(193 days)
LawMax™ Dilator is intended for use in the dilation of the peripheral vasculature.
LawMax™ dilator is intended to dilate the puncture tunnel of the skin, subcutaneous tissue and vascular wall. The device is compised of a dilator tube and a handle connected to its proximal end. There is a lumen in the tube center from distal end to proximal end which can accept a 0.038 inch guide wire. The tube surface is coatings which can reduce the friction during the insertion manipulation. Operator can monitor the tube using fluoroscope guidance. A handle groximal end of the tube is available to facilitate operation. There is a hemostasis valve which can be adjusted to prevent blood leaking. The specification of LawMax™ dilator is definite by the outer diameter of the cylindrical part of the tube.
The provided text is a 510(k) summary for a medical device called the LawMax™ Dilator. This document describes the device, its intended use, comparison to predicate devices, and the testing conducted to demonstrate its substantial equivalence to previously cleared devices.
Based on the nature of the device (a mechanical dilator for peripheral vasculature) and the information provided, it's highly unlikely that the 510(k) submission involved the specific types of AI-related studies and acceptance criteria questions you've asked (e.g., sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details). These questions are typically relevant for AI/ML-enabled diagnostic devices or software as a medical device (SaMD), which the LawMax™ Dilator is not.
The "acceptance criteria" for the LawMax™ Dilator would be that it meets the design specifications and performs as safely and effectively as its predicate devices. The "study that proves the device meets the acceptance criteria" refers to the non-clinical performance testing detailed in the document.
Therefore, I will answer the applicable questions based on the provided text, and explicitly state when a question is not relevant or cannot be answered from the provided information.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test/Criterion | Reported Device Performance Statement |
|---|---|---|
| Performance Tests | Primary Dimension Test | Met all design specifications and was substantially equivalent to the predicate device. |
| Exterior Surface Condition Test | Met all design specifications and was substantially equivalent to the predicate device. | |
| Liquid Leakage Test | Met all design specifications and was substantially equivalent to the predicate device. | |
| Bending Test | Met all design specifications and was substantially equivalent to the predicate device. | |
| Solvent Resistance of Coating | Met all design specifications and was substantially equivalent to the predicate device. | |
| Thickness of Coating | Met all design specifications and was substantially equivalent to the predicate device. | |
| Simulating Test | Met all design specifications and was substantially equivalent to the predicate device. | |
| Connection Strength (tube/handle) | Met all design specifications and was substantially equivalent to the predicate device. | |
| X-Ray Visible | Met all design specifications and was substantially equivalent to the predicate device. | |
| Conical Fitting Test | Met all design specifications and was substantially equivalent to the predicate device. | |
| Sterilization | Sterilization Validation | Met all design specifications and was substantially equivalent to the predicate device. |
| Package Integrity | Met all design specifications and was substantially equivalent to the predicate device. | |
| Endotoxicity Test | Met all design specifications and was substantially equivalent to the predicate device. | |
| Biocompatibility | Cytotoxicity Test | Met all design specifications and was substantially equivalent to the predicate device. |
| Sensitization Test | Met all design specifications and was substantially equivalent to the predicate device. | |
| Intracutaneous Reactivity Test | Met all design specifications and was substantially equivalent to the predicate device. | |
| Acute Systemic Toxicity | Met all design specifications and was substantially equivalent to the predicate device. | |
| Hemolysis Test | Met all design specifications and was substantially equivalent to the predicate device. | |
| Thrombosis Test | Met all design specifications and was substantially equivalent to the predicate device. | |
| Coagulation Test | Met all design specifications and was substantially equivalent to the predicate device. | |
| Pyrogen Test | Met all design specifications and was substantially equivalent to the predicate device. |
Note: The document states that "Performance testing was conducted to validate and verify that the proposed device met all design specifications and was substantially equivalent to the predicate device." For each listed test, this implies that the performance met the specified criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given text. For mechanical devices undergoing performance and biocompatibility testing, sample sizes for specific tests (e.g., number of dilators tested for bending strength, number of animals for biocompatibility) would typically be detailed in the full test reports, but not usually in the 510(k) summary. The concept of "data provenance" (country of origin, retrospective/prospective) is typically associated with clinical data for diagnostic or AI devices, which is not applicable here.
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 question is not applicable to this type of device and its testing. The "ground truth" concept is relevant for AI/ML diagnostic performance evaluation. For a mechanical dilator, performance is assessed through engineering tests and biological safety tests, not subjective expert evaluation of "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable to this type of device and its testing. Adjudication methods are typically used in clinical trials or expert review processes for diagnostic accuracy, which is not relevant for a mechanical dilator.
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 question is not applicable. An MRMC study is done for diagnostic imaging devices where human readers interpret images, often with or without AI assistance. The LawMax™ Dilator is a mechanical dilator, not an imaging or AI-enabled diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The LawMax™ Dilator is a physical medical instrument, not an algorithm or software. Therefore, the concept of "standalone algorithm performance" does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This question is not applicable in the context of device performance as described. The "ground truth" for a mechanical dilator's performance lies in its adherence to pre-defined engineering specifications, material properties, and biological safety standards, as evaluated by direct measurement and standardized test methods rather than expert consensus on a diagnostic outcome or pathology.
8. The sample size for the training set
This question is not applicable. Training sets are used for machine learning algorithms. The LawMax™ Dilator is a mechanical device, not an AI/ML product.
9. How the ground truth for the training set was established
This question is not applicable. As stated above, this device does not involve a training set or AI/ML algorithms.
§ 870.1310 Vessel dilator for percutaneous catheterization.
(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).