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510(k) Data Aggregation
(34 days)
GLW, Inc.
CREED™ Cannulated Screws are intended to maintain alignment and fixation of bone fractures in the presence of appropriate additional immobilization such as rigid fixation implants, cast or brace, nonunions, osteotomies, arthrodesis or bone grafts in the hand, foot, and ankle including distal tibia and fibula. These implants are not intended for spinal use.
CREED™ Cannulated Screws Subject device consists of components that will be available in Ø2.5mm thread diameter and lengths ranging from 20-44 mm. They areheadless compression screws. All screws are self-drilling and self-tapping. The screws are Titanium alloy Ti-6AL-4V ELI (ASTM F136) screws. A variety of instrumentation is offered as part of the kit to facilitate delivery of the screws. The screws are provided sterile via Gamma irradiation.
This document is a 510(k) Premarket Notification from the FDA regarding the "CREED™ Cannulated Screws." It is a premarket submission for a medical device and, as such, does not contain information about clinical studies with human participants, AI algorithms, or the evaluation of diagnostic performance.
The document primarily focuses on demonstrating substantial equivalence of a new medical device (CREED™ Cannulated Screws) to a legally marketed predicate device (also CREED™ Cannulated Screws, K200291) based on mechanical performance and material characteristics, not on clinical outcomes or diagnostic accuracy.
Therefore, I cannot provide the requested information regarding:
- Acceptance criteria for diagnostic performance
- Study proving device meets acceptance criteria (in the context of diagnostic performance)
- Sample size for test set or data provenance
- Number of experts or their qualifications for ground truth
- Adjudication method
- MRMC comparative effectiveness study
- Standalone algorithm performance
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Sample size for training set
- How ground truth for training set was established
The "Performance Data" section explicitly states: "Static bending (ASTM F1264) test results were presented along with engineering rationale for other relevant measures." This indicates that the performance evaluation was based on mechanical testing, not clinical or diagnostic studies.
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(157 days)
GLW, Inc.
The Artemis Proximal Femoral Nail System is indicated for fixation of stable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections.
Additionally, the long nail kit is indicated for the fixation of subtrochanteric fractures and shaft fracture extending distally to a point approximately 10 cm proximal to the intercondylar notch.
The Artemis Proximal Femoral Nail System is an intramedullary fracture fixation system intended for temporary stabilization of bone segments or fragments in the proximal femur. The system includes single-use, sterile implants (Proximal Femoral Nail Kit Short, Proximal Femoral Nail Kit Long, Locking Screw, Lag Screw, and optional anti-rotational locking pins) as well as non-sterile, reusable, Class I and II surgical instruments.
The nail and screws are made of titanium alloy Ti-6Al-4V. The titanium alloy nail is partially over-molded with carbon fiber reinforced polymer (CFR PEEK).
The Artemis Nails are available in short or long lengths from 180mm to 440mm and are cylindrical rods with preassembled Set Screws. The Nail is designed with holes, at the proximal and distal sections, for the insertion of a Lag Screw and Locking Screw, respectively. The Lag Screw has a diameter of 11mm and is available in various lengths ranging from 70mm to 130mm. The Locking Screw has a diameter of 5mm and is available in various lengths ranging from 25mm to 110mm. Optional Anti-rotational Locking Pins are also available to aid in rotational stability.
The provided document describes the FDA 510(k) clearance for the Artemis Proximal Femoral Nail System. This document is a regulatory submission for a medical device that does not involve AI/ML components for diagnostic purposes, and therefore, the acceptance criteria and study proving device performance are based on mechanical and physical properties rather than algorithmic performance on image data.
Therefore, I cannot provide information on the following points:
- 1. A table of acceptance criteria and the reported device performance (in terms of AI/ML metrics): The document reports mechanical testing results, not AI/ML performance metrics.
- 2. Sample size used for the test set and the data provenance: There is no "test set" in the context of AI/ML for this device. The testing refers to mechanical and physical properties.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment is not relevant for this type of device submission.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
However, based on the provided text, I can infer the "acceptance criteria" and "study proving device meets acceptance criteria" in the context of a non-AI medical device submission:
Acceptance Criteria and Study for the Artemis Proximal Femoral Nail System:
The acceptance criteria for the Artemis Proximal Femoral Nail System are based on its mechanical performance and material characteristics, demonstrating that the device is substantially equivalent to a predicate device. This is a common pathway for Class II medical devices where performance can be validated through engineering and physical testing, rather than clinical studies or AI algorithm performance.
