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The EasyClip XPress Staples are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.

EasyClip Xpress is comprised of superelastic bone staples, as well as associated instrumentation required for implantation of the staples.

This document is a 510(k) premarket notification for a medical device called "EasyClip Xpress," which are superelastic bone staples. It describes the device, its intended use, and its equivalence to legally marketed predicate devices. However, it does not contain the detailed information requested regarding acceptance criteria, study methodologies, or performance metrics in the context of an AI/ML device.

Therefore, I cannot extract the information required by your prompt. This document pertains to a traditional medical device and does not involve AI or algorithms requiring such performance evaluation studies.

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The ToeTac™ 10° Fixation System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for the hammertoe, claw toe, and mallet toe.

The Instratek ToeTac™ 10° Hammertoe Fixation System includes a threaded PEEK implant for bone fixation and a set of instruments used for implant site preparation and delivery. The device is offered in a sterile packaged kit that contains the implant, bone preparation instrumentation and a driver, as well as a single packaged implant.

The provided text is a 510(k) summary for the ToeTac™ 10° Hammertoe Fixation System. It describes the device and its intended use, but it does not contain information about acceptance criteria, detailed study results, sample sizes for test or training sets, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested information from the text. The document primarily focuses on establishing substantial equivalence to predicate devices based on design, materials, intended use, and technological characteristics, supported by general performance testing.

Here's how I would structure the answer if the information were available:

Acceptance Criteria and Study for the ToeTac™ 10° Hammertoe Fixation System

The provided text does not contain the specific acceptance criteria or detailed study results to address the requested information. The document is a 510(k) summary focused on establishing substantial equivalence, and while it mentions "Performance testing consisted of tests for pull out, torque and static and dynamic bend strength," it does not provide the quantitative criteria, the reported device performance against those criteria, or the methodology of the study in detail.

Therefore, I cannot populate the table or answer most of the specific questions.

If the information were present, it would typically look like this:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample size: (Information not provided in the text)
• Data provenance: (Information not provided in the text, but for mechanical testing, it would likely be laboratory-generated data.)

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

• This question is more applicable to studies involving human interpretation (e.g., imaging studies, clinical outcomes). For mechanical device testing, the "ground truth" is typically defined by engineering standards and measurement accuracy, not expert consensus. Information is not provided in the text.

4. Adjudication method for the test set

• Not applicable for typical mechanical device testing. Information is not provided in the text.

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

• No, the text mentions "Performance testing consisted of tests for pull out, torque and static and dynamic bend strength," which are biomechanical tests, not clinical MRMC studies.

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, not an AI algorithm.

7. The type of ground truth used

• For the mentioned performance tests (pull-out, torque, bending), the "ground truth" would be established by validated mechanical testing methodologies and instrumentation, typically referencing relevant ASTM or ISO standards for medical device testing.

8. The sample size for the training set

• Not applicable for a physical medical device in this context. There is no information about an "AI training set."

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

• Not applicable.

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The ToeTac™ Hammertoe Fixation System indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

The Instratek ToeTac™ Hammertoe Fixation System includes a threaded PEEK implant for bone fixation and a set of instruments used for implant site preparation and delivery. The device is offered in a sterile packaged kit that contains the implant, bone preparation instrumentation and a driver.

This document is a 510(k) premarket notification for the ToeTac™ Hammertoe Fixation System. It confirms that the FDA has reviewed the device and determined it to be substantially equivalent to legally marketed predicate devices.

The document contains information about the device's intended use, classification, and a summary. However, it does not contain information regarding acceptance criteria and a study proving the device meets those criteria, as typically seen in a comprehensive device validation report. Instead, it briefly mentions "Performance testing consisted of tests for axial pull out, torque, static and dynamic bend." without providing details of the acceptance criteria or quantitative results.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be extracted:

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

   • Acceptance Criteria: Not explicitly stated in the document.
   • Reported Device Performance: The document only generally states, "Performance testing consisted of tests for axial pull out, torque, static and dynamic bend." No specific quantitative performance data or comparison to acceptance criteria is provided.

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.

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 the document describes performance testing for a medical device (fixation system), not a diagnostic or AI-driven decision support system where "ground truth" would be established by experts for a test set.

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

   • This information is not applicable for mechanical performance testing of a fixation system.

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

   • This information is not applicable as the device is a hammertoe fixation system, not an AI diagnostic tool.

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

   • This information is not applicable as the device is a hammertoe fixation system, not an AI algorithm.

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

   • For performance testing of a mechanical device, "ground truth" typically refers to engineering standards or predicate device performance, not clinical ground truth established by experts or pathology. Details are not provided.

8. The sample size for the training set

   • This information is not applicable as the device is a mechanical fixation system, not an AI model requiring a training set.

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

   • This information is not applicable as the device is a mechanical fixation system, not an AI model requiring a training set.

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