(239 days)
The Mbrace Cable is designed as a cerclage system for long bones and to reattach the greater trochanter in case of fractures or osteotomies. The device is intended for long-term implantation inside the human body for single use only. The Mbrace Cable is not intended for use as a suture cable in soft tissue approximation and/or ligation.
The Mbrace cable is an implantable flexible braided cable made of UHMWPE and designed as a cerclage bone system. The Mbrace cable is provided individually packed, sterile and single-use.
Here's a breakdown of the acceptance criteria and study information based on the provided text, categorized as requested. It's important to note that the document primarily describes the non-clinical performance testing conducted to demonstrate substantial equivalence, rather than a clinical effectiveness study with human subjects.
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in a quantitative table format. Instead, it describes performance tests conducted and the general outcomes. The acceptance criteria can be inferred from the stated goals of the tests.
| Acceptance Criteria (Inferred from Test Goal) | Reported Device Performance |
|---|---|
| Quasi-Static Load to Failure: Demonstrate suitable ultimate strengths and related maximum displacements compared to the predicate device. | Tested; results showed the subject device's performance was sufficient to not raise new safety/effectiveness issues compared to the predicate. |
| Dynamic Resistance: Demonstrate ability to pass 1 million load cycles without signs of failure to ensure safe and effective clinical use. | Tested; the subject Mbrace Cable was able to pass 1 million load cycles without any signs of failure. |
| Pyrogenicity (Bacterial Endotoxin Test): Meet the standards of European Pharmacopoeia §2.6.14 (equivalent to USP ). | Tested according to European Pharmacopoeia §2.6.14. (Result is implied to be acceptable as no issues were raised). |
| Pyrogenicity (Pyrogen Test): Meet the standards of USP for pyrogenicity determination. | Tested according to USP . (Result is implied to be acceptable as no issues were raised). |
| Biocompatibility: Demonstrate biocompatibility of materials. | Assessed; considered the same as the additional predicate device (HS Fiber, K100006) due to identical materials, processing, and sterilization. |
| Design Validation (Sawbone Workshop): Evaluate device's suitability. | Conducted; results showed device's suitability (implied acceptable as no issues were raised). |
| Sterilization: Demonstrate effective sterilization (ETO). | Fully validated (The different sterilization method of the subject device is due to different materials but has no impact on safety/effectiveness). |
| Shelf-life: Evaluate shelf-life. | Evaluated (Implied acceptable performance as no issues were raised). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify the exact number of devices or test samples used for the quasi-static load, dynamic resistance, pyrogenicity, or biocompatibility tests. It only mentions that the tests were conducted. For the Design Validation, it states "sawbone workshop," implying physical models were used, but the quantity of models or devices tested within the workshop is not detailed.
- Data Provenance: Not explicitly stated. The manufacturer, Medacta International SA, is located in Switzerland, but the location where the tests were performed or the origin of any raw data used in validation is not mentioned. Given these are non-clinical hardware tests, "retrospective or prospective" doesn't directly apply in the same way it would to clinical patient data. The tests are prospective in the sense that they were planned and executed to support the submission.
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)
Not applicable. This device is a bone fixation cable, and the performance data presented is from non-clinical mechanical, material, and sterilization tests. The "ground truth" for these types of tests is established by industry standards, engineering principles, and validated test methods, rather than expert consensus on medical images or patient outcomes. The "sawbone workshop" likely involved surgical or biomechanical experts, but their number and specific qualifications are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly for diagnostic devices where multiple human readers interpret data to establish a ground truth or resolve discrepancies. These methods are not relevant for the non-clinical hardware validation tests 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
No. This is a medical device (bone fixation cable), not an AI/CAD system. Therefore, an MRMC study or AI assistance evaluation is not relevant or applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests described:
- Mechanical Performance: Ground truth derived from established engineering and biomechanical principles, material science, and relevant ISO/ASTM standards (implied, though not explicitly cited beyond "written protocols"). The predicate device's performance often serves as a benchmark for comparison.
- Biocompatibility: Ground truth from established biocompatibility standards (e.g., ISO 10993 series, though not explicitly cited).
- Pyrogenicity/Sterilization: Ground truth from pharmacopoeial standards (European Pharmacopoeia §2.6.14, USP , USP ).
8. The sample size for the training set
Not applicable. This is a medical device for which non-clinical performance data is provided, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 888.3010 Bone fixation cerclage.
(a)
Identification. A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.(b)
Classification. Class II.