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The Osteotomy Truss System (OTS) is intended to be used for internal bone fixation for bone fractures or osteotomies in the foot, such as:

• Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
• . Opening wedge of Medial Cuneiform or Cotton osteotomies
• Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
• Metatarsal/Cuneiform osteotomies
• . Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform osteotomies (TMT or Lapidus)
• . Hindfoot osteotomies
  The device is intended for use with supplemental fixation.
  The Osteotomy Truss System is not intended for use in the spine.

The Osteotomy Truss System (OTS) consists of five implant designs in a variety of footprints and implant height options to accommodate the patient's anatomy. It is intended to be used with supplemental fixation.
The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy.

This document is a 510(k) premarket notification decision letter from the FDA for the Osteotomy Truss System (OTS) by 4WEB Medical, Inc. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the typical format of a clinical study report.

Instead, it relies on non-clinical performance testing to demonstrate substantial equivalence to a previously cleared predicate device. This is common for Class II medical devices seeking 510(k) clearance, where a new clinical study is not usually required if substantial equivalence can be shown through other means.

Therefore, the specific information requested in your prompt regarding acceptance criteria, sample sizes for test/training sets, expert involvement, MRMC studies, or ground truth types derived from human data is not present in this FDA clearance letter.

However, I can extract the information provided about the performance standards the device was tested against (which, in this context, serve as the "acceptance criteria" for demonstrating substantial equivalence through non-clinical means) and the "study" (non-clinical testing) that proves the device meets these.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not applicable in the context of clinical studies. The testing described is non-clinical (mechanical and MRI compatibility). The specific number of devices or test specimens used for each non-clinical test (e.g., number of implants for static compression) is not stated in this document.
• Data Provenance: Not applicable in the sense of country of origin for human data. These are results from laboratory/engineering bench testing.

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

• Not applicable. This document describes non-clinical engineering and laboratory testing, not human expert-driven ground truth assessment.

4. Adjudication method

• Not applicable. Adjudication relates to resolving discrepancies in human expert assessments, which is not relevant here.

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

• No. An MRMC study is a clinical study involving human readers and cases, which was not performed for this 510(k) submission.

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

• Not applicable. This device is a physical orthopedic implant, not a software algorithm.

7. The type of ground truth used

• Engineering Standards and Measurements: The "ground truth" for the non-clinical tests is based on the specifications and parameters defined by the ASTM standards themselves, along with established engineering principles. For example, for static compression, the ground truth is the measured force required to cause deformation or failure, compared against a predefined standard or the predicate device's performance.

8. The sample size for the training set

• Not applicable. This is not an AI/ML algorithm that requires a training set.

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

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

Summary of what the document does communicate:

The clearance for the Osteotomy Truss System (OTS) is based on non-clinical performance testing demonstrating that the updated device does not introduce a new worst-case scenario compared to its predicate device (K220463) and is substantially equivalent. The tests performed align with recognized ASTM standards for orthopedic implants and MRI compatibility. This approach is typical for devices seeking 510(k) clearance that are similar in technology and intended use to existing cleared devices, where extensive new clinical data is not deemed necessary by the FDA.

Ask a specific question about this device

The Osteotomy Truss System (OTS) is intended to be used for internal bone fractures or osteotomies in the foot, such as:

• · Opening wedge osteotomies of the foot including osteotomies for Hallux Valgus
• · Opening wedge of Medial Cuneiform or Cotton osteotomies
• · Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)
• · Metatarsal/Cuneiform osteotomies
• · Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform osteotomies (TMT or Lapidus)
• · Hindfoot osteotomies
  The device is intended for use with supplemental fixation. The Osteotomy Truss System is not intended for use in the spine.

The Osteotomy Truss System (OTS) consists of three implant designs in a variety of footprints and opening wedge height options to accommodate the patient's anatomy. It is intended to be used with supplemental fixations.
The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy.

This 510(k) premarket notification describes a design update to an existing device, the Osteotomy Truss System (OTS). The submission focuses on demonstrating substantial equivalence to the predicate devices through non-clinical performance testing. Therefore, it does not involve clinical studies or in-depth performance metrics typically associated with AI/ML devices.

Here's an analysis based on the provided text, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

This submission relies on non-clinical performance testing (in vitro/bench testing and computational modeling). The document does not specify a "test set" in the context of patient data or clinical imaging. The tests were performed on the device itself and its components. Therefore, information regarding human data provenance (country of origin, retrospective/prospective) is not applicable.

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

Not applicable. The ground truth for the non-clinical performance testing is established by the specifications defined in the referenced ASTM standards and engineering principles for finite element analysis.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation of data where adjudication would be necessary.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This is a submission for a medical device (implant) and not an AI/ML-driven diagnostic or assistive tool.

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

No, a standalone performance study in the context of an algorithm or AI was not conducted. The device itself is the subject of the testing.

7. Type of Ground Truth Used

The ground truth used for this submission is based on:

• Established engineering standards: ASTM standards for mechanical testing and MR compatibility.
• Computational modeling results: Finite element analysis, which provides simulated performance data.
• Predicate device characteristics: The substantially equivalent performance to previously cleared predicate devices serves as the benchmark.

8. Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not an AI/ML device or a study involving machine learning.

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

Not applicable, as there is no training set involved.

Ask a specific question about this device

The Osteotomy Truss System (OTS) is intended to be used for internal bone fractures or osteotomies in the foot, such as:

-Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus

-Opening wedge of Medial Cuneiform or Cotton osteotomies

-Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy)

-Metatarsal Cuneiform osteotomies

• -Nonunion of arthrodesis of the Midfoot including Metatarsal Cuneiform osteotomies(TMT or Lapidus) -Hindfoot osteotomies
  These devices are intended to be used with supplemental fixation. The Osteotomy Truss System is not intended for use in the spine.

The Osteotomy Truss System is a titanium alloy implant used for correction of small bones in the foot. It is offered in three footprints and multiple sizes for each footprint with varying widths and thicknesses to accommodate a variety of small bone applications. Each device uses the 4WEB truss system of architecture. Implants are made from medical grade titanium allow (6Al4V-ELI) per ASTM F-136/ISO 5832-3.

The provided text is a 510(k) summary for a medical device (Osteotomy Truss System - OTS) and primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing. It does not contain information about acceptance criteria or a study proving the device meets those criteria, particularly in the context of AI/algorithm performance.

Therefore, I cannot fulfill your request with the provided input text. The information requested (acceptance criteria, device performance, sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details, etc.) would be typical for a clinical study evaluating the performance of a diagnostic or AI-driven device, which is not what this 510(k) summary describes.

This document describes a submission for a metallic bone fixation appliance, and the "Non-clinical testing" section refers to mechanical and MRI compatibility tests (ASTM standards), not clinical performance or AI algorithm validation.

Ask a specific question about this device