(226 days)
The device is indicated for use by medical professionals and patient 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.
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 document is a 510(k) Premarket Notification for a medical device (Pressure Therapy System, K161907). It aims to demonstrate substantial equivalence to a predicate device, not necessarily to prove the device meets specific performance acceptance criteria through the kind of study described in your request.
The document discusses the device's technical characteristics and how they compare to a predicate device. It also lists the standards a performance test was conducted against to demonstrate safety and effectiveness. However, it does not include the detailed type of study you're asking about (e.g., a multi-reader multi-case clinical study with performance metrics like sensitivity/specificity, specific acceptance criteria for diagnostic performance, or extensive details on ground truth establishment from a clinical dataset).
Here's a breakdown of what the document does provide in relation to your request, and what it does not provide:
1. A table of acceptance criteria and the reported device performance
- What's explicitly stated: The document lists standards that the device was tested against. This implies that meeting these standards served as "acceptance criteria" for safety and basic operational performance.
- IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)
- IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests)
- ISO10993-5 (Biological evaluations of medical devices -- Part 5: Tests for In Vitro cytotoxicity)
- ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)
- Reported Device Performance: The document states, "The Pt1002 pressure therapy system has been tested and met the following standards." It does not provide specific performance values (e.g., specific pressure accuracy tolerances, cycle time deviations) against quantified acceptance criteria. Instead, it concludes that the device "has substantially equivalent technological and performance characteristics" to the predicate device and "is as safe and effective as the predicate device."
- Missing from your request: There are no specific numerical acceptance criteria for diagnostic accuracy or clinical effectiveness (e.g., sensitivity, specificity for detecting a condition) because this is a physical therapy device, not a diagnostic AI.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable/Not Provided: This document describes a submission for a physical therapy device. The testing mentioned (compliance with IEC and ISO standards) would typically involve engineering tests on the device itself and biocompatibility tests on materials, not clinical trials with "test sets" of patient data in the way an AI diagnostic device would. Therefore, sample size for a "test set" and data provenance from patient data are not detailed, as they are not relevant to this type of device submission as described.
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/Not Provided: Ground truth by experts is relevant for diagnostic AI devices, clinical studies, or performance evaluations that require expert interpretation of data (e.g., images, physiological signals). For this physical therapy device, compliance with technical safety and biocompatibility standards does not involve expert-established ground truth in this manner.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable/Not Provided: As noted, this type of submission for a physical therapy device focuses on engineering and biocompatibility standards, not the adjudication of clinical outcomes or diagnostic 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
- No: This is not a diagnostic AI device, and therefore, an MRMC study is not relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a physical therapy device, not an algorithm, so the concept of standalone performance does not apply in the context of AI without human-in-the-loop.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable/Implicit: For the standards listed, the "ground truth" would be the defined specifications and methodologies within those standards (e.g., a specific electrical resistance value, a specific biocompatibility response under defined lab conditions). This is not "expert consensus" or "pathology" in the clinical sense.
8. The sample size for the training set
- Not Applicable/Not Provided: This is not an AI/machine learning device that requires a "training set" of data.
9. How the ground truth for the training set was established
- Not Applicable/Not Provided: As it's not an AI/machine learning device, the concept of establishing ground truth for a training set does not apply.
In summary:
This 510(k) submission for the "Pressure Therapy System" focuses on demonstrating substantial equivalence to a predicate device by comparing technical specifications and confirming compliance with recognized safety, electromagnetic compatibility, and biocompatibility standards. It does not provide the detailed performance study information with clinical acceptance criteria, test set, ground truth, or expert involvement that would be expected for a diagnostic device or an AI-powered system as detailed in your request.
§ 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).