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Intended to remove microbiological and particulate matter from the gases in the breathing circuit.

The Iso-Gard Filter Angled/Iso-Gard Filter Straight are breathing circuit bacterial filters intended to remove microbiological and particulate matter from the gases in the breathing circuit as described in 21 CFR 868.5260. This product is substantially equivalent to the Dryden Mini Bacteria Filter.

The Iso-Gard Filter Angled/Iso-Gard Filter Straight are similar in design and function to the Dryden Mini Bacteria Filter with reduced size, dead space and lighter weight. The Iso-Gard Filter Angled/Iso-Gard Filter Straight incorporates a luer port in the housing to allow for connection of carbon dioxide or pressure monitoring equipment. The Iso-Gard Filter Angled also incorporates an angled housing to allow for the option of omitting the connection of angled patient connectors. The bacterial/viral filtration efficiency of the filter medium is 99+% for both the Iso-Gard Filter Angled/Iso-Gard Filter Straight and the Dryden Mini Bacteria Filter.

The provided text is a 510(k) summary for the Gibeck Iso-Gard™ Filter Angled/Iso-Gard™ Filter Straight. This document is focused on establishing substantial equivalence to a predicate device and does not contain detailed information about specific acceptance criteria or a comprehensive study demonstrating direct performance against such criteria. Instead, it relies on comparison to a legally marketed predicate device.

However, based on the information provided, we can infer some aspects and highlight what is missing.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a sample size for a test set or data provenance (e.g., country of origin, retrospective/prospective). The submission relies on a comparison to a predicate device and the claim of substantial equivalence for product performance rather than presenting a new, dedicated clinical or performance study with a specific test set.

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

The document does not mention any specific experts or their qualifications used to establish ground truth for a test set. This type of detail is typically associated with clinical studies or performance evaluations that generate new data, which is not the primary focus of this 510(k) summary.

4. Adjudication method for the test set

The document does not describe any adjudication method for a test set.

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 document is for a medical device (bacterial filter), not an AI or diagnostic imaging device. Therefore, an MRMC study and discussions of human readers improving with AI assistance are not applicable.

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

This document is for a medical device (bacterial filter). It does not involve an algorithm or AI, so the concept of standalone performance for an algorithm is not applicable.

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

The document does not describe specific ground truth establishment for a new study. Instead, the "ground truth" for the submission is the established performance and safety of the predicate device (Dryden Mini Bacteria Filter), which the new device claims to be substantially equivalent to, especially regarding bacterial/viral filtration efficiency. The 99+% filtration efficiency is presented as a known characteristic of both the new device and the predicate.

8. The sample size for the training set

This document is for a medical device and does not involve machine learning algorithms, so there is no training set in the context of AI/ML.

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

As there is no training set mentioned or implied for an AI/ML context, this question is not applicable.

Summary of Device Performance and Substantial Equivalence Basis:

The Gibeck Iso-Gard filter's performance is primarily established by demonstrating "substantial equivalence" to the Dryden Mini Bacteria Filter. The key performance metric mentioned is bacterial/viral filtration efficiency of 99+%. The new device is stated to have this same efficiency while offering improvements in size, dead space, and weight, and incorporating additional features like a luer port. The submission asserts that these changes do not adversely affect safety or effectiveness.

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The Humid-Vent Filter Compact Angled/Humid-Vent Filter Compact Straight are heat and moisture exchangers as described in 21 CFR 868.5375 These products are substantially equivalent to the Gibeck Humid-Vent Filter heat and moisture exchanger.

The Humid-Vent Filter Compact Angled/Humid-Vent Filter Compact Straight are similar in design, materials and function to the Humid-Vent Filter with reduced size, dead space and lighter weight. The reduced dead space of the Humid-Vent Filter Compact Angled/Humid-Vent Filter Compact Straight allows for a tidal volume range of 150-1000 ml.

This document, K964382, is a 510(k) summary for a medical device: Gibeck Humid-Vent® Filter Compact Angled/Humid-Vent® Filter Compact Straight. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving performance against specific acceptance criteria through a study measuring diagnostic or predictive accuracy.

Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment cannot be provided from this document for the following reasons:

• No Diagnostic or Predictive Performance: The device is a "heat and moisture exchanger" (21 CFR 868.5375). Its function is to condition inspired air, not to diagnose, predict, or interpret medical conditions. Therefore, metrics like sensitivity, specificity, AUC, or accuracy, which are typical for AI/ML device acceptance criteria, are not applicable here.
• Substantial Equivalence, Not De Novo Performance Testing: 510(k) submissions primarily focus on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing design, materials, intended use, and performance claims to the predicate, rather than conducting new, large-scale clinical studies to establish novel performance metrics or acceptance criteria for diagnostic accuracy.
• Lack of AI/ML Component: There is no indication that this device incorporates AI or machine learning. The questions provided in the template are highly specific to AI/ML device evaluations.

In summary, the provided document does not contain the information requested because it is a 510(k) summary for a non-AI/ML device, focusing on substantial equivalence rather than diagnostic performance studies.

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The Gibeck, Inc. Warmbag Reusable Convective Warming Blanket is a thermal regulation system as described in 21 CFR 870.5900.

The Gibeck, Inc. Warmbag Reusable Convective Warming Blanket is a thermal regulation system as described in 21 CFR 870.5900.

The provided text is a 510(k) summary for a medical device called the "Gibeck, Inc. Warmbag Reusable Convective Warming Blanket." This document primarily focuses on establishing substantial equivalence to a predicate device, the "TropicAir Reusable Convective Warming Blankets." It does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or any details typically found in a clinical study report for assessing device performance.

Therefore, I cannot provide the requested information based on the input text. The document's purpose is to satisfy regulatory requirements for market approval based on equivalence, not to detail a specific performance study against defined acceptance criteria.

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combination products, i.e. bacterial/viral filters and heat and moisture exchangers

This document is a 510(k) Summary of Safety and Effectiveness for a medical device (Gibeck Iso-Gard® HEPA Filter-HME). It provides information about the device's performance characteristics and its substantial equivalence to a predicate device.

However, the provided text does not contain the information requested for an AI/ML device study. It describes a physical medical device (a filter/heat and moisture exchanger) and its testing against physical performance criteria, not an AI algorithm.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: While there are performance metrics (bacterial/viral filtration efficiency, moisture output), these are for a physical filter, not an AI algorithm.
2. Sample size used for the test set and the data provenance: Not applicable to a physical filter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

This document pertains to the regulatory submission for a physical medical device and its physical performance testing, not to an AI/ML diagnostic or prognostic device study.

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