(122 days)
The Air Compression Therapy Device(model: ST-502) is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in good health. The Air Compression Therapy Device (model: ST-502) simulates kneading and stroking of tissues by using an inflatable garment.
Air Compression Therapy Device, model: ST-502 is a powered inflatable tube massager. The Air Compression Therapy Device, model: ST-502 is consists of an air pump, air pressure sensor, leg sleeves and adapter. The air pump, air pressure sensor and control components are protectively housed in a plastic case of the control unit. The control unit is connected to the dedicated leg sleeves via a series of hoses; each leg sleeve has 3 compression chambers. The Air Compression Therapy Device, model: ST-502 utilizes the pneumatically controlled leg sleeves actuated by an electronically controlled air pump unit.
The "Power" button, "Intensity" button, "Mode" button and LED indicators/displays provide for user interface. There is also a port for connecting the AC adapter plug.
The leg sleeves consist of air pipes and three airbags encased inside a soft medical fabric for increased patient comfort and biocompatibility compliance.
In operation, the user simply turns the power on via the "Power" button. And the user presses the "Intensity" button, "Mode" button to adjust the pressure intensity and working mode of the device as the needs of users.
The compression massage direction is from foot room and push up the thighs. By inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The leg sleeves work under the action of sensor and microprocessor. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the sleeves to compress body.
During in the working condition, once the leg sleeves pressure of the airbags reach the proper level(240mmHg), the device is turned off, and the leg sleeves deflates to the ambient pressure through a valve inside the plastic case.
The provided text, a 510(k) Premarket Notification from the FDA, describes an "Air Compression Therapy Device, model: ST-502". This document focuses on demonstrating substantial equivalence to a legally marketed predicate device (K193354).
It does not contain information related to acceptance criteria and a study proving a device meets acceptance criteria in the context of an AI/ML-driven medical device. The device described is a physical medical device (a powered inflatable tube massager) and the evaluation is for substantial equivalence to a predicate, not performance against specific AI/ML metrics.
Therefore, I cannot provide the requested information about acceptance criteria and a study report as it pertains to an AI/ML device per your prompt, because the provided input does not describe such a device or study.
If the prompt was intended to ask about the non-AI/ML device described in the document, here's what can be inferred about its "acceptance criteria" and "proof" based on the provided FDA submission:
Interpretation for the provided Non-AI/ML Device (Air Compression Therapy Device):
For this type of device, "acceptance criteria" would primarily revolve around demonstrating performance and safety characteristics similar to the predicate device, as well as adherence to recognized consensus standards. The "study that proves the device meets the acceptance criteria" would be the collection of non-clinical tests and comparisons performed.
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a formal table of "acceptance criteria" and "reported device performance" in the way an AI/ML study would specify metrics and results. Instead, it demonstrates substantial equivalence by comparing technical characteristics and compliance with standards. The "acceptance" is implied by demonstrating equivalence to a legally marketed device and meeting safety and performance standards.
