(177 days)
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.
| Attribute | Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|---|
| Indication | Same as predicate devices | Bone-Tendon-Bone or Soft Tissue Graft Fixation for ACL/PCL Reconstruction (Matches predicate) |
| Dimensions | Comparable to predicate devices | Diameter: 7 - 10 mm; Length: 25 - 35 mm (Comparable to predicate ranges) |
| Material | Same as predicate Bioabsorbable Interference Screw | PLA (Matches predicate) |
| Sterilization | Same as predicate devices | Ethylene Oxide (Matches predicate) |
| Labeling | Same as predicate devices | Sterile, Single Use Only (Matches predicate) |
| Performance | "Tested against RCI Fixation Screw" (Specific results not provided in this document) | "Results recorded in attachment one" (Not available) |
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.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.