(315 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Reprocessed External Fixation Devices:
Acceptance Criteria and Device Performance Study for Reprocessed External Fixation Devices
Based on the provided 510(k) summary (K012623), the device in question is a reprocessed medical device, specifically external fixation devices. The regulatory approach for such devices often focuses on demonstrating that the reprocessed device performs identically to the original, new device, and that the reprocessing itself does not compromise the device's safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the types of tests conducted rather than explicit quantitative acceptance criteria with specific thresholds. However, the overarching acceptance criterion is substantial equivalence to the predicate devices. The reported performance is a qualitative statement that the device met this criterion.
| Acceptance Criterion Type | Description from Document | Reported Device Performance |
|---|---|---|
| Material Equivalence | "The design, materials, and intended use of the Reprocessed External Fixation Devices are identical to the predicate devices." | "The design, materials, and intended use of the Reprocessed External Fixation Devices are identical to the predicate devices." (Stated as a characteristic of the reprocessed device, implying it performs equivalently to the original materials.) |
| Functional Equivalence | "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." | "The mechanism of action of the Reprocessed External Fixation Device is identical to the predicate devices..." (This implies that any functional tests performed would have shown equivalent performance to original devices, although specific functional performance data is not detailed in terms of measurable outcomes in this summary.) "Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended." (This is the summary conclusion for the overall functional performance based on the specific tests mentioned below.) |
| Biocompatibility | Demonstrate that the reprocessed device remains biocompatible. | Listed as a conducted test: "Biocompatibility." The implication is that the reprocessed devices met biocompatibility standards equivalent to the original devices. (No specific data or numerical criteria provided in this summary.) |
| Reprocessing Validation | Demonstrate that the reprocessing methods are effective and do not degrade the device. | Listed as a conducted test: "Validation of reprocessing." The implication is that the reprocessing procedures effectively cleaned, sterilized, and restored the device to its original performance characteristics without damage. (No specific data or numerical criteria provided in this summary.) |
| Overall Safety & Effectiveness | Conclusion: device is safe, effective and substantially equivalent to predicate devices. | "Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended." and "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." |
Note: This is a 510(k) Summary, which typically does not include the detailed raw data or specific quantitative acceptance thresholds. It provides a high-level overview of the testing and conclusions. The actual data would be in the full 510(k) submission.
2. Sample Size for Test Set and Data Provenance
The document does not specify the sample size used for the benchmark and laboratory testing. It also does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective). Given that this is a reprocessed device, the "test set" would primarily refer to a batch of reprocessed devices subjected to various tests.
3. Number of Experts and Qualifications for Ground Truth
This type of study is a bench and laboratory testing of physical devices, not a study evaluating an AI algorithm's diagnostic performance against human experts. Therefore, the concepts of "number of experts," "ground truth establishment by experts," and their qualifications are not applicable to this submission. The "ground truth" would be the engineering and material science specifications of the original devices.
4. Adjudication Method for Test Set
As this is a physical device performance study and not an interpretation task done by experts, an adjudication method is not applicable. The test results would be quantitative (e.g., material strength, chemical residue levels) compared against predefined engineering specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned and is not applicable. This type of study is used to compare the diagnostic performance of human readers, often with and without AI assistance, on a set of medical cases. The submission describes testing of a physical medical device.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study refers to the evaluation of an AI algorithm's performance without human intervention. This document describes the testing of a physical medical device, not an AI algorithm. Therefore, such a study is not applicable.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is based on engineering specifications and performance data of the original, new devices, as well as established industry standards for biocompatibility and reprocessing. This is inferred from the statement: "Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended." The original intention and performance characteristics define the ground truth for the reprocessed device.
8. Sample Size for Training Set
The concept of a "training set" is relevant to machine learning or AI models. This submission is for a physical medical device (reprocessed external fixation devices). Therefore, a "training set" is not applicable.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for an AI algorithm, this question is not applicable.
