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iBreastExam™ device is intended to produce a surface pressure map of the breast as an aid in documenting palpable breast lesions identified during a clinical breast exam. iBreastExam™ device is intended for use by a qualified healthcare professional trained in its use and is not for home use.

The iBreastExam system consists of a group of hardware and software components. The hardware component(s) consist of: iBreastExam Scanhead, Computer System, USB Wall Charger and Charging Cables. The software component(s) consist of: iBEConnect Software Program.

The provided text does not contain detailed information about acceptance criteria and a comprehensive study showing the device meets those criteria. However, I can extract the available information and highlight what is missing based on your request.

Here's a breakdown of the information present and absent:

Information Present in the Document:

• Device Name: iBreastExam
• Intended Use: To produce a surface pressure map of the breast as an aid in documenting palpable breast lesions identified during a clinical breast exam. It is a documentation tool, not for diagnosis.
• Predicate Device: BREASTVIEW® VISUAL MAPPING SYSTEM (K010514)
• Performance Testing Mentioned:
  • Electrical safety tests
  • Electromagnetic compatibility tests
  • Biocompatibility tests
  • Side-by-side performance test between iBreastExam and the predicate device (BreastView).
  • Validation and verification performed on software and hardware subsystems.
• Conclusion: All test results were satisfactory and did not raise any additional safety or effectiveness concerns, leading to a substantial equivalence determination.

Information NOT Present in the Document (and therefore cannot be provided in the tables/sections you requested):

• Specific Acceptance Criteria: The document mentions "Performance tests were conducted per Class II Special Controls Guidance Document: Breast Lesion Documentation System," but it does not list the specific quantitative acceptance criteria for these tests (e.g., a required sensitivity, specificity, accuracy, or a threshold for deviation from the predicate).
• Reported Device Performance against specific criteria: While it states "all test results were satisfactory," it lacks numerical performance data for the iBreastExam against any defined acceptance criteria.
• Detailed Study Information:
  • Sample size for the test set.
  • Data provenance (country of origin, retrospective/prospective).
  • Number and qualifications of experts for ground truth.
  • Adjudication method for the test set.
  • Results of a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
  • Standalone algorithm performance (algorithm only without human-in-the-loop).
  • Type of ground truth used (expert consensus, pathology, outcomes data).
  • Sample size for the training set.
  • How ground truth for the training set was established.

Given the limited information, I will present what can be inferred or directly stated, and clearly mark the missing details.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified in the document.
• Data Provenance: Not specified in the document. (The document mentions a "side-by-side performance test" but gives no details on the study population or context.)

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not specified in the document. The document refers to the device aiding in documenting "palpable breast lesions identified during a clinical breast exam," implying clinical examination as the basis, but does not detail how ground truth for the testing was established or how many experts were involved.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not specified in the document.

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

• Was a MRMC study done? The document describes a "side-by-side performance test" with a predicate device, but it does not indicate a multi-reader multi-case (MRMC) comparative effectiveness study with human readers improving with AI assistance. The iBreastExam is described as a "documentation tool" for lesions already palpated.
• Effect size of human readers improving with AI vs without AI assistance: Not applicable/not provided based on the studies described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• The document implies a standalone performance for the device in capturing pressure maps, but it is explicitly stated that the device's output is an "aid in documenting palpable breast lesions identified during a clinical breast exam," and it's not for diagnosis. It's used by a "qualified healthcare professional." No specific standalone performance metrics (e.g., sensitivity/specificity for detecting lesions) are provided, only its ability to collect data and produce a map.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The document implies the ground truth for the "palpable breast lesions" would be based on clinical breast exam findings, as the device is intended to document such lesions. However, the specific method for establishing ground truth for the performance testing is not detailed. It does not mention pathology or outcomes data for the performance study.

8. The sample size for the training set

• Not specified in the document.

9. How the ground truth for the training set was established

• Not specified in the document.

In summary, the provided FDA 510(k) letter and summary describe the device's intended use, technological characteristics, and a general statement about performance testing leading to substantial equivalence. However, it lacks the detailed quantitative performance criteria, study design parameters (sample sizes, expert roles, ground truth establishment methods), and specific results that would be required to fully answer your request regarding acceptance criteria and their proven fulfillment. The document focuses on establishing substantial equivalence to a predicate device rather than providing a detailed performance study with explicit acceptance criteria.

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The NoTouch BreastScan system is intended to be used as an adjunctive screening device for the detection of breast cancer by measuring various temperature parameters from the surface of the breast.

The NoTouch BreastScan™ system is intended for viewing and recording heat patterns generated by the human body in the hospital, acute care settings, outpatient surgery, healthcare practitioner facilities or an environment where patient care is provided by qualified healthcare personnel. The patient include adult. The device is for adjunctive diagnostic screening for the detection of breast cancer and diseases affecting blood perfusion of tissue or organs. This device is intended for use by a qualified healthcare professional trained in its use.

The NoTouch BreastScan consists of a group of hardware components. The hardware components consist of:

• Two digital infrared cameras
• . A computer system, with printer
• . An air conditioner unit
• . A specially designed mobile cart.

Software Components include:

• . NoTouch BreastScan Software
• . PDF Viewer
• . Drivers for Infrared imagers
• . ThermaCam Researcher Software

The provided text is a 510(k) summary for the NoTouch BreastScan device. While it states that "Testing of NoTouch BreastScan was performed as per the requirements" and "Complete validation and verification was performed on all software and hardware subsystems," it does not contain the detailed acceptance criteria or the specific study results proving the device meets these criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device (BREASTSCAN IR) and outlining the general intended use and technological characteristics. There is no information regarding 1. acceptance criteria, 2. sample size for test set and data provenance, 3. number and qualifications of experts for ground truth, 4. adjudication method, 5. comparative effectiveness study (MRMC), 6. standalone performance, 7. type of ground truth used, 8. sample size for training set, or 9. how ground truth for the training set was established.

Therefore, I cannot fulfill your request with the provided input because the necessary information about acceptance criteria and the detailed study results are absent.

Ask a specific question about this device