(315 days)
Reprocessed external fixation devices are indicated for use in patients 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.
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 a 510(k) premarket notification for "Reprocessed External Fixation Devices" by Alliance Medical Corporation. The focus of this submission is to demonstrate substantial equivalence to predicate devices, primarily through the assertion that the reprocessed devices maintain identical characteristics and performance to new, legally marketed devices.
Based on the information provided, it's important to note that the acceptance criteria and study detailed are not typical performance metrics for a novel medical device. Instead, they center on demonstrating that the reprocessing process does not compromise the original device's safety and effectiveness. There are no specific AI components or human-in-the-loop performance studies described.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Design | Identical to predicate devices (original, new external fixation devices). | "The design...of the Reprocessed External Fixation Device s are identical to the predicate devices." |
| Materials | Identical to predicate devices. | "The...materials...of the Reprocessed External Fixation Device s are identical to the predicate devices." |
| Intended Use | Identical to predicate devices. | "The...intended use...of the Reprocessed External Fixation Device s are identical to the predicate devices." (Also, "There are no changes to the claims, intended use...") |
| Mechanism of Action | Identical to predicate devices, utilizing the same standard mechanical design, materials, shapes, and sizes. | "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." |
| Claims | No changes from predicate devices. | "There are no changes to the claims..." |
| Clinical Applications | No changes from predicate devices. | "There are no changes to the clinical applications..." |
| Patient Population | No changes from predicate devices. | "There are no changes to the patient population..." |
| Performance Specifications | No changes from predicate devices. | "There are no changes to the performance specifications..." |
| Method of Operation | No changes from predicate devices. | "There are no changes to the...method of operation." |
| Biocompatibility | Maintained post-reprocessing. | Biocompatibility testing was conducted. (Specific results not detailed, but implied to be acceptable for substantial equivalence). |
| Performance (Safety & Effectiveness) | Reprocessed devices perform as originally intended (i.e., equivalent to new devices). | "Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of the Reprocessed External Fixation Devices." and "Performance testing demonstrates that Reprocessed External Fixation Devices perform as originally intended." |
| Validation of Reprocessing | Reprocessing method is valid and consistently achieves desired outcomes. | "Validation of reprocessing" was performed. (Specific details of validation criteria and results are not provided but are implied to be sufficient for substantial equivalence). |
Study Details:
-
Sample size used for the test set and the data provenance:
The document states "Bench and laboratory testing was conducted." It does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The testing would involve a subset of the reprocessed devices mentioned in the list (e.g., specific models of clamps, rods, etc.). -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the text. Given the nature of a reprocessing submission, the "ground truth" would likely be defined by established engineering standards, material specifications, and performance benchmarks for new, equivalent devices, rather than expert interpretation of clinical data in the same way an AI diagnostic would require. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic studies involving expert readers, which is not the type of study described here. -
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:
No, an MRMC comparative effectiveness study was not done. This device is a reprocessed external fixation device, not an AI or diagnostic tool that assists human readers. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, a standalone algorithm-only performance study was not done. This is a physical medical device, not a software algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The ground truth for this submission is implicitly defined by the performance specifications and characteristics of the new, legally marketed predicate devices. The reprocessing validation and performance testing aim to demonstrate that the reprocessed devices meet these pre-established new device standards. This would involve objective measurements against engineering specifications for strength, fatigue, material integrity, sterility, biocompatibility, etc. -
The sample size for the training set:
This information is not applicable and therefore not provided. This is not an AI/machine learning device that requires a training set. -
How the ground truth for the training set was established:
This information is not applicable as there is no training set for this type of device.