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K012623
10F3
510(k) Summary of Safety and Effectiveness
Submitter:
Alliance Medical Corporation 10232 South 51st Street Phoenix, Arizona 85044
Contact:
Don Selvey Vice President, Regulatory Affairs and Quality Assurance (480) 763-5300
| Date of preparation: | 8 August 2001 |
|---|---|
| Name of device: | Reprocessed External Fixation Devices |
| Common Name: | External Fixation Devices, Fixation Appliance, Single/MultipleComponent and Invasive Traction Component |
| Classification Name: | Single/Multiple Component Metallic Bone Fixation Appliances andAccessories |
Reprocessed device(s):
| MANUFACTURER | MODEL NUMBER | DESCRIPTION |
|---|---|---|
| SYNTHES (USA) | 392.88 | NUT FOR 8.0MM THREADED RODS |
| SYNTHES (USA) | 393.36 | TUBE-TO-TUBE CLAMP |
| SYNTHES (USA) | 393.361 | TITANIUM ROD-TO-ROD CLAMP |
| SYNTHES (USA) | 393.436 | RING-TO-ROD CLAMP |
| SYNTHES (USA) | 393.44 | EXTERNAL FIXATION CLAMP |
| SYNTHES (USA) | 393.45 | EXTERNAL FIXATION CLAMP |
| SYNTHES (USA) | 393.464 | ADJUSTABLE PIN CLAMP |
| SYNTHES (USA) | 393.48 | ANGLED EXTERNAL FIXATION CLAMP |
| SYNTHES (USA) | 393.64 | ROD-TO-PIN ADJUSTABLE CLAMP |
| SYNTHES (USA) | 393.647 | COMBINATION CLAMP |
| SYNTHES (USA) | 393.71 | UNIVERSAL JOINT FOR TWO TUBES |
| SYNTHES (USA) | 393.722 | 3/4 FIXATION RING |
| SYNTHES (USA) | 393.732 | 3/4 STEEL RING |
| SYNTHES (USA) | 393.734 | 3/4 EXTERNAL FIXATION RING |
| SYNTHES (USA) | 393.736 | 3/4 EXTERNAL FIXATION RING |
| SYNTHES (USA) | 393.751 | ROD-TO-PIN UNIVERSAL CLAMP |
| SYNTHES (USA) | 393.753 | ROD CLAMP |
| SYNTHES (USA) | 393.756 | ROD TO ROD CLAMP |
| SYNTHES (USA) | 394.8 | CARBON FIBER ROD |
| SYNTHES (USA) | 394.80 | CARBON FIBER ROD |
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| MANUFACTURER | MODEL NUMBER | DESCRIPTION |
|---|---|---|
| SYNTHES (USA) | 394.82 | CARBON FIBER ROD |
| SYNTHES (USA) | 394.83 | CARBON FIBER ROD |
| SYNTHES (USA) | 394.84 | CARBON FIBER ROD |
| SYNTHES (USA) | 394.85 | CARBON FIBER ROD |
| SYNTHES (USA) | 394.86 | CARBON FIBER ROD |
| SYNTHES (USA) | 394.87 | CARBON FIBER ROD |
| SYNTHES (USA) | 395.55 | OPEN CLAMP |
| SYNTHES (USA) | 395.56 | PIN TO ROD COUPLER |
| SYNTHES (USA) | 395.57 | ROD TO ROD COUPLER |
| SYNTHES (USA) | 395.597 | ROD TO PIN COUPLER |
| SYNTHES (USA) | 395.6 | CARBON FIBER ROD |
| SYNTHES (USA) | 395.62 | CARBON FIBER ROD |
| SYNTHES (USA) | 395.63 | CARBON FIBER ROD |
| SYNTHES (USA) | 395.64 | CARBON FIBER ROD |
| SYNTHES (USA) | 395.65 | CARBON FIBER ROD |
| SYNTHES (USA) | 395.66 | CARBON FIBER ROD |
| SYNTHES (USA) | 395.72 | CONNECTING BARS (S.S.) |
| SYNTHES (USA) | 395.73 | CONNECTING BARS (S.S.) |
| SYNTHES (USA) | 395.73C | CONTRA ROD |
| SYNTHES (USA) | 395.74 | CONNECTING BARS (S.S.) |
| SYNTHES (USA) | 395.75 | CONNECTING BARS (S.S.) |
| SYNTHES (USA) | 395.76 | CONNECTING BARS (S.S.) |
| SYNTHES (USA) | 395.77 | CONNECTING BARS (S.S.) |
| SYNTHES (USA) | 395.782 | CARBON FIBER ROD |
| SYNTHES (USA) | 395.784 | CARBON FIBER ROD |
| SYNTHES (USA) | 459.014 | EXTERNAL FIXATION DEVICE |
