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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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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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