(64 days)
"The Sensor Pad® is indicated as an aid for performing breast selfexamination."
The Sensor Pad® is a thin polyether polyurethane bladder, 9.5 inches in diameter containing a small quantity of a lubricating fluid. The very thin nature of the polyether 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, results in an easy sliding relationship between the upper and lower surfaces of the bladder. Therefore when properly used between the finger and the soft tissues of the patient, a reduction of friction is observed.
The provided text describes the "Sensor Pad®," an aid for breast self-examination. The intent of the submission is to change its classification from "Prescription Use Only" to "OTC Use." The document primarily focuses on demonstrating substantial equivalence to a previously cleared device (K955249) and the safety and effectiveness for OTC use.
Here's an analysis of the provided information regarding acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
The device's acceptance criteria are not explicitly stated in numerical or qualitative thresholds. Instead, the reported performance is described conceptually as demonstrating the device's ability to reduce friction and its effectiveness in tactile detection of lumps. The key "acceptance" was the FDA's "substantial equivalence" determination for OTC use.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Friction Reduction (ability to facilitate tactile examination) | Physical tests demonstrated the Sensor Pad's ability to reduce friction, as measured by the coefficient of friction. |
| Biocompatibility (safety of materials) | Biocompatibility data pertinent to the materials used in the manufacture of the Sensor Pad® were provided. |
| Tactile Detection of Lumps (effectiveness in BSE) | Clinical studies investigated the tactile detection of lumps using the Sensor Pad® as compared to using a lubricant and/or unaided detection. |
| Clinical Performance during BSE (overall utility) | Clinical studies investigated the clinical performance of the Sensor Pad® during breast self-examination. |
| Safety and Effectiveness for OTC Use | Additional testing was conducted to demonstrate that a change from "Prescription Use Only" to "OTC Use" does not alter the intended use or the safety or effectiveness of the device. The FDA's substantial equivalence determination inherently implies acceptance of the safety and effectiveness for its intended use, including the proposed OTC change, based on the provided evidence. |
2. Sample Sizes and Data Provenance
The document mentions "six clinical studies" for performance testing. However, specific sample sizes for these studies are not provided. The data provenance (country of origin, retrospective/prospective) is also not specified.
3. Number of Experts and Qualifications
The document does not specify the number or qualifications of experts used to establish ground truth for any test set.
4. Adjudication Method
The document does not describe an adjudication method for any test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document mentions comparisons: "investigations of the tactile detection of lumps using the Sensor Pad® as compared to using a lubricant and/or unaided detection." While this suggests a comparative study, it does not explicitly state that it was an MRMC comparative effectiveness study involving human readers with and without AI assistance. The Sensor Pad® itself is not an AI device, but rather a physical aid. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not directly applicable in this context.
6. Standalone (Algorithm Only) Performance Study
The Sensor Pad® is a physical device, not an algorithm. Therefore, a standalone (algorithm only) performance study was not performed nor relevant for this product.
7. Type of Ground Truth Used
The document broadly refers to "tactile detection of lumps" and "clinical performance." The specific type of ground truth (e.g., expert consensus on palpation, pathology reports, or long-term outcomes data) used in the clinical studies is not explicitly detailed. It can be inferred that ground truth was established through clinical examination and potentially follow-up, but the method isn't specified.
8. Sample Size for the Training Set
The document does not mention a training set as this device is not an AI/machine learning model. The studies described are for validating the product's performance directly.
9. How Ground Truth for the Training Set was Established
As there is no training set for an AI/machine learning model, this information 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.