(83 days)
The Aware™ Pad is indicated as an aid for performing breast self-examination.
Aware TM Pad is a thin polyurethane bladder, 9.5 inches in diameter containing a small quantity of silicone fluid. The very thin nature of the polyester polyurethane allows the pad to conform to the shape of the tissues underlying it. The very low coefficient of friction property of the silicone fluid in combination with the very thin and flexible bladder, provides easy sliding between the upper and lower surfaces of the bladder. Therefore, when properly used between the finger and the soft breast tissues of the patient, a reduction of friction is observed.
The provided text is a 510(k) summary for the Aware™ Pad, a device indicated as an aid for performing breast self-examination. This document is a regulatory submission for market clearance and does not contain a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study would for a diagnostic or therapeutic device.
Instead, the submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, the Sensor Pad® (K973450). This process does not typically involve the detailed performance studies or pre-defined acceptance criteria that would be seen for higher-risk devices or novel technologies.
Therefore, many of the requested information points (acceptance criteria, specific study details, ground truth, expert qualifications, sample sizes for test/training, MRMC studies, standalone performance) are not applicable or not provided within the scope of this 510(k) summary.
Here's a breakdown based on the information available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable. The 510(k) submission for the Aware™ Pad does not define explicit performance acceptance criteria and does not report detailed performance metrics from a study in the same way a diagnostic device would. The primary "performance" assessed is its technological characteristics demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not defined in the document. The regulatory pathway is based on "substantial equivalence" to a predicate device, not on meeting specific quantitative performance metrics. | The device is described as a thin polyurethane bladder containing silicone fluid. Its technological characteristics aim to reduce friction during breast self-examination, facilitating easy sliding between the finger and breast tissues. This is compared to the predicate device, the Sensor Pad®. |
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable/Not Provided. A "test set" in the context of device performance testing for the Aware™ Pad is not described in this 510(k) summary. The submission relies on establishing substantial equivalence based on technological characteristics and intended use.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not Applicable/Not Provided. The concept of "ground truth" established by experts for a test set is not presented for this device given the nature of the 510(k) submission and the device's function.
4. Adjudication Method for the Test Set
Not Applicable/Not Provided. As there is no described test set or expert evaluation detailed, an adjudication method is not relevant or described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported for the Aware™ Pad in this 510(k) summary. This type of study is typically used for imaging or diagnostic devices to assess reader performance. The Aware™ Pad is a simple aid for self-examination, not a diagnostic tool requiring such rigorous clinical validation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable. The Aware™ Pad is a physical device (a pad to aid tactile examination), not an algorithm or software. Therefore, the concept of "standalone algorithm performance" is not relevant.
7. The Type of Ground Truth Used
Not Applicable/Not Provided. For this device, ground truth in the sense of a clinical outcome or diagnostic truth is not defined. The basis for market clearance is "substantial equivalence" to an existing device, implying that the predicate's effectiveness is already established for its intended use as an aid for breast self-examination.
8. The Sample Size for the Training Set
Not Applicable/Not Provided. The Aware™ Pad is a physical device and does not involve AI/machine learning, and therefore does not have a "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set was Established
Not Applicable/Not Provided. As there is no training set, this question is not applicable.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.