(79 days)
The Bonebridge POYA 3.5mm Posteromedial Tibia System is intended for adult patients and indicated for internal fixation of posteromedial proximal tibia fractures, including buttressing of fractures of the proximal and metaphyseal areas of the tibia. Additionally, the longer plates are indicated for fractures extending to the tibial shaft.
The POYA 3.5mm Medial Proximal Tibia System is intended for adult patients and indicated to buttress metaphyseal fractures of the medial tibia plateau, split- type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. Also, for use in the fixation of osteopenic bone and fixation of nonunions and malunions of the medial proximal tibia.
The SALTI 2.5/3.5mm Ankle System is intended for fixation of the ankle in adult patients and particularly in osteopenic bone. Specifically,
- the Medial and Anterolateral Distal Tibia Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia.
- . The Posterior Distal Tibia Plate is intended to buttress partial articular fractures and bone fragments of the distal tibia.
- . The Lateral Distal Fibula Plates are intended for fixation of osteotomies, fractures, nonunions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula.
The Bonebridge Osteosynthesis Plating System is intended for treating fractures of various bones. It consists of plates, locking and non-locking screws for fixation and corresponding instruments. The plating system is further subdivided into variants/types based on the anatomical location of the fracture.
Plates and screws are made of stainless steel (ISO 5832-1 or ASTM F138 or ASTM F139) or pure titanium (ASTM F67 or ISO 5832-2). All materials used are biocompatible, corrosion-resistant and nontoxic in a biological environment. Surgical instruments are made of stainless steel (ASTM F899, ISO 7153-1, ISO 5832-1, and ASTM F138/139), 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. Non-clinical testing has demonstrated the devices are MR Conditional.
The provided document is a 510(k) premarket notification letter from the FDA for a medical device called the "Bonebridge Osteosynthesis Plating System." This type of document is centered on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing acceptance criteria and proving performance through novel clinical studies in the way one might expect for a new, innovative diagnostic or AI device.
Therefore, the information typically requested in your prompt regarding acceptance criteria and performance against those criteria (such as sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) is not present in this document.
The document primarily focuses on non-clinical tests to show that the new device is as safe and effective as its predicates. Here's a breakdown of the available information in relation to your request:
1. Table of acceptance criteria and the reported device performance:
The document states that "All predefined acceptance criteria were successfully met" for mechanical testing, but it does not explicitly list these acceptance criteria or the specific numerical performance values for each. It only reports a "Pass" for each category of non-clinical testing.
| Test Category | Acceptance Criteria (Explicitly stated in document?) | Reported Device Performance |
|---|---|---|
| Sterilization validation | Minimal dose of 25kGy (for gamma irradiation) | Pass |
| SAL of 10^-6 (for gamma irradiation) | Pass | |
| 132°C (270F) for 4 minutes and 20 min drying time (for steam sterilization) | Pass | |
| Packaging validation | N/A (referenced standards ISO 11607 1/2, ASTM F1980, ISTA 2A, ASTM F1929, ASTM F1886/1886M, ASTM F88/F88M, DIN 58953-6 Chapter 2.14) | Pass |
| Biocompatibility | N/A (referenced standards ISO 10993-series and FDA guidance) | Pass |
| Mechanical testing | Substantially equivalent to predicate devices for maximum force (static) and maximum force for a given number of cycles (dynamic). | Pass |
| MRI safety | "MR conditional" considering local SAR | Pass |
| Assessment of displacement force and torque effects (ASTM F2052-21, ASTM F2213-17) | Pass | |
| Assessment of heating effects (ASTM F2182-19) | Pass | |
| Assessment of image artifacts (ASTM F2119-07 (2013)) | Pass | |
| Usability tests | No significant usability issues (based on primary objectives prior Application/ Usability Risk Assessment update) | Successful |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not provided in the document. The document describes mechanical testing and refers to "design verification" which would involve testing prototypes, but does not detail the sample sizes for these tests, nor does it refer to patient data for performance evaluation.
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):
This information is not applicable/not provided. The "ground truth" concept is highly relevant for diagnostic devices or AI, where human experts (e.g., radiologists, pathologists) determine the correct diagnosis or outcome. For a bone plating system, performance is primarily assessed through biomechanical testing and material properties, not through expert-labeled patient data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable/not provided for the reasons stated above. Adjudication relates to resolving disagreements among experts when establishing ground truth.
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:
This is not applicable/not provided. MRMC studies are typically for evaluating the impact of AI or diagnostic tools on human reader performance, which doesn't apply to a bone plating system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable/not provided. This device is a physical bone plating system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
As discussed, the concept of "ground truth" in the diagnostic/AI sense is not applicable here. The "truth" for this device's performance is derived from standardized engineering and material testing (e.g., mechanical load tests, biocompatibility assessments, sterilization efficacy).
8. The sample size for the training set:
This information is not applicable/not provided. There is no "training set" for this type of physical medical device. Training sets are relevant for machine learning algorithms.
9. How the ground truth for the training set was established:
This information is not applicable/not provided.
In summary: The document is a 510(k) submission for a bone plating system and focuses on demonstrating substantial equivalence through non-clinical testing. It does not contain information related to acceptance criteria or studies in the context of diagnostic or AI device performance as described in your prompt. The "acceptance criteria" where mentioned implicitly refer to passing engineering specifications and regulatory standards.
§ 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.