(287 days)
Airpro-690 is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as Primary lymphedema, Edema following trauma and sport injuries, Post immobilization edema, Venous insufficiencies, Lymphedema.
Air Compression System include the host, sleeves, and the air tube to connect them together. Through a multi-chamber inflatable sleeve orderly conducting of rhythmic squeezing inflation and deflation, it cyclic pressure on limb tissue, so as to promote venous blood return, enhance arterial infusion, improve blood circulation and lymphatic circulation. Two port on the back of the controller, labeling as Channel 1/2. And four air ways on each channel. The two channels can work independently, or simultaneously. The system can identify the channel and type of wearing sleeves automatically. If two channels were connected with sleeves, the system will inflate 1/2 channel simultaneously. Treatment Time, pressure, Channel and Treatment Mode are all can be adjusted on Parameter Settings Interface of the main unit.
This document does not describe a study that uses a test set, ground truth, or expert review for device performance related to a diagnostic or AI-driven system.
Instead, this is a 510(k) Premarket Notification from the FDA for a medical device called the "Air Compression Therapy System, Model: Airpro-690". This submission focuses on demonstrating substantial equivalence to a predicate device (LX7(V7)) through non-clinical testing for product safety and performance, rather than clinical performance based on diagnostic accuracy or AI model output.
Therefore, most of the requested information (acceptance criteria for diagnostic performance, sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, and training set information) is not applicable to this type of regulatory submission.
Here's what can be extracted and inferred based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document lists various non-clinical tests and standards that the device met to demonstrate safety and performance, establishing substantial equivalence to the predicate device. These are not acceptance criteria in the sense of diagnostic accuracy metrics.
| Characteristic / Test | Acceptance Criteria (Implied: Compliance with Standard) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1: 2009-10-15 | Met (Sleeve material demonstrated biocompatibility safety by passing ISO 10993-5 and ISO 10993-10 tests) |
| Material (Patient Contact) | ISO 10993-5:2009 (in vitro cytotoxicity) | Passed |
| ISO 10993-10:2010 (irritation and skin sensitization) | Passed | |
| Electrical Safety | ANSI AAMI ES60601-1:2005/(R) 2012 and A1:2012 | Met (Demonstrated electrical safety) |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2014 | Met |
| Software Verification & Validation | Company's Design Control process | Met |
| Basic Unit Characteristics | Design specifications | Met |
| Output Specifications | Design specifications | Met |
| Power Source | Safety and effectiveness (evaluated against predicate) | Similar to predicate, but passed ANSI/AAMI ES60601-1: 2005+ A1: 2012 test. |
| Related Power | Safety and effectiveness (evaluated against predicate) | Similar to predicate, but passed ANSI/AAMI ES60601-1: 2005+ A1: 2012 test. |
| Pressure Range | Safety and effectiveness (Implied: within acceptable therapeutic range) | 0~180mmHg (Smaller than predicate's maximum, but deemed not to raise additional risks) |
| Operating Time/Therapy Time | Safety and effectiveness (Implied: comparable to predicate) | 10, 20, 30 minutes (Similar to predicate's 10~30 minutes) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document pertains to the regulatory clearance of a physical medical device through substantial equivalence, not the clinical performance evaluation of an AI/diagnostic algorithm using a test set of data. The "tests" mentioned are non-clinical engineering and bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. See point 2.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 2.
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-driven diagnostic system involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. See point 5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" for this device's clearance is its compliance with recognized safety and performance standards (e.g., ISO, ANSI/AAMI, IEC) and its functional similarity to a legally marketed predicate device.
8. The sample size for the training set
- Not Applicable. There is no AI model or "training set" in the context of this device's regulatory submission.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
Summary of the document's relevance to the prompt:
The provided document details a 510(k) submission for an Air Compression Therapy System. It focuses on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device by showing it meets the same safety and performance standards through non-clinical testing (electrical safety, EMC, biocompatibility, software verification, and validation, etc.). It does not contain information about studies related to diagnostic accuracy, AI performance, or human reader effectiveness with AI.
§ 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).