(30 days)
The CUBEScan BioCon-1100 is a B-mode pulsed-echo ultrasound device. The BioCon-1100 projects ultrasonic energy through the lower abdomen of a patient to obtain images of the bladder to calculate the urine volume non-invasively. The BioCon-1100 is intended to be used by a qualified medical professional in hospitals and other healthcare facilities to non-invasively measure the urine volume in the bladder. Contraindications for the BioCon-1100 are fetal use on pregnant patients.
The CUBEScan BioCon-1100 (Bladder volume measurement system) is a safe, easy to use, noninvasive system for measuring bladder volume (residual volume). The CUBEScan BioCon-1100 is a B-mode ultrasound device, which consists of a probe that sends and receives ultrasonic waves, and a console that processes ultrasonic signals and converts them into the desired data. The 3Dmechanical sector transducer take the bladder in 12 sections and calculate the volume of the bladder based on the images which appear on the LCD screen. In addition, the pre-scan function allows users to easily locate the location of the bladder before scanning, making measurement easier. Measurement results can be transferred to a computer, and data can be managed using CubePro-1100.
The provided text is a 510(k) summary for the CUBEScan BioCon-1100, a medical device for non-invasive bladder volume measurement. It clarifies that no clinical studies were required or performed to support substantial equivalence for this specific submission (K201995). The changes in this submission relate to the operating system, graphical user interfaces, rolling cart dimensions, and IPX rating, which were deemed not to affect device performance or indications for use.
Therefore, many of the typical acceptance criteria and study details for an AI/ML device (like those related to ground truth, expert consensus, MRMC studies, effect sizes, etc.) are not applicable to this submission, as it is for a traditional ultrasound device with minor technical updates, not an AI/ML product.
Based on the provided text, here's what can be extracted:
Acceptance Criteria and Device Performance (Not applicable for AI/ML performance, but for general device safety and effectiveness)
The document primarily states that the specific changes (Linux OS, GUIs, cart dimensions, IPX rating) "do not affect the device performance characteristics and does not change the device Indication for use." The underlying performance relates to accuracy of urine volume measurement, which is inherent to this type of device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device Intent Met | The CUBEScan BioCon-1100 is "as safe, as effective, and performance is substantially equivalent to the predicative devices." The changes "do not affect the device performance characteristics and does not change the device Indication for use." |
| Acoustic Output Conformance | The device has been evaluated for acoustic output and found to conform to applicable medical device safety standards and guidance documents. |
| Biocompatibility Conformance | The device has been evaluated for biocompatibility and found to conform to applicable medical device safety standards and guidance documents. |
| Thermal, Electrical, Electromagnetic, and Mechanical Safety Conformance | The device has been evaluated for thermal, electrical, electromagnetic, and mechanical safety and found to conform to applicable medical device safety standards and guidance documents. |
| IPX Rating | Changed to IPX 5 (specific performance not detailed beyond the rating itself). |
| Operating System | Changed to Linux (performance impact stated as none). |
| Graphical User Interfaces | Changed (performance impact stated as none). |
| Rolling Cart Dimensions | Height and width changed (performance impact stated as none). |
Study Details (based on the provided 510(k) Summary)
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Sample size used for the test set and the data provenance: Not applicable. The document explicitly states: "The subject of this premarket submission, CUBEScan BioCon-1100, did not require clinical studies to support substantial equivalence." The testing was non-clinical (acoustic, biocompatibility, electrical, thermal, electromagnetic, mechanical safety).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical studies were performed requiring independent ground truth establishment by experts.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical studies were performed.
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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 not an AI/ML device, and no MRMC study was performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical studies were performed. For non-clinical testing, ground truth would refer to engineering specifications and compliance with standards.
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The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no "training set" in the context of machine learning.
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How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.
Conclusion from the document:
The CUBEScan BioCon-1100, as described in K201995, is cleared based on demonstrating substantial equivalence to a predicate device (CUBEScan BioCon-1100, K200548) through non-clinical testing (acoustic output, biocompatibility, thermal, electrical, electromagnetic, and mechanical safety) and by asserting that the minor technical changes (OS, GUI, cart, IPX) do not alter the device's performance characteristics or indications for use. The document explicitly states that no clinical studies were required or performed for this submission. Therefore, information typically requested for AI/ML device studies (like expert adjudication, MRMC, training/test set details, ground truth methods) is not present because it's not relevant to this specific 510(k) clearance.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.