(103 days)
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
| Acceptance Criteria (Standards Adhered To) | Reported Device Performance |
|---|---|
| Material Composition | |
| ASTM F136: Wrought Titanium-6 Aluminum-4 Vanadium ELI Alloy for Surgical Implant Applications | Compliant, Flower Bone Screws made of titanium alloy compliant with ASTM F136. |
| ISO 7153-1: Surgical instruments Metallic materials Part 1: Stainless steel (for general purpose instruments) | Compliant, general purpose instruments provided with the device. |
| Biocompatibility | |
| ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process | Compliant, biological evaluation performed. |
| ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Compliant, tests for in vitro cytotoxicity performed. |
| Sterilization | |
| ISO 11137-1: Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices | Compliant, ensures sterility. |
| Mechanical Strength/Performance | |
| Engineering analysis demonstrating appropriate mechanical strength for claimed intended use (worse case testing) | Performed; demonstrates appropriate mechanical strength and functioned as intended; test results show substantial equivalence to predicate devices. |
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.
§ 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.