(42 days)
The Sintea Biotech Traumafix System is indicated for use in the following conditions: - Fracture . - Limb lengthening . - Reconstruction . - . Traction
Not Found
Here's an analysis of the provided text regarding the Sintea Biotech Traumafix System, structured to address your specific questions.
Based on the provided text, the Sintea Biotech Traumafix System received 510(k) clearance due to its substantial equivalence to a predicate device, the Lima-Lto External Circular Stabilizer (ECS). The documentation does not describe a study that proves the device meets specific acceptance criteria in the manner one might expect for a novel AI device or a new clinical claim. Instead, the acceptance is based on demonstrating equivalence to an already legally marketed device. Therefore, many of your specific questions regarding acceptance criteria and study details (like sample sizes, expert ground truth, MRMC studies, standalone performance, training sets) are not applicable or cannot be answered from this type of regulatory submission.
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use | Same |
| Indications for Use | Same |
| Implanted Material | Same |
| External Material | Same |
| Mode of Fixation | Identical |
| Form, Function, Components, Instruments, Geometry, Features, Packaging | Similar |
| Labeling | Same |
| Sterilization Method | Same |
| Safety and Effectiveness | Equivalent to predicate device, confirmed by mechanical tests and clinical performance of predicate device. |
Explanation: The "acceptance criteria" here are effectively the criteria for establishing substantial equivalence to the predicate device. The “reported device performance” is the assertion by the manufacturer that their device meets these equivalence criteria.
Study Details and Ground Truth
Given that this is a 510(k) submission based on substantial equivalence to a predicate device, a traditional study to "prove the device meets acceptance criteria" in the sense of a new clinical investigation with detailed performance metrics was not performed for this specific device. Instead, the argument is that because it is essentially the "same device" as the predicate (Lima-Lto External Circular Stabilizer), its safety and effectiveness are established.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable for a distinct test set used for clinical performance validation of this specific device. The submission relies on mechanical tests and the established clinical performance of the predicate device. The text does not provide details of any specific clinical test set for the Sintea Biotech Traumafix System.
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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. There is no mention of an expert panel establishing ground truth for a test set in the provided summary. Ground truth, in this context, is implicitly derived from the established safety and effectiveness of the predicate device as a legally marketed product.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No such adjudication method is described as there isn't a described clinical test set requiring such expert review.
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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 device is a mechanical bone fixation system, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies and "human reader improvement with AI" are not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for demonstrating safety and effectiveness is primarily the established clinical performance and safety record of the predicate device (Lima-Lto External Circular Stabilizer), combined with mechanical test data on the substantial equivalence of the Sintea Biotech Traumafix System's materials and design to the predicate. No new clinical outcomes data for the Sintea Biotech Traumafix System are presented in this summary.
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The sample size for the training set:
- Not applicable. As this is a mechanical device, there is no "training set" in the context of machine learning or AI.
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How the ground truth for the training set was established:
- Not applicable. See point 7.
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AUG 0 6 2002
SUMMARY OF SAFETY AND EFFECTIVENESS Sintea Biotech Traumalix System
Mechanical tests of the Sintea Biotech Traumafix System demonstrate that the device is safe and effective for its intended use. The referenced predicate device, the Lima-Lto External Circular Stabilizer (ECS), is in fact the same device as the Sintea Biotech Traumafix System, and therefore the favorable clinical performance of the Lima ECS provides additional confirmation that the Sintea Biotech Traumafix System is safe and effective for its intended use. The Sintea Biotech Traumatix System and the Lima-Lto. EC'S are similar in that:
- the devices have the same intended use and indications for use
- the implanted portion of the devices is made of the same material
- the external portion of the devices is made of the same material ●
- the mode of fixation of the devices is identical
- the devices have similar form, function, components, instruments, geometry, . features and packaging
- the devices have the same labeling and sterilization method .
The use of QSR-based process controls, testing standards, material standards and similarities to the predicate device establish that the Sintea Biotech Traumafix System is equivalent to the Lima-I to F.CS and that it is safe and effective for its intended use.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing right, stacked on top of each other. Above the profiles are three curved lines that resemble wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 0 6 2002
Sintea Biotech, Inc. Marianne Grunwaldt 407 Lincoln Road, Suite 10L Miami Beach, Florida 33139
Re: K022065 Trade Name: Sintea Biotech Traumafix System, Model TFX. 00.00.X Regulation Number: 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: JEC Dated: July 19, 2002 Received: July 22, 2002
Dear Ms. Grunwaldt:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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. Marianne Grunwaldt
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 ℃FR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, (Misbranding by reference to premarket notification( (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours.
to Mark A. Millkerson
:
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Sintea Biotech Traumafix System Device Name:
Indications For Use:
The Sintea Biotech Traumafix System is indicated for use in the following conditions:
- Fracture .
- Limb lengthening .
- Reconstruction .
- . Traction
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Lo Mark N Milken
Division Sign-Off) Livision of General, Restorative and Neurological Devices
(Optional Format 3-10-98)
510(k) Number K022063
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.