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The HTS is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants in the HTS can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).

The 4WEB HTS implants consists of a series of titanium implants that are designed to provide stability and fixation of the lesser toes in the foot. The 4WEB HTS implants have proximal and distal fixation features to provide structural support and will be offered in multiple sizes to accommodate various patients' anatomy. The implants are manufactured from Ti6Al4V alloy. Each implant is available in a sterile/packaged form.

This document is a 510(k) summary for the Hammertoe Truss System (HTS). It indicates that the purpose of the submission is to update the HTS implant offering to include two smaller sizes. The document outlines the device description, indications for use, and a comparison to predicate devices, focusing on the mechanical properties and MRI compatibility.

Here's an analysis based on your request, keeping in mind that the document mainly focuses on mechanical performance and equivalence to a predicate device, rather than a clinical study with patients or human readers.

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)

This submission describes engineering performance testing and simulation analysis, not a clinical study on a test set of patient data. Therefore, the concepts of "sample size for the test set" and "data provenance" in a clinical context are not applicable. The testing was done on physical device prototypes or through computer-simulated models.

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 is not applicable as the submission reports on mechanical and MRI compatibility testing of a physical device, not a diagnostic or AI-driven system requiring expert review of medical images.

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

This is not applicable. Adjudication methods are relevant for studies involving human interpretation of data, typically in clinical trials or diagnostic accuracy studies.

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. This submission focuses on the safety and effectiveness of a physical implantable device based on mechanical and MRI compatibility testing, demonstrating substantial equivalence to a predicate device. It does not involve AI or human readers.

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

No, a standalone algorithm performance study was not done. This submission is for a physical medical device (implant).

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

The "ground truth" for this type of submission is based on engineering standards and established test methods (e.g., ASTM standards) for evaluating the mechanical properties and MRI compatibility of medical implants. The "truth" is whether the device physically performs in accordance with these validated standards and demonstrates similar characteristics to the predicate device.

8. The sample size for the training set

This is not applicable. The device is a physical implant, not an AI or machine learning model that requires a training set. The "training" for such devices involves design, manufacturing, and extensive bench testing.

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

This is not applicable for the reasons mentioned in point 8.

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The Hammertoe Truss System (HTS) is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants in the Hammertoe Truss System (HTS) can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).

The 4WEB HTS implants consists of a series of titanium implants that are designed to provide stability and fixation of the lesser toes in the foot. The 4WEB HTS implants have proximal and distal fixation features to provide structural support and will be offered in multiple sizes to accommodate various patients' anatomy. The implants are manufactured from Ti6Al4V alloy. Each implant is available in a sterile/packaged form.

This document is a 510(k) summary for the Hammertoe Truss System (HTS), a medical device intended for fixation of osteotomies and reconstruction of lesser toes. It does not describe an AI/ML powered device, and therefore the requested information about acceptance criteria and studies proving the device meets them in the context of AI/ML are not applicable here.

However, I can extract the relevant performance testing information for this physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of numerical thresholds for each test. Instead, it refers to performance testing completed "per the following standards," implying that compliance with these standards and their methodologies serves as the acceptance criteria. The "reported device performance" is implicitly that the device met these standards, leading to the conclusion of substantial equivalence.

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

This information is not provided in the document. The document refers to "Performance testing has been completed per the following standards," but does not detail the specific sample sizes used for each test or the provenance of any 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)

This is not applicable as this is not an AI/ML device requiring expert-established ground truth for a test set. The performance is based on physical and material testing standards.

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

Not applicable, as this is not an AI/ML device.

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, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

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

Not applicable. For this physical medical device, the "ground truth" or standard for performance is adherence to established ASTM mechanical and MR compatibility standards.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device and therefore does not have a training set.

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

Not applicable, as this is not an AI/ML device and therefore does not have a training set.

Ask a specific question about this device