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510(k) Data Aggregation
(258 days)
The MEDRON Vessel Dilator is designed for percutaneous entry into a vessel in order to enlarge the opening of the vessel for the placement of a catheter in a vein or artery.
The MEDRON Vessel Dilator is a dilator consisting of a radiopaque HDPE (high density polyethylene) shaft with an overmolded HDPE Hub. The dilator comes in a variety of diameters ranging from 6F to 17.5F. It is also available in two models, a straight model and a stepped model. The straight model has a consistent diameter along the length of the shaft until it tapers at the distal tip. In the stepped model, the distal segment of the dilator shaft has a smaller diameter than the proximal segment as well as a taper at the distal tip.
The provided document is a 510(k) summary for the MEDRON Vessel Dilator. It outlines an equivalency study comparing the MEDRON Vessel Dilator to a predicate device, the Medcomp Vessel Dilator (K162389). However, it does not describe a study involving an AI/Machine Learning device or its performance. Instead, it details non-clinical performance tests (biocompatibility and functional testing) for a traditional medical device (vessel dilator).
Therefore, I cannot provide information for all your requested points as they pertain to AI/ML device studies. I will address the relevant sections based on the available information for a conventional medical device.
Information based on the provided document:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Test/Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity (L-929 MEM Elution) | Non-cytotoxic (Grade 0 reactivity) | Cell culture treated with test sample exhibited no reactivity (Grade 0). Result: Non-cytotoxic |
| Sensitization (Magnusson-Kligman) | Negative for dermal sensitization | Challenge sites treated with test sample exhibited no erythema or edema (Grade 0). Result: Negative for dermal sensitization | |
| Irritation (Intracutaneous Toxicity) | Non-irritating (mean test score ≤ 1) | Mean test score in 0.9% Normal Saline extract was 0, and in Sesame Oil was 0.5. Result: Non-irritating | |
| Systemic Toxicity (Acute - Systemic Injection) | No abnormal clinical signs indicative of toxicity | No study animals were observed with abnormal clinical signs indicative of toxicity during the 72-hour test period. Result: Non-toxic | |
| Systemic Toxicity (Acute - Material Mediated Pyrogen) | Non-pyrogenic (temperature increases not exceeding acceptable limit) | Temperature increases for all test animals did not exceed the acceptable test limit for maximum individual temperature rise. Result: Non-pyrogenic | |
| Hemocompatibility (Hemolysis, direct contact) | Non-hemolytic (difference in hemolytic indices near 0%) | The difference between the hemolytic indices of the test article and the negative control was 0.00%. Result: Non-hemolytic | |
| Hemocompatibility (Hemolysis, Extract) | Non-hemolytic (difference in hemolytic indices near 0%) | The difference between the hemolytic indices of the test article and the negative control was 0.08%. Result: Non-hemolytic | |
| Complement Activation (SC5b-9) | Negative for complement system activation (activation similar to or lower than negative control) | Activation caused by the test article was similar to the activation caused by the negative control after 30 and 60 minutes exposure and lower than the activation caused by the negative control after 90 minutes exposure. Result: Negative for complement system activation | |
| Functional Testing | Dimensional Verification | All devices meet dimensional specifications per engineering drawings | All devices met dimensional specifications. |
| Hub Workmanship | All devices meet acceptance criteria for size identification and are free of extraneous matter and process or surface defects | All devices met acceptance criteria for size identification and were free of extraneous matter and process or surface defects. | |
| Inspection for Luer Taper | All samples meet criteria specified in ANSI/HIMA MD70.1-1983 and ISO 594-2 | All samples met the criteria specified in ANSI/HIMA MD70.1-1983 and ISO 594-2. | |
| Tensile Strength (Hub and Shaft Joint) | All devices meet minimum force breakage requirements specified in ISO 11070 | All devices met minimum force breakage requirements specified in ISO 11070. | |
| Tip Deformation, Discoloration, Workmanship | All device tips free of deformation, discoloration, and process or surface defects | All device tips were free of deformation, discoloration and process or surface defects. | |
| Guidewire Test (Compatibility) | Guidewire passes through dilator from hub to tip without drag | All devices met acceptance criteria as the guidewire passed through the dilators from hub to tip without drag from hub end to tip. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes for each non-clinical test (biocompatibility and functional testing). It refers to "test samples," "study animals," and "all test animals" without providing specific numbers. The data provenance is not specified, but these are laboratory-based non-clinical tests, not human data.
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)
This section is not applicable as the document describes non-clinical performance and biocompatibility testing for a medical device, not an AI/ML system requiring expert-established ground truth from images or other clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the reasons stated above. Adjudication methods are relevant for human interpretation tasks, not laboratory device testing.
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
This section is not applicable. The document describes a 510(k) submission for a physical medical device (vessel dilator) and its comparisons to a predicate device based on technological characteristics and non-clinical tests. It does not involve AI or human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This section is not applicable as the device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the biocompatibility tests, the "ground truth" is established by standard biological responses observed in laboratory models (e.g., cell cultures, animal models) under controlled conditions, and interpreted against predefined criteria (e.g., Grade 0 reactivity, no abnormal clinical signs). For functional tests, the "ground truth" is based on engineering specifications and adherence to relevant international standards (e.g., ANSI/HIMA MD70.1-1983, ISO 594-2, ISO 11070).
8. The sample size for the training set
This section is not applicable as the device is not an AI/ML system requiring a training set.
9. How the ground truth for the training set was established
This section is not applicable as the device is not an AI/ML system requiring a training set.
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