(265 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 lymph edema following trauma and sport injuries, Post immobilization edema, Venous insufficiencies, Lymph edema.
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 is a 510(k) Pre-market Notification for the "Pressure Therapy System PT1003", which seems to be a medical device. This document focuses on demonstrating substantial equivalence to a predicate device (PT1002), rather than providing detailed acceptance criteria and a study design for a new, AI-powered diagnostic device.
Therefore, the information required to answer your specific questions about AI/ML device acceptance criteria and a study proving performance (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) is not present in the provided document.
The document discusses:
- Device Description: A pneumatic compression system (PT1003) for treating conditions like lymphedema and venous insufficiencies.
- Predicate Device: PT1002, an earlier version by the same manufacturer.
- Substantial Equivalence: The primary goal of the 510(k) submission is to show that PT1003 is substantially equivalent to PT1002 in terms of intended use, indications, and technological characteristics.
- Minor Differences: Changes in appearance and PCB components (microprocessors, touch keys) are noted, with the manufacturer asserting these changes do not affect safety or performance.
- Performance Characteristics: Mentions adherence to various safety standards (AAMI ANSI ES 60601-1, IEC 60601-1-2, ISO10993-5, ISO 10993-10) and general "function tests" (min/max air pressure, electric current, airflow, noise level, modes A and B). It states that test results are "almost same" as the predicate device.
Without the specific details about AI/ML components and their performance evaluation, I cannot generate the table or answer the questions related to AI device acceptance criteria and study proving its performance.
The document's "Performance characteristic" section is very general and does not provide:
- Specific Acceptance Criteria (quantitative thresholds for performance metrics).
- Detailed Study Design: e.g., how the "function tests" were conducted, the sample size of devices tested, the number of measurements taken, or the statistical methods used to compare results between PT1003 and PT1002.
- Ground Truth Establishment: For a simple physical therapy device evaluating pressure and airflow, "ground truth" would likely be derived from calibrated measurement instruments, not expert consensus or pathology, and these details are not provided.
In summary, the provided text describes a traditional medical device 510(k) submission, not an AI/ML powered device, and therefore lacks the information needed to answer your questions about AI device validation.
§ 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).