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The Hoffmann 3 Modular External Fixation System components are external fixation frame components for use with the components of the Hoffmann II MRI and Hoffmann II Compact MRI External Fixation Systems, in conjunction with Apex Pins. It is intended to provide stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rods, casts or other means of internal fixation.

The indications for use of external fixation devices include:

• Bone fracture fixation
• Osteotomy
• Arthrodesis
• Correction of deformity
• Revision procedure where other treatments or devices have been unsuccessful
• Bone reconstruction procedures

This Traditional 510(k) submission is intended to address the addition of new components to the previously cleared Hoffmann 3 Modular External Fixation System. The Hoffmann 3 Modular External Fixation System consists of Rods. Posts: Couplings, Clamps and Pins that can be combined to construct different frame configurations that are MR conditional. The additional components consist of a Multiplanar Rod to Rod Coupling, Multiplanar Pin to Rod Coupling, 30° Rod Coupler, 4/5 Apex Pin, 5/6 Transfixing Pin and a Ø11mm Semi Circular Rod. This external fixation system may also be used with the components in other Howmedica Osteonics external fixation systems such as the Hoffmann II MRI and Hoffmann II Compact MRI External Fixation Systems and in conjunction with other commercially available Apex Pins.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Hoffmann 3 Modular External Fixation System

1. Acceptance Criteria and Reported Device Performance

Overall Conclusion: The non-clinical testing demonstrated that the Hoffmann 3 System components are substantially equivalent to devices currently cleared for marketing. No specific quantitative performance metrics beyond "substantially equivalent" are provided in this summary.

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

• Test Set Sample Size: Not explicitly stated. The document refers to "non-clinical laboratory testing and engineering evaluations," which implies various test samples were used for each type of mechanical and material test.
• Data Provenance: The testing was "non-clinical laboratory testing and engineering evaluations," which suggests the data was generated in a controlled laboratory environment (likely in the US, given the FDA submission). It is considered prospective testing for the purpose of this submission.

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

• Not applicable. This submission relies on engineering and laboratory testing for substantial equivalence, not clinical data or expert interpretation of clinical outcomes. Ground truth in this context refers to established engineering and material science standards.

4. Adjudication Method for the Test Set

• Not applicable. This was based on objective engineering and material testing against established predicate device performance and standards, not on subjective human assessment requiring adjudication.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Testing: Clinical testing was not required for this submission." This indicates that the FDA deemed non-clinical, bench testing sufficient for this 510(k) submission, likely because it was an addition of new components to an already cleared system.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study

• Not applicable. This is a medical device (external fixation system), not an AI algorithm. Its performance is inherent in its physical and mechanical properties, not in an interpretive algorithm.

7. Type of Ground Truth Used

• Engineering and Material Standards: The "ground truth" for the non-clinical testing was based on established engineering principles, material science standards, and performance characteristics demonstrated by the legally marketed predicate devices (K111786 Hoffmann 3 Modular External Fixation System, K051306 Hoffmann II MRI External Fixation System, K053472 Hoffmann II MRI Components, K001886 Apex Fixation Pins).

8. Sample Size for the Training Set

• Not applicable. This device is not an AI/ML algorithm or software that requires a training set. The "training" for proving substantial equivalence came from the existing knowledge of the predicate devices and established engineering principles.

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

• Not applicable, as there is no training set mentioned or implied for this type of device submission.

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The Hoffmann 3 Modular External Fixation System is used to provide stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts or other means of internal fixation.

The Hoffmann 3 Modular External Fixation System components are external fixation frame components for use with the components of the Hoffmann II MRI and Hoffmann II Compact MRI External Fixation Systems, in conjunction with Apex Pins. It is intended to provide stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rods, casts or other means of internal fixation.

The indications for use of external fixation devices include:

• Bone fracture fixation .
• Osteotomy ' .
• . Arthrodesis
• . Correction of deformity
• . Revision procedure where other treatments or devices have been unsuccessful
• . Bone reconstruction procedures

This Traditional 510(k) submission is intended to address a sterilization modification to the previously cleared Hoffmann 3 Modular External Fixation System and the addition of a new Apex Fixation Pin. The Hoffmann 3 Modular External Fixation System consists of Rods, Couplings, Clamps and Pins that can be combined to construct different frame configurations that are MR conditional. The additional component will be a new Apex Fixation Pin manufactured from stainless steel. The modification is to provide the previously cleared components and the additional Apex Fixation Pin as part of a sterile kit. This external fixation system may also be used with the components in other Howmedica Osteonics external fixation systems such as the Hoffmann II MRI and Hoffmann II Compact MRI External Fixation Systems and in conjunction with other commercially available Apex Pins.

