(88 days)
The AOS Small Bone Nail System is intended for fixation of fractures and osteotomies of the fibula, radius and ulna, including fractures where the medullary canal is narrow or flexibility of the implant is paramount.
The AOS Small Bone Nail is a titanium alloy (Ti-6Al-4V) intramedullary nail available in various lengths (110mm to 260mm) and diameters (2.5mm to 5.0mm). The nail is compatible with use of 3.5mm and 2.7mm cortical locking screws that allow for additional fracture fixation and locking capabilities.
The provided text describes a 510(k) premarket notification for the "AOS Small Bone Nailing System." A 510(k) submission generally aims to demonstrate substantial equivalence to a legally marketed predicate device rather than strictly proving a device meets predefined acceptance criteria through a study with outcome measures. Therefore, much of the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, etc.) is not directly applicable or provided in this type of regulatory document.
However, based on the information provided, I can construct a table and address the other points within the context of a 510(k) substantial equivalence submission.
1. Table of Acceptance Criteria and Reported Device Performance
In the context of a 510(k) for a medical device like an intramedullary nail, "acceptance criteria" and "device performance" primarily relate to demonstrating mechanical equivalence to a predicate device and fulfilling the same indications for use.
| Acceptance Criteria (Demonstrated Equivalence to Predicate) | Reported Device Performance (AOS Small Bone Nailing System) |
|---|---|
| Material: Same as predicate | Titanium alloy (Ti-6Al-4V) - Same material as predicate. |
| Intended Use: Same as predicate | Fixation of fractures and osteotomies of the fibula, radius and ulna, including fractures where the medullary canal is narrow or flexibility of the implant is paramount. - Same intended use as predicate. |
| Biocompatibility: Same as predicate | Biocompatible - Same biocompatibility as predicate. |
| Device Classification: Same as predicate | Class II, 21 CFR 888.3020 |
| Fundamental Technology: Similar to predicate | Similar in shape and design, same fundamental technology as predicate devices. |
| Dimensions: Similar lengths, diameters | Available in various lengths (110mm to 260mm) and diameters (2.5mm to 5.0mm). Compatible with 3.5mm and 2.7mm cortical locking screws. - Same lengths, same shaft diameter, same locking screw diameters as predicates. |
| Mechanical Strength: At least equivalent to predicate | Mechanically, the subject nail proved stronger than the predicate device used for testing. Comparative mechanical testing per a four-point bend test (ASTM F1264-14) demonstrated substantial equivalence. |
| Cortical Screws: Longer screws (not necessarily an acceptance criterion but a feature) | Longer cortical screws provided more engagement with the bone. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions "comparative mechanical testing per a four point bend test based on ASTM F1264-14." However, it does not specify the exact sample size (number of nails tested) for this mechanical test.
- Data Provenance: The data is from preclinical testing performed by the manufacturer, Advanced Orthopaedic Solutions, Inc. (AOS). This is not clinical data from patients. The country of origin for the data is not explicitly stated beyond being conducted by AOS, which is based in Torrance, California, USA. It is inherently prospective data, as it was generated specifically for this regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and not provided in the document. The device in question is a medical implant (intramedullary nail), and the "ground truth" for its mechanical performance is established through standardized engineering tests, not expert human assessment of images or clinical outcomes.
4. Adjudication Method for the Test Set
This is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers to resolve discrepancies in expert opinions or diagnoses. Mechanical testing does not involve such 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. The device is an intramedullary nail, not an AI or imaging device that would involve human readers or AI assistance. No MRMC study was conducted or referenced.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This is not applicable. The device is a surgical implant, not an algorithm or AI system. Its performance is assessed through mechanical properties and clinical outcomes (which are not presented here, as the submission states "No clinical data referenced").
7. The Type of Ground Truth Used
The "ground truth" for the device's performance in this context is the results of standardized mechanical testing (four-point bend test based on ASTM F1264-14), which assesses physical properties like strength and flexibility. The intended use and material composition also serve as "ground truths" in the demonstration of substantial equivalence to predicate devices.
