(136 days)
The Fist Assist Model FA-1 is an arm massager intended to temporarily relieve minor muscle aches and to temporarily increase circulation to the treated areas.
The Fist Assist Model FA-1 is a wearable, non-sterile, battery operated, intermittent pneumatic compression device for use on the arm over clothing. It is composed of two major components that are permanently attached to one another:
- the control module that contains the electronics with miniature pump and
- the wrap made of elastic cloth that holds the control module and internal air bladder and uses hook tape for attachment to any part of the wrap exterior.
The control module and wrap are integral and permanently attached. It is powered by (2) AA batteries.
The Fist Assist Model FA-1 has a single operation mode. When powered on by depressing the single push button switch, it goes through pressure cycles wherein the air bladder inflates to 60 mmHg and is held at that pressure for 20 seconds; the air bladder is then deflated and a minimal pressure of 10 mmHg (or less) and is held for 55 seconds until the next inflation to 60 mmHg begins again. The cycle repeats continuously until the power is turned off using the single push button switch. The device will turn off automatically after 1 hour of continuous use. When wearing this device, the device should only be used over full clothing and never on direct skin.
The provided text describes the submission of the Fist Assist Devices Model FA-1 for FDA 510(k) clearance, asserting its substantial equivalence to predicate devices. However, the document does not contain information about a study proving the device meets specific acceptance criteria related to its efficacy in the stated indications for use (temporary relief of minor muscle aches and temporary increase in circulation).
The "acceptance criteria" discussed in the document primarily relate to non-clinical testing for safety and performance of the device's physical and electrical aspects, rather than clinical efficacy. Therefore, I cannot extract information about a study proving the device meets acceptance criteria for its intended medical benefits.
Here's what can be extracted regarding the device's non-clinical testing and performance:
Acceptance Criteria and Reported Device Performance (Non-Clinical/Engineering):
The document details various non-clinical tests performed to demonstrate the device's safety and fundamental operational characteristics, comparing them to established standards.
| Acceptance Criteria (Non-Clinical/Engineering) | Reported Device Performance and Compliance |
|---|---|
| Transportation Testing: Device packaging must meet standards for parcel delivery. | Tested to ISTA 3A-2018, General Simulation Performance Test Procedure for Parcel Delivery System (70kg or less). Results: All units tested met the requirements of the standard. |
| Biocompatibility: Materials should not cause adverse biological reactions. | "The biocompatibility of the materials has not been verified by the FDA and contact of the cuffs/accessories to direct skin may lead to skin irritation, skin sensitization and/or cytotoxicity." (Note: This is a disclosure rather than a demonstration of meeting acceptance criteria, indicating the device is intended for use over clothing to mitigate this concern). |
| Software Validation: Software must be validated to perform as intended. | Performed using "General Principle of Software Validations: Final Guidance for Industry and FDA Staff, dated January 11, 2002". Results: All tested variables were found to meet acceptance criteria established. |
| Electrical Testing: Electrical safety must meet relevant standards. | Performed using AAMI/ANSI ES 60601-1:2005/(R)2012 And A1:2012. Results: The Device met all test requirements for electrical safety. |
| EMC Evaluation: Electromagnetic compatibility must meet standards. | Performed using IEC 60601-1-2:2014. Results: The Device met all test requirements for EMC. |
| Bench Testing (Mechanical Functionality): Key process parameters must function as intended. | Mechanical testing performed to confirm functionality of key process parameters. Results: All parameters tested were found to meet acceptance criteria established. |
| Device Pressure Range: Device operates within specified pressure limits. | Reported Performance: 10-60 mmHg. (This is a design specification, not a test result proving it always stays within this range over time or under various conditions, but it's part of the technical characterization). |
| Max. Inflation Pressure: Device does not exceed maximum inflation pressure. | Reported Performance: 60 mmHg, preprogrammed. (Similar to above, a design specification). |
| Deflation Hold Time: Device maintains specified deflation duration. | Reported Performance: 55 seconds. (Similar to above, a design specification). |
| Pre-Programmed Treatment Time: Device operates for specified duration and allows user control. | Reported Performance: 60-minute preprogrammed treatment. Cycle can be stopped by user. Device turns off automatically after 1 hour of continuous use. (Similar to above, a design specification and operational feature). |
Information Not Available in the Provided Text:
The provided document is a 510(k) clearance letter and summary, which typically focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and non-clinical performance data. It does not contain the following information that would be expected for a study proving clinical efficacy or diagnostic performance of an AI/ML device:
- Study Proving Efficacy: No study proving the device meets acceptance criteria for its medical indications (temporary relief of muscle aches, increase in circulation) is described. The 510(k) process for this type of device often relies on comparison to known safe and effective predicate devices rather than new clinical efficacy trials.
- Sample size for the test set and data provenance: N/A (no clinical efficacy test set described)
- Number of experts used to establish ground truth: N/A
- Qualifications of experts: N/A
- Adjudication method for the test set: N/A
- MRMC comparative effectiveness study: N/A
- Standalone (algorithm only) performance: N/A (This is a physical device, not an algorithm-only product in the AI sense)
- Type of ground truth used: N/A
- Sample size for the training set: N/A
- How the ground truth for the training set was established: N/A
In summary, the document confirms that the device has undergone various non-clinical engineering and safety tests and met their respective acceptance criteria. However, it does not describe a clinical study for the device's indications for use. For 510(k) clearance of this type of device (a pneumatic massager), a rigorous clinical trial demonstrating efficacy against specific endpoints with predefined acceptance criteria is often not required if substantial equivalence to a legally marketed predicate device can be demonstrated through technological comparison and non-clinical performance data.
§ 890.5650 Powered inflatable tube massager.
(a)
Identification. A powered inflatable tube massager is a powered device intended for medical purposes, such as to relieve minor muscle aches and pains and to increase circulation. It simulates kneading and stroking of tissues with the hands by use of an inflatable pressure cuff.(b)
Classification. Class II (performance standards).