Search Results

The ANTHEM® Fracture System is indicated for fixation of fractures, arthrodesis and reconstruction of bones for the appropriate size of the device to be used in adult patients, including the clavicle, scapula, humerus, radius, ulna, small bones (metacarpals, metatarsals, phalanges), wrist, pelvis, fibula, ankle, and foot. The clavice hook plate may be used for dislocations of the acromioclavicular joint. Mini fragment plates are also indicated for fixation of fractures of the acetabulum, patella, and bone fragments, replantation, malunions and for non-load bearing stabilization and reduction of long bone fragments. Metaphyseal plates are indicated for non-load bearing stabilization and reduction of long bone fragments, and for fixation of bones including the radius and ulna.

In addition, small fragment, mini fragment, proximal tibia, clavicle, metaphyseal, and distal fibula plates are indicated for use in infant, child, and adolescent pediatric subgroups and small stature adults. Distal tibia, metaphyseal, and mini fragment plates are indicated for use in adolescents (12-21 years of age). Plating can be used in patients with osteopenic bone.

The ANTHEM® Fracture System is a family of plates and screws designed to be used for internal bone fixation. The implants are available in various sizes and shapes to accommodate patient anatomy, and may be contoured or straight, with various lengths and types of screws. ANTHEM® implants are manufactured from titanium, titanium allov, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F67, F136, F1295, F1472, F1537, F2229, F138 and F139.

I am sorry, but the provided text from the FDA 510(k) clearance letter for the ANTHEM® Fracture System (K212433) does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria for an artificial intelligence (AI) or machine learning (ML) enabled device.

The document describes a medical device for bone fixation (plates and screws) and primarily focuses on its physical characteristics, materials, and mechanical performance testing (in accordance with ASTM F382 and ASTM F543) to demonstrate substantial equivalence to predicate devices. It discusses the "Performance Data" in terms of engineering analysis and biocompatibility, not AI performance criteria.

Therefore, I cannot provide the requested information, as the input document does not pertain to an AI/ML device study.

Ask a specific question about this device

The ANTHEM® Fracture System is indicated for fixation of fractures, arthrodesis and reconstruction of bones for the appropriate size of the device to be used in adult patients, including the clavicle, scapula, humerus, radius, ulna, small bones (metacarpals, phalanges), wrist, pelvis, femur, tibia, fibula, ankle, and foot. The clavicle hook plate may be used for dislocations of the acromioclavicular joint. Mini fragment plates are also indicated for fixation of fractures of the acetabulum, patella, and bone fragments, replantation, malunions and nonunion, and for non-load bearing stabilization and reduction of long bone fragments. Metaphyseal plates are indicated for non-load bearing stabilization and reduction of long bone fragments, and for fixation of bones including the radius and ulna.

Small fragment, mini fragment, proximal tibia, clavicle, metaphyseal, and distal fibula plates may be used in all pediatric subgroups (except neonates) and small stature adults. Distal tibia, metaphysed, and mini fragment plates may be used in adolescents (12-21 years of age). Plating may be used in patients with osteopenic bone.

The ANTHEM® Fracture System is a family of plates and screws designed to be used for internal bone fixation. The implants are available in various sizes and shapes to accommodate patient anatomy, and may be contoured or straight, with various lengths and types of screws. ANTHEM® implants are manufactured from commercially pure titanium alloy, cobalt chromium molybdenum alloy, or stainless steel.

This document pertains to the 510(k) premarket notification for the ANTHEM® Fracture System (K202496), a metallic bone fixation device. The information provided describes the device, its intended use, and the basis for its substantial equivalence to predicate devices. However, this document does not describe a study involving an AI/algorithmic device, nor does it provide acceptance criteria and performance data for such a device in the context of human-in-the-loop or standalone performance.

The performance data mentioned in the document relates to mechanical testing (ASTM F382) and biocompatibility/sterility testing (Bacterial Endotoxin Testing and material standards) of the physical medical device (bone plates and screws). It does not involve evaluation of an algorithm's diagnostic or assistive performance.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving an AI device meets these criteria, as the provided text describes a traditional hardware medical device submission.

