(166 days)
The ActivaScrew™ Interference is indicated for fixation of tissue, including ligament or tendon to bone, or a bone-tendon to bone in the presence of appropriate immobilization / controlled mobilization. Interference fixation is intended for surgeries of knee, shoulder, elbow, ankle, foot and hand/wrist.
The product family consists of fully threaded ActivaScrew™ Interference, diameters 4 - 10 mm and lengths 10 - 33 mm. The ActivaScrew™ Interference is constructed of bioabsorbable poly(L-lactide-co-glycolide) (PLGA).
Here's an analysis of the provided text regarding the Bioretec ActivaScrew™ Interference, focusing on the acceptance criteria and the study that proves the device meets them:
Disclaimer: The provided text is a 510(k) summary for a medical device. 510(k) submissions primarily demonstrate substantial equivalence to existing legally marketed devices, rather than establishing de novo safety and effectiveness through extensive clinical trials as would be required for a PMA. Therefore, the "acceptance criteria" discussed here relate to demonstrating equivalence rather than clinical performance targets. Similarly, the "study" refers to non-clinical testing for equivalence.
Acceptance Criteria and Reported Device Performance
The Bioretec ActivaScrew™ Interference sought clearance by demonstrating substantial equivalence to predicate devices. The acceptance criteria were implicitly met by showing that the new device performs "substantially similar" to the predicates in specific mechanical tests.
| Acceptance Criteria Category | Reported Device Performance (Compared to Predicates) |
|---|---|
| Intended Use | Same (fixation of tissue, including ligament or tendon to bone, or a bone-tendon to bone in the presence of appropriate immobilization / controlled mobilization; interference fixation for knee, shoulder, elbow, ankle, foot, hand/wrist surgeries) |
| Principles of Operation | Same |
| Design Characteristics | Very similar (fully threaded, diameters 4-10mm, lengths 10-33mm) |
| Material | Same as previously cleared ActivaScrew™ (poly(L-lactide-co-glycolide) (PLGA)) |
| Mechanical Properties | Sufficient for indications, substantially similar to predicates (demonstrated through pull-out testing, shear strength testing) |
| Degradation Properties | Substantially similar to predicates (demonstrated through inherent viscosity and dimensional stability testing) |
The study (non-clinical testing) did not raise "any new questions of safety or effectiveness of the ActivaScrew™ Interference and demonstrates that the ActivaScrew™ Interference performs mechanically in a manner substantially similar to the tested predicate device."
Study Details
Given this is a 510(k) submission focusing on substantial equivalence, the "study" described is a series of non-clinical, in vitro tests comparing the new device to predicate devices. It is not a clinical study with human patients, nor a study involving AI.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document does not specify the exact sample sizes (number of screws or test repetitions) for each non-clinical test (pull-out, shear strength, inherent viscosity, dimensional stability).
- The data provenance is not explicitly stated beyond being "non-clinical tests and in vitro testing." Given the manufacturer (Bioretec Ltd.) is based in Finland, the testing likely occurred in Finland or by a contract lab; however, this is not confirmed in the text. These are prospective tests conducted specifically for this submission.
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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 question is not applicable to this submission. "Ground truth" in the context of clinical disease detection or diagnosis, and the involvement of experts for adjudication, are concepts relevant to diagnostic device performance studies (e.g., for AI/ML devices). This submission is for a physical orthopedic implant and relies on engineering and material science standards and comparative mechanical testing, not expert interpretation of clinical data for a "ground truth" diagnosis.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable. See point 2.
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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 is not applicable. This is not an AI/ML device, nor a diagnostic device requiring human reader interpretation. No MRMC study was conducted.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- This is not applicable. This is not an algorithm or AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- This is not applicable in the traditional sense for diagnostic performance. For this device, the "ground truth" for demonstrating equivalence largely relies on established engineering principles, material science properties, and direct mechanical comparison to physically identical predicate devices against specified performance metrics (e.g., force to failure, material degradation rate). The "truth" is the measured physical property.
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The sample size for the training set:
- This is not applicable. There is no "training set" as this is not an AI/ML device.
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How the ground truth for the training set was established:
- This is not applicable. There is no "training set" or "ground truth" for one in this context.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.