF System, focusing on acceptance criteria and supporting studies:
Transcorp ACIF System: Acceptance Criteria and Supporting Studies
This 510(k) summary focuses on "substantial equivalence" to predicate devices rather than clinical efficacy studies often seen with AI/software devices. The acceptance criteria and supporting studies mentioned are primarily related to non-clinical performance testing of a physical implant.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Static Axial Compression (per ASTM F2077-03) | Performed and deemed acceptable |
| Dynamic Axial Compression (per ASTM F2077-03) | Performed and deemed acceptable | |
| Static Compression Shear (per ASTM F2077-03) | Performed and deemed acceptable | |
| Dynamic Compression Shear (per ASTM F2077-03) | Performed and deemed acceptable | |
| Static Torsion (per ASTM F2077-03) | Performed and deemed acceptable | |
| Dynamic Torsion (per ASTM F2077-03) | Performed and deemed acceptable | |
| Subsidence Resistance | Subsidence Testing (per ASTM F2267-04) | Performed and deemed acceptable |
| Biocompatibility/Wear | Wear Testing Analysis (Particulate Generation via ASTM F1877-05) | Performed; wear debris collected and analyzed, deemed acceptable |
Note: The document only states that these tests were "performed" and that the results "demonstrated substantial equivalence" to predicate devices. It does not provide specific numerical outcomes or detailed acceptance ranges (e.g., maximum deflection, fatigue life cycles, subsidence amount, wear particulate size/quantity). The general statement "deemed acceptable" is inferred from the FDA's clearance based on substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each test. For mechanical and wear testing of physical implants, a representative sample size of the manufactured device is typically used, often following industry standards for testing implantable devices (e.g., 5-10 samples per test condition).
- Data Provenance: The tests are explicitly stated as "non-clinical performance testing." This implies they were conducted in a laboratory setting, likely on manufactured prototypes or production units of the device. There is no mention of human-derived data, country of origin related to patient data, or retrospective/prospective studies as these are not relevant for this type of medical device's 510(k) clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not Applicable. For this type of physical device (intervertebral body fusion device) undergoing mechanical and wear testing, "ground truth" is established by adherence to international standards (e.g., ASTM F2077-03, ASTM F2267-04, ASTM F1877-05) and internal engineering specifications, not by expert consensus on clinical data. The performance is objectively measured against physical criteria.
4. Adjudication Method for the Test Set
- Not Applicable. Adjudication methods (like 2+1 or 3+1) are used for resolving disagreements in expert opinion when establishing ground truth, typically in image analysis or clinical endpoint studies. Since this device underwent non-clinical laboratory testing, such an adjudication method is not relevant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is not mentioned and would be irrelevant for a physical intervertebral body fusion device undergoing mechanical and wear testing. MRMC studies are typically performed for diagnostic imaging devices or AI-powered clinical decision support tools to evaluate human reader performance with and without AI assistance.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- Not Applicable. This is a physical implant, not an algorithm or software device. The concept of "standalone algorithm performance" does not apply here. The device's performance is its inherent mechanical and material properties.
7. Type of Ground Truth Used
- Objective Engineering Standards and Physical Measurements. The "ground truth" for the performance tests relies on:
- ASTM Standards: F2077-03 (Static and Dynamic Axial Compression, Compression Shear, Torsion), F2267-04 (Subsidence), F1877-05 (Wear Debris Analysis).
- Material Specifications: Implant grade PEEK conforming to ASTM F2026-08.
- Comparison to Predicate Devices: Performance is likely compared to the mechanical properties and wear characteristics of the K081730 Alphatec Novel Spinal Spacer System and P980048 BAK/C Vista Cervical Interbody Fusion Device to demonstrate "substantial equivalence."
8. Sample Size for the Training Set
- Not Applicable. This device did not involve any machine learning algorithms, and therefore, there is no "training set" in the context of AI/software. If "training set" refers to samples used during product development or iteration, this information is not provided in a 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no AI/software involved and thus no "training set," this question is not relevant.
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Ko92794
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510(k) Summary Pursuant to 21 CFR 807.92c
SEP 1 8 2010
Submitted By:
Andrew Rodenhouse Transcorp, Inc. 1000 100th St. SW Suite F Byron Center, MI 49315 Ph: 616-877-4177 Fax: 616-877-4522
Date:
September 10, 2010
Device Information:
| Trade Name: | Transcorp ACIF System |
|---|---|
| Common Name: | Intervertebral Body Fusion Device |
| Classification: | 21 CFR Section 888.3080, Product Code ODP,Class II |
Predicate Devices:
K081730 Alphatec Novel Spinal Spacer System P980048 BAK/C Vista Cervical Interbody Fusion Device
Device Description:
The Transcorp Anterior Cervical Intervertebral Fusion (ACIF) System includes various size implants manufactured from implant grade PEEK conforming to ASTM F2026-08. The implant is hollow to allow for autogenous bone graft material. The implant is provided nonsterile.
Intended Use:
The Transcorp ACIF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as neck pain of discogenic origin with
Page 1 of 2
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the degeneration of the disc confirmed by history and radiographic studies. Transcorp ACIF implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation.
Performance Data:
Performance testing was performed on the Transcorp ACIF System. Static and dynamic axial compression, static and dynamic compression shear, static and dynamic torsion testing per ASTM F2077-03, and subsidence testing per ASTM F2267-04. A wear testing analysis was performed to determine particulate generation during dynamic axial compression and dynamic torsion testing. The wear debris was collected and analyzed per ASTM F1877-05. No clinical testing was performed.
Substantial Equivalence:
The Transcorp ACIF System is equivalent to the predicate devices in design, function, intended use, and indications for use. The results of non-clinical performance testing and analysis have demonstrated that the Transcorp ACIF System is substantially equivalent to the predicate devices.
Pay 2.f2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Transcorp, Inc. % Mr. Andrew Rodenhouse 1000 100th Street, SW - Suite F Byron Center, Michigan 49315
Re: K092794
SEP 1 3 2010
Trade/Device Name: Transcorp ACIF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: September 02, 2010 Received: September 02, 2010
Dear Mr. Rodenhouse:
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, listing 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
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Page 2 - Mr. Andrew Rodenhouse
comply with all the Act's requirements, including, but not limited to: registration and listing (21 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 (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.
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 vours.
Barbara Buettner
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number: Ko92794
Device Name: Transcorp ACIF System i;
SEP 1 3 2010
Indications for Use:
The Transcorp ACIF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. Transcorp ACIF implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral body fusion device. The device must be used with supplemental fixation.
Prescription Use X Over-the-counter use or (per CFR 801.109)
Concurrence of CDRH, Office of Device Evaluation (ODE)
signature
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
KO92794 510(k) Number_
§ 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.