(141 days)
The Synthes ArcoFix System is indicated for use, via the lateral or anterolateral surgical approach, in the treatment of thoracic and thoracolumbar (T1-L5) spine instability as a result of the following:
• Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Spondylolisthesis
• Spondylolysis
• Fracture (including dislocation and subluxation)
• Spinal stenosis
• Deformities (i.e. scoliosis, kyphosis, lordosis whether neuromuscular or related to deficient posterior elements)
• Tumors (neoplastic disease)
• Pseudoarthrosis
• Failed previous fusion.
The Synthes ArcoFix System is an addition to Synthes' existing anterior/anterolateral/lateral thoracolumbar spine systems. The ArcoFix implant consists of an expandable plate and 4 bone screws, all manufactured from Titanium Aluminum Niobium (Ti-6Al-7Nb) ASTM F1295, the same as the predicates.
The provided text describes a 510(k) submission for the Synthes ArcoFix System, a spinal intervertebral body fixation orthosis. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive new clinical studies with acceptance criteria based on performance metrics.
Therefore, the study information requested regarding acceptance criteria and performance with specific metrics like sensitivity, specificity, or reader improvement does not apply to this 510(k) summary. The submission states directly: "Clinical data and conclusions were not needed for this device."
Instead, the submission focuses on non-clinical bench testing to demonstrate substantial equivalence.
Here's a breakdown based on the characteristics of this 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance | Reported Performance |
|---|---|---|
| Non-Clinical Bench Testing for Substantial Equivalence | The Synthes ArcoFix System must demonstrate substantial equivalence in design, function, material, and intended use as compared to the predicate devices (Synthes VentroFix MIS (K031100) and Synthes Anterior Tension Band (ATB) System (K022791)). This typically involves mechanical testing (e.g., static and dynamic compression, bending, torsion), material characterization, and dimensional verification to ensure the new device performs similarly and meets relevant industry standards. | "Bench testing results demonstrate that the Synthes ArcoFix System is substantially equivalent to the predicate devices." (Specific quantitative results are not provided in this summary.) |
Explanation: In a 510(k) for a device like this spinal implant, the "acceptance criteria" are generally met by demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is often achieved through non-clinical testing that simulates the stresses and uses the device would undergo. The success criterion is the demonstration of "substantial equivalence" based on these tests.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided summary. For mechanical bench testing, samples typically include a statistically relevant number of devices or components to account for manufacturing variability and to demonstrate conformance to specifications.
- Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing conducted by Synthes Spine. It would be prospective in nature as the testing is specifically performed for the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: For non-clinical bench testing of a spinal implant, "ground truth" as it relates to expert consensus on interpretation of clinical data (like images) is not relevant. The "ground truth" or reference for the bench tests would be established by engineering specifications, relevant ASTM or ISO standards, and the performance characteristics of the predicate devices. The experts involved would be engineers and material scientists.
4. Adjudication method for the test set
- Not Applicable: Adjudication methods (e.g., 2+1, 3+1) are typically used for clinical study data where there is subjectivity in interpretation (e.g., image reading). For objective bench testing, the results are typically quantitative measurements, and "adjudication" in the clinical sense is not performed. Test results are compared against predetermined engineering specifications or predicate device performance.
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 type of study is specifically for evaluating the impact of AI systems on human reader performance, usually in diagnostics like radiology. The Synthes ArcoFix System is a medical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable: This question pertains to the performance of an AI algorithm in isolation. The Synthes ArcoFix System is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Engineering Specifications and Predicate Performance: For the non-clinical bench testing, the "ground truth" would be defined by established engineering and material science principles, relevant international standards (e.g., ASTM, ISO) for spinal implants, and the known, acceptable performance characteristics of the predicate devices. Compliance with these established criteria constitutes meeting the "ground truth" for non-clinical substantial equivalence.
8. The sample size for the training set
- Not Applicable: Training sets are used in machine learning for AI algorithms. This is a physical medical device; thus, there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable: As there is no training set, this question is not relevant.
