(26 days)
Intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 - 21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.
The ALPS Small Bone Locked Plating System Line Extension consists of three Titanium alloy plates offered to be used with non-locking, locking and variable angle screws manufactured from Titanium alloy and CoCr for bone fixation and the management of fractures, fusions, revisions and reconstructive surgeries.
The provided text is related to a 510(k) submission for a medical device called the "ALPS Small Bone Locked Plating System Line Extension." This submission focuses on establishing substantial equivalence to existing predicate devices, primarily through pre-clinical data. There is no information in the provided text about acceptance criteria or a study that proves the device meets specific performance criteria in terms of a clinically relevant outcome (e.g., diagnostic accuracy, patient outcomes).
The document is a 510(k) summary, which is a regulatory submission to the FDA for medical devices that are substantially equivalent to already legally marketed devices. The "study" mentioned for demonstrating substantial equivalence is pre-clinical and focuses on mechanical properties, not an evaluation of how humans or algorithms perform with the device.
Therefore, for the information requested, I can only provide what is explicitly stated or can be inferred, and will indicate where information is not present in the provided text.
Here's a breakdown based on your request:
Acceptance Criteria and Study for ALPS Small Bone Locked Plating System Line Extension
The provided 510(k) summary primarily demonstrates substantial equivalence through pre-clinical testing, rather than studies involving human or AI performance. The "acceptance criteria" and "reported device performance" are framed in terms of mechanical and material properties, aligning with the regulatory pathway of demonstrating equivalence to existing devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance |
|---|---|
| Pre-clinical Data: | Pre-clinical Data: |
| Similarity in design, dimensions, and material to predicate devices. | The technological characteristics of the ALPS Small Bone Locked Plating System Line Extension are similar to the predicate devices including design, dimensions and material. |
| Evaluation through axial load construct testing. | Pre-clinical data, including axial load construct testing, was used to demonstrate substantial equivalence. |
| Evaluation of galvanic corrosion potential. | Pre-clinical data, including evaluation of galvanic corrosion potential, was used to demonstrate substantial equivalence. |
| No new issues of safety or efficacy raised compared to predicate devices. | "No new issues of safety or efficacy have been raised." |
| Indicated for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of specific bones. | The device meets the indications for use as described for the predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided. This device is a bone fixation system, not a diagnostic or AI-driven device that would typically involve a "test set" of patient data or data provenance in the context of diagnostic accuracy. The "test set" in this context refers to components or constructs used in pre-clinical mechanical testing. The sample sizes for these pre-clinical tests are not specified in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable / Not Provided. As this is a pre-clinical evaluation of a bone implant, there is no "ground truth" established by clinical experts (like radiologists for image interpretation) for a "test set" of clinical data. The "ground truth" for mechanical testing is based on engineering principles and established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. Adjudication methods are typically used to resolve discrepancies in expert interpretations of clinical data or images. This concept does not apply to the pre-clinical mechanical testing performed for this 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
- No, an MRMC comparative effectiveness study was not done. This device is an implantable bone fixation system, not an AI-based diagnostic tool. Therefore, MRMC studies involving human readers or AI assistance are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, a standalone algorithm performance study was not done. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Mechanical and Material Standards: The "ground truth" for the substantial equivalence claim is based on engineering principles, material science standards, and the performance characteristics of the predicate devices. This includes demonstrating equivalent axial load construct strength and galvanic corrosion potential.
8. The sample size for the training set
- Not Applicable / Not Provided. There is no "training set" in the context of this device. A training set is typically used for machine learning algorithms, which are not part of this device submission.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. As there is no training set, there is no ground truth established for one.
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Section 5 — 510(k) Summary
| Submitted by: | Biomet Trauma56 East Bell DrivePO Box 587Warsaw, IN 46581Phone: (305) 269-6386Fax: (305) 269-6400 | JUL 0 3 2013 |
|---|---|---|
| Contact Person: | Suzana Otaño, Global Project Manager, Regulatory Affairs | |
| Date Prepared: | May 28, 2013 | |
| Proprietary Name: | ALPS Small Bone Locked Plating System Line Extension | |
| Common Name: | Plate, Fixation, Bone | |
| Classification Name: | Single/multiple component metallic bone fixation appliances andaccessories (21 CFR § 888.3030) | |
| Predicate Devices: | The ALPS Small Bone Locked Plating System Line Extension issubstantially equivalent to currently marketed systems ALPS SmallBone Locked Plating System (K101240), LCL and Fusion PlatingSystem (K091294) and the Mini Fragment Plating System (K061748). | |
| Device Description: | The ALPS Small Bone Locked Plating System Line Extension consistsof three Titanium alloy plates offered to be used with non-locking,locking and variable angle screws manufactured from Titanium alloyand CoCr for bone fixation and the management of fractures,fusions, revisions and reconstructive surgeries. | |
| Indications for Use: | The system is intended for use in stabilization and fixation offractures, revision procedures, fusions, reconstructions (osteotomy)and non-unions of the bones of the hand, foot, wrist, ankle, finger,toe, humerus, olecranon, clavicle, scapula and pelvis, particularly inosteopenic bone. The system can be used in both adult andpediatric patients (adolescents (>12 - 21 years of age)), where theimplant would not cross open epiphyseal plates in skeletallyimmature patients. | |
| TechnologicalCharacteristics: | The technological characteristics of the ALPS Small Bone LockedPlating System Line Extension are similar to the predicate devices |
ALPS Small Bone Locked Plating System Line Extension - Traditional 510(k)
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Biomet Trauma
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including design, dimensions and material.
Summary of Substantial Equivalence: The ALPS Small Bone Locked Plating System Line Extension is substantially equivalent to currently marketed devices as demonstrated with pre-clinical data including axial load construct testing and evaluation of galvanic corrosion potential. No new issues of safety or efficacy have been raised.
ALPS Small Bone Locked Piating System Line Extension - Traditional 510(k) Biomet Trauma
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 3, 2013
Biomet Trauma % Ms. Suzana Otaño Global Project Manager, Regulatory Affairs 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581
Re: K131670
Trade/Device Name: ALPS Small Bone Locked Plating System Line Extension Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS Dated: May 28, 2013 Received: June 7, 2013
Dear Ms. Otaño:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical
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Page 2 - Ms. Suzana Otaño
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Erin DKeith
For
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 4 - INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name:
ALPS Small Bone Locked Plating System Line Extension
Indications For Use:
Intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 - 21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.
Prescription Use (Per 21 CFR 801 Subpart D) AND/OR Over-the-Counter (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth L. Frank -S
Division of Orthopedic Devices
Page 1 of 1
ALPS Small Bone Locked Plating System Line Extension - Traditional 510(k) Biomet Trauma
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§ 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.