(30 days)
The Liv™ Breast Self Examination Aid is indicated as an aid for performing breast-self examinations.
The Liv™ Breast Self Examination Aid is indicated as an aid for performing breast-self examinations. The device is made of soft, latex-free polyurethane and filled with a non-toxic lubricant. While allowing the breast tissue to remain in place during an exam, your fingers can still move effortlessly across the breast while detecting abnormalities.
The provided text is a 510(k) summary for the Liv™ Breast Self Examination Aid. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed studies with specific acceptance criteria and performance metrics for the new device.
Based on the provided text, here's what can be extracted and what information is not available:
1. A table of acceptance criteria and the reported device performance
No direct acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy) are provided in this 510(k) summary. The submission primarily relies on demonstrating substantial equivalence to a predicate device.
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. The document does not describe a clinical study with a test set.
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. The document does not describe a clinical study with a ground truth established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. The document does not describe a clinical study with a test set requiring adjudication.
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 breast self-examination aid and not an AI-powered diagnostic device. No MRMC study was conducted or described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm; it's a physical device used by individuals for self-examination.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The document does not describe a study involving ground truth.
8. The sample size for the training set
Not applicable. The device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. The device is not an AI algorithm, so there is no training set or ground truth for it.
Summary of available information regarding acceptance criteria and study:
The Liv™ Breast Self Examination Aid is cleared based on demonstrating substantial equivalence to a previously cleared predicate device, the My Breast Friend device (K023390).
Acceptance Criteria (Implied by Substantial Equivalence):
- Identical in materials and functionality: The device must be made of materials and operate in a manner that is sufficiently similar to the predicate device. The summary states: "In summary, the Liv™ Breast Self Examination Aid meets or exceeds all safety requirements for a device in its regulatory class and is found to be identical in materials and functionality when compared to the stated predicate device."
- Safety and Effectiveness: The device must meet or exceed all safety requirements for its regulatory class and be deemed safe and effective for its intended use, as determined through comparison with the predicate.
- Compliance with general controls: The device must comply with general controls provisions of the Act, including annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
- Intended Use Match: The intended use of the new device must be the same as or very similar to the predicate device. The intended use for both the Liv™ device and implicitly the predicate is "as an aid for performing breast-self examinations."
Study/Evidence that proves the device meets the acceptance criteria:
The primary "study" in this context is the substantive equivalence comparison to the predicate device, My Breast Friend (K023390).
- Methodology: The submission highlights that the Liv™ Breast Self Examination Aid is "identical in materials and functionality when compared to the stated predicate device." This suggests a comparative analysis of the device's physical properties (soft, latex-free polyurethane, non-toxic lubricant) and its mechanism of action (allowing fingers to move effortlessly across breast tissue while detecting abnormalities) against the predicate.
- Predicate Device: My Breast Friend device from MBF Sales, LLC (K023390).
- Conclusion: The FDA reviewed the 510(k) submission and determined "the device is substantially equivalent... to legally marketed predicate devices." This determination itself serves as the "proof" that the device met the regulatory acceptance criteria for market clearance under the 510(k) pathway.
This type of 510(k) submission does not typically involve new clinical performance studies with acceptance criteria for sensitivity, specificity, etc., unless there are significant differences between the new device and the predicate that could affect safety or effectiveness. For a physical aid such as this, the focus is on material safety and functional equivalence.
§ 892.1710 Mammographic x-ray system.
(a)
Identification. A mammographic x-ray system is a device intended to be used to produce radiographs of the breast. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.