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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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