Search Results

The BioRCI® Screw is used for fixation of bone-tendon-bone or soft tissue grafts during Anterior/Posterior Cruciate Ligament (ACL/PCL) reconstruction procedures.

The Modified BioRCI® Screw is an interference screw in the range of 7-12mm in diameter and 20-35mm in length.

The provided document is a 510(k) summary for the BioRCI® Screw Modification, a bone fixation screw. It does not describe an AI/ML powered device or a study involving human readers and AI assistance.

Therefore, I cannot provide details on acceptance criteria and a study proving device performance in the context of AI/ML, human readers, or related metrics.

The document discusses the substantial equivalence of the modified device to a predicate device based on traditional medical device manufacturing and performance testing.

Here's an analysis of what is provided, framed by your request, showing why AI/ML specific information is absent:

1. A table of acceptance criteria and the reported device performance:
   The document states: "In vitro performance testing, material biocompatibility and sterilization validation demonstrate the modified device is safe, substantially equivalent and performs as intended."
   It does not provide a table with specific quantitative acceptance criteria (e.g., tensile strength thresholds, biocompatibility indices) or the exact numerical results from these tests. It only makes a summary statement that these tests demonstrate "safe, substantially equivalent and performs as intended."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   The document mentions "in vitro performance testing," but does not specify the sample sizes (e.g., number of screws tested) for these tests, nor the data provenance beyond "in vitro." It's highly likely these were laboratory tests conducted by the manufacturer.

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 to traditional in-vitro performance testing of a bone fixation screw. "Ground truth" in this context would be defined by engineering specifications and material science standards, not expert medical opinion on an output.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable. Adjudication methods like 2+1 are typically used for establishing ground truth in image interpretation or diagnostic studies involving human consensus, not for mechanical testing of a screw.

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 MRMC comparative effectiveness study was not done. This device is a physical bone fixation screw, not an AI diagnostic or assistive tool.

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 is a physical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
   For "in vitro performance testing," the ground truth would be established by engineering specifications, material properties, and relevant ASTM or ISO standards for medical devices (e.g., strength requirements, material composition standards). For "biocompatibility," ground truth is established by ISO 10993 standards and related testing for biological response. For "sterilization validation," ground truth is established by standards like ISO 11135 or 11137.

8. The sample size for the training set:
   This is not applicable. The device is a physical screw, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established:
   This is not applicable as there is no training set for a physical medical device.

In summary, the provided information relates to the regulatory submission for a physical medical device (a bone fixation screw) and, as such, does not contain the AI/ML specific information requested.

Ask a specific question about this device

The BioRCI Screw is used for fixation of bone-tendon-bone or soft tissue grafts during Anterior and/or Posterior Cruciate Ligament (ACL/PCL) reconstruction.

The BioRCI Screw is a screw that has a range of diameters from 7 to 10 mm and a length that ranges from 25 mm to 35 mm. The material of construction for both the BioRCI and the Bioabsorbable Interference screws is polylactic acid.

The provided text describes a 510(k) summary for the BioRCI Screw. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study on device performance against specific acceptance criteria.

Therefore, most of the requested information (acceptance criteria, specific study design, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth details for training and testing sets) is not available in the provided text.

Based on the information given, here's what can be extracted:

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

The document doesn't explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it relies on demonstrating equivalence in design, materials, and intended use as a proxy for performance. The "Performance F." section states: "The BioRCI Screw has been tested against the RCI Fixation Screw. Both screws had results that are recorded in the test results located in attachment one." However, "attachment one" is not included in the provided text, so the actual test results or performance metrics are unknown.

The table below summarizes the attributes for comparison, indicating design and material similarity rather than quantitative performance.

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

• Sample Size (Test Set): Not specified in the provided text.
• Data Provenance: Not specified in the provided text. The document refers to "test results located in attachment one," but this attachment is not included, nor does it describe data provenance.

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

• This information is not available in the provided text. The submission is for a medical device (screw), and "ground truth" as typically used for AI/ML models is not directly applicable in this context. The "truth" would be based on engineering and biomechanical testing standards.

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

• This information is not available in the provided text.

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 available in the provided text. This is a medical device, not an AI diagnostic tool, so an MRMC study is not relevant to this submission.

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

• This information is not available in the provided text. This is a physical medical device, not an algorithm.

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

• The concept of "ground truth" as used for AI/ML algorithms is not directly applicable here. For a medical device like a fixation screw, the "truth" or validation would typically be based on:
  • Biomechanical testing: Measuring properties like torsional strength, pull-out strength, fatigue life, etc., against established ASTM standards or predicate device performance.
  • Material characterization: Ensuring the material (PLA) meets specifications.
  • Biocompatibility testing: Ensuring the material is safe for implantation.
    The document mentions "Performance F." and refers to "test results located in attachment one," implying such testing was done, but the details are not provided.

8. The sample size for the training set:

• This information is not available in the provided text. "Training set" is not relevant for this physical device submission.

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

• This information is not available in the provided text. "Ground truth for training set" is not relevant for this physical device submission.

Ask a specific question about this device