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