If you provide a document that details the regulatory submission for an AI/algorithmic device, I would be able to answer your questions.

Ask a specific question about this device

The ANTHEM® Fracture System is indicated for fixation of fractures, arthrodesis and reconstruction of bones for the appropriate size of the device to be used in adult patients, including the clavicle, scapula, humerus, radius, ulna, small bones (metacarpals, metatarsals, phalanges), wrist, pelvis, fibula, ankle, and foot. The clavice hook plate may be used for dislocations of the acromioclavicular joint. Mini fragment plates are also indicated for fixation of fractures of the acetabulum, patella, and fragments, replantation, malunions, and for non-load bearing stabilization and reduction of long bone fragments.

Small fragment, mini fragment, proximal tibia, clavicle and distal fibula plates may be used in all pediatric subgroups (except neonates) and small stature adults. Distal radius and mini fragment plates may be used in adolescents (12-2 years of age). Plating may be used in patients with osteopenic bone.

The ANTHEM® Fracture System is a family of plates and screws designed to be used for internal bone fixation. The implants are available in various sizes and shapes to accommodate patient anatomy, and may be contoured or straight, with locking and non-locking screws. ANTHEM® implants are manufactured from titanium, titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F67, F136, F1295, F1472, F1537, F2229, F138 and F139. All implants are for single use only.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the ANTHEM® Fracture System:

This 510(k) summary does not include the type of detailed acceptance criteria and study information typically found for AI/ML-driven medical devices analyzing diagnostic images or other complex data. Instead, this document describes a traditional orthopedic implant (bone plate and screws). Therefore, the "acceptance criteria" and "study" described here pertain to the mechanical and material performance of the physical device, not an algorithm's diagnostic accuracy or performance.

Many of your requested points (e.g., sample size for test set, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to a submission for a physical, non-AI orthopedic implant like the ANTHEM® Fracture System.

However, I can extract the relevant information that is present in the document.

Acceptance Criteria and Study for the ANTHEM® Fracture System

The acceptance criteria for the ANTHEM® Fracture System are based on demonstrating substantial equivalence to predicate devices through mechanical performance testing and material composition.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified in terms of a "test set" from patient data. The "sample size" here refers to the number of individual implants or test specimens subjected to mechanical testing. This information is typically detailed in the full test reports, which are not included in this 510(k) summary.
• Data Provenance: Not applicable as this is not patient- or algorithm-derived data. The data originates from in vitro mechanical testing performed in a laboratory setting.

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 principles and adherence to ASTM standards, not by clinical expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical image interpretation or diagnostic performance studies, not for mechanical device testing.

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 device is a physical surgical implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This device is a physical surgical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Ground Truth: For mechanical testing, the "ground truth" is defined by the established and validated ASTM (American Society for Testing and Materials) standards. The device's performance metrics (e.g., bending strength, pullout force) are compared against the requirements and typical performance of legally marketed predicate devices under these standardized tests.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established

• Not applicable. This is not an AI/ML device.

Summary of the Study:
The study performed for the ANTHEM® Fracture System was a mechanical performance study and engineering analysis. It involved:

• Mechanical Testing: static and dynamic bending, insertion/removal, axial pullout, static torsion, and cantilever bend tests. These tests were conducted in accordance with specific ASTM international standards (F382, F543, F2193).
• Engineering Analysis: This analysis compared the design, materials, and expected performance of the ANTHEM® Fracture System to its predicate devices to demonstrate substantial equivalence, rather than direct human clinical outcomes comparisons.

The goal of these studies was to demonstrate that the ANTHEM® Fracture System is substantially equivalent to previously cleared predicate devices in terms of safety and effectiveness for its intended use, based on established engineering and material science principles, rather than clinical trial data.