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@ SYNTHES* Spine
MAY 2 3 2008
5 510(k) Summary
| 510(k) Summary | ||
|---|---|---|
| Name of Firm: | Synthes Spine | |
| 1302 Wrights Lane East | ||
| West Chester, PA 19380 | ||
| 510(k) Contact: | Kirsten Stowell | |
| Associate Regulatory Affairs Specialist | ||
| Telephone: 610-719-5534Facsimile: 610-719-5102 | ||
| Email: stowell.kirsten@synthes.com | ||
| Date Prepared: | January 2, 2008 | |
| Trade Name: | Synthes ArcoFix System | |
| Classification: | 21 CFR 888.3060 - Spinal Intervertebral Body Fixation Orthosis | |
| Class II | ||
| Orthopaedic and Rehabilitation Devices Panel | ||
| Product Code: KWQ | ||
| Predicates: | Synthes VentroFix MIS (K031100) | |
| Synthes Anterior Tension Band (ATB) System (K022791) | ||
| Device | The Synthes ArcoFix System is an addition to Synthes' existing | |
| Description: | anterior/anterolateral/lateral thoracolumbar spine systems. The ArcoFix implant | |
| consists of an expandable plate and 4 bone screws, all manufactured from | ||
| Titanium Aluminum Niobium (Ti-6Al-7Nb) ASTM F1295, the same as the | ||
| predicates. | ||
| Intended Use/ | Synthes ArcoFix System is indicated for use, via the lateral or anterolateral | |
| Indications for | surgical approach, in the treatment of thoracic and thoracolumbar (T1-L5) spine | |
| Use: | instability as a result of the following: | |
| • Degenerative Disc Disease (defined as back pain of discogenic origin | ||
| with degeneration of the disc confirmed by patient history and | ||
| radiographic studies) | ||
| • Spondylolisthesis | ||
| • Spondylolysis | ||
| • Fracture (including dislocation and subluxation) | ||
| • Spinal stenosis | ||
| • Deformities (i.e. scoliosis, kyphosis, lordosis whether neuromuscular or | ||
| related to deficient posterior elements) | ||
| • Tumors (neoplastic disease) | ||
| • Pseudoarthrosis | ||
| • Failed previous fusion. | ||
| Comparison of | The Synthes ArcoFix System is a result of design modifications to the predicate | |
| the device to | devices. It is substantially equivalent to the predicates in design, function, | |
| predicate | material, and intended use. | |
| device(s): | ||
| Performance | Non-Clinical Performance and Conclusions: | |
| Date | Bench testing results demonstrate that the Synthes ArcoFix System is | |
| (Non-Clinical | substantially equivalent to the predicate devices. | |
| and/or Clinical): | Clinical Performance and Conclusions: | |
| Clinical data and conclusions were not needed for this device. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2008
Synthes Spine CO. LP % Ms. Kirsten Stowell Associate Regulatory Affairs Specialist 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: K080020/S002
Trade/Device Name: Synthes ArcoFix System Regulation Number: 21 CFR 888.3060 Regulation Names: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: May 15, 2008 Received: May 19, 2008
Dear Ms. Stowell:
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.
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 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. Kirsten Stowell
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Wilkerson
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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Image /page/3/Picture/0 description: The image shows the logo for Synthes Spine. The logo consists of the Synthes symbol on the left, followed by the word "SYNTHES" in bold, sans-serif font. Below the word "SYNTHES" is the word "Spine" in a smaller, italicized font.
4 Indications for Use Statement
510(k) Number: (if known)
K 080020
Device Name: Synthes ArcoFix System
Indications for Use:
The Synthes ArcoFix System is indicated for use, via the lateral or anterolateral surgical approach, in the treatment of thoracic and thoracolumbar (T1-L5) spine instability as a result of the following:
- Degenerative Disc Disease (defined as back pain of discogenic origin with . degeneration of the disc confirmed by patient history and radiographic studies)
- Spondylolisthesis .
- Spondylolysis .
- Fracture (including dislocation and subluxation) .
- Spinal stenosis .
- Deformities (i.e. scoliosis, kyphosis, lordosis whether neuromuscular or related to . deficient posterior elements)
- ◆ Tumors (neoplastic disease)
- Pseudoarthrosis ●
- Failed previous fusion. .
Prescription Use X (21 CFR 801 Subpart D) AND / OR
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
CONFIDENTIAL
Traditional 510(k) - Synthes ArcoFix System
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign Off)
Division of General, Restorative,
and Neurological Devices
Page 15 of 29
| 510(k) Number | K080020 |
|---|---|
| --------------- | --------- |
15
§ 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.