This submission describes the Hoffmann 3 Modular External Fixation System, a medical device used for stabilizing fractures and other bone conditions. The submission focuses on a sterilization modification to previously cleared components and the addition of a new Apex Fixation Pin.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Device Performance

The provided document describes a Non-Clinical Testing approach to demonstrate substantial equivalence, rather than specific acceptance criteria for a new device's efficacy. The acceptance criteria essentially boil down to demonstrating that the modified device and new component meet safety and performance standards comparable to an existing, cleared predicate device.

No specific quantitative or statistical acceptance criteria (e.g., minimum tensile strength, maximum corrosion rate) are provided in the summary. The phrase "substantially equivalent" is the overarching criteria, validated through the non-clinical tests listed.

Study Information

The document explicitly states: "Clinical Testing: Clinical testing was not required for this submission." This means that the device's acceptance was based solely on non-clinical (laboratory and engineering) testing, not on studies involving human subjects or the evaluation of diagnostic performance as would be typical for AI/imaging devices.

Given the nature of the device (an external fixation system), the study focuses on engineering and material characteristics, not diagnostic or predictive performance. Therefore, many of the requested categories are not applicable.

Here's an breakdown based on the provided text:

1. Sample size used for the test set and the data provenance: Not applicable. The "test set" consists of physical Hoffmann 3 Modular External Fixation System components and the new Apex Fixation Pin. The provenance is the manufacturing process of these components.
2. 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 and material properties is established by engineering standards and measurements, not expert consensus.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This is relevant for subjective evaluations, not objective engineering tests.
4. 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 a mechanical device, not an AI-assisted diagnostic tool.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device.
6. The type of ground truth used:
   • Mechanical Properties: Established by standard engineering test methodologies and equipment, measuring parameters like strength, pullout force, bending resistance, and torque.
   • Material Properties: Established by corrosion testing and material analysis.
   • MR Compatibility: Established by specific protocols for radio frequency heating and artifact generation in an MRI environment.
7. The sample size for the training set: Not applicable. There is no "training set" in the context of this type of non-clinical engineering evaluation.
8. How the ground truth for the training set was established: Not applicable.

In summary, the Hoffmann 3 Modular External Fixation System received clearance based on non-clinical bench testing and engineering evaluations demonstrating substantial equivalence to previously cleared predicate devices. This type of submission relies on objective measurements against established engineering and material standards, rather than clinical studies or methodologies typically associated with AI-driven diagnostic tools.

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The Hoffmann 3 Modular External Fixation System components are external fixation frame components for use with the components of the Hoffmann II MRI and Hoffmann II Compact MRI External Fixation Systems, in conjunction with Apex Pins. It is intended to provide stabilization of open and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rods, casts or other means of internal fixation.

The Hoffmann 3 Modular External Fixation System consists of Rods, Posts, Couplings, Clamps and Pins that can be combined to construct different frame configurations that are MR conditional. The components for the subject device where manufactured from a variety of materials including austentic steel, titanium, and a Vectran coating. This line extension is intended to add additional components for connecting rods and fixed posts, design and material modifications to the couplings, pin clamp, rods and posts. Although the Hoffmann II MRI External Fixation System will continue to be marketed, the Hoffmann 3 Modular External Fixation System will be available with additional components for connecting rods and include design and material modifications to the couplings, pin clamp, rods and posts.

{"1. A table of acceptance criteria and the reported device performance": "The document does not explicitly state numerical acceptance criteria in a table format. Instead, it describes a comparative evaluation against a predicate device. The "reported device performance" is stated as demonstrating "comparable mechanical properties to the predicate components" and that the system "could be safely used in Magnetic Resonance Imaging under predetermined conditions."\n\nAcceptance Criteria (Implied from testing and claim of substantial equivalence):\n* Mechanical Properties: Comparable to the Hoffmann II MRI System's mechanical properties.\n* Magnetic Resonance Environment Safety: Safe for use in MRI under predetermined conditions (Radio Frequency Heating, Force and Torque, Artifact).\n\nReported Device Performance:\n* Mechanical testing demonstrated comparable mechanical properties to the predicate components.\n* Testing in a Magnetic Resonance Environment established that the Hoffmann 3 Modular External Fixation System could be safely used in Magnetic Resonance Imaging under predetermined conditions. (Specific results like % difference or specific thresholds are not provided in this summary.)", "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The document refers to "Non-Clinical Testing" and lists various mechanical and MRI environment tests. However, it does not specify the sample sizes used for these tests. There is no mention of human subject data, and thus no data provenance in terms of country of origin or retrospective/prospective studies are applicable for the type of testing described.", "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)": "This section is not applicable. The study described is non-clinical performance testing of a medical device (external fixator system) and does not involve the establishment of ground truth by human experts in the context of diagnostic interpretation. The 'ground truth' for this type of device would relate to engineering standards and safety parameters established by regulatory bodies or industry best practices, not expert consensus on medical images or patient outcomes.", "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of data (e.g., medical images) by multiple experts to establish a consensus ground truth. The tests performed for this device were non-clinical mechanical and MRI compatibility tests.", "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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an external fixation system, not a diagnostic imaging or AI-assisted device. The testing described focuses on the mechanical and MRI compatibility of the hardware components.", "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "This question is not applicable to the Hoffmann 3 Modular External Fixation System as it is a physical medical device, not an algorithm or AI system. There is no 'standalone' algorithm performance to report.", "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "For the non-clinical testing of this external fixation system, the 'ground truth' would be based on established engineering and material science principles, industry standards (e.g., for strength, bending, torsion, pull-out, rotation), and regulatory requirements for MRI compatibility (radio frequency heating, force and torque, artifact). It's not based on expert consensus, pathology, or outcomes data related to clinical diagnosis.", "8. The sample size for the training set": "This question is not applicable to the Hoffmann 3 Modular External Fixation System. This device is a physical medical hardware system, not a machine learning model or software that requires a 'training set.' The listed tests are non-clinical hardware performance tests.", "9. How the ground truth for the training set was established": "This question is not applicable, as there is no 'training set' for this physical medical device."}

