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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

Not Found

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 Silcraft XTank? Mobile Extremity Whirlpool System ("the Silcraft XTank") and Ferno's Ferno IIIe Hi-Lo Jr. Whirlpool System ("Ferno IIIe") are intended to be used for hydromassage of the user's extremities.

The Silcraft XTank2 and the Ferno IIIe have very similar technological characteristics. Each of these device primarily consists of the following components: (1) a tank to be filled with water; (2) a fill hose; (3) a base with four castors or wheels: (4) a handle to lift the device: (5) a control console; (6) a whirlpool motor: (7) whirlpool jets; (8) a power drain pump; (9) a manual drain and handle; and (10) a power supply cord.

The provided text is a 510(k) Summary for the Silcraft XTank2 Mobile Extremity Whirlpool System, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of submission, by its nature, does not involve clinical studies with acceptance criteria, performance metrics, or ground truth establishment in the way typically seen for novel medical devices or AI algorithms.

Instead, the submission focuses on demonstrating equivalence in intended use, principles of operation, and technological characteristics to an already approved device. Therefore, most of the requested information regarding acceptance criteria and a study proving performance is not applicable to this document.

Here's an explanation based on the provided text:

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

• Not Applicable. This document does not present acceptance criteria or reported device performance in the context of a clinical study or performance-based evaluation against specific metrics. The "performance" is implicitly demonstrated through the comparison of its technical characteristics and intended use to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. No test set or patient data was used in this type of submission. The evaluation is based on technical specifications and comparison to a predicate device.

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)

• Not Applicable. Ground truth for a test set is not established in this type of regulatory submission. The FDA reviews the provided information for substantial equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No test set or adjudication method 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

• Not Applicable. This device is an extremity whirlpool system, not an AI algorithm. Therefore, an MRMC study or any assessment of AI assistance is irrelevant.

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

• Not Applicable. This is not an algorithm; it is a physical medical device.

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

• Not Applicable. Ground truth, in the context of clinical validation, is not relevant to this submission. The "ground truth" for the FDA's decision is whether the device is substantially equivalent to a predicate device based on its design, intended use, and operational principles.

8. The sample size for the training set

• Not Applicable. No training set for an algorithm is used.

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

• Not Applicable. No training set or ground truth establishment for a training set is relevant.

Summary Basis for the Finding of Substantial Equivalence (from the document):

The safety and effectiveness of the Silcraft XTank2 is based on the long history of use of hydrobaths with very similar technological characteristics. The Silcraft XTank2 and the 510(k) cleared Ferno IIIe have the same intended use and very similar principles of operation and technological characteristics. Moreover, the minor technological differences between the Silcraft XTank2 and the Ferno IIIe, namely the Silcraft XTank's use of castors instead of wheels, the additional ¼ horsepower of the device's whirlpool motor, its four additional whirlpool jets, and its electrical requirement of 5 more volts, do not raise any new questions of safety or effectiveness. Thus, the Silcraft XTank is substantially equivalent to the Ferno IIIe.

In essence, for this 510(k) submission, the "acceptance criteria" are demonstrating substantial equivalence to a predicate device, and the "study" is the comparative analysis presented in the document itself.

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Models 2001, 3700D, 3600, and 3600XL: Full immersion bathing and hydromassage of the lower extremities of patients in a sitting position.

Models 2300 and 3300: Full immersion and hydromassage of patients in a sitting position.

Models 4300, 5300, 4400SS, and 5400SS: Full immersion bathing and hydromassage of patients in a reclining position.

Ten of the eleven models of the Silcraft Whirlpool System and all of the predicate devices consist primarily of the following components: (1) a tub; (2) a shower wand; (3) a control console; (4) a water temperature control; (5) a whirlpool motor; (6) multiple whirlpool jets; and (7) a built-in automatic or manual disinfection system. One models does not have a built-in disinfection system.

Each model of the Silcraft Whirlpool System and all of the predicate devices are labeled for use with one or more patient lift and/or transfer devices, including certain Silcraft transporters and lifts ("the Silcraft Patient Lift").

The provided text is a 510(k) premarket notification for the Silcraft Whirlpool System, seeking substantial equivalence to existing predicate devices. It does not contain information about acceptance criteria or a study proving the device meets performance criteria in the way a clinical trial or algorithm validation study would. Instead, the submission relies on demonstrating substantial equivalence based on similar intended use, principles of operation, and technological characteristics to legally marketed predicate devices.

Therefore, many of the requested sections (acceptance criteria table, sample size, expert qualifications, adjudication method, MRMC study, standalone performance, ground truth type, training set size, and ground truth establishment for training set) are not applicable to this type of regulatory submission.

Here's a breakdown of the information that can be extracted versus what is not present:

Information Present in the Document:

1. Acceptance Criteria and Reported Device Performance: This document does not establish specific acceptance criteria or report performance data as would be found in a clinical study of a novel device. The "acceptance criteria" here is effectively the demonstration of "substantial equivalence" to predicate devices based on intended use, principles of operation, and technological characteristics. The "reported device performance" is implicitly that it performs similarly to the predicate devices for bathing and hydromassage.

   • Acceptance Criteria (Implicit): Substantially equivalent intended use, principles of operation, and technological characteristics to legally marketed predicate devices.
   • Reported Device Performance (Implicit): Functions for bathing and hydromassage as existing whirlpool systems. Minor technological differences do not raise new questions of safety or effectiveness.

2. Sample Size used for the test set and the data provenance: Not applicable. This is not a study involving a test set of data. The "test set" in this context is the Silcraft Whirlpool System itself, being compared to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" was established by experts for a test set in this 510(k) submission.

