(60 days)
The KLS-Martin 3DX External Distraction System is a bone stabilizer and lengthening device when congenital deficiencies, mandibular hypoplasia or post traumatic defects of the mandible require gradual bone lengthening, including bone transport.
The device is comprised of two (2) interchangeable distraction arms, a central body which allows angular adjustment of the arms and pin clamps. The pin clamps will accept 2.0mm and 2.7mm Molina (K994154) pins. Bone stabilization can be achieved with carbon rods after distraction.
The provided document is a 510(k) summary for the KLS Martin 3DX External Distraction System. This type of document is a premarket notification for a medical device seeking to demonstrate substantial equivalence to a legally marketed predicate device.
Crucially, this document does NOT contain information about acceptance criteria or a study proving the device meets those criteria, as it is a summary of the notification process, not a performance study report.
510(k) submissions typically rely on comparisons to existing devices (predicate devices) and may include bench testing or non-clinical performance data to demonstrate that the new device performs as intended and is as safe and effective as the predicate. However, detailed acceptance criteria and a structured study demonstrating primary endpoint achievement against these criteria are not typically a required component of the 510(k) summary itself, nor are they usually presented in the format requested.
Therefore, I cannot provide the requested information based on the text provided. The document states that "Substantial equivalence is based on comparison of performance, method of distraction, bone stabilization and clinical literature assessment." This suggests that the "study" demonstrating performance was a comparison to predicate devices, rather than a standalone clinical trial with specific acceptance criteria.
To address the prompt directly based on the provided document, the response would be:
1. A table of acceptance criteria and the reported device performance:
* Acceptance Criteria: Not specified in the provided document.
* Reported Device Performance: The document states that "Substantial equivalence is based on comparison of performance, method of distraction, bone stabilization and clinical literature assessment" against predicate devices. The exact performance metrics or quantitative results are not detailed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
* Not applicable/Not provided. The document does not describe a "test set" in the context of human clinical data or a specific performance study. The comparison is against predicate devices and clinical literature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
* Not applicable/Not provided. No "test set" or ground truth establishment by experts is described for this device in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable/Not provided.
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/Not provided. This device is an external distraction system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable/Not provided. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Not applicable/Not provided in the context of a performance study. The "ground truth" for substantial equivalence is implicitly the performance and safety established by the predicate devices through their own regulatory pathways and clinical use.
8. The sample size for the training set:
* Not applicable/Not provided. The device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
* Not applicable/Not provided.
In summary, the provided 510(k) document is a regulatory notification focusing on substantial equivalence to predicate devices, rather than a detailed report of a performance study with explicit acceptance criteria and corresponding results for the KLS Martin 3DX External Distraction System.
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FEB 27 2004
510(K) SUMMARY
| Submitter: | KLS-Martin, L.P.11239-1 St. Johns Industrial Parkway SouthJacksonville, FL 32246Phone: 904-641-7746Fax: 904-641-7378 |
|---|---|
| Contact Person: | Jennifer DamatoDirector RA/QA |
| Date of Summary: | December 19, 2003 |
| Device Name: | KLS Martin 3DX External Distraction System |
| Trade Name: | 3DX External Distraction System |
| Common Name: | External Distraction System |
| ClassificationName and Number: | Plate, Bone (CFR 872.4760) |
| Regulatory Class: | Class II |
| Predicate Devices: | KLS Martin Molina Distractor (K994154)Howmedica Inc. Mandibular Bone Distractor II (K960297)Synthes External Multi Vector Mandible Distractor (K981362)Lorenz External Mandibular Distractor (K992873) |
| Intended Use: | The KLS-Martin 3DX External Distraction System is abone stabilizer and lengthening device whencongenital deficiencies, mandibular hypoplasia or posttraumatic defects of the mandible require gradualbone lengthening, including bone transport. |
| DeviceDescription: | The device is comprised of two (2) interchangeabledistraction arms, a central body which allows angularadjustment of the arms and pin clamps. The pin |
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clamps will accept 2.0mm and 2.7mm Molina (K994154) pins. Bone stabilization can be achieved with carbon rods after distraction.
Technological Characteristics:
Similarities to Predicate
The KLS Martin 3DX External Distraction System is the next generation in development based upon the KLS Martin Molina Distractor (K994154). The KLS Martin 3DX External Distraction System is similar to the Howmedica Inc. Mandibular Bone Distractor II (K960297), Synthes External Multi Vector Mandible Distractor (K981362) and the Lorenz External Mandibular Distractor (K992873)
Substantial Equivalence:
The KLS Martin 3DX External Distraction System is substantially equivalent in application and function to the KLS Martin Molina Distractor (K994154), the Howmedica Inc. Mandibular Bone Distractor II the Synthes External Multi Vector (K960297), Distractor (K981362) and the Lorenz Mandible External Mandibular Distractor (K992873).
Substantial equivalence is based on comparison of performance, method of distraction, bone stabilization and clinical literature assessment.
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FEB 27 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jennifer Damato Director Regulatory Affairs Quality Assurance KLS-Martin, L.P. 11239-1 Saint Johns Industrial Parkway South Jacksonville, Florida 32246
Re: K034027
Trade/Device Name: KLS Martin 3DX External Distraction System Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MON Dated: December 19, 2003 Received: December 29, 2003
Dear Ms. Damato:
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.
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Page 2 - Ms. Falk
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.
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 (301) 594-4613. 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/dsma/dsmamain.html
Sincerely vours.
Ques
Chiu Lin, Ph., D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K > 34027
KLS Martin 3DX External Distraction System Device Name:
Indications For Use:
The KLS Martin 3DX External Distraction System is a bone stabilizer and lengthening device when congenital deficiencies, mandibular hypoplasia or post traumatic defects of the mandible require gradual bone lengthening, including bone transport.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Susan Ryan
(Division Sign-Off) on of Anesthesiology, General Hospital, Infection Control, Dental De
510(k) Number:
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.