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To relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue.

The bathing system consists of a tub composed of fiberglass, which is covered by a panel containing all the integrated technical controls of the system. The bathing system is offered with or without a tub height positioning system, tub tilt system, hydro massage and an integrated disinfection system. The bathing system is not a sterile device.

The provided text is a 510(k) summary for the ArjoHuntleigh Parker 500 Immersion Hydrobath. This document details the device's classification, its substantial equivalence to predicate devices, and its intended use. However, it does not contain information regarding acceptance criteria for device performance or studies that prove the device meets such criteria.

The 510(k) process in the US often relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new performance studies with specific acceptance criteria that are then met by the new device. This submission states:

"Parker 500 uses the same fundamental technology features and safety functionalities as the Parker Bath Systems (K964926), Century/Safiift Whirlpool bathing system (K930624) and (K930665). Rhapsody (K001079). Therefore, it is concluded that there is no significant difference in the basic function, safety and efficacy between the Parker 500 and the predicate devices."

This indicates that the primary method of demonstrating safety and effectiveness was through comparison to existing, cleared devices, rather than through a new clinical or performance study with defined acceptance criteria.

Therefore, I cannot provide the requested information from the given text.

To reiterate, the following data points are not present in the provided document:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for the test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Information about standalone (algorithm-only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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To relieve pain and itching and as an aid in the healing process of inflamed and traumatized tissue, and it serves as a setting for removal of contaminated tissue

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This document is a 510(k) clearance letter from the FDA for an "Immersion hydrobath." It signifies that the device is substantially equivalent to a legally marketed predicate device. However, this type of regulatory document does not typically contain the detailed information required to describe acceptance criteria and a study proving device performance as requested.

The letter focuses on regulatory approval, referencing existing regulations and indicating that the device can be marketed. It does not include:

• A table of acceptance criteria and reported device performance.
• Details about a specific study (sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set information).

Therefore, based solely on the provided text, I cannot extract the information required to answer your prompt. This document is a regulatory approval, not a performance study report.

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The EMI mBath and eBath is a Product that consists of water agitators and a tub that is used in the bathing of an individual, by an attendee, in either a commercial or residential setting.

The eBath uses a microprocessor to control water filling and emptying, while the mBath uses manual gages. The eBath offers temperature monitoring, with an integrated AC powered hydraulic lift and transport chair in which an attendant can use to assist an individual. The Product is available in both 60" and 70" lengths along with an optional door and weight scale.

This document is a 510(k) clearance letter from the FDA for a medical device called the "EMI Bath." It does not contain any information about acceptance criteria, device performance testing, or studies that prove the device meets acceptance criteria.

The letter primarily states that the FDA has reviewed the premarket notification and determined the device to be substantially equivalent to legally marketed predicate devices. It lists the trade name, regulation number, regulatory class, and product code, and then outlines the general controls and regulations that the manufacturer must comply with.

Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory approval, not a technical report detailing performance studies.

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The Pacific Bath is intended for bathing patients and/or residents of nursing homes, hospitals, and assisted living facilities. These baths are to be given by trained personnel only. The Pacific Bath will not be marketed for therapeutic or other medical uses.

Pacific Recumbent Height Adjustable Bath

This document is a 510(k) clearance letter from the FDA for a medical device called the "Pacific Recumbent Height Adjustable Bath." It confirms that the device is substantially equivalent to legally marketed predicate devices.

The document does not contain information about acceptance criteria, device performance, ground truth, study design, or sample sizes related to the technical performance or clinical effectiveness of the device.

This type of FDA letter is primarily for regulatory clearance based on substantial equivalence to existing devices, meaning it likely relies on the established safety and performance of those predicate devices rather than requiring new, extensive performance studies with acceptance criteria as one might see for novel technologies or for specific performance claims.

Therefore, I cannot provide the requested information from this document.

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The Cascade Bath is intended for bathing patients and/or residents in nursing homes, hospitals, and assisted living facilities. These baths are to be given by trained personnel only.

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This document is a 510(k) premarket notification from the FDA to Penner Manufacturing Inc. regarding their Cascade Bath Model 6900. It's a clearance letter, not a study report. Therefore, it does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.

The document's purpose is to state that the FDA has reviewed Penner Manufacturing's notification and determined that the Cascade Bath Model 6900 is "substantially equivalent" to legally marketed predicate devices, allowing them to market the device.

