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510(k) Data Aggregation
(90 days)
The SafeTouch sheet and marking pen are used to mark the location of breast lumps that a woman may find while doing her monthly breast selfexamination.
SafeTouch® Breast Exam Recording Sheet
The provided FDA 510(k) summary for the "SafeTouch® Breast Exam Recording Sheet"does not contain information about acceptance criteria or a study proving device performance against such criteria.
This document is a letter from the FDA determining substantial equivalence for marketing the device. It typically does not include detailed performance studies, which are usually found in the original 510(k) submission itself or in separate technical documentation.
Therefore, I cannot extract the requested information from the provided text.
To answer your questions, I would need access to the actual 510(k) submission document, which would detail any performance testing conducted for the SafeTouch® device.
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(60 days)
SafeTouch is intended as an aide in relocating points of interest discovered upon the human body, once they are found. A typical application would be to indicate the location of discovered human breast lumps.
Thin plastic film with a preprinted numbered grid and orientation markings
The provided text describes a 510(k) premarket notification for a device named "SafeTouch," a Breast Exam Recording Sheet. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results. Therefore, the requested information regarding a formal study proving the device meets acceptance criteria is largely not present in the provided text.
Specifically, the document states: "In our tests, a soft, supple film is necessary for the performance of the device and for patient comfort and acceptance. The preprinted, numbered grid greatly improves the reproducibility of the findings and allows for the use of a new grid sheet with each examination if desired by the examiner or the patient." This statement is a general claim about the device's characteristics and perceived benefits, not a report of a structured study with quantifiable acceptance criteria.
Below is an attempt to address your request based only on the information available in the provided text, highlighting where information is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Reproducibility of findings (Location of breast lumps) | "The preprinted, numbered grid greatly improves the reproducibility of the findings." (No quantitative data on improvement or a specific acceptance threshold for reproducibility is provided). |
| Patient comfort and acceptance | "a soft, supple film is necessary for the performance of the device and for patient comfort and acceptance." (No specific acceptance criteria or study results on patient comfort/acceptance are provided). |
| Performance of the device (General functionality) | "a soft, supple film is necessary for the performance of the device." (This is a design characteristic, not a performance metric against a specific criterion). |
| Ability to use a new grid sheet with each examination | "allows for the use of a new grid sheet with each examination if desired by the examiner or the patient." (This is a feature description, not a performance outcome against a criterion). |
| Assistance in reproducibly representing location of lumps | The device is intended to "assist medical examiners in reproducibly representing the location of discovered breast lumps." (The document asserts its features contribute to this, but provides no data proving its effectiveness in meeting this goal against a specific threshold or comparison baseline, other than differentiating from the predicate in design features like the grid and orientation marks.) |
| Substantial Equivalence to Predicate Device (Docuform) | The FDA determined the device is "substantially equivalent" to legally marketed predicate devices. This is the overarching "acceptance" criterion for 510(k) clearance, but it is a regulatory finding, not a demonstration of specific clinical performance against predefined metrics. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The text mentions "In our tests," suggesting internal evaluation, but provides no details on the number of cases or subjects involved.
- Data Provenance: Not specified. Given the nature of the claim ("In our tests"), it is likely internal and could be retrospective or prospective, but no details are provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- No information provided.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No. The document describes a comparison between SafeTouch and Docuform based on device features (preprinted grid, orientation marks, size, process for transferring marks), not a comparative effectiveness study involving human readers with and without AI assistance. The device itself is a physical recording sheet, not an AI system.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical tool intended to be used by humans, not an algorithm.
7. The Type of Ground Truth Used
- Not specified. Given the intended use, "discovered breast lumps," the ground truth would presumably relate to the actual, confirmed location of such lumps. However, how this was established for any "tests" is not detailed.
8. The Sample Size for the Training Set
- Not applicable/Not specified. This is a physical non-AI device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable/Not specified.
Summary of Missing Information:
The provided 510(k) summary focuses on device description, intended use, and comparison to a predicate device to establish substantial equivalence. It does not provide details of a formal performance study with quantifiable acceptance criteria, sample sizes, expert involvement, or ground truth establishment. The mention of "In our tests" is qualitative and lacks the specific data points requested. This is typical for a Class I or unclassified device seeking 510(k) clearance, where substantial equivalence is often based on design features and intended use rather than extensive clinical performance data.
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