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The Hoffmann® 30 Degree Pelvic Double Ball Joint is intended to be used with the components of the Hoffmann® External Fixation System, Hoffmann® II External Fixation System, Monotube® TRIAX " External Fixation System and in conjunction with Apex Pins. This device is used to provide stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments such as IM rods, casts, or other means of internal fixation. The indications for use of external fixation devices include:

• Bone fracture fixation .
• Osteotomy .
• . Arthrodesis
• . Correction of deformity
• Revision procedure where other treatments or devices have been unsuccessful ●
• Bone reconstruction procedures .

The subject Hoffmann® 30 Degree Pelvic Double Ball Joint is a modification of the Hoffmann® 5 Hole Ball Joint. The modification involves lengthening the clamp, adding an additional ball joint, modifying the pin interface and tilting the pin holding portion of the clamp by 30 degrees.

This document describes a 510(k) premarket notification for the Hoffmann® 30 Degree Pelvic Double Ball Joint, an external fixation frame component. The focus of the submission is on demonstrating its substantial equivalence to a predicate device, the Hoffmann® 5 Hole Ball Joint, rather than proving performance against specific clinical acceptance criteria in a study.

Therefore, many of the requested categories (e.g., sample size, expert ground truth, MRMC study, training set) are not applicable to this type of device submission. The device is a mechanical component, and its "performance" is assessed through engineering testing to ensure it meets the same standards as the predicate device.

Here's the information that can be extracted or inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This is a mechanical device, and "test set" in the context of clinical data or imaging algorithms is not relevant here. The testing would be engineering verification and validation, likely using a sample of the manufactured device. The origin of the data would be laboratory-based engineering tests.

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 mechanical device. "Ground truth" in the context of expert consensus on clinical findings is not relevant.

4. Adjudication Method 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. This is a mechanical medical device, not an AI or imaging diagnostic tool.

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 concensus, pathology, outcomes data, etc)

The "ground truth" for this device would be its mechanical properties and performance against established engineering standards and comparison to the predicate device. For example, torque resistance, fatigue life, strength, etc., as determined by laboratory testing. Not expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set

Not applicable. This is a mechanical device, not a machine learning algorithm.

9. How the ground truth for the training set was established
Not applicable.

Summary of the Study (Implied by the 510(k) Summary):

The provided text details a 510(k) submission for a medical device: the Hoffmann® 30 Degree Pelvic Double Ball Joint. The "study" referenced is the testing conducted to demonstrate substantial equivalence to a predicate device, the Hoffmann® 5 Hole Ball Joint.

• Objective: To show that the modified device (Hoffmann® 30 Degree Pelvic Double Ball Joint) is as safe and effective as the legally marketed predicate device (Hoffmann® 5 Hole Ball Joint).
• Methodology (Inferred): This involved comparing the new device to the predicate in terms of:
  • Intended Use: Both are external fixation frame components.
  • Materials: Implied to be similar ("Equivalency of this device is based on similarities in intended use, materials and design...").
  • Design: Acknowledged modification (lengthening clamp, additional ball joint, modified pin interface, 30-degree tilt), but implied that these changes do not alter fundamental safety and effectiveness.
  • Performance: "Testing has been conducted on the Hoffmann® 30 Degree Pelvic Double Ball Joint demonstrating substantial equivalence to the predicate Hoffmann® 5 Hole Ball Joint." This testing would typically involve mechanical tests (e.g., fatigue, strength, torsional stability) to ensure the new design performs at least as well as the predicate under simulated physiological loads.
• Acceptance Criteria (Inferred): The acceptance criteria for the "study" was the demonstration of substantial equivalence to the predicate device. This means the new device met the same performance standards and exhibited similar characteristics to the predicate, even with design modifications. The specific quantifiable criteria (e.g., "must withstand X N-m of torque," or "fatigue life must exceed Y cycles") are not provided in this summary but would be part of the full 510(k) submission's engineering reports.
• Conclusion: The FDA determined that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.

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