| SYNTHES (USA) | 633-200 | STEEL ROD |
| SYNTHES (USA) | B18-200 | STEEL ROD |
| SYNTHES (USA) | B18-300 | STEEL ROD |
| SYNTHES (USA) | B18-350 | STEEL ROD |
| SYNTHES (USA) | B18-400 | STEEL ROD |
20F3
Predicate device(s): Synthes Large Fragment DCL System K000682 K010344 Synthes (USA) Adjustable Large Fixator System Synthes TraumaFix™ External Fixator K914558 Synthes (U.S.A.) Mini External Fixator K961350 K962484 Synthes Titanium External Fixator Clamps Synthes K973017 Combination Clamp and Dynamization Clip K963618 Synthes Simple Small External Fixator 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 bars and screws used
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2623 30F 3
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 fixation of Intended use: 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.
Reprocessed external fixation devices are indicated for use in patients Indications statement: requiring external skeletal fixation oand 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.
The design, materials, and intended use of the Reprocessed External Technological characteristics: Fixation Device s are identical to the predicate devices. 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 Device s.
- Biocompatibility ●
- Validation of reprocessing
Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended.
In accordance with the Federal Food, Drug and Cosmetic Act 21 CFR Conclusion: Part 807 and based on the information provided in this premarket notification, 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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling a stylized image. The image within the circle appears to be an abstract representation of a human figure or a bird-like shape. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 4 2002
Mr. Don Selvey Vice President Regulatory Affairs and Quality Assurance Alliance Medical Corporation 10232 South 51st Street Phoenix, Arizona 85044
Re: (K012623) K012634, K012645, K012648
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: April 3, 2002 Received: April 4, 2002
Dear Mr. Selvey:
We have reviewed your Section 510(k) premarket notifications of intent to market the devices referenced above and have determined the devices are 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices 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 devices comply 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 - Mr. Don Selvey
This letter will allow you to begin marketing your devices as described in your Section 510(k) premarket notifications. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices : to proceed to the market.
If you desire specific advice for your devices on our labeling regulation (21 CFR 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 devices, 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.
sincerely yours,
Mark McMillan
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 Statement
510(k) Number (if known):
(012623
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.
