(92 days)
The MILAGRO ADVANCE Interference Screw is intended for attachment of soft tissue grafts or bone-tendon-bone grafts to the tibia and/or femur during cruciate ligament reconstruction procedures.
Additionally, the 7, 8 and 9 mm x 23 mm screws will be indicated for: medial and lateral collateral ligament repair of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.
The MILAGRO ADVANCE Interference Screw is an absorbable, tapered, cannulated, threaded fastener for use in interference fixation of soft tissue grafts or bone-tendon grafts. The Interference Screw is made from a composite made of absorbable Poly (lactide-co-glycolide) polymer and Tricalcium Phosphate (TCP). The MILAGRO ADVANCE Interference Screw is provided sterile and is for single patient use only.
Here's an analysis of the provided text regarding the MILAGRO ADVANCE Interference Screw, focusing on acceptance criteria and the study conducted.
It's important to note that the provided documents are a 510(k) summary and FDA clearance letter, which typically focus on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria in the way one might see for a novel drug or a high-risk device. Therefore, some of the requested information, particularly regarding detailed statistical analysis, specific sample sizes for clinical trials, and multi-reader studies, might not be explicitly present or applicable to this type of submission.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Screw fixation strength (at time zero and throughout the healing period in in vitro testing) must be similar to predicate screws or meet established acceptance criteria. | "Results of the testing have demonstrated that the proposed screws are suitable for the intended use." (Implies similarity to predicate or meeting criteria, but specific numerical results or direct comparisons are not provided in this summary document.) |
| Mechanical Integrity | Screw torque testing must confirm no issue for screw insertion into the bone. | "Results of the testing have demonstrated that the proposed screws are suitable for the intended use." (Implies successful torque testing, but specific numerical results or direct comparisons are not provided in this summary document.) |
| Substantial Equivalence | Based on indications for use, technological characteristics, and comparison to predicate devices (K060830: MILAGRO Interference Screw; K032717: Biocryl Rapide Interference Screw), the proposed device must be shown to be substantially equivalent under the Federal Food, Drug, and Cosmetic Act. | The FDA "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." |
| Biocompatibility | The device, being made from an absorbable composite of Poly(lactide-co-glycolide) polymer and Tricalcium Phosphate (TCP), is expected to be biocompatible, though specific acceptance criteria for biocompatibility testing are not detailed in this summary. (This would typically involve ISO biocompatibility standards.) | Not explicitly stated in the provided text, but implied by regulatory approval as biocompatibility is a standard requirement for implantable devices. The use of established polymers and TCP would usually leverage prior knowledge of these materials' biocompatibility. |
| Sterility | The device must be provided sterile and for single patient use only. | "The MILAGRO ADVANCE Interference Screw is provided sterile and is for single patient use only." (This describes the product's state rather than a performance test result, but implicitly confirms it meets sterility requirements.) |
Study Details
Due to the nature of a 510(k) summary for a device demonstrating substantial equivalence, the "study" described is primarily non-clinical performance testing rather than a full-scale clinical trial.
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Sample size used for the test set and the data provenance:
- Test set sample size: Not explicitly stated. The document mentions "screw fixation strength testing" and "screw torque testing," which are typically benchtop mechanical tests performed on a specific number of devices. The exact number of screws or test conditions used is not detailed in this summary.
- Data provenance: Non-clinical (benchtop/laboratory) testing. No information on country of origin for this specific testing is provided, but it would typically be conducted by the manufacturer or a contract research organization. The study is described as "non-clinical testing," which implies it is prospective in nature for the purpose of this submission. There is no mention of human clinical data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this 510(k) submission. "Ground truth" established by experts (e.g., radiologists, pathologists) is relevant for diagnostic devices or those involving image interpretation. For a mechanical orthopedic implant, "ground truth" is established by engineering specifications, material properties, and mechanical testing standards. The "experts" involved would be engineers, material scientists, and quality assurance personnel.
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Adjudication method for the test set:
- Not applicable. Adjudication methods like "2+1" or "3+1" are used when interpreting subjective data (e.g., radiology scans) where multiple readers disagree. For objective mechanical tests like strength and torque, data is quantitative and ideally directly measurable against a defined specification.
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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:
- No. This type of study (MRMC, AI assistance) is for diagnostic or AI-enabled devices, which the MILAGRO ADVANCE Interference Screw is not. This device is a mechanical implant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This question pertains to AI algorithms. The device is a mechanical implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical testing described, the "ground truth" would be based on engineering specifications, established biomechanical performance standards, and comparison to the predicate device's known performance characteristics. This is primarily mechanical property data and performance specifications.
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The sample size for the training set:
- Not applicable. This question typically refers to machine learning algorithms. For mechanical devices, there isn't a "training set" in the computational sense. Development might involve iterative design and testing, but it's not analogous to an AI training set.
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How the ground truth for the training set was established:
- Not applicable. As above, there is no "training set" in the AI sense for this device. The design and validation are based on engineering principles, material science, and established biomechanical testing methods.
§ 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.