To answer your request, information from a separate study report or regulatory submission (that would have been part of Penner Manufacturing's 510(k) submission but is not included here) would be needed.

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The Superior Bath is intended for bathing patients and/or residents of nursing homes, hospitals, and assisted living facilities. These baths are to be given by trained personnel only.

Superior Bath Model 6300

I apologize, but the provided text from the FDA 510(k) clearance letter for the "Superior Bath Model 6300" does not contain any information regarding:

• Acceptance criteria for performance.
• Results of a study to prove the device meets acceptance criteria.
• Details about sample sizes (training or test sets).
• Data provenance.
• Number or qualifications of experts.
• Ground truth establishment or type.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.

The document is a standard FDA clearance letter confirming that the device, a bath for patients, is substantially equivalent to a legally marketed predicate device. It defines the "indications for use" as "The Superior Bath is intended for bathing patients and/or residents of nursing homes, hospitals, and assisted living facilities. These baths are to be given by trained personnel only."

Therefore, I cannot fulfill your request for the tables and study details based on the information provided in the input.

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The intended use of this device is the bathing and hygiene of residents/patients in hospitals, nursing homes, or assisted living facilities. The indications for use are the necessity and advisability of a clean and healthy environment in these facilities to prevent the spread of disease.

The safety and usefulness of the VÄNNA Bathing System is based on a long history of use of hydro-baths with similar characteristics. As referred to previously the VÄNNA Bathing System uses similar technology and components as other devises already on the market. Technological updates have been used in the VÄNNA Bathing System in the temperature sensor and temperature read-out indicators but these differences enhance the reliability of this devise.

This document is a 510(k) summary for the VÄNNA Bathing System, asserting its substantial equivalence to other legally marketed hydro-baths. It does not contain information about specific acceptance criteria, a study proving those criteria, or the detailed aspects of a clinical study (like sample sizes, ground truth establishment, or expert involvement) typically associated with software or AI/ML device submissions.

The 510(k) essentially states:

• Device: VÄNNA Bathing System (a hydro-bath).
• Basis for Equivalence: Long history of use of similar hydro-baths, similar technology and components to existing devices (Century Bathing System, Sanitas Bathing System, Smart Tub).
• Technological Updates: Temperature sensor and temperature read-out indicators, which enhance reliability.
• Intended Use: Bathing and hygiene of residents/patients in hospitals, nursing homes, or assisted living facilities, to prevent the spread of disease.

Therefore, I cannot provide the requested information because the provided text does not describe a study with acceptance criteria or performance metrics for a device that uses AI/ML or requires such detailed clinical validation. The submission is focused on demonstrating substantial equivalence to predicate devices based on design and intended use, not on proving performance against specific quantitative criteria through a study.

The questions in your prompt are highly relevant for software and AI/ML medical devices that undergo rigorous performance evaluation. This document describes a physical medical device (a bathing system) where the "acceptance criteria" are implied by its functional similarity and safety record to existing, predicate devices rather than a set of measurable performance targets.

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Bath for the bathing of disabled persons.

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This is a letter from the FDA to Medi-Man Rehabilitation Products, Inc. regarding their A-2000 Bathing Systems; Hydrosonic Bathing System (K992779). The letter states that the device has been reviewed and determined to be substantially equivalent to devices marketed prior to May 28, 1976. This allows Medi-Man Rehabilitation Products to market the device.

The document does not contain information about acceptance criteria or a study that proves the device meets acceptance criteria. It is a regulatory approval letter based on "substantial equivalence" to a predicate device, not a performance study. Therefore, I cannot provide the requested information.

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Hydrotherapy; Relieve pain and itching.

Hydrotone-Thermal Capsule System

The provided document is a 510(k) clearance letter from the FDA for the Hydrotone-Thermal Capsule System. It confirms that the device is substantially equivalent to a legally marketed predicate device for the indicated uses. However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter focuses on regulatory clearance, indicating the device can be marketed. It lists the "Indications for Use" as "Hydrotherapy; Relieve pain and itching." and provides contraindications. It does not include any performance metrics, study design, or results that would typically be found in a study demonstrating the device meets specific acceptance criteria.

Therefore, I cannot provide the requested information based on the given text. The document does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test sets.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies or effect sizes.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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