(234 days)
The ENSPLINTRx™ Distal Radius System is intended to be used for the fixation of unstable distal radius fractures in which closed reduction is not suitable:
- Joint destruction and/or subluxation visible on x-ray; .
- Osteotomy and repair of distal radius malunion with or without bone graft; .
- Non-displaced fractures in which the physician and patient opt for rigid stability .
- Transverse fractures of the distal radius with or without comminution (e.g. AO . classifications A2 and A3)
- Transverse fractures of the distal radius with an extension into the joint without . comminution (e.g. AO classification C1);
- Failed fracture fixation with or without bone graft for the types of fractures above; .
- The above types of fractures (i.e. AO classifications non-displaced transverse, A2, . A3, and C1) in which reduction has been lost following fixation with percutaneous pins with or without an external fixator.
The EnsplintRx™ configuration consists of a flexible implant manufactured from stainless steel.
Here's a breakdown of the acceptance criteria and study information for the ENSPLINTRx Distal Radius System, based on the provided 510(k) summary:
This device is not an AI/ML device, so many of the requested fields (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance) are not applicable. The device is a traditional medical device, relying on bench testing for substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Substantial equivalence in mechanical properties to predicate devices (implied by "bench top laboratory testing"). | "The results of the non-clinical (bench top) laboratory testing demonstrate that the device is substantially equivalent." |
| Material Properties | Substantial equivalence in materials to predicate devices. | "The EnsplintRx™ has similar... materials to the predicate device." |
| Intended Use | Alignment with the intended use of predicate devices, focusing on fixation of unstable distal radius fractures. | "The EnsplintRx™ has similar intended use... to the predicate device." |
| Biocompatibility | Implied to be acceptable through the use of stainless steel, a commonly used and well-understood biomedical material. | Not explicitly stated beyond material similarity to predicate devices, but commonly relied upon for stainless steel implants if the predicate used the same material. |
| Sterility | Not explicitly mentioned but is a standard requirement for implantable devices. | Not explicitly stated in the summary. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable: This device is a traditional implantable medical device, and its performance was demonstrated through non-clinical (bench-top) laboratory testing, not a clinical study involving human test sets or data provenance.
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: As this was non-clinical bench testing, there was no human "test set" and thus no need for experts to establish ground truth in the context of clinical interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: There was no clinical test set 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
- Not Applicable: This is not an AI/ML device, so no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable: This is not an AI/ML device, so standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Engineer-defined performance metrics through bench testing: The "ground truth" for this device's performance was established by engineering specifications and comparative mechanical testing against predicate devices. This involves measuring various mechanical properties (e.g., strength, stiffness, fatigue life) under controlled laboratory conditions, rather than clinical outcomes or diagnostic accuracy.
8. The sample size for the training set
- Not Applicable: This is not an AI/ML device, so there is no training set in the context of machine learning. The "training" for the device development would refer to engineering design, materials science, and manufacturing processes.
9. How the ground truth for the training set was established
- Not Applicable: As above, this is not an AI/ML device. The "ground truth" for the device's design and manufacturing (analogous to a training set for an AI) would be established through established engineering principles, material science standards, and regulatory requirements, informed by the performance of the predicate devices.
§ 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.