(85 days)
The BioactIF OSTEOTRANS™ Interference Screw is indicated for the fixation of bone-tendon-bone grafts or soft tissue grafts during anterior / posterior cruciate ligament reconstruction surgery.
The BioactIF OSTEOTRANS"M Interference Screw is a stcrile, single-use interference screw manufactured from composites of hydroxyapatite and poly-L-lactide (HA/PLLA). Screws are provided with various sizes typical of other marketed fixation devices.
This is a 510(k) summary for a medical device called the BioactIF OSTEOTRANS™ Interference Screw. It's a bioabsorbable interference screw used for ligament reconstruction surgery. The documentation provided does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner you've outlined for performance studies (e.g., accuracy, sensitivity, specificity, or human improvement with AI).
Instead, this document focuses on demonstrating substantial equivalence to predicate devices already on the market. This is a common pathway for medical device approval where the new device is shown to be as safe and effective as a legally marketed device, rather than requiring extensive de novo clinical trials for performance metrics.
Here's a breakdown of why your requested information isn't present in this specific document:
- Type of Device: This is a mechanical implant (an interference screw), not a diagnostic or AI-driven device. Acceptance criteria for such devices typically involve mechanical strength, biocompatibility, degradation profiles, and manufacturing standards, not performance metrics like sensitivity, specificity, or human reader improvement.
- Regulatory Pathway: The 510(k) pathway for medical devices emphasizes substantial equivalence. This means the manufacturer compares their device to existing, legally marketed predicate devices. The "study" mentioned here is primarily this comparison and demonstrative data (e.g., strength testing) to show it's "as safe and effective" as the predicates.
- Focus of the Document: The provided text is a 510(k) summary and FDA letter, which details the device's intended use, description, and the outcome of the FDA's review (substantial equivalence). It doesn't contain the detailed study protocols or results of bench testing or clinical trials that might define acceptance criteria as you've requested for an AI/diagnostic device.
Therefore, many of your requested points are not applicable or cannot be extracted from this document.
However, I can provide what is available about how the device meets regulatory requirements based on the provided text:
1. Table of Acceptance Criteria and the Reported Device Performance
As noted, explicit "acceptance criteria" for performance metrics like sensitivity/specificity are not defined for this type of device in this document. Instead, the "performance" demonstrated is its equivalence to predicate devices in:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Material Composition (HA/PLLA composites) for bioabsorption and mechanical properties | Manufactured from composites of hydroxyapatite and poly-L-lactide (HA/PLLA). Inherently similar to predicate devices regarding bioabsorption characteristics. |
| Design and Functional Characteristics (e.g., screw sizes, interference fit) | "The BioactIF OSTEOTRANS™ Interference Screw has very similar physical design features and functional characteristics as the predicate devices." "Screws are provided with various sizes typical of other marketed fixation devices." |
| Mechanical Strength for Fixation (implied requirement for an interference screw) | "Performance data demonstrate that the BioactIF OSTEOTRANS™ Interference Screw has the requisite strength... sufficient and sustained fixation for intended uses." (Specific numerical values for strength are not provided in this summary but would be in underlying lab reports). |
| Favorable Degradation Profile (implied requirement for a bioabsorbable device) | "favorable degradation profile sufficient and sustained fixation for intended uses." (Specific degradation timelines/profiles are not provided in this summary). |
| Indications for Use (fixation of grafts in ACL/PCL reconstruction) | "The BioactIF OSTEOTRANS™ Interference Screw is indicated for the same uses and anatomical regions as the predicate devices." |
| Substantial Equivalence to Predicate Devices (overall regulatory acceptance criterion) | "The BioactIF OSTEOTRANSTM Interference Screw is substantially equivalent in design, materials and intended use and principles of operation to the predicate devices." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- This document does not specify a "test set" in the context of diagnostic performance. The "performance data" mentioned (strength, degradation) would typically come from bench testing (in vitro/ex vivo), not patient data.
- Data provenance: Not specified, but generally, bench testing would be conducted in a laboratory setting associated with the manufacturer or a contracted lab.
- Retrospective or prospective: Not applicable to the type of data discussed.
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)
- Not applicable. There is no diagnostic "ground truth" to be established by clinical experts for this device in this summary. The "ground truth" for a mechanical device is its physical and chemical properties as measured in a lab.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No clinical expert adjudication is mentioned or relevant for this type of device and submission.
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. This device is an implantable screw, not an AI-driven diagnostic tool or system designed to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the performance data mentioned (strength, degradation), the "ground truth" would be established through laboratory testing and validated quantitative measurements according to established engineering and material science standards (e.g., ISO standards, ASTM standards).
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device that uses a "training set."
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 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.