(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 an FDA 510(k) summary for Reprocessed External Fixation Devices. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or conducting a study to prove performance against specific metrics for a novel AI/software device. Therefore, much of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable or present in this type of submission.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Effectiveness (as originally intended for predicate device) | Bench and laboratory testing was conducted to demonstrate performance. |
| Functional Equivalence to Predicate Device | Validation of reprocessing function testing performed. |
| Performance Equivalence to Predicate Device | Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended. |
| Design, Materials, Intended Use, Mechanism of Action, Claims, Clinical Applications, Patient Population, Performance Specifications, Method of Operation identical to predicate device | The design, materials, and intended use of the Reprocessed External Fixation Devices are identical to the predicate devices. The mechanism of action is identical. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation. |
| Sterility (after reprocessing) | Modified external fixation devices will be provided non-sterile. Sterilization of the devices will occur in the hospital prior to use. (This is a change, but implies the expectation for pre-use sterility.) |
Explanation: The "acceptance criteria" for a reprocessed device in a 510(k) submission are primarily centered around demonstrating that the reprocessed device is substantially equivalent to the original, legally marketed predicate device(s) and performs "as originally intended" after reprocessing. Specific quantitative, measurable acceptance criteria in the sense of an algorithm performance are not typically included in such submissions for mechanical devices.
Missing Information/Not Applicable to this Device/Submission Type:
- 2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/software device undergoing a diagnostic performance test. The "test set" here refers to the actual reprocessed devices that underwent bench and laboratory testing. The submission does not specify the number of individual reprocessed units tested. Data provenance is also not relevant in the context of device reprocessing.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/software devices (e.g., expert consensus on medical images) does not apply here. The "ground truth" for a reprocessed device's performance is its original specifications and how untouched, new versions of the device perform.
- 4. Adjudication method for the test set: Not applicable for a reprocessed mechanical device.
- 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. This is not an AI-assisted diagnostic device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this reprocessed device is its performance against the original device's specifications and intended function. The benchmark is the performance of the new, original (predicate) fixation devices.
- 8. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
- 9. How the ground truth for the training set was established: Not applicable.
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K652 062
AUG 2 5 2005
PART B: 510(k) SUMMARY
- Alliance Medical Corporation Submitter: 10232 South 51st Street Phoenix, Arizona 85044 Contact: Moira Barton Requlatory Affairs Manager (480) 763-5300 (o) (480) 763-5310 (f) mbarton@alliance-medical.com July 20, 2005 Date of preparation: 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):
- Reprocessed Howmedica® External Fixation Devices K012648
- 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.
- External Fixation Devices are intended to be used for the Intended use: 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 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.
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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 reprocessing Function TestingPerformance 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
AUG 2 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Moira Barton Regulatory Affairs Manager Alliance Medical Corporation 10232 South 51st Street Phoenix, Arizona 85044
Re: K052062
KU32002
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, JEC Dated: July 19, 2005 Received: July 25, 2005
Dear Ms.Barton:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate To use stated in the encreate) to tegains and the Medical Device Amendments, or to commerce price to May 20, 1978, in ecordance with the provisions of the Federal Food, Drug, devices that have been recitablicat require approval of a premarket approval application (PMA). and Cosmetic 71ct (11ct) that ao nov request to the general controls provisions of the Act. The I ou may, merelore, mainer are a Act include requirements for annual registration, listing of general oonline provider proctice, 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 is clusioned (600 wor of ols. Existing major regulations affecting your device can may be subject to subli additions, 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 r rease be actived a determination that your device complies with other requirements of the Act that I Dri has made a associations administered by other Federal agencies. You must of any I cuteral statutes and equivements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of R Part 8077, and its systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quany 05001 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 his letter will anow you to begin manxelling of substantial equivalence of your device to a legally prematket notheadon. The PDA inding of backander vol.
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
s and the may be If you desire specific advice for your ac not the one of the regulation entitled, and comact the Office of Comphalloo at (210) = 6 % = 3 % = 1 807.97). You may obtain " Misbranding by reference to prematics noutheaters" (ex Act from the Division of Small other general information on your responsibility of the toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its to the commiss brokers Manufacturers, International and Ochess http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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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2. Indications for Use Statement
Device Name: Alliance Medical Corporation Reprocessed External Fixation Devices
Indications for Use: Reprocessed external fixation devices are indicated for Indications for Use: Replocessed external fixation and treatment of fractures,
use in patients requiring external skeletal fixation and treatment on bone use in patients requiring extential sichelring fracture revision, bone
osteotomy, arthrodesis, correction of define of hony or soft is osteotomy, arthrodesis, correction of bening, correction of bony or soft tissue
reconstruction procedures, limb lengthening, correction of bony or soft tissue
reconstruction reconstruction proocuured, iima long or soft tissue defects.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K05206²
Prescription Use
(per 21 CFR 801.109) $\checkmark$
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.