| MANUFACTURER | MODELNUMBER | DESCRIPTION |
|---|---|---|
| SYNTHES (USA) | 392.88 | NUT FOR 8.0MM THREADED RODS |
| SYNTHES (USA) | 393.36 | TUBE-TO-TUBE CLAMP |
| SYNTHES (USA) | 393.361 | TITANIUM ROD-TO-ROD CLAMP |
| SYNTHES (USA) | 393.436 | RING-TO-ROD CLAMP |
| SYNTHES (USA) | 393.44 | EXTERNAL FIXATION CLAMP |
| SYNTHES (USA) | 393.45 | EXTERNIAL FIXATION CLAMP |
| SYNTHES (USA) | 393.464 | ADJUSTABLE PIN CLAMP |
| SYNTHES (USA) | 393.48 | ANGLED EXTERNAL FIXATION CLAMP |
| SYNTHES (USA) | 393.64 | ROD-TO-PIN ADJUSTABLE CLAMP |
| SYNTHES (USA) | 393.647 | COMBINATION CLAMP |
| SYNTHES (USA) | 393.71 | UNIVERSAL JOINT FOR TWO TUBES |
| SYNTHES (USA) | 393.722 | 3/4 FIXATION RING |
| SYNTHES (USA) | 393.732 | 3/4 STEEL RING |
| SYNTHES (USA) | 393.734 | 3/4 EXTERNAL FIXATION RING |
| SYNTHES (USA) | 393.736 | 3/4 EXTERNAL FIXATION RING |
| SYNTHES (USA) | 393.751 | ROD-TO-PIN UNIVERSAL CLAMP |
| SYNTHES (USA) | 393.753 | ROD CLAMP |
| SYNTHES (USA) | 393.756 | ROD TO ROD CLAMP |
| SYNTHES (USA) | 394.8 | CARBON FIBER ROD |
| SYNTHES (USA) | 394.80 | CARBON FIBER ROD |
| SYNTHES (USA) | 394.82 | CARBON FIBER ROD |
| SYNTHES (USA) | 394.83 | CARBON FIBER ROD |
| SYNTHES (USA) | 394.84 | CARBON FIBER ROD |
| SYNTHES (USA) | 394.85 | CARBON FIBER ROD |
| SYNTHES (USA) | 394.86 | CARBON FIBER ROD |
| SYNTHES (USA) | 394.87 | CARBON FIBER ROD |
| SYNTHES (USA) | 395.55 | OPEN CLAMP |
CONFIDENTIAL
Alliance Medical Corporation Reprocessed External Fixation Devices Traditional 510(k)
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| SYNTHES (USA) | 395.56 | PIN TO ROD COUPLER |
|---|---|---|
| SYNTHES (USA) | 395.57 | ROD TO ROD COUPLER |
| SYNTHES (USA) | 395.597 | ROD TO PIN COUPLER |
| SYNTHES (USA) | 395.6 | CARBON FIBER ROD |
| SYNTHES (USA) | 395.62 | CARBON FIBER ROD |
| SYNTHES (USA) | 395.63 | CARBON FIBER ROD |
| SYNTHES (USA) | 395.64 | CARBON FIBER ROD |
| SYNTHES (USA) | 395.65 | CARBON FIBER ROD |
| SYNTHES (USA) | 395.66 | CARBON FIBER ROD |
| SYNTHES (USA) | 395.72 | CONNECTING BARS (S.S.) |
| SYNTHES (USA) | 395.73 | CONNECTING BARS (S.S.) |
| SYNTHES (USA) | 395.73C | CONTRA ROD |
| SYNTHES (USA) | 395.74 | CONNECTING BARS (S.S.) |
| SYNTHES (USA) | 395.75 | CONNECTING BARS (S.S.) |
| SYNTHES (USA) | 395.76 | CONNECTING BARS (S.S.) |
| SYNTHES (USA) | 395.77 | CONNECTING BARS (S.S.) |
| SYNTHES (USA) | 395.782 | CARBON FIBER ROD |
| SYNTHES (USA) | 395.784 | CARBON FIBER ROD |
| SYNTHES (USA) | 459.014 | EXTERNAL FIXATION DEVICE |
| SYNTHES (USA) | 633-200 | STEEL ROD |
| SYNTHES (USA) | B18-200 | STEEL ROD |
| SYNTHES (USA) | B18-300 | STEEL ROD |
| SYNTHES (USA) | B18-350 | STEEL ROD |
| SYNTHES (USA) | B18-400 | STEEL ROD |
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Mark n Milk (Division Sign-Off) Division of General, Restorativeand Neurological Devices | ||
| 510(k) Number | K012623 | |
| Prescription Use(per 21 CFR 801.109) | or | Over-the-Counter Use |
(per 21 CFR 801.109)
CONFIDENTIAL
§ 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.