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

The Stryker 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

The Hoffmann LRF System is a modular, ring-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. The system components are manufactured from stainless steel, aluminum, PEEK, and carbon fiber.

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.

This document is a 510(k) Premarket Notification from the FDA regarding the Hoffmann LRF System. It states that the device is substantially equivalent to a previously marketed predicate device (K203568).

The crucial information for addressing your request, particularly regarding acceptance criteria and performance studies, is explicitly absent.

Here's why and what can be inferred:

• No Acceptance Criteria or Performance Data Presented: The document states under "Performance Data":
  • "Non-Clinical Testing: No performance testing is necessary to support the claim of substantial equivalence."
  • "Clinical Testing: No clinical testing is necessary to support the claim of substantial equivalence."

This means that for this specific 510(k) submission (K233741), the FDA's clearance was based on the device's substantial equivalence to a predicate device (K203568), rather than requiring new, specific performance study data or predefined acceptance criteria to be met for this submission. The change from the predicate device is noted as a "dimensional change to the struts."

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement because this information is not provided in the supplied text. The FDA's decision was based on a comparison to an already cleared device, implying that the performance and safety characteristics were considered to be sufficiently similar, and no new studies were deemed necessary for this particular submission.

In summary, based only on the provided text, the answer to all your specific questions regarding acceptance criteria and study details is that this information is not available within this 510(k) submission document.

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The Sever 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

The Hoffmann LRF System is a modular, ring-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 and utilizes stainless steel, aluminum, PEEK, and carbon fiber.

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 does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for the Stryker Hoffmann LRF System, which is an external fixation device.

The document states:

• "Software validation was performed on the expanded functionality." (page 5)
• "Clinical testing was not required for this submission." (page 5)
• "Non-clinical testing was not required as part of this submission." (page 5)

This indicates that clinical (and most non-clinical) performance data, as well as detailed acceptance criteria for a study demonstrating performance, are not included in this particular submission summary. The clearance is based on substantial equivalence to a previously cleared device (K182968), with the only new aspect being "expanded functionality" related to software. The nature and scope of this software validation are not elaborated upon in the provided text, nor are specific acceptance criteria or study results for this software provided.

Therefore, I cannot provide the requested information based on the given text.

Ask a specific question about this device

The Stryker 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

The Hoffmann LRF System is a modular, ring-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 and utilizes stainless steel, aluminum, PEEK, and carbon fiber.

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.

This document is a 510(k) premarket notification for the Hoffmann LRF System, an external fixation device. It describes the device, its intended use, indications for use, and a comparison to a predicate device. However, it explicitly states:

"Clinical testing was not required to be provided for this submission."

Therefore, the document does not contain any information about a study proving the device meets acceptance criteria in the way you are asking (e.g., performance metrics, sample sizes, expert adjudication, MRMC studies, or ground truth establishment relevant to AI/device performance studies).

The "Performance Data" section only mentions "Non-Clinical Testing" which includes:

• Corrosion Test
• Self-holding Function Test Over Time
• Pullout Test

These are mechanical tests, not clinical performance studies measuring diagnostic accuracy or treatment effectiveness in humans.

Based on the provided text, I cannot answer your questions regarding acceptance criteria and performance study details because such a study was not required or provided in this FDA submission.

The document is a regulatory approval notice for a physical medical device (an external fixation system), not a software or AI-driven diagnostic device that would typically involve the types of performance studies you are inquiring about (e.g., those requiring expert review, ground truth establishment, or human-in-the-loop performance measurements).

Ask a specific question about this device

The Stryker 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

The Hoffmann LRF System is a modular, ring-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 and utilizes stainless steel, aluminum, PEEK, and carbon fiber.

The provided text describes a medical device submission (K163656) for the Hoffmann LRF System. It focuses on regulatory approval and comparison to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of an AI/algorithm-driven device.

Therefore, many of the requested elements (acceptance criteria, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this document, as it pertains to a mechanical external fixation system.

However, I can extract information related to the performance data presented within the document:

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

Note: The document implicitly defines "acceptance criteria" through the comparison to predicate devices, where the subject device must demonstrate equivalent or superior mechanical performance. Specific numerical acceptance values are not provided.

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 for the test set: Not applicable / Not provided. The testing described is non-clinical mechanical testing, not a test set of data points as in an AI study.
• Data provenance: Not applicable. The data comes from "Comparative mechanical testing," implying laboratory tests, not patient data.

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-established ground truth.

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

Not applicable. This is not an AI/algorithm-driven device, and no MRMC study was mentioned.

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

Not applicable. This is a mechanical device, not an algorithm.

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

Not applicable. The "ground truth" for mechanical testing is established engineering standards and comparative performance against predicate devices.

8. The sample size for the training set

Not applicable. There is no training set for a mechanical device.

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

Not applicable. There is no training set mentioned.

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