Ask a specific question about this device

The ANTHEM™ Fracture System is indicated for fixation of fractures, arthrodesis and reconstruction of bones for the appropriate size of the device to be used in adult patients, including the clavicle, scapula, humerus, radius, ulna, small bones (metacarpals, metatarsals, phalanges), wrist, pelvis, fibula, ankle, and foot. The clavicle hook plate may be used for dislocations of the acromioclavicular joint.

Small fragment, proximal tibia, clavicle and distal fibula plates may be used in all pediatric subgroups (except neonates) and small stature adults. Distal radius plates may be used in adolescents (12-21 years of age). Plating may be used in patients with osteopenic bone.

The ANTHEM™ Fracture System is a family of plates and screws designed to be used for internal bone fixation. The implants are available in various sizes and shapes to accommodate patient anatomy, and may be contoured or straight, sterile and non-sterile, with locking and non-locking screws. ANTHEM™ implants are manufactured from medical grade titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F136, F1295, F1472, F1537, F2229, F138 and F139. All implants are for single use only.

Here's an analysis of the provided FDA 510(k) summary regarding the ANTHEM™ Fracture System, focusing on acceptance criteria and supporting studies.

General Observation: The provided document is for a medical device (bone fixation system), not a diagnostic algorithm or AI product. Therefore, the typical "acceptance criteria" related to diagnostic performance (sensitivity, specificity, AUC) and associated studies (MRMC, standalone) are not applicable in this context. The acceptance criteria here would be related to mechanical performance, material properties, and biological safety, demonstrating substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The primary study type used to demonstrate that the device meets acceptance criteria and is substantially equivalent is non-clinical performance testing and engineering analysis.

• Performance Data: "Performance of the ANTHEM™ Fracture System plates and screws was evaluated in accordance with ASTM F543 and ASTM F382. An engineering analysis was conducted for the plates and screws to demonstrate substantial equivalence to the predicate devices." (Page 4)

This indicates that mechanical tests were performed according to specified ASTM standards for bone screws and plates. The "engineering analysis" would involve comparing the design, materials, and expected performance of the new device to the predicate devices.

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

• Sample Size: The document does not explicitly state a "sample size" in terms of number of devices tested. For mechanical testing, this typically refers to a specified number of samples (e.g., 5, 10, or more) of each device configuration required by the ASTM standard to be tested to demonstrate compliance. This information is usually detailed in the full test report, not summarized in the 510(k) statement.
• Data Provenance: Not applicable in the context of this type of medical device submission. The tests are laboratory-based mechanical and material property evaluations, not clinical data.

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

• Not Applicable: This submission is for a physical medical device (bone fixation system), not a diagnostic algorithm. Therefore, "ground truth" established by human experts in the diagnostic sense (e.g., radiologists interpreting images) is not relevant here. Ground truth in this context would be defined by the physical dimensions, material properties, and mechanical performance test results as measured by calibrated equipment according to standard protocols.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

• Not Applicable: Adjudication methods like 2+1 are used in clinical studies where human interpretation of data (e.g., imaging) needs to be reconciled to establish a consensus ground truth. This is not relevant for the mechanical testing of a bone fixation device.

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: The device is a physical bone fixation system, not an AI diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not Applicable: The device is a physical bone fixation system, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Technical Ground Truth: For this device, the "ground truth" and acceptance criteria are derived from:
  • Mechanical Standards: Adherence to established ASTM standards (F543 for screws, F382 for plates) for mechanical properties (e.g., strength, fatigue resistance).
  • Material Standards: Adherence to established ASTM standards for medical-grade materials (e.g., F136 for titanium alloy, F1537 for cobalt chromium molybdenum alloy, F138/F139/F2229 for stainless steel).
  • Dimensional Specifications: Compliance with design specifications and tolerances that match predicate devices.
    The "truth" is objective, measurable, and defined by engineering and material science principles, not clinical outcomes or expert interpretation of patient data.

8. The Sample Size for the Training Set

• Not Applicable: This is not a machine learning or AI device. There is no "training set" in the context of establishing substantial equivalence for a physical medical device. Device design and manufacturing processes are developed based on engineering principles and predicate device characteristics, not through data training.

