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The Hoffmann ® II Micro™ External Fixation System is intended for use to provide stabilization of open and/or unstable fractures in children and adults where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting or other means of internal fixation and for use in reconstruction procedures in conjunction with commercially available Fixation Pins and/or Kirschner Wires. Specific indications include, but are not limited to:

• Bone fracture fixation .
• . Osteotomy
• Arthrodesis .
• Correction of deformity .
• Revision procedure where other treatments or devices have been unsuccessful .
• Non-unions and delayed unions .
• Compression/distraction and lengthening .

This line extension is to modify the lengthener components to the Hoffmann® II Micro™ External Fixation System. This component is an external fixation frame component and can be used with the components in other Howmedica Osteonics' external fixation systems such as the Hoffmann® II Micro " External Fixation System, Hoffmann® II External Fixation System, Hoffmann® II Compact" External Fixation System, Hoffmann® II Hybrid Frame System, Monotube Triax "External Fixation System.

This document is a 510(k) premarket notification for a medical device called the "Hoffmann® II Micro™ Lengthener Line Extension." It does not contain information about acceptance criteria or a study proving the device meets those criteria.

Instead, the document details:

• The device's proprietary and common name.
• Its classification and product code.
• Contact information for the manufacturer.
• A brief description of the device as a line extension to modify lengthener components for external fixation systems.
• The intended use of the Hoffmann® II Micro™ External Fixation System, which includes stabilization of fractures, osteotomy, arthrodesis, correction of deformity, revision procedures, non-unions, delayed unions, and compression/distraction and lengthening.
• A statement of substantial equivalence to predicate devices based on intended use, materials, design, and mechanical performance.
• A letter from the FDA confirming the 510(k) clearance based on substantial equivalence to legally marketed predicate devices.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance study details from the provided text. This type of submission relies on demonstrating similarity to existing, legally marketed devices rather than presenting new performance data against specific acceptance criteria.

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The Hoffmann® II Micro™ External Fixation System is intended for use to provide stabilization of open and/or unstable fractures in children and adults where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting or other means of internal fixation and for use in reconstruction procedures in conjunction with commercially available Fixation Pins and/or Kirschner Wires. Specific indications include, but are not limited to:

• Bone fracture fixation .
• . Osteotomy
• Arthrodesis .
• . Correction of deformity
• Revision procedure where other treatments or devices have been unsuccessful .
• Non-unions and delayed unions .

The new components are additions to the Hoffmann® II Micro™ External Fixation System. They are external fixation frame components intended to be used with the components in other Howmedica Osteonics' external fixation systems such as the Hoffmann® External Fixation System, Hoffmann® II External Fixation System, Hoffmann® II Compact™ External Fixation System, Hoffmann® II Hybrid Frame System, Monotube Triax™ External Fixation System.

This document is a 510(k) premarket notification for modifications to the Hoffmann® II Micro™ External Fixation System. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting device performance from a study with specific metrics like sensitivity, specificity, or accuracy.

Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, and sample sizes for testing and training cannot be extracted from this document, as it describes a different type of regulatory submission.

Here's what can be inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. This document is a 510(k) premarket notification for modifications to an existing device. It does not contain pre-defined performance metrics or reported performance data in the typical sense of a diagnostic or predictive device study. The "acceptance criteria" for a 510(k) submission revolve around demonstrating substantial equivalence to predicate devices. The reported "performance" is that the modifications meet this equivalence.

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

Not applicable. This document refers to "testing" conducted to demonstrate substantial equivalence but does not specify a test set sample size or data provenance in the context of a clinical performance study. The testing would likely involve mechanical or biocompatibility tests, not a clinical data set.

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

Not applicable. This type of information is pertinent to studies involving human interpretation or clinical outcomes, which is not the focus of this 510(k) submission for an external fixation system.

4. Adjudication method for the test set:

Not applicable. See point 3.

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

No. This is a 510(k) for modifications to a mechanical device. MRMC studies are typically for evaluating the performance of diagnostic imaging solutions with human readers.

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

No. This device is an external fixation system, not an algorithm or AI-driven system.

7. The type of ground truth used:

Not applicable for a clinical performance study. For a 510(k) of a mechanical device, "ground truth" would relate to engineering specifications, material properties, and mechanical performance standards, established through recognized test methods.

