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The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of:

• Open and Closed Fractures
• Post-traumatic joint contracture which has resulted in loss of range of motion
• Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
• Pseudoarthrosis or non-union of long bones
• Limb lengthening by epiphyseal, diaphyseal, or metaphyseal distraction
• Correction of bony or soft tissue deformity
• Correction of segmental bony or soft tissue defects
• Joint arthrodesis
• Management of comminuted intra-articular fractures of the distal radius
• Bone transport

The Hoffmann LRF System is indicated in adults for:

• Osteotomy
• Revision procedure where other treatments or devices have been unsuccessful
• Bone reconstruction procedures
• Fusions and replantations of the foot
• Charcot foot reconstruction
• Lisfranc dislocations

Hoffmann LRF (Limb Reconstruction Frame) System is a modular, rinq-based, external fixation system designed to address certain orthopedic conditions of the limbs. Through a series of pins and wires, the bone is connected to this system with the rings statically placed, or gradually manipulated, depending on the type of correction needed. The modular design allows the system to be customized according to the needs of the patient. This system utilizes steel, aluminum, PEEK, and carbon fiber.

This submission extends K140961 by introducing a new strut and associated components. This strut can be used in all Hoffmann LRF applications that do not require the use of a foot ring, but are specifically designed for bone lengthening and bone transport. Total components added to the Hoffmann LRF System with this submission: Transport Strut, Bone Transport Strut End Cap, Safety Clip, and Lengthening Ruler, all of which are single-use, and a Tray, which is multi-use. All are provided nonsterile.

Components of the following systems may be used with this system: Monticelli-Spinelli External Fixation System, Apex Pins, Trauma Pelvic Set, Hoffmann II External Fixation System, Hoffmann 3 External Fixation System, Hoffmann II External Fixation System 90° Post, Hoffmann II Miami Post, Hoffmann II Carbon Connecting Rods, Hoffmann II MRI External Fixation System, and Hoffmann II Compact MRI External Fixation System.

Use of these components does not confer MRI compatibility to the Hoffmann LRF system.

The provided text is a 510(k) summary for the Hoffmann LRF System and does not contain information about acceptance criteria or a study proving that the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics and non-clinical mechanical testing.

Here's an breakdown of the relevant sections without the requested information:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document. The document describes mechanical tests performed but does not list specific acceptance criteria or quantitative performance outcomes against those criteria.

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 mentions "Comparative mechanical testing," "component tests," and "frame construct tests." However, it does not specify the sample sizes used for these tests or the data provenance. It states "Clinical testing was not performed, or required, for this submission."

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 information is not applicable as clinical testing was not performed, and ground truth in the context of expert consensus is not mentioned for mechanical testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as clinical ground truth establishment is not relevant to the described 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: Not applicable. The device is a physical medical device (an external fixation system), not an AI-assisted diagnostic or treatment tool. No MRMC study was mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated for the mechanical tests. For physical devices, "ground truth" would typically refer to established engineering standards or reference measurements. The document states "Mechanical testing demonstrated that the subject system performs as intended and at least as well as the predicate," implying a comparison to the predicate's performance.

8. The sample size for the training set: Not applicable, as this is a physical medical device and not an AI/machine learning model.

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

Summary of what is present in the document regarding performance:

• Non-Clinical Testing:
  • Types of tests:
    • Component tests: Static four-point bending, Dynamic four-point bending, Static cantilever bending, Dynamic cantilever bending.
    • Frame construct tests: Static compression, Dynamic compression.
  • Purpose: To demonstrate substantial equivalence to the Ilizarov predicate system (K031181).
  • Conclusion: "Mechanical testing demonstrated that the subject system performs as intended and at least as well as the predicate."
• Clinical Testing: "Clinical testing was not performed, or required, for this submission."

