(197 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "All test results were satisfactory" (per electrical safety, EMC, biocompatibility, and side-by-side performance tests). Specific quantitative performance against acceptance criteria is not provided. |
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.
§ 884.2990 Breast lesion documentation system.
(a)
Identification. A breast lesion documentation system is a device for use in producing a surface map of the breast as an aid to document palpable breast lesions identified during a clinical breast examination.(b)
Classification. Class II (special controls). The device, when it is a breast examination recording sheet, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9. The special control is FDA's guidance entitled “Class II Special Controls Guidance Document: Breast Lesion Documentation System.” See § 884.1(e) for the availability of this guidance document.