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510(k) Data Aggregation
(25 days)
ULTRASOUND SCANNER, TYPE 2400
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Cardiac, Fetal Doppler, Intraoperative, Neurosurgery, Obstetrics, Pediatrics, Transrectal, Small Parts (organ s), Transvaginal, Peripheral vascular, Musculo-skeletal.
2400 supports the following scanning modes and combinations thereof: B-mode, M-mode, PWD mode and CFM mode. An optional ECG signal can be superimposed the ultrasound information in all modes and mode combinations. The system can perform simple geometric measurements, and perform calculations in the areas of Vascular, Urology, Cardiology and OB/GYN applications. The system can guide biopsy- and puncture needles. Transducers are linear and convex arrays and mechanical sector. The patient contact materials comply with ISO10993-1 All transducers used together with 2400 are Track 3 transducers.
The provided 510(k) summary for the B-K Medical A/S Ultrasound Scanner Type 2400 (K024236) does not contain a typical clinical study with acceptance criteria and a detailed report of device performance against those criteria in the way a new diagnostic algorithm or AI system would.
Instead, this submission is for a traditional ultrasound system, and its "acceptance criteria" are related to established safety standards and demonstrating substantial equivalence to a predicate device for its intended uses. The "study" proving it meets these "criteria" primarily involves:
- Engineering and Safety Testing: Compliance with recognized international standards for medical electrical equipment and acoustic output.
- Comparison to a Predicate Device: Demonstrating that the new device's technological characteristics and intended uses are substantially equivalent to a previously cleared device.
Therefore, the requested information elements related to AI/algorithm performance (such as sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable or extractable from this document.
Here's an attempt to structure the available information per your request, with significant caveats that much of it either doesn't apply or can't be found in this specific document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Category) | Description | Reported Device Performance/Evidence |
|---|---|---|
| Acoustic Output Safety | Acoustic output (Ispta, MI, TI values) must stay below pre-amendment upper limits. Standards: "Information for Manufacturers Seeking Clearance of Diagnostic Ultrasound Systems and Transducers, FDA, CDRH, September 30, 1997" and "Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment" (NEMA 1997). | * Ispta: ≤ 720 mW/cm² (Track 3, non ophthalmic). The system in 2400 is the same as in 2102 and assures output stays below this limit. |
| * MI: ≤ 1.9 (Track 3, non ophthalmic). The system in 2400 is the same as in 2102 and assures output stays below this limit. | ||
| * TI (Thermal Index): maximum 6.0. The system in 2400 is the same as in 2102 and assures output stays below this limit. | ||
| Electrical & Mechanical Safety | Compliance with IEC 60601-1. | The scanner 2400 "has been tested by a recognized, certified body according to IEC 60601-1." |
| Biocompatibility | Patient contact materials comply with ISO10993-1. | "All transducers used together with 2400 are Track 3 transducers. The patient contact materials comply with ISO10993-1". |
| Clinical Measurement Accuracy | Measurements and calculations meet described accuracies (as stated in User Guide). | "Clinical measurements and calculations are described and accuracies are provided in the User Guide." (Specific accuracy values are not provided in this 510(k) summary.) |
| Substantial Equivalence (Intended Use) | The intended uses of the 2400 device must be contained within, or equivalent to, those of the predicate device (B-K Medical A/S 2102 Ultrasound Scanner K000567, K003986, K011417). | The provided tables show that the intended uses (clinical applications and modes of operation) for the 2400 system and its various transducers (1850, 8661, 8662, 8803, 8811) are either previously cleared (P) by FDA for the predicate device, or are new but within the scope of similar predicate devices/technologies (E - added under Appendix E for specific transducers for intraoperative, pediatric, small organ, musculo-skeletal, and peripheral vessel applications; N - new for tissue harmonic imaging mode for some applications). The overall intended uses are deemed substantially equivalent by the FDA letter. |
| Substantial Equivalence (Technology) | The technological characteristics of the 2400 device must be substantially equivalent to the predicate device (B-K Medical A/S 2102). | "The predicate device has the same major technological characteristics as the subject device described above. Minor differences consist: Digital beamformer, modified data acquisition technique, modified user interface and mechanical outline." These minor differences were deemed not to raise new questions of safety or effectiveness. |
Regarding items specific to AI/algorithmic performance (which are NOT in this submission):
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This is not an AI/algorithm submission.
- 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.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. Performance is inherent to the physical device and its integrated software, not a separate algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI/algorithm. Ground truth for a diagnostic ultrasound system refers to its ability to produce diagnostically useful images and accurate measurements, usually validated through engineering measurements, phantom studies, and comparison to established clinical standards and the predicate device's performance.
- The sample size for the training set: Not applicable. (There might be internal software development and testing data, but it's not described as a "training set" in the AI sense for regulatory submission.)
- How the ground truth for the training set was established: Not applicable.
Summary of the "study" proving the device meets acceptance criteria:
The "study" in this context is a combination of engineering testing, adherence to recognized standards, and a direct comparison to a legally marketed predicate device.
- Acoustic Output, Electrical, and Biocompatibility Safety: Compliance was demonstrated through testing by a recognized, certified body (IEC 60601-1) and adherence to specific FDA guidance and NEMA standards for acoustic output and ISO standards for biocompatibility. The system's acoustic output control mechanism is stated to be identical to the predicate device, which had already been cleared.
- Clinical Measurement Accuracy: The document states that accuracies are provided in the User Guide, implying that these have been established through internal validation and characterization of the device's measurement capabilities.
- Substantial Equivalence: The core of the regulatory submission is demonstrating that the new Type 2400 Ultrasound Scanner is substantially equivalent to the predicate device (Type 2102). This involves showing that the intended uses and technological characteristics are either identical or that any differences do not raise new questions of safety or effectiveness. The detailed tables listing modes of operation and clinical applications for the system and its various transducers, marked as "previously cleared (P)" or "added under Appendix E (E)" or "new (N)", serve as the evidence for this comparison. The FDA's clearance letter confirms their agreement that the device is substantially equivalent for the stated indications for use. This means its performance is considered comparable to the predicate device, which is already accepted as safe and effective.
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