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The Stryker Hoffmann LRF (Limb Reconstruction Frame) System is indicated in pediatric patients and adults for the treatment and fixation of:

• Open and Closed Fractures
• Post-traumatic joint contracture which has resulted in loss of range of motion
• Fractures and disease which generally may result in joint contractures or motion and fractures requiring distraction
• Pseudoarthrosis or non-union of long bones
• Limb lengthening by epiphyseal or metaphyseal distraction
• Correction of bony or soft tissue deformity
• Correction of segmental bony or soft tissue defects
• Joint arthrodesis
• Management of comminuted intra-articular fractures of the distal radius

The Stryker Hoffmann LRF System is indicated in adults for:

• Osteotomy
• Revision procedure where other treatments or devices have been unsuccessful
• Bone reconstruction procedures
• Fusions and replantations of the foot
• Charcot foot reconstruction
• Lisfranc dislocations

Originally cleared in K113327, the Hoffmann LRF System is an external fixation device that consists of carbon and aluminum full/open rings and ring segments, aluminum foot rings, threaded rods and threaded rod connecting nuts, telescopic struts, static struts and connection bolts, posts and connecting nuts, wires and wire bolt offset adapters, pin bolts and pin adapters, and washers.

Modifications to the previously cleared telescopic strut and wire bolt components, as part of the currently marketed Hoffmann LRF (Limb Reconstruction Frame) System in K113327, were cleared in K130334.

Additional components (carbon foot ring, foot arch, hinge coupling) were cleared in K130907 as a line extension to the currently marketed Hoffmann LRF (Limb Reconstruction Frame) System in K113327.

This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the inclusion of additional components to the previously cleared Hoffmann LRF (Limb Reconstruction Frame) System, in K130907. The additional components of this submission will consist of the following: constrained hinge strut, universal hinge strut, motor struts, spherical washer, hinge bolt, self-locking nut, half hinge, universal joint, adjustment instrument, slotted plate and buckle.

This external fixation system may also be used with the components of other Stryker Trauma AG external fixation systems such as the Monticelli Spinelli External Fixation System, the Hoffmann II, Hoffman II MRI and Hoffmann 3 External Fixation System, and the Apex Fixation Pins.

The provided FDA 510(k) summary for the Hoffmann LRF (Limb Reconstruction Frame) System describes a medical device, not an AI/ML-driven diagnostic or prognostic tool. Therefore, the information requested about acceptance criteria for AI models, sample sizes for training/test sets, expert ground truth, MRMC studies, standalone performance, and data provenance is not applicable in this context.

This submission is for additional components to an existing external fixation device, and the evaluation relies on non-clinical laboratory testing to demonstrate substantial equivalence to predicate devices, rather than clinical performance data or AI model validation.

Here's the relevant information from the document as it pertains to the device's performance demonstration:

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

Note: The document states "Testing demonstrated that the Hoffmann LRF (Limb Reconstruction Frame) System added components are substantially equivalent to the predicate device components." The specific quantitative acceptance values (e.g., maximum deflection, fatigue life cycles) from ASTM F1541-02 and the precise performance metrics achieved are not detailed in this summary. The "acceptance criteria" here are implied by the standard itself and the need to show equivalence.

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

• Sample Size: The document does not specify the number of components or test units used for each non-clinical test (Static Cantilever Bending, Dynamic Cantilever Bending, Dynamic Frame Testing).
• Data Provenance: This relates to non-clinical laboratory testing of mechanical properties, not patient data. It was performed by Stryker Trauma AG, headquartered in Switzerland, though the specific lab location is not stated. These are "prospective" engineering tests designed to evaluate the physical properties of the device components.

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. Ground truth, in the context of AI models, refers to expert-labeled data. For a physical medical device, "ground truth" for non-clinical testing is typically defined by engineering specifications, material properties, and established test standards (e.g., ASTM F1541-02). The "experts" would be the engineers and technicians conducting and analyzing the mechanical tests. Their qualifications are not specified but would be standard for mechanical engineering and materials testing.

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

Not applicable. Adjudication methods are used to resolve discrepancies in expert labeling for AI ground truth. For mechanical testing, if there were issues, they would typically involve repeated tests, calibration checks, or review by senior engineers. The document does not mention an adjudication method.

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 an external fixation system, not an AI-assisted diagnostic or prognostic tool. No human readers, cases, or AI assistance are involved in its performance evaluation as described here.

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

Not applicable. This is not an algorithm or AI model. The "standalone" testing refers to the non-clinical mechanical tests where the device components were tested without human intervention impacting the mechanical properties being measured.

