(329 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
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.
§ 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.