(301 days)
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.
§ 890.5100 Immersion hydrobath.
(a)
Identification. An immersion hydrobath is a device intended for medical purposes that consists of water agitators and that may include a tub to be filled with water. The water temperature may be measured by a gauge. It is used in hydrotherapy 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.(b)
Classification. Class II (special controls). The device, when it is a hydromassage bath or a powered sitz bath, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.