(54 days)
The ActivaScrew™ is indicated for fixation of bone fractures, osteotomies, arthrodeses, bone grafts and osteochondral fractures of upper extremity, ankle and foot in the presence of appropriate immobilization.
The ActivaScrew™ is indicated for fixation of bone fractures, osteotomies, arthrodeses, bone grafts and osteochondral fractures of upper extremity, ankle and foot in the presence of appropriate immobilization. Screws are available as fully and partially threaded in several different sizes, including diameters of 2.0 – 4.5 mm and lengths of 10 – 90 mm. The ActivaScrew™ is made of the completely bioabsorbable poly(L-lactide-co-glycolide) (PLGA) material, and they degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolized by the body. As the operated bone fracture or osteotomy gains strength during healing, the ActivaScrew™ gradually loses its strength, however, maintaining its function at least 8 weeks. Bioabsorption takes place approximately within two years thus eliminating the need for implant removal surgery.
The Bioretec ActivaScrew™ received 510(k) clearance based on substantial equivalence to predicate devices, namely the Inion OTPS™ Biodegradable Fixation System (K030900) and the Bioretec ActivaPin™ (K061164). The clearance did not provide acceptance criteria and directly reported device performance metrics in the same way clinical studies do for novel devices. Instead, the focus was on demonstrating that the ActivaScrew™ has substantially similar performance to its predicates through non-clinical and in-vitro testing.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state specific acceptance criteria in terms of numerical thresholds for device performance. Instead, the acceptance was based on demonstrating "substantial equivalence" to predicate devices. This typically means the device performs within the expected range for its class and intended use, and any differences do not raise new questions of safety or effectiveness.
Therefore, a direct table of acceptance criteria vs. statistical device performance is not available in this 510(k) summary. The summary states:
| Performance Aspect | Reported Device Performance |
|---|---|
| Mechanical Performance | "substantially similar performance as compared to its predicate devices" through "Non-clinical tests and in vitro -testing" |
| Material Degradation | Degradation in vivo by hydrolysis into alpha-hydroxy acids, metabolized by the body. Gradual loss of strength, maintaining function for at least 8 weeks. Bioabsorption within approximately two years. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "non-clinical tests and in vitro -testing."
- Sample Size: The specific sample sizes for these tests are not provided in the 510(k) summary.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given it's non-clinical/in-vitro testing, it would generally be considered laboratory-based performance rather than human data.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable to this 510(k) summary. The substantial equivalence determination for this device relies on non-clinical and in-vitro testing, not on clinical data requiring expert consensus or ground truth derived from expert review.
4. Adjudication Method:
This information is not applicable as the clearance was based on non-clinical and in-vitro testing, not on clinical studies requiring adjudication of outcomes or diagnoses.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned or performed as part of this 510(k) submission. No effect size of human reader improvement with/without AI assistance is provided. This type of study is not typically required for a Class II device like a bone fixation screw based on substantial equivalence to existing predicates.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):
This information is not applicable. The Bioretec ActivaScrew™ is a physical medical device (a bone fixation screw), not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm or "human-in-the-loop performance" does not apply.
7. Type of Ground Truth Used:
For the non-clinical and in-vitro testing, the "ground truth" would likely be derived from:
- Material specifications and established testing standards: Performance metrics (e.g., tensile strength, bending strength, degradation rate) would be compared against expected values or regulatory standards for similar implant materials and designs.
- Performance of predicate devices: The "ground truth" for comparison would be the known mechanical and degradation characteristics of the predicate devices.
8. Sample Size for the Training Set:
This information is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The design and manufacturing process would involve material characterization and engineering validation, not data training.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for this type of device.
§ 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.