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Balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.

The Bantam (280mm balloon lengths) catheter is a standard over-the-wire PTA catheter. The co-axial catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the internal lumen allows access to the distal tip of the catheter for guidewire insertion (max 0.018"). The balloon expands to a known diameter at specific pressure.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Bantam OTW PTA Catheter:

Executive Summary:

The Bantam OTW PTA Catheter (280mm balloon lengths) was cleared through a Special 510(k) pathway, demonstrating substantial equivalence to a predicate device (Bantam K093139). The clearance relies entirely on in vitro testing to show that its technological characteristics and performance criteria are comparable to the predicate. No clinical studies, human-in-the-loop performance, or AI-assisted studies were conducted or required for this type of device clearance.

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" as pass/fail thresholds with specific numerical values for each test. Instead, it describes "performance criteria" that were evaluated through in vitro testing to demonstrate comparability to the predicate device. The reported device performance is implicitly understood to have met these criteria because the device was granted substantial equivalence.

Note: The document states that the results "demonstrate that the technological characteristics and performance criteria... are comparable to the predicate device." This implies that the Bantam (280mm) performed within acceptable ranges relative to the Bantam K093139 for all tested parameters. Specific numerical values for the predicate or the new device are not provided in this summary.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not specify the exact sample size for each in vitro test. It generally states that "in vitro tests were performed."
• Data Provenance: The data is from in vitro testing conducted by Clearstream Technologies Ltd. The country of origin for the data is implicitly Ireland, where Clearstream Technologies Ltd. is located. This is a prospective study in the sense that the testing was performed specifically to support this 510(k) submission, but it is not a clinical (human) prospective study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This was an in vitro engineering performance study, not a clinical study requiring expert ground truth or assessment of cases. The "ground truth" for these tests would be the established engineering standards and methodologies (e.g., ISO 10555-1) and the performance of the predicate device under these same tests.

4. Adjudication Method for the Test Set

Not applicable. As this was an in vitro engineering performance study, there was no human reader or panel involved in adjudicating the "correctness" of the findings in the way one would for a clinical study with subjective interpretations. The tests yield objective measurements against predefined standards or comparisons.

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 submission is for a medical device (PTA catheter), not an AI algorithm.
• No MRMC or human-in-the-loop studies were conducted or required.
• The concept of human readers improving with AI assistance is not relevant to this device.

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

Not applicable. This is a physical medical device. There is no algorithm component to evaluate in a standalone manner.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this submission is based on:

• Engineering standards: Compliance with ISO 10555-1.
• Predicate device performance: The performance of the legally marketed Bantam (K093139) under the same in vitro tests, as the new device is compared to it for "substantial equivalence."
• FDA guidance: Adherence to FDA guidance on non-clinical testing of medical devices.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this type of device.

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Balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.

The Bantam and Bantam & PTA Catheters are standard over-the-wire PTA catheters. The co-axial catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the internal lumen allows access to the distal tip of the catheter for guidewire insertion (max 0.018" and 0.014"). The balloon expands to a known diameter at specific pressure.

The provided document is a 510(k) summary for a medical device (PTA Catheters) and does not describe acceptance criteria, a study proving device meeting acceptance criteria, or any of the specific details requested in the prompt (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance).

Instead, it focuses on:

• Applicant Information: ClearStream Technologies Ltd, contact details.
• Device Information: Trade name (Bantam and Bantam α PTA Catheter), common name, classification, product code.
• Predicate Device: Savvy Long PTA Catheter (K072947).
• Device Description: Standard over-the-wire PTA catheters with a balloon for inflation and a lumen for guidewire insertion.
• Intended Use: Balloon dilatation of femoral, popliteal, and infra-popliteal arteries (excluding coronary arteries).
• Comparison to Predicate Device: Stated as "substantially equivalent."
• Test Data: Mentions safety and effectiveness demonstrated through "non-clinical design verification and design validation tests and analyses," but provides no details on these tests, their results, or acceptance criteria.
• FDA Correspondence: Official letter from FDA granting marketing clearance based on substantial equivalence to the predicate device.
• Indications for Use Form: Reiterates the intended use.

Therefore, I cannot provide the requested information based on the input document. The document primarily serves as a regulatory submission and clearance notice, not a detailed scientific study report.

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The Altimate Medical EasyStand Bantam is intended to assist persons who have difficulty rising from a seated position to a standing position and is indicated for persons weighing between 50 - 100 lbs., including pediatrics.

The EasyStand Bantam is a standing frame for indov use that allows users with various degrees of pirysical disability to ob supported in a suitioning, weight-bearing position. The optional Shadow Tray device is a sit-io stands standing and can be used as a desk/workstation in the seated and/or standing position. The device comes in two il (accommodating individuals ranging in height from 28" – 40" (71cm – 102 cm) and so books (23kg) and small (accommodating individuals ranging in height from 20" – 10 – 10 – 10 – 137 cm - 137 cm) and up to 100lbs (23kg).

The provided document is a 510(k) summary for the EasyStand Bantam, an electric lift chair. It primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory approval. It does not contain information about acceptance criteria, device performance metrics, or a study design to measure such performance, as would be typical for a clinical or performance study of an AI/ML device.

Therefore, I cannot provide the requested information in the format specified. The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets, data provenance (country, retrospective/prospective).
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study or human reader improvement.
6. Standalone algorithm performance.
7. Type of ground truth used (pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

Instead, the document focuses on:

• Device identification: Trade name, common name, classification, manufacturer.
• Intended Use: To assist persons who have difficulty rising from a seated position to a standing position and is indicated for persons weighing between 50 - 100 lbs., including pediatrics.
• Substantial Equivalence: Comparing the EasyStand Bantam to a legally marketed predicate device (Altimate Medical EasyStand Evolv; K062402) based on intended use, construction, and functionality. Key differences noted are user population (pediatric vs. larger persons) and additional features like a gas cylinder for seat elevation and a supine position option.
• Regulatory Status: 510(k) clearance by the FDA (K091242) for marketing the device.
• Performance Standards: States that "Although no performance standards or special controls have been developed to test positioning chairs, Altimate Medical has chosen to test the EasyStand Bantam against the standards as referenced in this submission." (The specific standards referenced are not detailed in the provided pages).

This document serves as regulatory submission for device marketing authorization, not a clinical or performance study with the detailed metrics you've requested for an AI/ML device.

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