(143 days)
M-ARS ACL: Anatomic Ribbon Surgery System - M-ARS ACL Tibial Pull Suture Plate (PSP): Reconstructive treatment of ruptured anterior and posterior cruciate ligaments by means of autologous grafts.
M-ARS ACL: Anatomic Ribbon Surgery System: M-ARS ACL Extracortical Femoral Button: Reconstructive therapy of ruptures to the anterior cruciate ligament by means of autologous grafts.
The M-ARS ACL: Anatomic Ribbon Surgery System components are implantable devices used for the reconstructive treatment of ligament ruptures as well as the fixation of an implanted Anterior Cruciate Ligament graft by means of suspensory extracortical fixation.
The M-ARS ACL: Anatomic Ribbon Surgery System Extracortical Fixation Button component is an implantable extracortical suspension device used to secure the graft fixation on the femoral side during ACL reconstruction surgery. The M-ARS ACL: Anatomic Ribbon Surgery System Tibial Pull Suture Plate (PSP) component is an implantable extracortical suspension device used to secure the graft fixation on the tibial side during ACL reconstruction surgery.
The M-ARS ACL: Anatomic Ribbon Surgery System Extracortical Fixation Button and Tibial Pull Suture Plate are manufactured with Titanium-6 Vanadium Extra Low Interstitial (Ti-6Al-4V ELI).
The provided text describes a 510(k) premarket notification for the "M-ARS ACL: Anatomic Ribbon Surgery System," which is a medical device for reconstructive treatment of ruptured anterior and posterior cruciate ligaments. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance criteria through a study with acceptance criteria.
Therefore, many of the requested categories (e.g., acceptance criteria table, sample sizes, expert ground truth, MRMC study, standalone performance, training set data) are not applicable as this submission is for a medical device that relies on the established safety and effectiveness of predicate devices, and the studies conducted are primarily non-clinical and comparative in nature, not performance studies with specific statistical acceptance criteria for a new AI or diagnostic device.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document as it is a 510(k) submission for a surgical implant device, not a diagnostic or AI device that typically presents performance metrics against acceptance criteria. The focus is on demonstrating substantial equivalence to predicate devices through material, design, and functional comparisons, along with non-clinical testing for safety.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size (Test Set): Not applicable for the type of studies performed. The document mentions "design comparison" and "cadaver workshop." These are not statistical studies with defined test set sample sizes in the context of device performance metrics.
- Data Provenance: Not applicable. The studies are non-clinical (design comparison, cadaver workshop).
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):
- Experts and Qualifications: For the "cadaver workshop," the text mentions "surgeon evaluations to verify the design features and surgical technique." The specific number or qualifications of these surgeons are not detailed. This workshop serves to evaluate usability and design, not to establish a "ground truth" in the way it would be for a diagnostic AI system.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. There is no mention of a formal adjudication process for the non-clinical studies described.
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:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices or AI tools, which is not the nature of the M-ARS ACL system.
- Effect Size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance Study: No, a standalone performance study was not done. This device is a surgical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: Not applicable in the traditional sense of a diagnostic or AI device. For the non-clinical studies, "ground truth" would be related to engineering specifications, material properties, and surgical technique verification by surgeons. There's no pathological or outcomes data used to establish "ground truth" for the device's technical performance in this context.
8. The sample size for the training set:
- Training Set Sample Size: Not applicable. This device is not an AI or machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Training Set Ground Truth Establishment: Not applicable.
Summary of Device Performance and Acceptance Criteria (as described in the context of a 510(k) submission for this device):
The document does not explicitly state "acceptance criteria" for performance metrics in the way one would for a diagnostic test (e.g., sensitivity, specificity thresholds). Instead, the "performance" is demonstrated through:
- Design Comparison: Geometrical and comparative analysis between the M-ARS ACL System and predicate devices to show mechanical equivalence. The acceptance criterion here is implied as being "substantially equivalent" in design and mechanical properties to legally marketed predicate devices.
- Cadaver Workshop: Surgeon evaluations to verify design features and surgical technique. The implied acceptance criterion would be that surgeons can successfully use the device and technique, and that the design is appropriate for its intended use.
- Substantial Equivalence Evaluation: A comparative analysis, especially for the Tibial Pull Suture Plate, against the predicate device. This ensures that any differences in design do not raise new questions of safety or effectiveness.
- Biocompatibility and Sterilization: The device materials (Titanium Alloy ELI) have an extensive history of use in medical devices and have been previously reviewed by the FDA, implying they meet established biocompatibility standards. The device is sterile and single-use, meeting standard regulatory requirements for such implants.
- Pyrogenicity: Medacta uses Bacterial Endotoxin Test (LAL test) and Pyrogen Test (USP chapter ), indicating compliance with standards for sterility and pyrogenicity, though they do not label the devices as non-pyrogenic or pyrogen-free.
Conclusion stated in the document: "Substantial equivalence has been demonstrated through a comparison of intended use, design and technological characteristics as well as performance evaluations. The M-ARS ACL: Anatomic Ribbon Surgery System is as safe and effective as the predicate devices, Karl Storz's Flipptack (K982571) and Karl Storz's Endotack (K022853)."
In essence, the "acceptance criteria" are the demonstration of substantial equivalence to predicate devices, supported by non-clinical studies verifying design, materials, and surgical technique.
§ 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.