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JUN 2 4 2002
K012648 10F2
510(k) Summary of Safety and Effectiveness
| Submitter: | Alliance Medical Corporation10232 South 51st StreetPhoenix, Arizona 85044 |
|---|---|
| Contact: | Don SelveyVice 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 |
|---|---|---|
| HOWMEDICA | 3362-1-304 | OMEGA PLUS SIDEPLATE |
| HOWMEDICA | 4920-1-100 | TUBE-TO-ROD CLAMP |
| HOWMEDICA | 4940-1-020 | PIN-TO-ROD CLAMP |
| HOWMEDICA | 4940-1-058 | PIN-TO-ROD CLAMP |
| HOWMEDICA | 5029-1-511 | 5 HOLE LIGHTWEIGHT ALLOY |
| HOWMEDICA | 5029-2-110 | 10 HOLE LIGHTWEIGHT |
| HOWMEDICA | 5029-2-111 | 10 HOLE LIGHTWEIGHT ALLOY |
| HOWMEDICA | 5029-8-200 | STEEL ROD |
| HOWMEDICA | 5029-8-250 | STEEL ROD |
| HOWMEDICA | 5029-8-300 | STEEL ROD |
| HOWMEDICA | 5029-8-825 | CARBON FIBER ROD |
| HOWMEDICA | 5029-8-835 | CARBON FIBER ROD |
| HOWMEDICA | 5029-8-840 | CARBON FIBER ROD |
| HOWMEDICA | 5029-8-845 | CARBON FIBER ROD |
| HOWMEDICA | 5029-8-850 | CARBON FIBER ROD |
| HOWMEDICA | 5049-3-032 | ARTICULATION COUPLING |
| HOWMEDICA | 5150-2-380 | CARBON FIBER ROD |
| HOWMEDICA | 5150-2-391 | CARBON TUBE |
| HOWMEDICA | 5150-3-065 | EXTERNAL FIXATION PIN CLAMP |
| HOWMEDICA | 5151-3-065 | EXTERNAL FIXATION PIN CLAMP |
:
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K012648
20F2
| Predicate device(s): | K802722 | Extended Ball Joint with Rod Hoffmann ExternalFixation System | |||
|---|---|---|---|---|---|
| K930836 | Howmedica | Mono-Tube™ | External | FixationSystem | |
| K971755 | Hoffman II Compact External Fixation System | ||||
| Device description: | External fixation devices are specially designed frames, clamps, rods,rod-to-rod couplings, pins, posts, fasteners, wire fixations, fixationbolts, washers, nuts, hinges, sockets, connecting bars and screws usedfor the management of bone fractures and reconstructive, as well ascorrective, orthopedic surgery. Materials used include metal alloys,plastic and composites. These materials are chosen to address a widerange of fractures and applications as well as to allow for theappropriate amount of rigidity and stability. | ||||
| Intended use: | External Fixation Devices are intended to be used for the fixation ofsupracondylar, or condylar fractures of the femur; for fusion of a joint;for surgical procedures that involve cutting the bone, for fixation ofbone fractures; bone reconstruction; as a guide pin for insertion of otherimplants; or may be implanted through the skin so that a pulling force ortraction may be applied to the skeletal system; and others may be usedfor fixation of bone fractures, for bone reconstructions, as a guide pinfor insertion of other implants, or it may be implanted through the skinso that a pulling force (traction) may be applied to the skeletal system. | ||||
| Indications statement: | Reprocessed external fixation devices are indicated for use in patientsrequiring external skeletal fixation oand treatment of fractures,osteotomy, arthrodesis, correction of deformities, fracture revision,bone reconstruction procedures, limb lengthening, correction of bonyor soft tissue deformities and segmental bony or soft tissue defects. | ||||
| Technological characteristics: | The design, materials, and intended use of the Reprocessed ExternalFixation Device s are identical to the predicate devices. Themechanism of action of the Reprocessed External Fixation Device isidentical to the predicate devices in that the same standardmechanical design, materials, shapes and sizes are utilized. There areno changes to the claims, intended use, clinical applications, patientpopulation, performance specifications, or method of operation. | ||||
| Performance data: | Bench and laboratory testing was conducted to demonstrateperformance (safety and effectiveness) of the Reprocessed ExternalFixation Devices. | ||||
| Biocompatibility | |||||
| Validation of reprocessing | |||||
| Performance testing demonstrates that Reprocessed External FixationDevices perform as originally intended. | |||||
| Conclusion: | In accordance with the Federal Food, Drug and Cosmetic Act 21CFR Part 807 and based on the information provided in thispremarket notification, Alliance Medical Corporation concludes thatthe modified device (the Reprocessed External Fixation Device) issafe, effective and 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 & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized symbol featuring three human profiles facing right, with flowing lines above and below them.
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 . SEM 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,
Marke McMullens
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
Enclósure
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Indications for Use Statement
K012648 510(k) Number (if known):
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 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.
Mark N Milkerson
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109)
or
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
CONFIDENTIAL
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.