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To create a percutaneous dilational tracheostomy using guidewire, dilators, and components of this product which allows for tracheal access for airway management.

The new kit is designed to permit percutaneous creation of a tracheostomy stoma for subsequent insertion of a size 7, 8 or 9mm tracheostomy tube. The kit contains all of the standard components to which the users are accustomed from use of the Rusch predicate device: scalpel, gauze swabs, needle and cannula, syringe, guidewire, guiding catheter, short pre-dilator and set of serial dilators which are also used for introduction of the tracheostomy tube.

The provided text is a 510(k) summary for a medical device (Percutaneous Dilation Tracheostomy Kit) seeking market clearance. In 510(k) submissions, the primary "acceptance criterion" is often substantial equivalence to a predicate device, rather than specific performance metrics demonstrated through controlled studies with explicit acceptance criteria.

The 510(k) process focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. This is typically achieved by comparing technical characteristics and indications for use, and sometimes through performance testing if the device introduces new technology or significantly different characteristics.

Based on the provided text, here's an analysis structured around your request:

1. A table of acceptance criteria and the reported device performance

The submission does not explicitly list quantitative "acceptance criteria" in the way one might expect for an AI/algorithm-based device (e.g., AUC > X, sensitivity > Y). Instead, the core acceptance criterion is substantial equivalence to predicate devices. The "reported device performance" is essentially the claim of having similar technical characteristics and safety/effectiveness as the predicates.

2. Sample size used for the test set and the data provenance

The document does not describe a clinical "test set" in the context of an algorithm or diagnostic device. For this type of physical medical device, "testing" likely refers to bench testing, biocompatibility testing, material testing, and potentially limited cadaver or animal testing (though not explicitly detailed here). There is no mention of a "test set" in terms of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to the provided 510(k) summary. The submission focuses on product design, materials, and comparison to predicates, not on establishing ground truth for a diagnostic algorithm.

4. Adjudication method for the test set

Not applicable, as no test set in the diagnostic sense is described.

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 is not applicable. The device is a physical tracheostomy kit, not an AI or imaging-related device that would be subject to such a study design.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable, as the device is a physical kit, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For this device, the "ground truth" to be demonstrated is largely based on the established safety and performance of its predicate devices and the physical characteristics/materials meeting design specifications.

8. The sample size for the training set

Not applicable, as there is no "training set" for an algorithm described.

9. How the ground truth for the training set was established

Not applicable.

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The Bolton PTA Catheter is indicated for percutaneous transluminal angioplasty of narrowed or obstructed peripheral arteries such as the iliac, femoral, iliofemoral, renal, popliteal, tibial, tibioperoneal, infrapopliteal, peroneal, and profunda vessels and for treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is not intended for use in the coronary arteries.

The Bolton PTA Catheter is a single use, dual lumen, percutaneous, angioplasty catheter with a distally mounted semi-compliant balloon for the dilatation of narrowed peripheral vessels. The dual lumen consists of a balloon lumen and a guidewire lumen with two radiopaque to aid in balloon positioning. The catheter is packaged sterile and is nonpyrogenic.

The provided text is a 510(k) summary for the "Bolton PTA Catheter". This document outlines the premarket notification for a medical device and its substantial equivalence to previously approved devices. It is a regulatory filing, not a study report. Therefore, it does not contain any information regarding acceptance criteria, device performance metrics, sample sizes, expert involvement, or any form of clinical study data as typically described in the context of AI/ML models.

The document specifically states:

• "Summary of Non-Clinical Testing: Bench testing was conducted... The results of the bench and biocompatibility tests demonstrate that the Bolton PTA catheter is safe and effective for its intended use."

This indicates that non-clinical (bench and biocompatibility) testing was performed to demonstrate safety and effectiveness, which is typical for a Class II medical device undergoing 510(k) clearance. However, it does not provide the specific acceptance criteria or the study results in the format requested, particularly concerning diagnostic performance metrics like those for an AI/ML device.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert involvement, or multi-reader multi-case studies, as this information is not present in the provided text.

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