(64 days)
The Marchetti-Vicenzi Humeral Intramedullary Nail is a single-use device intended for use in the fixation of fractures of the humerus. Specific indications include all types of fractures and pseudoarthroses occurring between the surgical neck of the humerus and 3 cm proximal to the olecranon fossa.
The Marchetti-Vicenzi Humeral Intramedullary Nail is an intramedullary rod made up of several pins that provide elastic fixation of humeral fractures. The cylindrical, rod-like base of the nail is tapered and is preloaded with either four or five pins. A bolt system holds the tips of the pins together until the nail is properly inserted, at which time the bolt is removed back through the canal and the pins diverge and return to their preconditioned position. The cylindrical base that holds the pins contains a screw hole through which a screw can be inserted for distal locking. Distal locking is required for the humeral nail.
The provided text describes a medical device, the Marchetti-Vicenzi Intramedullary Nail, Humeral, and its 510(k) submission to the FDA. However, it does not contain the detailed information typically found in a study proving acceptance criteria for an AI/software device, as requested in the prompt.
The document is a traditional 510(k) submission for a physical medical device (an intramedullary nail), which relies on physical testing and comparison to predicate devices, rather than AI-driven performance metrics. Therefore, many of the requested fields (like sample size for test set, number of experts, adjudication method, AI assistance in MRMC, standalone algorithm performance, training set details) are not applicable or not present in this type of submission.
Here's an attempt to answer based only on the provided text, indicating where information is not available or not applicable for an AI device.
Acceptance Criteria and Study for Marchetti-Vicenzi Intramedullary Nail, Humeral
Based on the provided document, the acceptance criteria and study focus on mechanical performance and substantial equivalence to predicate devices, rather than acceptance criteria for an AI/software device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied/Stated) | Reported Device Performance |
|---|---|
| Clinical Indications | Fixation of fractures of the humerus, including all types of fractures and pseudoarthroses between the surgical neck and 3 cm proximal to the olecranon fossa. |
| Bending Strength (vs. predicate) | Statistically higher bending strength (in both 4-pin and 5-pin configurations) when compared to Rush Pins. |
| Rigidity (vs. predicate) | Statistically higher rigidity (in both 4-pin and 5-pin configurations) when compared to Rush Pins. |
| Substantial Equivalence to Predicate | Deemed "substantially equivalent" to predicate devices (Rush Pins marketed by Zimmer) by the FDA for the stated indications for use. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified for a clinical or performance study involving human subjects or a large dataset. The "performance data" refers to mechanical testing.
- Data Provenance: Not applicable in the context of an AI device's test set. The performance data is from laboratory mechanical testing of the physical nail.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This information is for AI/software device validation. The "ground truth" for this physical device's performance would be derived from biomechanical testing standards and measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This information is for AI/software device validation.
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, an MRMC study was not done. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is not an AI algorithm. Its performance is inherent to the physical device's design and materials.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance claims ("statistically higher bending strength and rigidity") is derived from mechanical testing data comparing the Marchetti-Vicenzi Humeral Nail to its predicate device (Rush Pins).
8. The sample size for the training set:
- Not applicable. This is not an AI/software device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/software device that requires a training set with established ground truth.
§ 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.