(219 days)
DYNAMIK Lumbar Interbody Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1, DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). This device is to be used with autogenous bone graft. DYNAMIK Lumbar Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
DYNAMIK range of products consists of lumbar Interbody cages available in various models to adapt to anatomical variations and surgical techniques. DYNAMIK cages are manufactured as single solid-machined piece made of PEEK conforming ASTM F2026. Markers made of titanium conforming ASTM F136 are used to visualize the position of the implant in the disc space. DYNAMIK Lumbar Interbody Devices are made of PEEK conforming ASTM F2026 with a titanium marker made of TA6V 4 ELI conforming to ISO 5832.3 and ASTM F 136 and are supplied sterile. DYNAMIK Lumbar Interbody Devices are supplied with DYNAMIK Lumbar Interbody Device is indicated for
The provided text describes the DYNAMIK Intervertebral Body Fusion Device, but it does not contain any acceptance criteria or a study that proves the device meets specific performance metrics in the way typically associated with AI/ML device validation.
The document is a 510(k) summary for a medical device (spinal implant), not an AI/ML diagnostic tool. Therefore, information regarding sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth for training was established is not applicable to this type of device submission and is not present in the provided text.
Instead, the performance data provided is related to the mechanical properties and substantial equivalence of the implant, not to diagnostic accuracy or AI performance.
Here's a breakdown of what is available based on your request, highlighting the differences for this type of device:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied by Regulatory Guidance) | Reported Device Performance |
|---|---|
| Conformance to Class II Special Controls Guidance Document: Intervertebral Body Fusion Device (June 12, 2007) | Device conforms to Class II Special Controls Guidance Document. |
| Mechanical properties (e.g., strength, durability, fatigue resistance) as evidenced by standards ASTM F 2077-03 and ASTM F 2267-04 | Mechanical testing was conducted per ASTM F 2077-03 and ASTM F 2267-04. (Specific values or "pass/fail" against acceptance limits for these tests are not provided in this summary, but the implication is that it met them to be cleared). |
| Substantial equivalence to predicate devices in terms of intended use, material, design, mechanical properties, and function. | Device is substantially equivalent to its predicate devices (LUMBAR I/F. CAGE, OPAL ORACLE SPACER, LUCENT) in terms of intended use, material, design, mechanical properties, and function. |
2. Sample size used for the test set and the data provenance:
- Not applicable. This is a physical implant, not an AI/ML device requiring a diagnostic test set. The "testing" refers to mechanical properties in a lab.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for this device relates to its mechanical integrity and biocompatibility, which are assessed through material science and engineering tests, not expert interpretation of diagnostic images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication is not relevant for mechanical testing.
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 a spinal 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 is a physical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The "ground truth" for this device's safety and effectiveness is established through adherence to recognized industry standards (ASTM F2026, ASTM F136, ISO 5832.3) for materials, and mechanical testing standards (ASTM F 2077-03 and ASTM F 2267-04). Additionally, biocompatibility and substantial equivalence to previously cleared devices serve as the basis for approval.
8. The sample size for the training set:
- Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI/ML algorithm is involved.
In summary: The provided document is a regulatory submission for a traditional medical device (intervertebral body fusion device), not an Artificial Intelligence/Machine Learning (AI/ML) powered device. As such, the performance criteria and supporting "study" relate to mechanical properties, material conformance, and substantial equivalence to predicate devices, rather than diagnostic accuracy or AI algorithmic performance metrics.
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FEB - 6 2009
510k summary of safety and effectiveness
As required by section 807.92(c)
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| As required by section 807.92(c) | |
|---|---|
| Submitter | SPINEART |
| International Center Cointrin 20 route de pré-bois | |
| CP1813 | |
| 1215 GENEVA 15 | |
| SWITZERLAND | |
| Contacts | Franck PENNESI Director of Industry & Quality |
| Phone : +41 22 799 40 25 | |
| Fax : +41 22 799 40 26 | |
| Mail : fpennesi@spineart.ch | |
| Regulatory contact : Dr Isabelle DRUBAIX | |
| (Idée Consulting) idrubaix@nordnet.fr | |
| Preparation date | Revised January 15, 2009 |
| Trade Name | DYNAMIK Intervertebral body fusion device |
| Classification Name | Intervertebral body fusion device |
| Class | II |
| Product Code | MAX |
| CFR section | 21 CFR 888.3080 |
| Device panel | Orthopedic |
| Legallymarketedpredicate devices | LUMBAR I/F. CAGE manufactured by DEPUY ACROMED |
| (P960025), OPAL ORACLE SPACER (K072253) | |
| manufactured by SYNTHES SPINE and LUCENTManufactured by SPINAL ELEMENTS INC (K071724) | |
| Description | DYNAMIK range of products consists of lumbar |
| Interbody cages available in various models to adapt | |
| to anatomical variations and surgical techniques. | |
| DYNAMIK cages are manufactured as single solid-machined piece made of PEEK conforming ASTM | |
| F2026. Markers made of titanium conforming ASTM | |
| F136 are used to visualize the position of the implantin the disc space. DYNAMIK Lumbar Interbody Devices | |
| are made of PEEK conforming ASTM F2026 with atitanium marker made of TA6V 4 ELI conforming toISO 5832.3 and ASTM F 136 and are supplied sterile.DYNAMIK Lumbar Interbody Devices are supplied with | |
| DYNAMIK Lumbar Interbody Device is indicated for | |
| Intended Use | intervertebral body fusion procedures in skeletally |
| mature patients with degenerative disc disease (DDD) | |
| at one or two contiguous levels from L2-S1, DDD is | |
| defined as discogenic back pain with degeneration of | |
| the disc confirmed by patient history and radiographic | |
| studies. These DDD patients may also have up to | |
| Grade I spondylolisthesis or retrolisthesis at the | |
| involved level(s). This device is to be used with | |
| autogenous bone graft. DYNAMIK Lumbar Interbody | |
| Device is to be used with supplemental fixation. | |
| Patients should have at least six (6) months of non- | |
| operative treatment prior to treatment with an | |
| intervertebral cage. | |
| Performance data | DYNAMIK Lumbar Interbody Device conforms to Class |
| II Special Controls Guidance Document: Intervertebral | |
| Body Fusion Device- Document issued on: June 12, | |
| 2007. | |
| Mechanical testing was conducted per ASTM F 2077- | |
| 03 and ASTM F 2267-04 | |
| DYNAMIK Lumbar Interbody Device is substantially | |
| Substantial | equivalent to its predicate devices in terms of |
| equivalence | intended use, material, design, mechanical properties |
| and function. |
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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 legs and a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged around the border of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB = 6 2009
Spineart % Mr. Franck Pennesi International Center Cointrin 20, route de Pre-Bois CP 1813 1215 Geneva 15 Switzerland
Re: K081888
Trade/Device Name: Dynamik Intervertebral Body Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: January 19, 2009 Received: January 21, 2009
Dear Mr. Pennesi:
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 or any 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. Franck Pennesi
Enclosure
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 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" (21.CFR 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 Syreers 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 W. Millikan
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE
Kost 1888 510(k) Number (if known): Device Name: DYNAMIK Lumbar Interbody Device Indications for Use:
DYNAMIK Lumbar Interbody Device is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1, DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylollsthesis or retrollsthesis at the involved level(s). This device is to be used with autogenous bone graft. DYNAMIK Lumbar Interbody Device is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF
NEEDED)
Concurrence of CDRH, Office of Device Evalual DRY SREI Sign-Off)
Division of General, Restorative, and Neurological Devices
age 13 /
510(k) Number 168188
§ 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.