(156 days)
The purpose of the HT-Wedge is to pneumatically lift and position the head and chest of a patient who is lying in the supine position without manual lifting.
The HT-Wedge is an inflatable wedge with square headrest and two intake appendages, one for the head and one for the chest. An inflation/deflation valve is found in each appendage. There is also a tongue attached to the wedge that lies under the patient's buttocks. The inflatable portion of the product is 22" wide and 31 1/4" long. There are four attachment straps, two located on each side of the wedge in order for it to be secured to the OR table. The tongue adds an additional 20" in length. The wedge is constructed of polyurethane coated nylon with 2 one-way, inflation/deflation valves.
This document is a 510(k) summary for a medical device (HT-Wedge), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance data against specific quantitative acceptance criteria typically seen for diagnostic AI/ML devices.
Therefore, the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, the number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully extracted from the provided text.
The document indicates that "Safety Testing and performance characteristics have been conducted and successfully completed in order to ensure compliance with specifications," but it does not provide the specific specifications or the results of these tests. It relies on citing compliance with voluntary standards (ISO 10993) for biocompatibility rather than performance metrics related to lifting and positioning.
Here's a breakdown of what can be inferred or directly stated from the provided text, and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred from 510(k) context) | Reported Device Performance (from document) |
|---|---|
| Functional Equivalence: Device must perform the same intended function as the predicate device. | "The purpose of the HT-Wedge is to pneumatically lift and position the head and chest of a patient who is lying in the supine position without manual lifting." "The HoverTech International® HT-Wedge is substantially equivalent to the HoverJack air patient lift... in function and intended use." "The basic technology is exact since they both require the same UL Listed air supply and make use of the same one-way inflation valve." "The basic technology and performance characteristics of these systems are the same." |
| Safety: Device must not raise new issues of safety compared to the predicate device. | "The differences described in the submission between the HoverTech International® HT-Wedge and that of the predicate devices do not raise any new issues of safety or effectiveness." "Safety Testing and performance characteristics have been conducted and successfully completed in order to ensure compliance with specifications. These reports are maintained as required by 21 CFR 820, Quality Systems Regulations." "An assessment of known and reasonable hazards has been conducted to ensure that any risk associated with the device as of the date of product release is as low as reasonably possible." Compliance with ISO 10993 (biocompatibility) standards (Part 5: Cytotoxicity, Part 10: Irritation and Sensitization, Part 1: Evaluation & testing within a risk management process) is stated as voluntary standards adhered to. This addresses material safety from patient contact. |
| Effectiveness: Device must be as effective as the predicate device for its intended use. | "The differences described in the submission between the HoverTech International® HT-Wedge and that of the predicate devices do not raise any new issues of safety or effectiveness." The overall conclusion is "The HT-Wedge and its predicate device included in this submission are substantially equivalent." |
| Compliance with Regulations/Standards: Device must meet applicable regulatory requirements and voluntary standards. | "These reports [Safety Testing and performance characteristics] are maintained as required by 21 CFR 820, Quality Systems Regulations." "The device will comply with the following voluntary standards: ISO 10993-5, ISO 10993-10, ISO 10993-1." Compliance with regulations for medical devices (e.g., annual registration, listing, good manufacturing practice, labeling, medical device reporting) is mentioned in the FDA letter. |
| Mechanical Performance (e.g., lift capacity, inflation time, durability): (Implicit for a patient lift) | The document states "Safety Testing and performance characteristics have been conducted and successfully completed to ensure compliance with specifications," but does not detail these specifications or the results. It implies equivalence to the predicate in "basic technology and performance characteristics" but provides no quantitative data. |
2. Sample Size Used for the Test Set and Data Provenance:
- Not Applicable / Not Provided. This summary is for a physical patient lift, not an AI/ML device relying on a test set of data (e.g., images). The "testing" referred to is likely engineering and safety testing on the device itself, not a dataset.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not Applicable / Not Provided. Ground truth establishment by experts is relevant for diagnostic AI/ML algorithms. For this physical device, "ground truth" would relate to its engineering specifications and safety, verified through manufacturing processes and compliance with standards. "Design review has been conducted by a cross-functional team, including but not limited to regulatory, quality, engineering and manufacturing," but detailed qualifications or number of individuals are not specified.
4. Adjudication Method for the Test Set:
- Not Applicable / Not Provided. This applies to expert review of data, not physical device testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. This is a physical patient lift, not a diagnostic AI assistance system. MRMC studies are used to evaluate human reader performance with and without AI assistance in diagnostic tasks.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Not Applicable. This is not an algorithm. Performance relates to its mechanical and functional specifications.
7. The Type of Ground Truth Used:
- For this device, "ground truth" would be internal engineering specifications, safety standards (e.g., biocompatibility standards like ISO 10993), and the performance characteristics of the legally marketed predicate device. The document implies that the device performs as designed and meets safety standards, and that its performance is equivalent to the predicate.
- The document explicitly mentions "Safety Testing and performance characteristics have been conducted and successfully completed in order to ensure compliance with specifications." These specifications are the "ground truth" the device was tested against, but the detailed specifications themselves are not provided in this 510(k) summary.
8. The Sample Size for the Training Set:
- Not Applicable / Not Provided. There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable / Not Provided. (See point 8)
§ 880.5500 AC-powered patient lift.
(a)
Identification. An AC-powered lift is an electrically powered device either fixed or mobile, used to lift and transport patients in the horizontal or other required position from one place to another, as from a bed to a bath. The device includes straps and slings to support the patient.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.