8. The Sample Size for the Training Set
This is not applicable and not provided. The device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for this type of device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Advanced Orthopaedic Solutions, Inc. (AOS) Alex Bhaskarla Regulatory Affairs Manager 3203 Kashiwa St. Torrance, California 90505
January 24, 2017
Re: K163014
Trade/Device Name: AOS Small Bone Nailing System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary Fixation Rod Regulatory Class: Class II Product Code: HSB Dated: October 7, 2016 Received: October 28, 2016
Dear Alex Bhaskarla:
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 devicerelated 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
| Indications for Use |
| Form Approved: OMB No. 0910-0120 |
|---|
| Expiration Date: January 31, 2017 |
| See PRA Statement below. |
| 510(k) Number (if known) | K163014 |
|---|---|
| Device Name | AOS Small Bone Nailing System |
| Indications for Use (Describe) | The AOS Small Bone Nail System is intended for fixation of fractures and osteotomies of the fibula, radius and ulna, including fractures where the medullary canal is narrow or flexibility of the implant is paramount. |
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
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| FORM FDA 3881 (8/14) | Page 1 of 1 |
|---|---|
| PSC Publishing Services (301) 443-6740 | EF |
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Image /page/3/Picture/1 description: The image shows the logo for Advanced Orthopaedic Solutions. The logo consists of the letters "AOS" in a stylized font, with the "A" in a dark teal color, the "O" in a light gray color, and the "S" in a dark teal color. Below the letters, the words "ADVANCED ORTHOPAEDIC SOLUTIONS" are written in a smaller, sans-serif font.
6. TRADITIONAL 510(K) SUMMARY
| DATE PREPARED: | October 7, 2016 |
|---|---|
| SUBMITTED BY: | Advanced Orthopaedic Solutions, Inc.3203 Kashiwa StreetTorrance, CA 90505Phone: (310) 533-9966Establishment Registration #: 2032480Owner Operator Number: 9046896 |
| CONTACT PERSON: | Alex BhaskarlaAdvanced Orthopaedic Solutions, Inc.3203 Kashiwa StreetTorrance, CA 90505Phone: (310) 533-9966 |
| DEVICE NAME: | AOS Small Bone Nail System |
| COMMON NAME: | Intramedullary Fixation Rod/Pin |
| CLASSIFICATION: | Class II, 21 CFR 888.3020, Intramedullary FixationRod/Pin |
| DEVICE CODE: | HSB |
| SUBSTANTIALLYEQUIVALENT DEVICES: | Synthes Elastic Intramedullary Nail (EIN) K971783Acumed Small Bone Locking Rod System II K031438Acumed Small Bone IM Nail System K143276Smith & Nephew Intramedullary Nail System K983942 |
| DEVICE DESCRIPTION: | The AOS Small Bone Nail is a titanium alloy (Ti-6Al-4V) intramedullary nail available in various lengths(110mm to 260mm) and diameters (2.5mm to5.0mm). The nail is compatible with use of 3.5mmand 2.7mm cortical locking screws that allow foradditional fracture fixation and locking capabilities. |
| INDICATIONS FOR USE: | The AOS Small Bone Nail System is intended forfixation of fractures and osteotomies of the fibula,radius and ulna, including fractures where themedullary canal is narrow or flexibility of the implantis paramount. |
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| SUBSTANTIAL EQUIVALENCE: | Information presented supports substantial equivalence of the AOS Small Bone Nail System to the predicate devices. The proposed system has the same indications for use, is similar in shape and design, and has the same fundamental technology. |
|---|---|
| BASIS FOR SUBSTANTIAL EQUIVALENCE: | The AOS Small Bone Nailing System has the |
AOS Small Bone Nailing System has the following similarities to the predicates:
- same device classification ●
- same lengths
- same material .
- same anatomical sites
- same intended use ●
- same biocompatibility
- same shaft diameter
- same locking screw diameters ●
The AOS Small Bone Nailing System has longer cortical screws. Longer screw lengths provide more engagement with the bone. Mechanically, the subject nail proved stronger than the predicate device used for testing.
- PRECLINICAL TESTING: The AOS Small Bone Nail System was subjected to comparative mechanical testing per a four point bend test based on ASTM F1264-14. The results demonstrate that the AOS Small Bone Nail are substantially equivalent to the predicates.
- STANDARDS: Recognized industry standards are cited in the Standards Report
- CLINICAL DATA: There is no clinical data referenced in this 510(k)
PERFORMANCE TESTING
No performance standards applicable to this device have been adopted under Section 514 of the Food, Drug and Cosmetic Act. Performance testing of the AOS Small Bone Nail System was conducted in accordance with various international standards and internal AOS methods.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.