(72 days)
The Acumed Small Bone Locking Rod II System is indicated for use in fractures and osteotomies of the fibula, radius, and ulna. These are similar to intended use of predicate devices and do not raise new issues of safety and effectiveness.
The Acumed Small Bone Locking Rod II is an intramedullary rod with solid and cannulated versions. Rods are manufactured in multiple lengths (110 mm to 270mm) and diameters (3.0 to 4.5 mm). The rod has openings used in conjunction with titanium alloy cortical screws, which lock it in place.
This device, the Acumed Small Bone Locking Rod System II, is a medical implant intended for use in fractures and osteotomies of the fibula, radius, and ulna. The provided 510(k) summary does not contain information about a study proving the device meets specific acceptance criteria based on performance data or clinical/non-clinical tests.
Instead, the submission states that "An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable."
The basis for regulatory clearance (Substantial Equivalence) is primarily due to the device's technological characteristics and intended use being similar to legally marketed predicate devices.
Therefore, I cannot populate the table or provide detailed information for points 2 through 9 as requested, because this type of study information is explicitly stated as "not applicable" in the provided document for this device's 510(k) submission.
Here's a summary of what can be extracted based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable | Not applicable |
| (No specific performance criteria or data were assessed for this 510(k) submission.) | (The device's safety and effectiveness were based on substantial equivalence to predicate devices, not on a new performance study.) |
Information that cannot be provided from the text:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no new performance or clinical study data was presented.
- 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 no new performance or clinical study data was presented.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no new performance or clinical study data was presented.
- 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, as this device is a physical intramedullary rod and not an AI/software device involving reader performance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this device is a physical intramedullary rod.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable, as no new performance or clinical study data was presented.
- The sample size for the training set: Not applicable, as no new performance or clinical study data was presented.
- How the ground truth for the training set was established: Not applicable, as no new performance or clinical study data was presented.
Reasoning from the document:
The 510(k) summary explicitly states: "An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable." This indicates that the device's clearance was based on demonstrating "substantial equivalence" to existing predicate devices, rather than on new performance studies with acceptance criteria, test sets, or ground truth establishment. The similarities cited are in intended use and material (titanium 6AL EVI alloy conforming to ASTM F136, similar to predicate devices made of identical titanium alloy or stainless steel).
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.