Search Results

The Allofix™ Anchor is indicated for use in the attachment of soft . tissue to bone in orthopedic procedures.
The Allofix™ Anchor is indicated for use in soft tissue approximation and/or ligation of orthopaedic procedure.

The anchor, suture, and inserter are all packaged together. The kit contains one allograft anchor, loaded with two strands of #2 polyethylene suture, blue, and one strand of white. The anchor and suture are housed in an inserter. The anchor resides at the tip of the tube while the bulk of the suture resides within the inserter handle.

The inserter, with the loaded anchor, et al, delivers the product to the site. The inserter is composed of a plastic body and a stainless steel tube with two #2 sutures. A drill or punch is provided to create a hole to deliver the anchor. The inserter contents are housed within a plastic tray. All components are single use and sterile.

Here's a summary of the acceptance criteria and study information for the Allofix™ Anchor, based on the provided text:

Acceptance Criteria and Device Performance

The provided document does not explicitly state quantitative acceptance criteria or a direct comparison table for the Allofix™ Anchor. Instead, it refers to the device meeting "design input requirements for strength" and exceeding values of "metal and polymeric devices used for similar types of fixation."

Inferred Acceptance Criteria based on "Summary of Studies (P)":

Study Details

The provided text describes "Biomechanical testing" as the study performed.

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified in the provided text.
   • Data Provenance: Not explicitly stated, however, the testing was conducted to investigate design requirements, implying it was likely a laboratory-based biomechanical study. There is no information regarding the country of origin of data or whether it was retrospective or prospective in the context of patient data.

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

   • Not applicable. This was a biomechanical study, not a study involving expert review or ground truth establishment by medical professionals. The "ground truth" would be the measured physical properties (strength, dimensions, repeatability) of the anchor itself against engineering specifications.

3. Adjudication method for the test set:

   • Not applicable. This was a biomechanical study.

4. 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, an MRMC comparative effectiveness study was not done. The device is a bone anchor, not an AI-assisted diagnostic or imaging device.

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

   • Not applicable. This is a physical medical device, not an algorithm. The "standalone" performance here refers to the device's physical properties as measured in the biomechanical tests.

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

   • The "ground truth" for this biomechanical study refers to the engineering specifications and performance benchmarks set for device strength, dimensions, and insertion repeatability. The device's performance was measured against these predefined physical and mechanical properties.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

The Allofix™ Anchor is indicated for use in the attachment of soft tissue to bone in orthopedic procedures.
The Allofix™ Anchor is indicated for use in soft tissue approximation and/or ligation of orthopaedic procedure.

The anchor, suture, and inserter are all packaged together. The kit contains one allograft anchor, loaded with two strands of #2 polyethylene suture, blue, and one strand of white. The anchor and suture are housed in an inserter. The anchor resides at the tip of the tube while the bulk of the suture resides within the inserter handle. The inserter, with the loaded anchor, et al, delivers the product to the site. The inserter is composed of a plastic body and a stainless steel tube with two #2 sutures. A drill or punch is provided to create a hole to deliver the anchor. The inserter contents are housed within a plastic tray. All components are single use and sterile.

Here's an analysis of the provided text regarding the Allofix™ Anchor, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text only briefly mentions "design input requirements for strength" and "design requirements" for dimensions. It does not provide specific quantitative acceptance criteria. Therefore, the table below reflects the qualitative statements made.

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

The document states "Biomechanical testing of the Allofix™ Anchor was performed". It does not specify the sample size used for this testing. The data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective, but it's implied to be in vitro biomechanical testing.

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

This information is not provided. The "ground truth" for the biomechanical tests would likely be established by the testing methodology itself (e.g., universal testing machine readings for strength, precise measurement tools for dimensions), rather than expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Biomechanical testing generally relies on objective measurements rather than expert adjudication.

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

An MRMC comparative effectiveness study was not done. This device is a medical implant (bone anchor), not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable. The Allofix™ Anchor is a physical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the "strength" and "dimensions" tests would be based on objective physical measurements obtained through biomechanical testing equipment and metrology, compared against the pre-defined design specifications. It is not expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This is not applicable as the Allofix™ Anchor is not an AI/ML device that requires a training set.

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

This is not applicable as the Allofix™ Anchor is not an AI/ML device.

Ask a specific question about this device