(16 days)
The devices are intended to treat fractures of various bones, including the clavicle, scapula, pelvis, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metatsals, and phalanges) according to the standard of the AO Foundation (AO Principles of Fracture Management).
All aap bone screws are for single use only and are not intended for any spinal fixation procedures.
The aap Cortical Screws 1.5, self-tapping are bone screws, to be implanted by a surgeon in order to achieve an internal fixation of bone fragments typically after fractures or osteotomies. The screws can be used along with the aap bone plate as well as lag screws, to hold together fragments of bone. The devices are made of Implant Stainless Steel or Titanium alloy.
Variations of the aap Cortical Screw 1.5, self-tapping
• Cortical Screw 1.5, self-tapping
• Cortical Screw 1.5, self-tapping, Titanium
Here's an analysis of the provided text regarding acceptance criteria and study information:
Based on the provided FDA 510(k) summary for the "aap Cortical Screws 1.5, self-tapping" and "aap Cortical Screws 1.5, self-tapping, Titanium," the document primarily focuses on establishing substantial equivalence to a predicate device rather than presenting performance data from a specific clinical or comprehensive validation study with explicit acceptance criteria as would be found for complex AI or diagnostic devices.
The information provided indicates that the device is a Class II medical device (Smooth or Threaded Metallic Bone Fixation Fastener) and the submission is a "special 510(k) premarket notification" to obtain clearance for the titanium version of an already cleared stainless steel screw.
Therefore, the answers to most of the questions related to clinical study performance and AI-specific criteria will be "Not applicable" or "Not specified in this document" because the regulatory pathway for this type of device (a bone screw) focuses on demonstrating equivalence in design, materials, and intended use, often through engineering rationale and comparison to existing devices, rather than a clinical trial with specific performance metrics like sensitivity/specificity or human reader improvement.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Premarket Clearance Basis: Substantial Equivalence to predicate device (aap Screw Implants K072411). | The new device has similar intended use, design, functionality, components, technological characteristics, and materials in use to the predicate. Engineering rationale supports substantial equivalence. |
| Material Equivalence: Made of Implant Stainless Steel (ASTM F138 or ISO 5832-1) or Ti6Al4V (ASTM F136 or ISO 5832-3). | Device is made of Implant Stainless Steel or Ti6Al4V, meeting specified ASTM/ISO standards. |
| Intended Use: Treat fractures of various bones as per AO Foundation standards. | Indications for Use align with fracture treatment across specified bones (clavicle, scapula, pelvis, long bones, small bones) following AO Principles. |
| No Spinal Fixation: Not intended for spinal fixation. | Explicitly stated: "All aap bone screws are for single use only and are not intended for any spinal fixation procedures." |
| Single Use Only: | Explicitly stated: "All aap bone screws are for single use only." |
| Safety and Effectiveness: Differences between subject and predicate devices are minor and do not raise new questions concerning safety and effectiveness. | Engineering rationale concludes that differences are minor and do not impact safety or effectiveness. |
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 specified in this document. The submission relies on "engineering rationale" and demonstration of substantial equivalence rather than a clinical test set with human subjects.
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 specified in this document. This information would be relevant for devices that require expert interpretation or ground truth establishment (e.g., AI-powered diagnostic tools). For a bone screw, "ground truth" relates to its mechanical properties and biocompatibility, which are assessed through material testing and design specifications, not expert consensus on cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not specified in this document. Adjudication methods are typically used in clinical studies where multiple experts evaluate cases and a consensus or adjudication process is needed for ground truth. This is not relevant for the regulatory pathway described for this bone screw.
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
- Not applicable / No MRMC study was done. This device is a passive bone fixation fastener, not an AI software or diagnostic tool designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical bone screw, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Engineering Rationale and Material Standards: The "ground truth" for demonstrating the safety and effectiveness of this device primarily stems from established engineering principles, material standards (ASTM F136, F138; ISO 5832-1, 5832-3), and comparison to the predicate device's design and performance. There is no mention of patient outcomes data or pathology results being used as ground truth for this 510(k) submission.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, this is a physical device and the concept of a "training set" and its ground truth is not relevant here.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.