4. Adjudication method: Not applicable. There was no adjudication process for a test set. The FDA reviews the submitted comparison to predicate devices.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not applicable. This is not a study comparing human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, not applicable. This is a medical device, not an algorithm.

7. The type of ground truth used: Not applicable. There is no concept of "ground truth" in the context of a 510(k) submission based on substantial equivalence to existing hydrobaths. The "truth" is that the predicate devices are legally marketed and considered safe and effective for their intended use.

8. The sample size for the training set: Not applicable. There is no training set mentioned or used.

9. How the ground truth for the training set was established: Not applicable.

Summary based on the provided document:

The Silcraft Whirlpool System obtained regulatory clearance (K971593) by demonstrating substantial equivalence to several legally marketed predicate devices. The basis for this finding was the shared intended use (bathing and hydromassage), similar principles of operation, and similar technological characteristics as the predicate devices. The document explicitly states that "minor technological differences... do not raise any new questions of safety or effectiveness."

For the Silcraft Disinfectant, substantial equivalence was based on its EPA registration and compliance with relevant EPA and FDA guidance for general purpose disinfectants.

The submission does not involve clinical studies with acceptance criteria, test sets, or expert ground truths for performance evaluation of "device meets the acceptance criteria" in the way one might expect for a novel diagnostic or therapeutic device or AI algorithm. Instead, the "study" is implicitly the comparative analysis presented in the 510(k) submission, comparing the new device to existing, legally marketed devices.

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

The Parker Bath System consists of a fiberglass base unit and a movable fiberglass tub unit. The base unit contains the air spa blower unit and the battery pack, charger, and electro-hydraulic unit for moving the tub on models with electro-hydraulic powered movement. The tub unit contains the thermostatically controlled water mixing valve, shower hose, soap dispenser and air jet system. Some of the Parker Bath System models allow the tub to be moved vertically for ease of entry/exit of the patient and for ease of access for the caregiver. The vertical movement is powered either by a manual hydraulic pump or a 24 VDC battery powered electro-hydraulic pump unit. The tub units can all be tilted from an upright position for entry/exit/podiatry therapy to a fully reclined position for full body bathing/therapy. The tilting is powered either by a manual hydraulic pump or a 24 VDC battery powered electro-hydraulic pump unit. The patient enters the tub though a pivoting side door and sits on a molded in seat while the tub is in the upright position. The footwell of the tub can be prefilled with warm water through the thermostatically controlled mixing valve prior to the patient entering the tub. After the door is closed and latched, the air spa blower can be turned on for podiatry and lower leg hydromassage therapy, or the tub can be reclined, allowing the water to flow up and around the patient at which point bathing can be done using the integral shower hose or the air spa blower can be turned on for a full body hydromassage. After the bath the tub is tilted to the upright position, the water flows back to the footwell and the patient can be dried off and clothed while the water flows out the drain in the footwell.

The provided text is a 510(k) summary for the Parker Bath System, a medical device. This document is a premarket notification to the FDA, not a study report. It describes the device, its indications for use, and its substantial equivalence to predicate devices. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies (MRMC or standalone).

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The output table and requested information fields will be empty or state that the information is not present.

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

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Information not available in the provided text.

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)
Information not available in the provided text.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Information not available in the provided text.

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
Information not available in the provided text. This device is a bathing system, not an AI-assisted diagnostic tool, so an MRMC study with AI assistance is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Information not available in the provided text. This device is a bathing system, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Information not available in the provided text.

8. The sample size for the training set
Information not available in the provided text.

9. How the ground truth for the training set was established
Information not available in the provided text.

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to aid in adding moisture to necrotic areas in order to aid in the debridement of wounds, to aid in the relief of pain and discomfort, to aid in the cleansing of open wounds, and as a form of physical therapy for certain types of pathologies.

The Banks Hydro-Therapy Chair provides whirlpool therapy in the home so that patients do not require unnecessary hospitalization or require transportation to a hospital. The Banks Hydro-Chair comprises: a chair for supporting the patient, the chair may comprise a backrest, armrest, seat and frame; a hydro-pad, suction cups for removably fastening the chair to a bath tub, the lateral stability of the chair may be increased by a Stable Bar that is removably fastened to the backrest and a corresponding side wall of the bath in which the whirlpool therapy is taking place. The Hydropad is connected at the base of the Chair and the posterior opening of the Hydro-pad connects to a hose(typically rubberized tubing)) which is connected to a blower motor which exerts a powerful pressure of air circulating through the ports of the Hydro-pad. Streams of water jet through the ports causing a swirling motion of the water in which the Hydro-pad is immersed. The Chair is also composed of a seat portion and the Chair is open so jets of water can reach the sacral, coccyx, rectum, groin and vaginal areas of the patient utilizing the Hydro-Therapy Chair. The seating and backing of the Chair are made of soft polyethylene material to prevent undue pressure to the skin during therapy. For handicapped and disabled persons, the arm frames of the Chair are easily removable.

This 510(k) summary for the Banks Hydro-Therapy Chair does not include any information about acceptance criteria or a study proving the device meets them.

The document explicitly states:

"Pursuant to 809.92(b)(1)-(3), applicant believes no assessment of performance data is necessary."

Therefore, I cannot provide the requested information. The device's submission to the FDA was based on substantial equivalence to a predicate device (Ferno-Washington, Inc. "Ferno-Ille-Hi-Lo, Jr.™") without the need for new performance data.

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