(392 days)
THE SYNTEC HUMERAL NAIL 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 INTO THE SHAFT, AND IMPENDING PATHOLOGIC HUMERAL FRACTURES.
The Syntec Humeral Nail System are manufactured from commercially SUS316L (stainless steel) and Ti-6AL-4V (Titanium alloy). It is an intramedullary (IM) straight nail with a 5° proximal bend configuration to fit the anatomy of the humerus and is inserted proximally over ø2.0 calibrated guide wires. Those nail accepts only an ø3.8mm Cortical Screw in various lengths for cross-screw fixation in both the proximal and distal portion of the nail. Also, an End Cap ø8 ~ ø 9 in 9mm lengths is available for proximal closing of the nail. The Syntec Humeral Nail System (nail, screw and end cap) are provided Non-Sterile and single use only. Also, it is not for spinal use. Associated instrumentation such as aiming device for proximal and distal, insertion guide wire, drill accessories, system and removal instruments are available with the system.
Here's an analysis of the provided text regarding acceptance criteria and device performance:
The provided document is a 510(k) Summary for a medical device (Syntec Humeral Nail System), which primarily focuses on demonstrating substantial equivalence to a predicate device. It does not contain the detailed information typically found in a study report that rigorously tests a device against pre-defined acceptance criteria using clinical or algorithmic performance metrics.
Therefore, I cannot extract the information required to populate all sections of your request. Specifically, the document does not contain information on:
- Acceptance criteria and reported device performance related to specific clinical or diagnostic outcomes.
- Sample size for a test set (clinical or imaging data).
- Data provenance for a test set.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
- Standalone (algorithm-only) performance.
- Sample size for a training set.
- How ground truth for a training set was established.
The document only refers to "Performance Data" in the context of mechanical testing according to a standard, and then makes a general statement about substantial equivalence based on that.
Here's what can be extracted and inferred from the provided text according to your request:
1. Table of Acceptance Criteria and the Reported Device Performance
Based on the document, the "acceptance criteria" appear to be related to demonstrating mechanical equivalence to a predicate device based on a recognized standard. The reported performance is a general statement of equivalency.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Mechanical performance in accordance with ASTM-F1264-14 | "The testing was done to our Syntec Humeral Nail System device to demonstrate substantial equivalence." |
| Safety and effectiveness as the predicate device (K132945) | "According device test report of performance data demonstrate that the Syntec Humeral Nail is as safe and effective as K132945." |
| Same intended uses, indications, technological characteristics, and principles of operation as the predicate device | "Thus, the Syntec Humeral Nail System is substantially equivalent in design, configuration, function, and indications for use to the I.T.S. IM Nail Systems CFN-CTN-CHN (K132945)." |
2. Sample size used for the test set and the data provenance
The document mentions "device test report of performance data" and testing according to ASTM-F1264-14, which refers to mechanical testing. It does not specify sample sizes of devices tested, nor does it refer to patient data or its provenance for any clinical or diagnostic performance assessment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document describes mechanical testing of the device itself, not an assessment requiring expert interpretation of clinical data or images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. The document describes mechanical testing of the device itself, not an assessment requiring expert consensus.
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. The Syntec Humeral Nail System is an intramedullary fixation rod, a physical implant. It is not an AI-powered diagnostic device or an AI-assisted tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical testing, the "ground truth" would be established by the physical and mechanical properties and behaviors of the device as measured against the specifications outlined in the ASTM standard. There is no clinical or diagnostic "ground truth" as described (expert consensus, pathology, outcomes data) relevant to the performance data cited here.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI model.
Summary of what the document does convey regarding "acceptance criteria" and "study":
The "study" described, albeit briefly, is primarily focused on mechanical performance testing against the ASTM-F1264-14 standard to demonstrate that the Syntec Humeral Nail System performs similarly to its predicate device (I.T.S. IM Nail Systems CFN-CTN-CHN). The "acceptance criteria" appear to be met when the device's mechanical test results support a conclusion of substantial equivalence regarding safety and effectiveness compared to the predicate, particularly in its intended uses and technological characteristics. There is no mention of clinical trials or studies assessing patient outcomes or diagnostic accuracy in the context of what you've asked.
§ 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.