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510(k) Data Aggregation
(156 days)
D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INT'L
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)
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(101 days)
D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INT'L
The device is a motorized device intended for medical purposes to assist in transfer of a patient to and from beds, chairs, treatment facilities, wheelchairs or transport vehicles.
The HoverTech International Transformer is a battery powered patient transport device with a motorized drive to aid the caregiver in maneuvering the device while transporting patients within care facilities. Its intended function and use is to transport patients to various areas within the patient care facility and may contain supports for fluid infusion equipment. It can also be used to support the patient in a seated or supine position during examinations, physical therapy and other clinical activities within the patient care facility. The adjustability of the Transformer allows for better patient access by caregivers and also provides for enhanced patient comfort.
The provided text describes a 510(k) summary for the HoverTech International® Transformer, a battery-powered patient transport device. However, it does not contain the specific information required to answer your request about acceptance criteria and a study proving the device meets them.
Here's why and what information is missing:
- Acceptance Criteria and Reported Device Performance: The document states that "Safety Testing and performance characteristics have been conducted and successfully completed in order to ensure compliance with specifications." However, it does not list what those specific specifications or acceptance criteria are, nor does it provide the results or reported performance of the device against them. It only mentions compliance with voluntary standards like IEC and UL for safety and biocompatibility. These are general standards, not specific performance metrics for this particular device.
- Sample Size, Ground Truth, Adjudication, MRMC, Standalone Studies, Training Set: All of these data points are typical for studies evaluating diagnostic or predictive algorithms/devices, especially in fields like medical imaging. Since the HoverTech International® Transformer is a physical patient transport device (a powered wheeled stretcher), these types of studies (MRMC, standalone algorithm performance, training/test sets for AI, ground truth establishment by experts/pathology) are not applicable to this device's regulatory submission as described.
Summary of missing information:
- Table of acceptance criteria and reported device performance: Not provided. The document generally states "compliance with specifications" and "safety testing," but no specific metrics or results are reported.
- Sample size used for the test set and data provenance: Not applicable in the context of this physical device.
- Number of experts used to establish the ground truth for the test set and qualifications: Not applicable.
- Adjudication method: Not applicable.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance study: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
What is present in the document is a declaration of compliance with general safety and electrical standards:
- Voluntary Standards the device will comply with:
- IEC 60601-1 (General Requirements for Safety)
- IEC 60601-1-2 (Electromagnetic Compatibility)
- IEC 60601-2-38 (Safety of Electrically Operated Hospital Beds - applicable parts only for loading and pinch points)
- UL 2601-1 (Standard for Medical Electrical Equipment)
- CAN/CSA C22.2 No. 601.1-M90 (Standard for Medical Equipment)
- ISO 10993-5 (Biocompatibility - In Vitro cytotoxicity)
- ISO 10933-10 (Biocompatibility - irritation and sensitization, delayed type hypersensitivity)
The document concludes that the device is "substantially equivalent" to a predicate device (Transmotion Medical Model TMM6 Power Drive Chair) based on "intended use, basic technology, and performance characteristics." The "performance characteristics" are implied to be met through the safety testing and compliance with the listed voluntary standards, but no specific performance data is disclosed in this summary.
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