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

The "ground truth" for this device's performance in non-clinical testing is based on:

• Engineering Specifications: The design parameters and material specifications of the device components.
• Standardized Test Methods: Adherence to established industry standards like ASTM F1541-02, which provides defined procedures and expected performance envelopes for external skeletal fixation devices.
• Predicate Device Performance: The mechanical performance of the legally marketed predicate devices, against which the new components are shown to be "substantially equivalent."

8. The sample size for the training set

Not applicable. There is no training set as this is not an AI/ML device.

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

Not applicable. There is no training set for an AI/ML device.

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The Stryker Hoffmann LRF (Limb Reconstruction Frame) System is indicated in pediatric patients and adults for the treatment and fixation of:

• Open and Closed Fractures .
• . Post-traumatic joint contracture which has resulted in loss of range of motion
• Fractures and disease which generally may result in joint contractures or loss of range . of motion and fractures requiring distraction
• Pseudoarthrosis or non-union of long bones .
• Limb lengthening by epiphyseal or metaphyseal distraction .
• Correction of bony or soft tissue deformity t
• Correction of segmental bony or soft tissue defects .
• Joint arthrodesis .
• Management of comminuted intra-articular fractures of the distal radius .

The Stryker Hoffmann LRF System is indicated in adults for:

• . Osteotomy
• · Revision procedure where other treatments or devices have been unsuccessful
• Bone reconstruction procedures .
• Fusions and replantations of the foot .
• Charcot foot reconstruction .
• Lisfranc dislocations .

This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market additional components as a line extension to the currently marketed Hoffmann LRF (Limb Reconstruction Frame) System, previously cleared in KI 13327. The Hoffmann LRF System is an external fixation device that consists of carbon and aluminum full/open rings and ring segments, aluminum foot rings, threaded rods and threaded rod connecting nuts, telescopic struts, static struts and connection bolts, posts and connecting nuts, wires and wire bolts, wire bolt offset adapters, pin bolts and pin adapters. The additional components will consist of the following: carbon foot ring, foot arch, hinge coupling and compatibility with the previously cleared Hoffmann 3 couplings. This external fixation system may also be used with the components of other Stryker Trauma AG external fixation systems such as the Monticelli Spinelli External Fixation System, the Hoffmann II MRI External Fixation System, and the Stryker Trauma Pelvic Set and in conjunction with commercially available Apex Pins. Hoffmann II External Fixation 90° Post. Carbon Connecting Rod and Miami Post.

The provided text describes a 510(k) submission for a medical device (external fixation device) and explicitly states that clinical testing was not required. This means there is no study conducted to prove device performance against acceptance criteria in a clinical setting with human subjects.

The submission focuses on non-clinical laboratory testing to demonstrate substantial equivalence to previously cleared predicate devices. Therefore, the following information, which pertains to clinical studies, cannot be provided based on the given text:

• A table of acceptance criteria and the reported device performance (in a clinical context).
• Sample size used for the test set and data provenance (for clinical data).
• Number of experts used to establish ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study results.
• Standalone (algorithm only) performance.
• Type of ground truth used (for clinical data).
• Sample size for the training set (for clinical data).
• How ground truth for the training set was established (for clinical data).

However, the provided text does detail the non-clinical testing performed. Here's a summary of that information:

Acceptance Criteria and Device Performance (Non-Clinical Testing)

Study Details (Non-Clinical Testing):

1. Sample size used for the test set and data provenance: Not explicitly stated beyond "additional components and component compatibility." The provenance is internal laboratory testing by Stryker Trauma AG.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This was engineering performance testing.
3. Adjudication method: Not applicable. This was engineering performance testing.
4. Multi-reader multi-case (MRMC) comparative effectiveness study: No, this was not a clinical study.
5. Standalone performance (algorithm only without human-in-the-loop performance): Not applicable. This is a mechanical device, not an algorithm.
6. Type of ground truth used: Based on the compliance with ASTM F1541-02 - "Standard Specification and Test Methods for External Skeletal Fixation Device," the ground truth is defined by the standardized test methods and their performance requirements.
7. Sample size for the training set: Not applicable. This was engineering performance testing.
8. How the ground truth for the training set was established: Not applicable. This was engineering performance testing.

Conclusion stated by the submitter: "Clinical testing was not required for this submission. The Hoffmann LRF (Limb Reconstruction Frame) System is substantially equivalent to the predicate devices identified in this premarket notification."

