(91 days)
The Flower Bone Screw Set is intended to be used for the fixation of bone fractures, fusion of joints or bone reconstruction.
The subject Flower Bone Screw Set is an extension of the Flower Bone Screw Set (K132248) consisting of headless compression screws and cannulated bone screws, made of a titanium alloy compliant with ISO 5832-3. The device is provided with general purpose instruments.
This document is a 510(k) summary for the Flower Bone Screw Set, which is a medical device. It's important to note that this document describes a device (bone screws), not an AI/ML algorithm or software as a medical device. Therefore, many of the requested criteria, such as "effect size of how much human readers improve with AI vs without AI assistance" or "sample size for the training set," are not applicable to this type of device submission.
The "performance data" section for this hardware device focuses on mechanical testing and material compliance, not clinical performance in the way an AI/ML product would be evaluated.
Here's an analysis of the provided information, with N/A for criteria that don't apply to a physical device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was tested) | Reported Device Performance (Result) |
|---|---|
| Bacterial Endotoxins Test | The Flower Bone Screw Set was tested (worst case) according to or conforms to ASTM/AAMI ST72. |
| Mechanical Strength | An engineering analysis was performed to demonstrate that the Flower Orthopedics bone screws provide adequate and substantially equivalent mechanical strength for the claimed intended use. |
| Material Compliance | Made of a titanium alloy compliant with ISO 5832-3. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated. The document refers to "worst case" testing for bacterial endotoxins and an "engineering analysis" for mechanical strength. For physical devices, "sample size" often refers to the number of units tested, but this level of detail is not provided.
- Data Provenance: Not applicable in the context of clinical data for an AI/ML device. The testing was performed on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is a hardware device; ground truth in the context of clinical interpretation or diagnosis by experts is not relevant to its type of testing. Engineering and material science experts would have been involved in the design and testing, but their role is different from establishing clinical "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept pertains to resolving discrepancies in expert interpretations, which is not relevant for the types of tests (bacterial endotoxin, mechanical strength) performed on bone screws.
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 study is not applicable as this is a physical medical device (bone screw), not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For Bacterial Endotoxins: The "ground truth" is adherence to the ASTM/AAMI ST72 standard. The test itself determines the level of endotoxins.
- For Mechanical Strength: The "ground truth" is established through engineering analysis and comparison to the mechanical strength of predicate devices, ensuring it is "adequate and substantially equivalent" for its intended use. This is based on established biomechanical principles and regulatory guidances for similar devices.
- For Material Compliance: The "ground truth" is the ISO 5832-3 standard for titanium alloy composition.
8. The sample size for the training set
- Not applicable. This is a hardware device; there is no "training set" in the AI/ML sense.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" for this physical device.
§ 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.