(59 days)
The Hoffmann® II Micro™ External Fixation System is intended for use to provide stabilization of open and/or unstable fractures in children and adults where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting or other means of internal fixation and for use in reconstruction procedures in conjunction with commercially available Fixation Pins and/or Kirschner Wires. Specific indications include, but are not limited to:
- Bone fracture fixation .
- . Osteotomy
- Arthrodesis .
- . Correction of deformity
- Revision procedure where other treatments or devices have been unsuccessful .
- Non-unions and delayed unions .
The new components are additions to the Hoffmann® II Micro™ External Fixation System. They are external fixation frame components intended to be used with the components in other Howmedica Osteonics' external fixation systems such as the Hoffmann® External Fixation System, Hoffmann® II External Fixation System, Hoffmann® II Compact™ External Fixation System, Hoffmann® II Hybrid Frame System, Monotube Triax™ External Fixation System.
This document is a 510(k) premarket notification for modifications to the Hoffmann® II Micro™ External Fixation System. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting device performance from a study with specific metrics like sensitivity, specificity, or accuracy.
Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and sample sizes for testing and training cannot be extracted from this document, as it describes a different type of regulatory submission.
Here's what can be inferred from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
Not applicable. This document is a 510(k) premarket notification for modifications to an existing device. It does not contain pre-defined performance metrics or reported performance data in the typical sense of a diagnostic or predictive device study. The "acceptance criteria" for a 510(k) submission revolve around demonstrating substantial equivalence to predicate devices. The reported "performance" is that the modifications meet this equivalence.
| Metric | Acceptance Criteria (Implicit for 510(k)) | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Similarities in intended use, materials, and design to predicate devices, with testing demonstrating equivalence. | "Testing has been conducted on the Hoffmann® II Micro™ new components demonstrating substantial equivalence to the predicate devices." (from Section {0}) |
2. Sample size used for the test set and the data provenance:
Not applicable. This document refers to "testing" conducted to demonstrate substantial equivalence but does not specify a test set sample size or data provenance in the context of a clinical performance study. The testing would likely involve mechanical or biocompatibility tests, not a clinical data set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This type of information is pertinent to studies involving human interpretation or clinical outcomes, which is not the focus of this 510(k) submission for an external fixation system.
4. Adjudication method for the test set:
Not applicable. See point 3.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No. This is a 510(k) for modifications to a mechanical device. MRMC studies are typically for evaluating the performance of diagnostic imaging solutions with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This device is an external fixation system, not an algorithm or AI-driven system.
7. The type of ground truth used:
Not applicable for a clinical performance study. For a 510(k) of a mechanical device, "ground truth" would relate to engineering specifications, material properties, and mechanical performance standards, established through recognized test methods.
8. The sample size for the training set:
Not applicable. There is no concept of a "training set" in the context of this 510(k) submission for an external fixation system.
9. How the ground truth for the training set was established:
Not applicable. See point 8.
In summary:
This 510(k) notification for the Hoffmann® II Micro™ External Fixation System focuses on demonstrating substantial equivalence to predicate devices for its modified components. The "study" mentioned is the "testing" conducted to prove this equivalence, likely involving mechanical and material characterization rather than clinical performance studies with metrics like sensitivity or specificity. Therefore, many of the typical questions asked for AI or diagnostic device studies are not applicable to this document.
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SEP 2 4 2004
Modifications to the Hoffmann® II Micro
510(k) Premarket Notification
510(k) Summary of Safety and Effectiveness for the Modifications to the Hoffmann® II Micro™ External Fixation System
| Proprietary Name: | Hoffmann® II Micro™ External Fixation System |
|---|---|
| Common Name: | External Fixation Frame Components |
| Classification Name and Reference | Single/multiple component metallic bone fixationappliances and accessories, 21 CFR §888.3030 andSmooth or threaded metallic bone fixation fastener,21 CFR §888.3040 |
| Device Product Code: | 87 KTT, 87 LXT & 87 JEC |
| For Information contact: | Vivian Kelly, Regulatory Affairs SpecialistHowmedica Osteonics Corp.325 Corporate DriveMahwah, NJ 07430Phone: (201) 831-5581Fax: (201) 831-6038 |
| Date Summary Prepared: | July 26, 2004 |
Intended Use:
The Hoffmann ® II Micro" External Fixation System is intended to provide stabilization of open and/or unstable fractures in children and adults where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting or other means of internal fixation in conjunction with commercially available Fixation Pins and/or Kirschner Wires.
Description:
Description.
The new components are additions to the Hoffmann® II Micro™ External Fixation System. They are external fixation frame components intended to be used with the components in other Howmedica Osteonics' external fixation systems such as the Hoffmann® External Fixation System, Hoffmann® II External Fixation System, Hoffmann® II Compact™ External Fixation System, Hoffmann® II Hybrid Frame System, Monotube Triax™ External Fixation System.
Substantial Equivalence:
Equivalency is based on similarities in intended use, materials and design to the predicate devices. Testing has been conducted on the Hoffmann® II Micro™ new components demonstrating substantial equivalence to the predicate devices.
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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 and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized human figure.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 4 2004
Ms. Vivian Kelly Regulatory Affairs Specialist Howmedica Osteonics Corporation 325 Corporate Drive Mahwah, New Jersey 07430
Re: K042019 Ro+2019
Trade/Device Name: Hoffman® II Micro™ External Fixation System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT Dated: July 26, 2004 Received: July 27, 2004
Dear Ms Kelly:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved your 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 for use suated in the encrease 1976, the enactment date of the Medical Device Amendments, or to conniner of the ride 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). and Cosmetter Fer (110) that the device, subject to the general controls provisions of the Act. The 1 ou may, there controls of the Act include requirements for annual registration, listing of general connologic would be mactice, 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 If your device to such additional controls. Existing major regulations affecting your device can may or subject to back academations, 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 I Tours of actived 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 unly 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. Vivian Kelly
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis ictier with anow you to orgin mailoning of substantial equivalence of your device to a legally premits to the are in the Privating sification 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 If you desire spoonly at (301) 594-4659. Also, please note the regulation entitled, Contact the Office of Cremarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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,
Mark M. Wilkerson
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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Indications for Use
510(k) Number (if known):
Device Name: Hoffmann® II Micro™ External Fixation System
Indications for Use:
The Hoffmann® II Micro™ External Fixation System is intended for use to provide stabilization of open and/or unstable fractures in children and adults where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting or other means of internal fixation and for use in reconstruction procedures in conjunction with commercially available Fixation Pins and/or Kirschner Wires. Specific indications include, but are not limited to:
- Bone fracture fixation .
- . Osteotomy
- Arthrodesis .
- . Correction of deformity
- Revision procedure where other treatments or devices have been unsuccessful .
- Non-unions and delayed unions .
Over-The-Counter Use Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number. K042019
Page 1 of 1
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.