(27 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.
The provided text describes the 510(k) summary for a reprocessed external fixation device (K052064). This submission focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering and functional testing rather than clinical trials with human subjects. Therefore, many of the typical elements of an AI/ML device study (like sample size for test sets, expert consensus for ground truth, MRMC studies, standalone performance, etc.) are not applicable in this context.
Here's an analysis of the provided information in relation to the requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was measured) | Reported Device Performance (Result) |
|---|---|
| Validation of reprocessing | Not explicitly detailed, but implied to be sufficient to ensure devices are safe and effective after reprocessing. |
| Function Testing (mechanical performance) | "Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended." (Implies meeting original specs) |
| Safety & Effectiveness (overall) | Concluded to be "safe, effective and substantially equivalent to the predicate devices." |
Explanation: The acceptance criteria for a reprocessed device primarily revolve around demonstrating that the reprocessing does not degrade the device's original performance characteristics or safety. The performance data provided is high-level, stating that testing was conducted and that the reprocessed devices perform as originally intended. Specific pass/fail thresholds for individual tests are not detailed in this summary.
2. Sample Size Used for the Test Set and the Data Provenance
This is not applicable to this 510(k) submission. No test set involving human data or images was used. The evaluation was based on bench and laboratory testing of the reprocessed devices themselves.
The data provenance is from laboratory and bench testing, presumably conducted by Alliance Medical Corporation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This is not applicable. The "ground truth" for a reprocessed medical device in this context is its ability to perform identically to virgin devices according to established mechanical and functional standards. This is determined through engineering tests directly on the devices, not by expert interpretation of data.
4. Adjudication Method for the Test Set
This is not applicable. There was no "test set" in the sense of clinical data requiring adjudication.
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
This is not applicable. This submission is for a reprocessed physical medical device, not an AI/ML-powered diagnostic tool. Therefore, no MRMC studies or human reader performance analyses were conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
For this device, the "ground truth" for performance is established by the original design specifications and performance characteristics of the predicate (virgin) external fixation devices. The reprocessed devices are compared against these established standards through defined bench and laboratory tests to ensure they function equivalently. The "ground truth" is therefore established through engineering specifications and validated testing methods.
8. The Sample Size for the Training Set
This is not applicable. There is no AI/ML algorithm that requires a "training set" in this submission.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set.
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PART B: 510(k) SUMMARY
- Submitter: Alliance Medical Corporation 10232 South 51st Street Phoenix, Arizona 85044 Contact: Moira Barton Requlatory Affairs Manager (480) 763-5300 (o) (480) 763-5310 (f)
- Date of preparation: July 15, 2005
Trade/Proprietary Name: Reprocessed External Fixation Name of device: Devices Common or Usual Name: External Fixation Devices, Fixation Appliance, Single/Multiple Component Classification Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories and Smooth or Threaded Metallic Bone Fixation Fastener
Predicate device(s):
- K012645 Reprocessed EBI® External Fixation Devices
- External fixation devices are specially designed frames, clamps, Device description: 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.
- Intended use: External Fixation Devices are intended to be used for the fixation of supracondylar, or condylar fractures of the femur; for fusion of a joint; for surgical procedures that involve cutting the bone, for fixation of bone fractures; bone reconstruction; as a guide pin for insertion of other implants; or may be implanted through the skin so that a pulling force or traction may be applied to the skeletal system; and others may be used for fixation of bone fractures, for bone reconstructions, as a quide 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.
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| Indicationsstatement: | Reprocessed external fixation devices are indicated for use inpatients requiring external skeletal fixation and treatment offractures, osteotomy, arthrodesis, correction of deformities,fracture revision, bone reconstruction procedures, limblengthening, correction of bony or soft tissue deformities andsegmental bony or soft tissue defects. |
|---|---|
| Technologicalcharacteristics: | The design, materials, and intended use of the ReprocessedExternal Fixation Devices are identical to the predicate devices.The mechanism of action of the Reprocessed External FixationDevice is identical to the predicate devices in that the samestandard mechanical design, materials, shapes and sizes areutilized. There are no changes to the claims, intended use,clinical applications, patient population, performancespecifications, or method of operation. The only change is themodified external fixation devices will be provided non-sterile.Sterilization of the devices will occur in the hospital prior to use. |
| Performance data: | Bench and laboratory testing was conducted to demonstrateperformance (safety and effectiveness) of the ReprocessedExternal Fixation Devices.Validation of reprocessingFunction Testing |
| Performance testing demonstrates that Reprocessed ExternalFixation Devices perform as originally intended. | |
| Conclusion: | Alliance Medical Corporation concludes that the modified device(the Reprocessed External Fixation Device) is safe, effectiveand substantially equivalent to the predicate devices, asdescribed herein. |
:
:
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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 and Human Services. The logo features a stylized representation of a human face in profile, composed of three curved lines. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the emblem.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 5 2005
Ms. Moira Barton Regulatory Affairs Manager Alliance Medical Corporation 10232 South 51st Street Phoenix, Arizona 85044
Re: K052064
Trade/Device Name: Alliance Medical Corporation 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 Dated: July 19, 2005 Received: July 29, 2005
Dear Ms. Barton:
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.
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Page 2 - Ms. Moira Barton
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with and hy Jurve FDA finding of substantial equivalence of your device to a legally promance hodicated on "ceresults 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 n you a tone of Compliance at (240) 276-0120. 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,
M. N. Mello
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Mark N. Melkerson Acting 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 Statement 2.
Device Name: Alliance Medical Corporation Reprocessed External Fixation Devices
Indications for Use: Reprocessed external fixation devices are indicated for Indications for OSC: Reprocessed external skeletal fixation and treatment of fractures, use in pationto roquinis, correction of deformities, fracture revision, bone osteolony, antifrodesis, obrootion of hending, correction of bony or soft tissue deformities and segmental bony or soft tissue defects.
Concurrence of CDRH, Office of Device Evaluation (ODE)
2
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K052064
Prescription Use _ (per 21 CFR 801.109) or
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
§ 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.