(77 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Small Organ (prostate), Transrectal. This Ultrasound imaging system is intended for transrectal diagnostic imaging of the prostate gland. This imaging can be used to guide other procedures such as biopsy of the prostate.
The TargetScan™ Transrectal Ultrasound system is intended for diagnostic prostate applications. The TargetScan™ Transrectal Ultrasound system allows the probe to remain stationary inside the patient while the user controls the position of the scan planes that are displayed on the monitor. The probe design allows the capture of transverse and longitudinal scan planes. The system is PC based allowing comprehensive imaging, planning, targeting and data storage/ retrieval.
The provided text is a 510(k) summary for a medical device called the TargetScan™ Transrectal Ultrasound System (K041639). It outlines the device's intended use, technological characteristics, and regulatory compliance. However, it does not contain information about acceptance criteria, device performance, or any clinical studies to demonstrate device effectiveness.
The document primarily focuses on:
- Administrative details: Applicant, contact, date, trade name, common name, establishment registration, classification, and predicate device.
- Device Description: Explains the system's function for diagnostic prostate applications, including its ability to remain stationary while the user controls scan planes and its PC-based imaging capabilities.
- Intended Use: Specifies the purpose (transrectal diagnostic imaging of the prostate, guidance for biopsy), intended patient population (adults), and environment of use (medical professionals in physician offices or hospitals).
- Technological Characteristics: Compares the subject device to its predicate, highlighting similarities in intended use, external design, imaging planes, and biopsy targeting. The key difference mentioned is the subject device's ability to scan the whole prostate without moving the probe in the patient, as the transducer itself moves internally.
- Testing: Lists the safety and electromagnetic compatibility standards the device will comply with (IEC60601-1, EN60601-1, UL2601-1, IEC 60601-2-37, IEC 60601-1-2).
- FDA Clearance Letter: Confirms substantial equivalence to predicate devices, outlines regulatory requirements, and requests a post-clearance special report with acoustic output measurements.
- Indications for Use Forms: Detail the specific clinical applications and modes of operation for the system and probe, indicating "N" for new indications for "Small Organ (prostate)" and "Transrectal" applications in B-mode.
Therefore, based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets them, nor can I provide answers to most of your specific questions.
Here's a breakdown of what can be extracted and what is missing:
1. Table of acceptance criteria and the reported device performance:
- Not Available: The document lists standards for safety and electromagnetic compatibility (e.g., IEC60601-1), which are essential for device approval, but these are general compliance standards, not performance-based acceptance criteria for the imaging capabilities or specific clinical effectiveness. There are no reported performance metrics for diagnostic accuracy, image quality, or clinical outcomes.
2. Sample sized used for the test set and the data provenance:
- Not Available: No information about a test set size, data provenance, or any clinical data is provided. This document is a 510(k) summary, which often relies on substantial equivalence to a predicate device rather than extensive new clinical trials, especially for a diagnostic imaging system of this nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Available: Since no test set or ground truth establishment is mentioned, this information is not present.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Available: No information about a test set or adjudication method is provided.
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:
- Not Available: This device is a diagnostic ultrasound system, not an AI-powered diagnostic tool. There is no mention of AI assistance or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Available: This device is a human-operated imaging system. No standalone algorithm performance is discussed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Available: No information regarding ground truth is provided.
8. The sample size for the training set:
- Not Available: No machine learning or AI components are described, so there is no mention of a training set.
9. How the ground truth for the training set was established:
- Not Available: As above, no training set is discussed.
In summary, the K041639 document is a regulatory submission for a diagnostic ultrasound system. It demonstrates compliance with general safety and performance standards relevant to such devices but does not provide details of clinical performance studies, such as specific acceptance criteria or reported accuracy/effectiveness data typically found in clinical evaluation sections for novel diagnostic algorithms or AI-driven systems. This type of 510(k) relies on demonstrating substantial equivalence to a pre-existing device rather than extensive new clinical validation for its inherent diagnostic capabilities beyond what the predicate already demonstrated.
§ 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.