(90 days)
Reprocessed external fixation devices are indicated for use in patients requiring external skeletal fixation and treatment of fractures, osteotomy, arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures, limb lengthening, correction of bony or soft tissue deformities and segmental bony or soft tissue defects.
External fixation devices are specially designed frames, clamps, rods, rod-to-rod couplings, pins, posts, fasteners, wire fixations, fixation bolts, washers, nuts, hinges, sockets, connecting bars and screws used for the management of bone fractures and reconstructive, as well as corrective, orthopedic surgery. Materials used include metal alloys, plastic and composites. These materials are chosen to address a wide range of fractures and applications as well as to allow for the appropriate amount of rigidity and stability.
- Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Validation of Reprocessing | Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended. |
| Function Testing | Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended. |
| Substantial Equivalence to Predicate Devices | The design, materials, and intended use are identical to predicate devices. The mechanism of action is identical. There are no changes to claims, intended use, clinical applications, patient population, performance specifications, or method of operation. |
-
Sample Size Used for the Test Set and Data Provenance:
The document states that "Bench and laboratory testing was conducted," but it does not specify a sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This information is not provided in the submitted text. -
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:
The document does not mention the use of experts to establish ground truth for the test set. The validation appears to be based on direct performance testing of the reprocessed devices against their original intended performance. -
Adjudication Method for the Test Set:
Since no experts were mentioned in establishing ground truth, there was no adjudication method described. -
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. The study focused on the performance of the reprocessed devices themselves, not on human reader performance with or without AI assistance. -
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, the performance testing described appears to be a standalone evaluation of the reprocessed external fixation devices. It assesses whether the devices, after reprocessing, perform as originally intended, without human-in-the-loop interaction in the context of an AI algorithm. However, this is a medical device, not an AI algorithm, so the term "standalone" here refers to the device's functional performance. -
Type of Ground Truth Used:
The ground truth used was implied to be the original performance specifications and functionality of new, non-reprocessed external fixation devices. The goal of the testing was to demonstrate that the reprocessed devices perform "as originally intended," suggesting comparison to the known performance of new devices. -
Sample Size for the Training Set:
This is a submission for a medical device (reprocessed external fixation devices), not an AI algorithm. Therefore, the concept of a "training set" is not applicable in this context. -
How the Ground Truth for the Training Set Was Established:
As this is not an AI algorithm, the concept of a "training set" and establishing its ground truth is not applicable.
{0}------------------------------------------------
K02371Y
510(k) SUMMARY
| Submitter: | Alliance Medical Corporation10232 South 51st StreetPhoenix, Arizona 85044 | |
|---|---|---|
| Contact: | Don SelveyVice President, Regulatory Affairs & Quality Assurance(480) 763-5300 (o)(480) 763-5310 (f) | |
| Date of preparation: | August 29, 2002 | |
| Name of device: | Trade/Proprietary Name: Reprocessed External FixationDevicesCommon or Usual Name: External Fixation Devices, FixationAppliance, Single/Multiple ComponentClassification Name: Single/Multiple Component Metallic BoneFixation Appliances and Accessories and Smooth or ThreadedMetallic Bone Fixation Fastener | |
| Predicate device(s): | Legally marketed external fixation devices under various 510(k)premarket notifications. | |
| K802814K831576K944092K955848 | Orthofix® Axial External Fixation SystemOrthofix®Additional Accessories for the Orthofix® SystemOrthofix® Modulsystem | |
| Device description: | External fixation devices are specially designed frames, clamps,rods, rod-to-rod couplings, pins, posts, fasteners, wire fixations,fixation bolts, washers, nuts, hinges, sockets, connecting barsand screws used for the management of bone fractures andreconstructive, as well as corrective, orthopedic surgery.Materials used include metal alloys, plastic and composites.These materials are chosen to address a wide range offractures and applications as well as to allow for the appropriateamount of rigidity and stability. | |
| Intended use: | External Fixation Devices are intended to be used for thefixation of supracondylar, or condylar fractures of the femur; forfusion of a joint; for surgical procedures that involve cutting thebone, for fixation of bone fractures; bone reconstruction; as aguide pin for insertion of other implants; or may be implantedthrough the skin so that a pulling force or traction may beapplied to the skeletal system; and others may be used forfixation of bone fractures, for bone reconstructions, as a guidepin for insertion of other implants, or it may be implantedthrough the skin so that a pulling force (traction) may be applied |
.
{1}------------------------------------------------
to the skeletal system.
- Reprocessed external fixation devices are indicated for use in Indications statement: patients requiring external skeletal fixation and treatment of fractures, osteotomy, arthrodesis, correction of deformities. fracture revision, bone reconstruction procedures, limb lenathening, correction of bony or soft tissue deformities and segmental bony or soft tissue defects.
- Technological The design, materials, and intended use of the Reprocessed External Fixation Devices are identical to the predicate devices. characteristics: The mechanism of action of the Reprocessed External Fixation Device is identical to the predicate devices in that the same standard mechanical design, materials, shapes and sizes are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation.
- Bench and laboratory testing was conducted to demonstrate Performance data: performance (safety and effectiveness) of the Reprocessed External Fixation Devices.
- Validation of reprocessing .
- Function Testing .
Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended.
- Conclusion: Alliance Medical Corporation concludes that the modified device (the Reprocessed External Fixation Device) is safe, effective and substantially equivalent to the predicate devices, as described herein.
{2}------------------------------------------------
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Don Selvey Vice President Regulatory Affairs and Quality Assurance Alliance Medical Corporation 10232 South 51st Street Phoenix, Arizona 85044
FEB 0 3 2003
Re: K023714
Trade Name: Reprocessed External Fixation Devices Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: KTT, KTW, JEC Dated: November 1, 2002 Received: November 5, 2002
Dear Mr. Selvey:
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.
{3}------------------------------------------------
Page 2 - Mr. Don Selvey
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) 594-4659. 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 yours,
Sincerely yours,
Mark A. Melbern
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
{4}------------------------------------------------
Indications for Use Statement ll.
510(k) Number (if known):
KO23714
Device Name: Alliance Medical Corporation Reprocessed External Fixation Devices
Indications for Use: Reprocessed external fixation devices are indicated for use in patients requiring external skeletal fixation and treatment of fractures, osteotomy, arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures, limb lengthening, correction of bony or soft tissue deformities and segmental bony or soft tissue defects.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N. Milliken
Division Sign-Off) Division of General. Restorative and Neurological Devic
510(k) Number K0237
Prescription Use (per 21 CFR 801.109) or
Over-the-Counter Use _
Alliance Medical Corporation Reprocessed External Fixation Devices Traditional 510(k)
§ 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.