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The Hoffmann LRF (Limb Reconstruction Frame) System is intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediatric patients and adults.

The Stryker Hoffmann LRF (Limb Reconstruction Frame) System is indicated in pediatric patients and adults for the treatment and fixation of:

• Open and Closed Fractures
• Post-traumatic joint contracture which has resulted in loss of range of motion
• Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
• Pseudoarthrosis or non-union of long bones
• Limb lengthening by epiphyseal or metaphyseal distraction
• Correction of bony or soft tissue deformity
• Correction of segmental bony or soft tissue defects
• Joint arthrodesis
• Management of comminuted intra-articular fractures of the distal radius

The Stryker Hoffmann LRF System is indicated in adults for:

• Osteotomy
• Revision procedure where other treatments or devices have been unsuccessful
• Bone reconstruction procedures
• Fusions and replantations of the foot
• Charcot foot reconstruction
• Lisfranc dislocations

This Traditional 510(k) submission is being supplied to the U.S. FDA to provide authorization to market the modified telescopic strut and wire bolt components of the Hoffmann LRF (Limb Reconstruction Frame) System, previously cleared in K113327. The Hoffmann LRF System is an external fixation device that consists of Carbon and Aluminum Full/Open rings and ring segments, Aluminum foot rings, threaded rods and threaded rod connecting nuts, telescopic struts, static struts and connection bolts, posts and connecting nuts, wires and wire bolts, wire bolt offset adapters, pin bolts and pin adapters. This external fixation system may also be used with the components of other Stryker Trauma AG external fixation systems such as the Monticelli Spinelli External Fixation System, the Hoffmann II MRI External Fixation System, and the Stryker Trauma Pelvic Set and in conjunction with commercially available Apex Pins, Hoffmann II External Fixation 90° Post, Carbon Connecting Rod and Miami Post.

The Hoffmann LRF (Limb Reconstruction Frame) System, specifically the modified telescopic strut and wire bolt components, demonstrated substantial equivalence to predicate devices through non-clinical laboratory testing.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "testing was performed for the Hoffmann LRF (Limb Reconstruction Frame) System on the modified telescopic strut and wire bolt components," implying a sufficient number of components were tested to satisfy the requirements of ASTM F1541-02. The specific quantity of individual components tested is not provided.
• Data Provenance: The testing was "non-clinical laboratory testing," indicating it was conducted in a controlled lab environment. The country of origin for the testing is not specified, but the sponsor, Stryker Trauma AG, is located in Switzerland. The documentation for the 510(k) submission was prepared in the U.S.
• Retrospective or Prospective: Prospective, as the tests were conducted specifically for this submission to evaluate the modified components.

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

• Not applicable. This was non-clinical laboratory testing of device components, not a clinical study involving human patients or expert interpretation of medical images/data to establish ground truth.

4. Adjudication Method for the Test Set:

• Not applicable. This was non-clinical, objective laboratory testing against established engineering standards (ASTM F1541-02), not a study requiring adjudication of expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not done. The submission explicitly states, "Clinical Testing: Clinical testing was not required for this submission."

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

• Not applicable. This device is a mechanical external fixation system, not a software algorithm or AI system. The "standalone" performance refers to the device components' mechanical properties. The non-clinical laboratory testing effectively serves as the standalone performance evaluation of the modified components.

7. The Type of Ground Truth Used:

• The "ground truth" for the non-clinical testing was defined by the performance requirements and testing methodologies outlined in ASTM F1541-02 -- "Standard Specification and Test Methods for External Skeletal Fixation Device." The standard dictates how specific mechanical properties (e.g., dynamic and static strength, pull-out strength) should be measured and provides a framework for evaluating whether a device meets acceptable performance levels for its intended use. In this case, the ground truth was the objective mechanical properties as measured against the standard and compared to the predicate device.

8. The Sample Size for the Training Set:

• Not applicable. This was non-clinical mechanical testing, not a machine learning or AI study that requires a training set.

9. How the Ground Truth for the Training Set was Established:

• Not applicable, as there was no training set.

Ask a specific question about this device

The Hoffmann LRF (Limb Reconstruction Frame) System is intended for fixation of fractures, joint contractures, fusions, limb lengthening, deformity correction, bone and soft tissue reconstruction in pediatric patients and adults.

