(238 days)
The device is air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.
The system consists of an air pump, leg sleeves and hoses working together as one unit. The air pump is connected to the dedicated sleeves via a series of hoses; one sleeve has 4 compression chambers. The compression massage direction is from limb end to body center 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 sleeve works under the action of sensor and microprocessor. This software is to control the timing and the pressure reflected by the sensor, it cycles the airflow to reach the function of cycling compression of body parts.
The provided text describes a 510(k) premarket notification for the "Pressure Therapy System PT1003". This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a predetermined set of acceptance criteria for a novel AI/imaging device. As such, many of the requested categories for AI/imaging device studies (like MRMC studies, effect size of AI assistance, expert qualifications, sample provenance, training sets, etc.) are not applicable or not provided in this regulatory submission.
However, I can extract information related to the performance characteristics, safety testing, and how the device's adherence to standards and safety was demonstrated.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in the format typically used for AI/imaging performance metrics (e.g., sensitivity, specificity, AUC). Instead, it demonstrates compliance with recognized medical device standards and functional tests to ensure safety and performance comparable to legally marketed predicate devices.
| Acceptance Criteria (Implied from testing) | Reported Device Performance (PT1003) |
|---|---|
| Electrical Safety (AAMI ANSI ES 60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012) | Met the standard. |
| Electromagnetic Compatibility (IEC 60601-1-2 Edition 3: 2007-03) | Met the standard. |
| Home Healthcare Environment Safety (IEC 60601-1-11 Edition 2.0 2015-01) | Met the standard. |
| Biocompatibility - Cytotoxicity (ISO10993-5) | Met the standard. |
| Biocompatibility - Irritation & Skin Sensitization (ISO 10993-10) | Met the standard. |
| Minimum and Maximum Air Pressure | Tested as defined, result "almost same" as predicate. Max pressure 200 mmHg, Min pressure 20 mmHg. |
| Maximum Electric Current Value | Tested as defined, result "almost same" as predicate. |
| Maximum Airflow Value | Tested as defined, result "almost same" as predicate. |
| Noise Level | Tested as defined, result "almost same" as predicate. |
| Modes A and B functionality | Tested as defined, result "almost same" as predicate. |
| Pressure Range Comparator (compared to K182668) | Max Pressure of 200mmHg is within the safe range established by predicate K182668 (0-200mmHg). |
| Indications for Use Equivalence | Identical to predicate K183169 ("to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas"). |
2. Sample size used for the test set and the data provenance
This document does not describe a test set in the context of clinical data for AI/imaging performance. The testing performed consists of bench testing and electrical/biocompatibility safety evaluations on the device itself. Therefore, concepts like "sample size" for a data set or "data provenance" (country of origin, retrospective/prospective) are not applicable. The tests were performed on the "PT1003" device following defined procedures.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" for AI/imaging interpretation is not relevant for this type of device (a powered inflatable tube massager). The evaluation focuses on engineering, safety, and functional performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring adjudication of expert interpretations.
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 not an AI/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/imaging device. The "standalone" performance here refers to the device's functional and safety performance in isolation, which was indeed assessed through the listed standards and function tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's evaluation is primarily established by regulatory standards (e.g., IEC, ISO, AAMI ANSI ES) and the functional and safety performance of legally marketed predicate devices. The device is deemed safe and effective if it meets these standards and its performance characteristics (like pressure range, cycle time) are comparable to or safely within the established parameters of already cleared devices.
8. The sample size for the training set
Not applicable. This is not an AI/imaging device, and therefore does not involve a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
Not applicable. As above, no training set for AI was used.
§ 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).