(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.
§ 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.