(72 days)
The Air-Flex is a multi-function physical therapy table intended for medical purposes that consists of a motorized table which can be equipped to provide patients with powered distraction, powered flexion and muscle relaxation therapy.
The AIR-FLEX with AUTO-DISTRACTION is a modification of the AIR-FLEX table originally cleared under K932810 on 02/17/1995. This new platform will replace the model originally cleared under K932810.
The device is a Hi-Lo multi-function physical therapy table as defined under 21 CFR 890.5880. Neither the proposed device nor the predicate device provides heat.
The proposed device differs from the predicate device in that it utilizes precision pneumatic actuators for distraction force and positioning rather than electric motors that were used on the predicate. The height adjustment of the proposed device is performed using the same electric motor as the predicate.
The proposed device has a new, optional automatic cycling mode intended to provide intermittent distraction and flexion.
Additionally, the AIR-FLEX with AUTO-DISTRACTION can be configured with up to four pneumatically dropped sections including cervical (straight down and forward motion), thoracic, lumbar and pelvic. Each drop is activated by pressing a clearly marked button and is executed via a foot pedal.
An Air-thoracic Breakaway (with release) allows for a thoracic recoil movement and features an adjustable air tension spring controlled by a foot pedal allowing the spring to lock at any point down to 5.5 inches. This allows the use of the table with patients with large abdominal areas. The Air-Breakaway can be combined with thoracic and lumbar drop.
The proposed device can be fitted with an elevation headpiece. This raises up to 5 inches and is fitted with a tilting section. Manual or Air-activated drops can be added as options.
The activation of the selected drop can be made by footswitches or optional cocking foot strips. The AIR-FLEX with AUTO-DISTRACTION table is configured to match the owner's preferences.
The optional Auto-Flex allows the therapist to treat patients manually (for which the AIR-FLEX table is already cleared) or easily switch to AUTO-FLEX for motorized flexion. The stroke (controls the amount of flexion) can be adjusted.
The patient lies prone on the treatment surface and the patent is secured around the waist using a seat-belt type strap with quick release buckle to the stationary part of the table. The ankles are secured using straps to the movable part of the table. Once the therapist is sure that the patient is properly secured, the therapist unlocks the movable section and sets the distraction force, which is read on a gauge on the table. The therapist has the option to perform manual cycling and, where the table is configured with the automatic cycling module, can now set the overall treatment time, relax level, the rate to increase, time to hold (Pull Time) and the time to rest (Rest Time).
This 510(k) premarket notification for the "Air-Flex with Auto-Distraction" device is a submission for a modification of an already cleared device (K932810). For such modifications, the primary focus of the submission is to demonstrate substantial equivalence to the predicate device, rather than proving efficacy from scratch with a new clinical study.
Therefore, the document does not contain a typical study that would "prove the device meets acceptance criteria" in the way a new device submission or a premarket approval (PMA) would. Instead, the "acceptance criteria" are implicitly met by demonstrating that the new features do not introduce new safety or effectiveness concerns and perform similarly to features on the predicate or well-understood mechanisms.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for a modified device proving substantial equivalence, formal "acceptance criteria" in the sense of performance targets from an efficacy study are not explicitly stated in this document. The "performance" is primarily assessed by comparing technological characteristics and safety features to the predicate device and relevant consensus standards.
| Feature/Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Distraction Force | Must provide the same total amount of distraction force as the predicate device (K932810). | The total amount of distraction force is the same as the predicate device. Provided by a pneumatically (air) powered linear actuator, replacing electric motors. Uses a precision, high reliability load cell for force feedback to a microprocessor, similar to the predicate. |
| Automatic Cycling | Must safely and controllably provide intermittent distraction and flexion. | Microprocessor-controlled automatic cycling allows adjustment of overall treatment time, relax level, rate to increase, time to hold (Pull Time), and time to rest (Rest Time). |
| Safety Features | Must include safety mechanisms comparable to or improved from the predicate, especially regarding patient discomfort and electrical safety. | Patient-held cut-out switch immediately aborts treatment and gradually bleeds off traction force if pressed. An alarm sounds, and treatment cannot start if the switch is not attached or is defective. Electrical isolation via transformers and power supplies brings voltage for motors, valves, and switches to 24 Volts D.C. Safety Extra Low Voltage (SELV), mirroring the original Air-Flex table. |
| Material/Construction | Materials should be the same or similar to the predicate. | The materials used in construction (frame, upholstery) are the same or similar. |
| Compliance to Standards | Designed to comply with relevant consensus standards. | Designed to comply with IEC 60601-1 (Medical Electrical Equipment - Part 1: General Requirements for Safety). |
2. Sample Size Used for the Test Set and Data Provenance
No test set or clinical data is mentioned in this submission. The demonstration of substantial equivalence relies on technological comparison and compliance with standards, not on a new clinical study with a test set of patients.
- Sample Size: Not applicable.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as no external "test set" and corresponding ground truth establishment is described for a clinical study. The "ground truth" for the device's technical specifications and safety would be based on engineering specifications, testing against standards, and comparison with the predicate device.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication 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 is a physical therapy table, not an AI-assisted diagnostic or therapeutic device that involves "human readers" or AI assistance in interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The type of "ground truth" implicitly used for this 510(k) submission is:
- Engineering Specifications and Design Verification: The device's components and functionalities (e.g., distraction force, automatic cycling, safety cut-out) are verified against their design specifications, which are themselves derived from safety standards and the performance of the predicate device.
- Compliance with Standards: Verification that the device design and manufacturing processes comply with recognized consensus standards (e.g., IEC 60601-1).
- Predicate Device Performance: The "ground truth" for what constitutes acceptable overall performance and safety is largely established by the performance and safety record of the legally marketed predicate device (Air-Flex K932810). The submission argues that the new device's changes do not negatively impact this established safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable, as this device does not involve machine learning or AI models that require training sets.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this device does not involve machine learning or AI models.
§ 890.5880 Multi-function physical therapy table.
(a)
Identification. A multi-function physical therapy table is a device intended for medical purposes that consists of a motorized table equipped to provide patients with heat, traction, and muscle relaxation therapy.(b)
Classification. Class II (performance standards).