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510(k) Data Aggregation
(220 days)
Sterile bioabsorbable bone screw (Biocomposite ACL screw) is a fixation screw that fixes soft tissue such as ligaments, tendons, and the articular capsules to bone, and is used in orthopedic surgery(Cruciate ligament reconstruction procedures).
The Sterile bioabsorbable bone screw (Biocomposite ACL screw) is an absorbable bone fixation screw that fixes soft tissues such as ligament, tendon, and the articular capsules to bone, and is used in orthopedic surgery.
The implanted screw is made of poly(L-lactide-co-glycolide), PLGA and tri-calciumphosphate(S-TCP). Poly(L-lactide-co-glycolide), PLGA is gradually decomposed in vivo by hydrolysis and eventually excreted in carbon dioxide and water. Tri-calciumphosphate(ß-TCP) is gradually degraded in vivo by hydrolysis and eventually re-used as a calcium source.
Sterile bioabsorbable bone screw (Biocomposite ACL screw) is supplied EO gas sterile state and it is packed in Aluminum Pouch.
This is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than clinical performance studies. Therefore, the typical information sought for AI/CADe devices (like ground truth establishment, reader studies, effect size with AI assistance, training set details, etc.) is not applicable here because this is a mechanical medical device, not an AI/CADe system.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and the Reported Device Performance
The acceptance criteria are implied by adherence to referenced standards and successful completion of specific mechanical tests. The reported device performance is simply "PASS" for all tested criteria, indicating it met the established benchmarks.
| No. | Test Article | Acceptance Criteria (Implied by standard and test method) | Reported Device Performance |
|---|---|---|---|
| 1 | Axial Pullout Strength | Test referring ASTM F2502-A3.Test Method for Axial Pullout of Absorbable Bone Screws. After fully inserting the screw into the artificial bone (20PCF), Apply tensile load to the specimen at a rate 5mm/min until the screw fails or releases from the block. Measure the maximum load. (Specific performance values not quantifiable from the text, but the test was deemed successful.) | PASS |
| 2 | Torsional Yield Strength | Test referring ASTM F2502-A1.Test Method for Determining the Torsion Properties of Absorbable Bone Screws. After placing the specimen in the holding device, Rotate the screw in inserting direction at a rate of 1 revolution/min. Torsional yield strength is determined by an off-set method (2 degree off-set) on the torque versus rotation angle curve measured in the test. (Specific performance values not quantifiable from the text, but the test was deemed successful.) | PASS |
| 3 | Driving Torque | Test referring ASTM F2502-A2.Test Method for Driving Torque of Absorbable Bone Screws. Make a hole in the fixed artificial bone (20PCF) using an instrument compatible with the product. Measure the maximum strength when the screw is inserted 4 revolutions at a rate of 5 revolutions per minute. * Inserting load (axial load) = 1.14kgf. (Specific performance values not quantifiable from the text, but the test was deemed successful.) | PASS |
| 4 | Degradation testing | Mechanical performance assessed after degradation according to ISO 13781. (Specific performance values not quantifiable from the text, but the test was deemed successful.) | PASS |
| 5 | Fatigue | After fully inserting the screw with the tendon into the fixed artificial bone (20PCF), a fatigue tensile load of 70 to 220N on the tendon is repeated 1000 cycles at 1 Hz. (Specific performance values not quantifiable from the text, but the test was deemed successful.) | PASS |
2. Sample size used for the test set and the data provenance
The document states "All specimens selected (worst-case) to verify the performance of the test criteria established based on literatures and comparison with the predicate device." However, specific numerical sample sizes for each test are not provided. The provenance of the test samples (e.g., country of origin, retrospective/prospective) is also not specified, though it is implied these are manufactured device samples undergoing bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the document describes bench testing for a mechanical device. The "ground truth" here is determined by objective mechanical measurements against established ASTM and ISO standards, not expert interpretation of medical images or conditions.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the document describes bench testing for a mechanical device. There is no human adjudication process involved in these mechanical performance tests.
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 applicable as this is a mechanical bioabsorbable bone screw, not an AI/CADe system. Therefore, no MRMC study or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as this is a mechanical bioabsorbable bone screw, not an AI/CADe system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is established by objective mechanical measurements against recognized international standards (ASTM and ISO) for medical device performance (e.g., axial pullout strength, torsional yield strength, driving torque, degradation testing, fatigue).
8. The sample size for the training set
This information is not applicable as this is a mechanical device undergoing bench testing, not an AI/CADe system requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable as this is a mechanical device undergoing bench testing, not an AI/CADe system.
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