Search Results

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

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.

Ask a specific question about this device

The Flower Bone Screw set is intended to be used for the fixation of bone fractures, fusion of joints or bone reconstruction.

The Flower Bone Screw Set consists of the following components and accessories: solid, cannulated, and headless compression screws, as well as washers, all made of a titanium alloy compliant with ASTM F136. The device is provided with general purpose instruments.

Acceptance Criteria and Study for Flower Bone Screw Set (K132248)

This device, the Flower Bone Screw Set, is a Class II medical device, which means it requires a 510(k) Pre-Market Notification rather than a full PMA (Pre-Market Approval). For 510(k) devices, the primary goal is to demonstrate substantial equivalence to existing legally marketed predicate devices. This typically involves showing that the new device has the same intended use, similar technological characteristics, and performs as safely and effectively as the predicate devices.

For this specific device, the "acceptance criteria" are primarily based on established international and national standards for medical devices and a successful engineering analysis rather than specific numerical performance targets against a disease state or condition.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided documentation does not specify a "test set" in the context of clinical data or patient samples as might be seen for diagnostic AI devices. Instead, the testing described is primarily bench testing and engineering analysis conducted on the device hardware itself.

• Sample Size: Not explicitly stated in terms of a discrete number of devices tested for each standard, but it would involve a sufficient number of samples to statistically demonstrate compliance with the relevant ASTM and ISO standards (e.g., destructive testing for mechanical properties, material composition analysis on multiple batches, etc.) and to support the "worse case" engineering analysis.
• Data Provenance: The data provenance is from bench testing and engineering analysis performed by the manufacturer, Flower Orthopedics Corporation. This is typically done in a controlled laboratory environment. It is not patient data, nor is it classified as retrospective or prospective clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This type of information is not applicable for this device submission. The "ground truth" for this device's performance is established by:

• Industry Standards: Compliance with established international and national standards (ASTM, ISO). These standards themselves are developed by committees of experts in relevant fields (materials science, biomedical engineering, medical device manufacturing, etc.).
• Engineering Principles: The engineering analysis relies on established principles of biomechanics, materials science, and mechanical engineering.
• Comparison to Predicates: The ultimate "ground truth" for substantial equivalence is the proven safety and effectiveness of the legally marketed predicate devices.

There is no mention of individual clinical experts or "ground truth" labels for a test set of data in this 510(k) summary.

4. Adjudication Method for the Test Set

Not applicable. As the "test set" consists of bench testing and engineering analysis results against predefined standards and engineering principles, there is no need for human expert adjudication in the sense of reviewing diagnostic outcomes or clinical cases. The adjudication is based on whether the test results meet the specified criteria of the standards and the conclusions of the engineering analysis.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study is not mentioned and would not typically be required or relevant for a device like a bone screw set. MRMC studies are employed primarily for diagnostic imaging devices or algorithms where the performance of human readers (with or without AI assistance) on a set of clinical cases is being evaluated. This device is a surgical implant, not a diagnostic tool.

6. Standalone Performance Study

Yes, a standalone performance evaluation of the device was conducted. This is represented by the "Performance Data" section which details:

• Compliance with various ASTM and ISO standards related to materials, biocompatibility, and sterilization.
• An engineering analysis to demonstrate appropriate mechanical strength.

These tests evaluate the device's inherent properties and performance against established benchmarks without direct human interaction as part of the performance metric.

7. Type of Ground Truth Used

The "ground truth" for evaluating the Flower Bone Screw Set is primarily:

• Compliance with Established Industry Standards: This includes material specifications (ASTM F136, ISO 7153-1), biocompatibility (ISO 10993-1, ISO 10993-5), and sterilization efficacy (ISO 11137-1).
• Engineering Principles and Analysis: The mechanical strength is validated through an engineering analysis based on accepted biomechanical principles and "worse case" testing scenarios.
• Substantial Equivalence to Predicate Devices: The overall "ground truth" for regulatory approval via 510(k) is that the device is shown to be as safe and effective as legally marketed predicate devices with the same intended use.

There is no mention of pathology, clinical outcomes data, or expert consensus on clinical cases being used as ground truth for this submission type.

8. Sample Size for the Training Set

Not applicable. This device is a mechanical surgical implant, not an AI/ML algorithm that requires a "training set" of data. The manufacturing processes and design principles are based on established engineering and materials science, not on machine learning models.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI/ML algorithm, there is no ground truth to establish for such a set.

Ask a specific question about this device