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

• Not Applicable: As there is no "training set," this question is not relevant.

Ask a specific question about this device

The ANTHEM™ Fracture System is indicated for fixation of fractures, arthrodesis and reconstruction of bones for the appropriate size of the device to be used in adult patients, including the clavicle, scapula, humerus, radius, ulpa, small bones (metacarpals, metatarsals, phalanges), wrist, pelvis, fibula, ankle, and foot. Small fragment and distal fibula plates may be used in all pediatric subgroups (except neonates) and small stature adults. Distal radius plates may be used in adolescents (12-21 years of age).

The ANTHEM™ Fracture System is a family of plates and screws designed to be used for internal bone fixation. The implants are available in various sizes and shapes to accommodate patient anatomy, and may be contoured or straight, sterile and non-sterile, with locking and non-locking screws. ANTHEM™ implants are manufactured from medical grade titanium alloy, cobalt chromium molybdenum alloy, or stainless steel. All implants are for single use only.

This document is a 510(k) Summary for the ANTHEM™ Fracture System, a medical device. Based on the provided text, there is no study described that proves the device meets specific acceptance criteria based on AI/algorithm performance, nor is there any mention of an AI device. The document explicitly describes the ANTHEM™ Fracture System as a system of "plates and screws designed to be used for internal bone fixation."

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance related to AI/algorithmic accuracy.
• Sample size and data provenance for an AI test set.
• Number of experts and qualifications for AI ground truthing.
• Adjudication method for an AI test set.
• MRMC comparative effectiveness study for AI assistance.
• Standalone AI performance.
• Type of ground truth used for AI.
• Sample size for training set for AI.
• How ground truth for a training set was established for AI.

The document focuses on the mechanical and material performance of bone fixation devices, not on diagnostic or AI-driven performance.

Here's a summary of the performance data that is mentioned in the document, which pertains to the physical device itself:

1. Acceptance Criteria and Reported Device Performance (for the physical device):

• Acceptance Criteria (Implicit Standard Performance): The device's performance was evaluated in accordance with recognized ASTM standards for bone fixation devices. This implies that the device had to meet performance benchmarks defined by these standards to demonstrate substantial equivalence to predicate devices. While specific numerical acceptance criteria are not explicitly stated (e.g., "minimum bending strength of X N-m"), the adherence to these standards serves as the implicit acceptance criteria for mechanical performance.
• Reported Device Performance:
  • Tests Conducted: Engineering analysis, bending strength tests (for plates and screws), pullout strength tests (for screws), and insertion/removal torque tests (for screws).
  • Outcome: "Performance data demonstrates substantial equivalence to the predicate devices."
  • Bacterial Endotoxin Testing (BET): Conducted in accordance with ANSI/AAMI ST-72:2011 to ensure sterility or low endotoxin levels.

2. Sample Size and Data Provenance (for the physical device testing):

• The document does not specify the sample sizes used for the mechanical performance tests (e.g., how many plates or screws were tested for bending strength).
• The data provenance is not mentioned (e.g., where the tests were conducted, whether the materials were from specific batches, etc.).

3. Number of experts used to establish the ground truth... and qualifications of those experts:

• Not applicable. This document is about a physical medical device (bone plates and screws), not an AI algorithm requiring expert review for ground truth.

4. Adjudication method for the test set:

• Not applicable. This document is about a physical medical device (bone plates and screws), not an AI algorithm.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done...:

• Not applicable. This document is about a physical medical device (bone plates and screws), not an AI algorithm.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable. This document describes a physical medical device, not an algorithm.

7. The type of ground truth used:

• For the physical device, "ground truth" would be the objective measurements obtained from standardized mechanical tests (e.g., actual force at failure, actual torque values) against the requirements of the ASTM standards.

8. The sample size for the training set:

• Not applicable, as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

• Not applicable, as this is not an AI/machine learning device.

Ask a specific question about this device