(112 days)
The Synthes MultiLoc Humeral Nailing System is indicated for fractures of the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures, proximal humeral fractures with diaphyseal extension, diaphyseal fractures of the humeral shaft, and impending pathologic humeral fractures.
The Synthes MultiLoc Humeral Nailing System consists of metallic rods and accessories which are intended for implantation in the medullary canal of the humerus for fracture fixation. The system features intramedullary nail devices, as well as bone screws and end cap accessories. The nails are cannulated, offered in 7.0mm, 8.5mm, and 10mm diameters, and are available in 180mm -315mm in overall length. The nails additionally feature a polymer inlay in the proximal end to enhance the stability of the 4.5mm MultiLoc locking screws. Cleared 4.5mm MultiLoc Screws, used to facilitate the proximal locking of the nail construct, can be interlocked with cleared Synthes 3.5mm Locking Screws to enhance the stability of the construct.
The provided text describes a medical device, the Synthes MultiLoc Humeral Nailing System, seeking FDA clearance via a 510(k) pathway. This pathway establishes substantial equivalence to a predicate device, rather than proving meeting specific acceptance criteria through a clinical study with performance metrics in the way a novel medical AI/ML device would.
Therefore, many of the requested categories are not applicable to the information provided for this type of device submission. The existing information focuses on bench testing to demonstrate mechanical equivalence to predicate devices, rather than human performance metrics.
Here's an analysis based on the provided text, indicating where information is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from predicate device) | Reported Device Performance (Synthes MultiLoc Humeral Nailing System) |
|---|---|
| Same indications for use as predicate devices. | The proposed system has the same indications for use: fractures of the proximal humerus (2-part surgical neck, 3-part, 4-part), proximal humeral fractures with diaphyseal extension, diaphyseal fractures of the humeral shaft, and impending pathologic humeral fractures. |
| Similar in design to predicate devices. | Similar in design to predicate devices. |
| Incorporates the same fundamental product technology as predicate devices. | Incorporates the same fundamental product technology as predicate devices. |
| Composed of the same materials as predicate devices. | Composed of the same materials as predicate devices. |
| Bending strength (static and dynamic) equivalent to predicate devices (according to ASTM F 1264-03). | In vitro bench testing, including static and dynamic 4-point bending, showed results supporting substantial equivalence compared to predicate devices. |
| Torsional strength equivalent to predicate devices. | In vitro bench testing showed results supporting substantial equivalence compared to predicate devices. |
| Eccentric dynamic fatigue strength of the construct equivalent to predicate devices. | In vitro bench testing showed results supporting substantial equivalence compared to predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated as a "test set" in the context of human data. The testing was in vitro bench testing. The number of samples for each type of mechanical test (static/dynamic bending, torsional, eccentric dynamic fatigue) is not provided.
- Data Provenance: The testing was "in vitro bench testing" performed according to ASTM F 1264-03. This implies lab-based mechanical testing, rather than data from a specific country or retrospective/prospective clinical studies on human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This device relies on mechanical testing against a standard and comparison to predicate devices, not on expert-established ground truth from clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
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 a medical implant, not an AI/ML diagnostic or assistive device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. See point 5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this submission is established through mechanical properties standards (ASTM F 1264-03) and demonstrating equivalence to the mechanical performance of legally marketed predicate devices.
8. The sample size for the training set
- Not Applicable. This device does not involve a "training set" in the context of AI/ML or statistical learning.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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.