1. Table of Acceptance Criteria and Reported Device Performance (Mechanical/Material Focus):
| Acceptance Category/Criteria | Acceptance Standard (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Meets relevant ASTM and ISO standards for intramedullary fixation devices. This implies acceptable static and dynamic strength, fatigue resistance, and stability in anticipated loading conditions. Specific standards cited are ASTM F1264 and ASTM F543, and ISO 7206-4. | "The Artemis Proximal Femoral Nail System successfully underwent mechanical testing in accordance with ASTM F1264 and ASTM F543. Performance testing of the Artemis Proximal Femoral Nail System components also included static and dynamic bending of the construct based on ISO 7206-4." (The "successful" completion implies meeting the acceptance thresholds defined by these standards). |
| Material Composition | Identical to predicate device(s) or well-established biocompatible and mechanically sound materials for medical implants. | "The nail and screws are made of titanium alloy Ti-6Al-4V. The titanium alloy nail is partially over-molded with carbon fiber reinforced polymer (CFR PEEK)." (This aligns with common materials for such implants and is stated to be identical to the predicate in the "Comparison" section.) |
| Device Dimensions/Design | Equivalent to predicate device in critical dimensions (diameter, angle, locking options) where relevant to function and safety. | "Materials Identical, Sterilization method Identical, Diameter Identical, Length Short-unchanged Subject Long-additional sizes, Angle Identical, Locking options Short-unchanged Subject Long-identical + additional anti rotational locking screws, Lag screw/locking screw Identical, Method of fixation Identical, Mechanics of action Identical." (The "additional sizes" for the long nail kit and "additional anti rotational locking screws" are acknowledged but presumably deemed not to raise new safety/effectiveness questions based on the testing performed, implying the design variations still meet the overall safety profile). |
| Sterilization | Validated to be consistent with predicate device or industry standards to ensure sterility. | "Sterilization method Identical" (to the predicate device). |
| Biocompatibility | Materials used are biocompatible as per predicate device or established standards. | Implied by "Materials Identical" to the predicate, which would have undergone biocompatibility assessment. |
| Intended Use | The device is suitable for the stated indications for use. | "The Artemis Proximal Femoral Nail System is indicated for fixation of stable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections. Additionally, the long nail kit is indicated for the fixation of subtrochanteric fractures and shaft fracture extending distally to a point approximately 10 cm proximal to the intercondylar notch." (The submission argues that the technological characteristics do not raise different questions of safety and effectiveness compared to the predicate, even with the expanded long nail kit indication, implying the mechanical testing supports this broader claim). |
| Substantial Equivalence | Demonstrated through comparison of indications, materials, and technological characteristics to a legally marketed predicate device, without raising new questions of safety or effectiveness. | "Documentation was provided to demonstrate that the Subject device, Artemis Proximal Femoral Nail System is substantially equivalent to the primary predicate Artemis Proximal Femoral Nail System (K201379)... Based on the indications for use, technological characteristics, materials, and comparison to the predicate devices, the subject Artemis Proximal Femoral Nail System has been shown to be substantially equivalent to a legally marketed predicate device." |
Study Proving the Device Meets Acceptance Criteria:
The study proving the device meets its acceptance criteria is primarily non-clinical performance testing, specifically mechanical testing.
- Type of Study: Mechanical Testing
- Specific Tests Conducted:
- ASTM F1264: Standard Specification for Extramedullary Splints and Bone Plates (likely referenced for general principles or associated components, though the primary device is intramedullary).
- ASTM F543: Standard Specification and Test Methods for Metallic Medical Bone Screws.
- ISO 7206-4: Implants for surgery — Partial and total hip joint prostheses — Part 4: Determination of endurance properties of stemmed femoral components. (This standard refers to hip prostheses, but its principles for static and dynamic bending of constructs are applied to the femoral nail system).