The Stryker Hoffmann LRF (Limb Reconstruction Frame) System is indicated in pediatric patients and adults for the treatment and fixation of:

• Open and Closed Fractures .
• Post-traumatic joint contracture which has resulted in loss of range of motion .
• . Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
• Pseudoarthrosis or non-union of long bones .
• Limb lengthening by epiphyseal or metaphyseal distraction .
• Correction of bony or soft tissue deformity .
• Correction of segmental bony or soft tissue defects .
• Joint arthrodesis .
• Management of comminuted intra-articular fractures of the distal radius

The Stryker Hoffmann LRF System is indicated in adults for:

• Osteotomy .
• . Revision procedure where other treatments or devices have been unsuccessful
• Bone reconstruction procedures .
• Fusions and replantations of the foot t
• Charcot foot reconstruction ●
• Lisfranc dislocations

The Hoffmann LRF System is an external fixation device that consists of Carbon and Aluminum Full/Open rings and ring segments, Aluminum foot rings, threaded rods and threaded rod connecting nuts, telescopic struts, static struts and connection bolts, posts and connecting nuts, wires and wire bolts, wire bolt offset adapters, pin bolts and pin adapters. This external fixation system may also be used with the components in other Howmedica Osteonics external fixation systems such as the Monticelli Spinelli External Fixation System, the Hoffmann II MRI External Fixation System, and the Stryker Trauma Pelvic Set and in conjunction with commercially available Apex Pins, Hoffmann II External Fixation 90° Post, Carbon Connecting Rod and Miami Post.

The provided text pertains to a 510(k) premarket notification for the Hoffmann LRF (Limb Reconstruction Frame) System. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical performance studies with specific statistical acceptance criteria.

Therefore, the information requested for acceptance criteria, device performance, sample sizes used for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable (N/A) in this context, as a clinical performance study with such metrics was explicitly not required for this 510(k) submission.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not Applicable (N/A) - No clinical test set was used.
• Data Provenance: Not Applicable (N/A) - No clinical data was used for a test set.

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

• Number of Experts: Not Applicable (N/A) - No clinical test set requiring expert ground truth was performed.
• Qualifications of Experts: Not Applicable (N/A)

4. Adjudication Method for the Test Set

• Adjudication Method: Not Applicable (N/A) - No clinical test set requiring adjudication was performed.

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

• MRMC Study Done: No.
• Effect Size: Not Applicable (N/A) - This device is an external fixation system, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Study Done: No. This device is an external fixation system, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not Applicable (N/A) - No clinical ground truth was established for performance evaluation against a specific diagnostic or prognostic outcome. The "ground truth" in this context refers to the material and mechanical properties of the device meeting established engineering standards and being comparable to predicate devices.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not Applicable (N/A) - No training set was used as this is not an AI/machine learning device.

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

• Ground Truth Establishment for Training Set: Not Applicable (N/A) - No training set was used.

Summary of the Study that Proves the Device Meets the Acceptance Criteria (Substantial Equivalence):

The Hoffmann LRF (Limb Reconstruction Frame) System demonstrated substantial equivalence by means of non-clinical laboratory testing.

• Study Design/Methodology: Non-clinical testing was performed in compliance with ASTM F1541-02 - "Standard Specification and Test Methods for External Skeletal Fixation Device."
• Tests Conducted: The testing included:
  • Static and dynamic frame testing.
  • Wire Strength testing.
  • Compression testing.
  • Bending testing.
  • Slipping testing.
  • Splitting testing on frame components.
• Conclusion of Testing: The testing "demonstrated that the Hoffmann LRF (Limb Reconstruction Frame) System is substantially equivalent to devices currently cleared for marketing."
• Predicate Devices: The device was compared to the following predicate devices to establish substantial equivalence in intended use, materials, and performance characteristics:
  • K031181 External Fixation Systems (Smith & Nephew)
  • K041706 Hoffman II Foot Ring
  • K003018 Titan Tibial Nail (T2 Nail)
• Clinical Testing: The submission explicitly states: "Clinical testing was not required for this submission." This reinforces that the evaluation was based on non-clinical, mechanical, and material comparisons to existing devices.

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