8. The sample size for the training set:

Not applicable. There is no concept of a "training set" in the context of this 510(k) submission for an external fixation system.

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

Not applicable. See point 8.

In summary:

This 510(k) notification for the Hoffmann® II Micro™ External Fixation System focuses on demonstrating substantial equivalence to predicate devices for its modified components. The "study" mentioned is the "testing" conducted to prove this equivalence, likely involving mechanical and material characterization rather than clinical performance studies with metrics like sensitivity or specificity. Therefore, many of the typical questions asked for AI or diagnostic device studies are not applicable to this document.

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The Hoffmann® II Micro External Fixation System is an intended to be used with the Half Pins or Transfixing Pins of the Hoffinann® External Fixation System and the Components of the Hoffmann® II External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.

This Special 510(k) submission is intended to address modifications to the predicate Hoffmann® II Micro "External Fixation System. The subject and predicate Hoffmann® II Micro" External Fixation Systems are both fabricated from stainless steel components and carbon connecting rods.

The provided text describes a Special 510(k) submission for the Hoffmann® II Micro™ External Fixation System Line Extension. This document focuses on demonstrating substantial equivalence to a predicate device through mechanical testing. It does not contain information about clinical studies with human participants, expert review, or AI algorithms. Therefore, many of the requested sections about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI performance, reader studies, and ground truth cannot be extracted from this specific document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not specified for the mechanical testing.
• Data Provenance: Not applicable. The "study" referenced is mechanical testing, not a clinical data study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This was mechanical testing, not a study requiring expert consensus or ground truth in the medical diagnostic sense.

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

• Not applicable. This was mechanical 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

• No. This document does not pertain to AI or human reader studies.

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

• No. This document is about a mechanical external fixation system, not an algorithm.

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

• For the mechanical testing: The "ground truth" was compliance with established engineering performance standards, as demonstrated by the predicate device's mechanical properties.

8. The sample size for the training set

• Not applicable. This device is not an AI algorithm requiring a training set.

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

• Not applicable. This device is not an AI algorithm.

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The Hoffmann® II Micro External Fixation System is intended to be used with the Half Pins or Transfixing Pins of the Hoffmann® External Fixation System and the Components of the Hoffmann® II External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures and where soft tissue may preclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.

This Special 510(k) submission is intended to address a material modification and design modifications to the predicate Hoffmann® II Compact" External Fixation System. The subject device, named the Hoffmann® II Micro External Fixation System, is a line extension of the Hoffmann® II Compact External Fixation System. The predicate Hoffmann® II Compact External Fixation System is fabricated from stainless steel and aluminum. The subject Hoffmann® II Micro External Fixation System is fabricated from stainless steel. The Hoffmann® II Micro External Fixation System is a miniaturization of the Hoffmann® II Compact "External Fixation System. The miniaturization involves modifying the overall size of the components as well as reducing the size of the mating components (Apex® pins and connecting rods).

The subject Hoffmann® II Micro External Fixation System shares the same intended use, and basic design concepts as that of the currently available Hoffmann® II Compact™ External Fixation System. Mechanical testing demonstrated comparable mechanical properties to the predicate components.

The provided text describes a 510(k) submission for a medical device and its substantial equivalence to a predicate device. However, it does not contain the information requested in your bullet points regarding acceptance criteria and the study that proves the device meets them.

The document focuses on:

• Device Identification: Naming the device, its common name, and classification.
• Device Description: Explaining that the Hoffmann® II Micro External Fixation System is a line extension of the Hoffmann® II Compact™ External Fixation System, miniaturized, and fabricated from stainless steel (whereas the predicate used stainless steel and aluminum).
• Intended Use: Stating its purpose for stabilizing open and/or unstable fractures.
• Substantial Equivalence: Confirming that mechanical testing demonstrated comparable mechanical properties to the predicate components, leading to FDA clearance.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, efficacy studies, sample sizes, expert involvement, or ground truth details, as this information is not present in the provided text.

The document states: "Mechanical testing demonstrated comparable mechanical properties to the predicate components." This is the extent of the "study" mentioned, aimed at proving substantial equivalence rather than defining and meeting specific acceptance criteria for performance in a clinical or diagnostic context.

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