Here's an inferred table based on the comparisons made:
| Characteristic/Criterion (Inferred) | Subject Device (Air Compression Therapy Device, model: ST-502) Result | Predicate Device (Model: S9019) | Comparison/Conclusion |
|---|---|---|---|
| Indications for Use | Temporary relief of minor muscle aches and pains and for temporary increase in circulation to treated areas in good health, simulating kneading and stroking with inflatable garment. | Same | Equivalent |
| Regulation Number | 21 CFR 890.5650 | 21 CFR 890.5650 | Same |
| Product Code | IRP | IRP | Same |
| Regulatory Class | Class II | Class II | Same |
| Over-The-Counter Use | Yes | Yes | Same |
| Treatment Area | Low limbs (Foot, calf and upper leg) | Low limbs (Foot, calf and upper leg) | Same |
| Environment of Use | Clinics, hospital, athlete training, and home | Same | Same |
| Patient Population | Adult | Adult | Same |
| Power Consumption | 12W | 12W | Same |
| Therapy Time | 20 mins | 20 minutes | Same |
| Output Pressure Range | 0-240 mmHg | 0-240 mmHg | Same |
| Air Pressure Levels | 3 levels (low: 150mmHg, medium: 185mmHg, high: 215mmHg) | 3 levels (low: 150mmHg, mid: 185mmHg, high: 215mmHg) | Same |
| Pressure Error Range | ± 25mmHg | ± 25mmHg | Same |
| Inflation/Keep/Deflation Time | 3-30s / 1-5s / 1-5s | 3-30s / 1-5s / 1-5s | Same |
| Mode Types | Sequential/Peristaltic | Sequential/Peristaltic | Same |
| Number of Chambers | 3 Chambers | 3 Chambers | Same |
| Number of Treatment Modes | 3 modes (M1, M2, M3 described) | 3 modes (Mode 1, Mode 2, Mode 3 described) | Same (descriptions are identical) |
| Noise Level | ≤ 65dB | ≤ 65dB | Same |
| Electrical Safety Standard | ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:20091(R)2012, A2:2010(R)2012 | ES 60601-1 | Compliant (Stated as same or compliant to equivalent/updated standards) |
| EMC Standard | IEC 60601-1-2 Edition 4.0 2014 | IEC60601-1-2 | Compliant (Stated as same or compliant to equivalent/updated standards) |
| Biocompatibility (Cytotoxicity) | ISO 10993-5 (positive results) | Implied, but material noted as different | Subject device validated, difference does not raise new safety questions. Meets standard. |
| Biocompatibility (Irritation/Sensitization) | ISO 10993-10 (positive results) | Implied, but material noted as different | Subject device validated, difference does not raise new safety questions. Meets standard. |
| Home Healthcare Standard | ANSI AAMI HA 60601-1-11:2015 | IEC 60601-1-11 | Compliant (Stated as same or compliant to equivalent/updated standards) |
| Software Verification | IEC 62304 Edition 1.1 2015 | Not explicitly listed for predicate, but implied by regulatory requirements. | Compliant with IEC 62304 and FDA guidance for software. |
| Sleeve Material | Polyester, Nylon (Velcro) | Nylon with Polyurethane laminate | Different, but biocompatibility tested and found acceptable (D1). |
| Size and Appearance (main unit) | L215W65H51mm | 10.2x5.9×25.6 inches (different units, but functionally similar) | Different dimensions, but compliance with electrical safety and EMC standards ensures safety/effectiveness not impacted (D2). |
| Weight | ~1400g-1600g | 4.6 pounds (~2087g) | Different weight, but compliance with electrical safety and EMC standards ensures safety/effectiveness not impacted (D3). |
| Safety Features | "Power" button stops therapy | "Standby" button stops therapy | Similar functionality (D5). |
| Operating Environment Humidity | 15%-93% | 5%-90% | Similar, and compliance with ANSI/AAMI ES60601-1-11 ensures acceptability (D6). |
2. Sample size used for the test set and the data provenance:
- This is not applicable in the context of an AI/ML test set.
- For this physical device, the "test set" would implicitly refer to the physical units subjected to the non-clinical tests (e.g., electrical safety, EMC, biocompatibility). The document does not specify the number of units tested, which is typical for such submissions where testing is generally done on representative samples.
- Data provenance is not specified, but these are typically lab-based non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable for this device as it's not an AI/ML device requiring expert ground truth for classification/detection.
- The "truth" for this device is based on objective measurements against engineering and safety standards (e.g., measuring pressure output, electrical leakage, electromagnetic emissions, and biological reactions in lab tests).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as there is no human-in-the-loop assessment or subjective interpretation being adjudicated. The tests are objective measurements against specified standard limits.
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 device, not an AI/ML diagnostic or assistive tool. No human reader studies were conducted or are relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-only device. The core functionality is mechanical (pneumatic compression).
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For this device, the "ground truth" for its safety and performance is established through compliance with recognized consensus standards (e.g., IEC 60601-1 for electrical safety, ISO 10993 for biocompatibility) and direct physical/mechanical measurements (e.g., pressure output, timing accuracy, noise level). There is no "pathology" or "outcomes data" ground truth in the sense of a medical diagnostic AI.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device and therefore does not have a "training set" in that context.
9. How the ground truth for the training set was established:
- Not applicable. As there's no training set for an AI/ML model.
§ 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).