- Data Provenance: The nature of mechanical testing means the "data provenance" is derived from laboratory tests conducted on samples of the device itself. This is typically done in a controlled, prospective manner. Country of origin of the data is not specified but would be the location of the GLW Medical Innovation's testing facilities or contracted labs.
- Sample Size Used for the Test Set: While not explicitly stated for each test, mechanical testing typically involves a sufficient number of samples (e.g., typically 3-6 or more samples per test condition, depending on the standard and variability) to ensure statistical significance and reproducibility of results for the physical properties being evaluated.
- Ground Truth: For mechanical testing, the "ground truth" is defined by the acceptance criteria established within the referenced ASTM and ISO standards. The device 'passes' if its performance (e.g., strength, fatigue life) meets or exceeds the minimum requirements specified in these industry standards for similar devices. There are no human experts establishing ground truth in terms of diagnostic interpretation or clinical outcomes for this specific submission.
- Clinical Data: The submission explicitly states: "No clinical data was necessary." This reinforces that the substantial equivalence determination was based entirely on non-clinical performance data (mechanical testing and comparison to the predicate).
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(269 days)
GLW, Inc.
The Artemis Proximal Femoral Nail System is indicated for fixation of stable and unstable intertrochanteric fractures, including but not limited to nonunion, malunion and tumor resections.
The Artemis Proximal Femoral Nail System is an intramedullary fracture fixation system intended for temporary stabilization of bone segments or fragments in the proximal femur. The system includes single-use, sterile implants (Proximal Femoral Nail Kit Short, Locking Screw, and Lag Screw) as well as non-sterile, reusable, Class I and II surgical instruments. The nail and screws are made of titanium alloy Ti-6Al-4V. The titanium alloy nail is partially over-molded with carbon fiber reinforced polymer (CFR PEEK).
The Artemis Nail is a cylindrical rod with a preassembled 4mm Set Screw, available in one size with a distal diameter of 11mm, a proximal diameter of 16.4mm, and a length of 180mm. The Nail is designed with holes, at the proximal and distal sections, for the insertion of a Lag Screw and Locking Screw, respectively. The Lag Screw has a diameter of 11mm and is available in various lengths ranging from 70mm to 130mm. The Locking Screw has a diameter of 5mm and is available in various lengths ranging from 25mm to 110mm.
This FDA 510(k) premarket notification describes the Artemis Proximal Femoral Nail System, an intramedullary fixation system. It confirms that clinical data was not needed for this device. The information provided heavily relies on comparisons to predicate devices and mechanical testing, rather than studies involving human participants or AI performance. Therefore, many of the requested details about acceptance criteria and study design are not applicable in this context.
Here's a breakdown of the available and unavailable information based on your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Comparability | Subject device (Titanium alloy & CFR PEEK) demonstrated substantial equivalence to predicate (Titanium alloy) through performance characteristics. Reference device used to address material difference. |
| Static Bending of Construct Performance | Comparable to predicate devices. |
| Dynamic Bending of Construct Performance | Comparable to predicate devices. |
| Screw Torque to Failure Performance | Comparable to predicate devices. |
| Compliance with ISO 7206-4 | Successfully underwent testing. |
| Compliance with ASTM F1264 | Successfully underwent testing. |
| Compliance with ASTM F543 | Successfully underwent testing. |
| No new issues of safety or effectiveness | Demonstrated through comparison testing to the predicate. |
2. Sample size used for the test set and the data provenance
Not applicable. This device is an implantable medical device, and its performance was evaluated through mechanical testing, not clinical studies with human test sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for mechanical testing is established by engineering standards and measurement accuracy, not expert human interpretation.
4. Adjudication method for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for diagnostic or AI-assisted performance evaluation, not for mechanical testing of an orthopedic implant.
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. This is not an AI-enabled device or a diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI-enabled device.
7. The type of ground truth used
For the safety and effectiveness assessment, the ground truth was based on:
- Mechanical Testing Standards: Adherence to established international and American standards such as ISO 7206-4, ASTM F1264, and ASTM F543.
- Predicate Device Performance: Performance data from legally marketed predicate devices served as a benchmark for comparison to demonstrate substantial equivalence.
8. The sample size for the training set
Not applicable. This document refers to the evaluation of a medical device (an intramedullary nail system), not an AI algorithm. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device evaluation.
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