(369 days)
The TRIFT 3.5mm 1/3 Tubular Plate is indicated for:
• Treatment of smaller fractures of long bones such as humerus, fibula, and ulna
The Bonebridge Osteosynthesis Plating System is intended for treating fractures of various bones. It consists of plates and non-locking screws for fixation and corresponding instruments.
Plates and screws are made of stainless steel (ISO 5832-1 or ASTM F138 or ASTM F139). All materials used are biocompatible, corrosion-resistant and nontoxic in a biological environment. Surgical instruments are made of stainless steel (ISO 5832-1 or ASTM F138 or ASTM F899), medical grade PEEK, medical grade EPDM terpolymer, or medical grade silicone.
All plates are sterilized with gamma irradiation and delivered sterile. Screws and instruments are delivered non-sterile. Devices supplied in a non-sterile condition must be cleaned and steam sterilized prior to surgical use.
The provided text describes a 510(k) premarket notification for a medical device called the "Bonebridge Osteosynthesis Plating System." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness through extensive clinical trials. Therefore, the information provided focuses on comparative testing and engineering validation rather than clinical study results with acceptance criteria.
Based on the provided document, here's an analysis addressing your points:
The document does not describe a study that proves the device meets specific performance acceptance criteria for an AI/software device, an MRMC study, or a standalone algorithm performance study. This is a different type of device (metallic bone fixation appliance) undergoing a different regulatory pathway (510(k) for substantial equivalence). The "acceptance criteria" referred to in the document pertain to engineering and material testing, not diagnostic performance of an AI.
However, I can extract the information relevant to the testing that was performed:
1. A table of acceptance criteria and the reported device performance
The document mentions "predefined acceptance criteria were successfully met" for mechanical testing, but it does not explicitly define those criteria or report specific numerical performance metrics in the summary. It broadly states the following validation results:
| Test/Validation Type | Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|---|
| Sterilization (Gamma) | Minimal dose of 25kGy, based on ISO 11137-2, with a Sterility Assurance Level (SAL) of 10^-6. | "The minimal dose of 25kGy is validated using VDmax25 method as described in ISO 11137-2 and confirmed a Sterility Assurance Level SAL of 10^-6." |
| Sterilization (Steam) | Cleaning and sterilization procedures validated in accordance with ISO 17664 and ISO 17665-1 at 132°C (270F) for 4 minutes and 20 min drying time. | "Cleaning and sterilization procedures have been successfully validated in accordance with ISO 17664 and ISO 17665-1 at 132°C (270F) for 4 minutes and 20 min drying time." |
| Packaging Validation | In accordance with ISO 11607 1/2 and ASTM F1980, including transport simulation (ISTA 2A) and verification tests (Dye-Penetration, Visual inspection, Seal strength, Microbial barrier testing according to specified ASTM/DIN standards). | "Validation of the sterile packaging has been successfully performed in accordance with ISO 11607 1/2 and ASTM F1980. Furthermore, a transport simulation was conducted according ISTA 2A followed by these packaging verification tests: Dye-Penetration, ASTM F1929 Visual inspection, ASTM F1886/1886M Seal strength, ASTM F88/F88M Microbial barrier testing, DIN 58953-6, Chapter 2.14" (All implied to have passed). |
| Biocompatibility | In accordance with ISO 10993-1. | "A biological assessment has been performed in accordance with ISO 10993-1." (Implied to be successful). |
| Mechanical Testing: Plates | "Predefined acceptance criteria were successfully met" (presumably related to static and dynamic testing and comparative performance to the predicate device). | "Static and dynamic testing has been performed and included statistical analysis and comparative testing to the predicate devices. The predefined acceptance criteria were successfully met." (No specific numbers provided). |
| Mechanical Testing: Screws | In accordance with ASTM F543 (Standard Specification and Test Methods for Metallic Medical Bone Screws), including comparative testing to predicate devices. | "Tested successfully in accordance with ASTM F543: Standard Specification and Test Methods for Metallic Medical Bone Screws an includes comparative testing to predicate devices." (Implied to be successful). |
| Design Verification | Successful completion of compatibility of implants and instruments, and assessment of anatomical shape and appearance. | "Design verification was successfully completed and included compatibility of implants and instruments as well as assessment of anatomical shape and appearance." (Implied to be successful). |
| MRI Safety | Assessment of displacement force/torque (ASTM F2052-15 & F2213-17), heating effects (ASTM F2182-11a), and image artifacts (ASTM F2119-07 (2013)). | "The Bonebridge Osteosythesis Plating System is MR conditional considering local SAR based on the following tests: Assessment of displacement force and torque effects in the main static magnetic field at 3Tesla. Additionally, the expected magnetic force in a stronger magnetic field gradient of 30T/m was extrapolated. (According to ASTM F2052-15 and ASTM F2213-17) Assessment of heating effects due to the RF-field during MR scans at 1.5Tesla and 3Tesla according to ASTM F2182-11a Assessment of image artifacts at 3Tesla according to ASTM F2119-07 (2013)" (All implied to support MR conditional status). |
| Usability | Based on IEC 62366-1, with acceptance criteria for primary objectives (e.g., safe and effective use; no significant usability issues). | "Summative usability evaluation studies in accordance with IEC 62366-1 support that there are no significant usability issues due to the study acceptance criteria of the primary objectives prior Application/ Usability Risk Assessment update. Therefore, the summative usability evaluation studies of the Bonebridge Osteosythesis Plating System are considered as successful. The study participants were able to use the products safely and effectively." |
2. Sample sizes used for the test set and the data provenance:
* Test Set Sample Size: Not specified for any of the tests. The document refers to "statistical analysis" for plates and "comparative testing" for screws, implying multiple samples were used, but the exact numbers are not provided in this summary.
* Data Provenance: Not specified within the summary. These are laboratory/engineering tests performed by the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* This question is largely not applicable to the type of testing described in the document. The "ground truth" for mechanical properties, sterility, biocompatibility, etc., is established by adherence to recognized international standards (ISO, ASTM) and validated laboratory methods, not by expert consensus on clinical images or interpretations.
* For usability, "study participants" were involved, but their qualifications and the number of "experts" (if any) establishing criteria beyond standard usability engineering principles are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not applicable as detailed in the document. This is not a study involving human interpretation of data requiring adjudication.
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 was not done. This device is a physical medical implant (bone plate), not an AI/imaging device. The concept of human readers and AI assistance is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* No, this was not done. Again, this is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
* For the mechanical and material tests, the "ground truth" is adherence to established international standards (ISO, ASTM) and engineering principles for material strength, biocompatibility, sterility, etc.
* For usability, the "ground truth" is the ability of participants to use the product safely and effectively against predefined usability objectives.
* Not applicable in the sense of clinical "ground truth" (e.g., pathology, patient outcomes) for diagnostic accuracy. The clinical justification is based on equivalence to predicate devices and established surgical interventions.
8. The sample size for the training set:
* Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
* Not applicable. See point 8.
§ 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.