Palm Bladder Scanner - PBSV7.1

• K Number: K210591
• Device Name: Palm Bladder Scanner - PBSV7.1
• Manufacturer: Mianyang Meike Electronic Equipment Co., Ltd.
• Date Cleared: 2021-06-09 ( 100 days)
• Product Code: IYO , ITX , IYX
• Regulation Number: 892.1560
• Type: Special
• Panel: RA
• Reference & Predicate Devices: K191307

Intended Use

Palm Bladder Scanner - PBSV7.1 is intended to project ultrasound energy through the lower abdomen of the nonpregnant patient to obtain an image of the bladder and uses that image to calculate the bladder volume non-invasively. It is contraindicated for fetal use and for use on pregnant patients. And it should not be used by those who are allergic to coupling agent and who have abdomen wound and skin disease.

Device Description

Palm Bladder Scanner - PBSV7.1 is a medical device with high performance combined with modern B-mode ultrasound technology and computer technology. The PBSV7.1 is composed of data processing host, 3D ultrasonic probe and application software. The 3D ultrasonic probe will transmit the collected data to the host, which will process the received data into ultrasonic images and bladder volume data. Images and data will be transmitted to the running application software on the Android system PC tablet through the USB interface.

AI/ML Overview

The provided text is a 510(k) Summary for the Palm Bladder Scanner - PBSV7.1, with a predicate device of Palm Bladder Scanner - PBSV5.1 (K191307). While it discusses safety and effectiveness, it does not include a detailed study with specific acceptance criteria and performance data for clinical use.

The document states: "Clinical testing was not performed for the subject device as part of the submission."

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes and data provenance for a test set.
3. Number of experts and their qualifications for ground truth.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used from a clinical study.
8. Sample size for the training set (clinical data).
9. How ground truth for the training set was established (clinical data).

Based on the provided text, the device's substantial equivalence is primarily established through non-clinical testing and comparison of technological characteristics with the predicate device.

Here's what can be extracted from the document regarding performance and testing, without a clinical study:

Acceptance Criteria & Reported Performance (Based on Technical Specifications & Bench Testing):

Acceptance Criteria (Predicate/Subject Device Performance)	Reported Device Performance (PBSV7.1)
Accuracy: ±15%, ±15 ml (PBSV5.1 Predicate)	±5%(≥100mL)/ ±5mL (0~100mL)
Maximum Measurement: 999ml (PBSV5.1 Predicate)	2000ml
Dead Zone: 8mm (PBSV5.1 Predicate)	≤3mm
Patient Case Record Memory: ≤100 Pieces (PBSV5.1 Predicate)	≤10000 Pieces

Explanation of the Study and Why it Lacks Clinical Details:

1. A table of acceptance criteria and the reported device performance:

   • As shown above, the "acceptance criteria" appear to be derived from the performance of the predicate device (PBSV5.1), and the "reported device performance" is the improved specification of the PBSV7.1. This is a comparison of technical specifications, not results from a clinical trial.

2. Sample sized used for the test set and the data provenance:

   • Not applicable for clinical data. The document explicitly states "Clinical testing was not performed for the subject device as part of the submission."
   • For non-clinical testing, the sample sizes and data provenance are not detailed in this summary. The summary mentions "non-clinical design verification and validation testing" and "comprehensive software verification and validation."

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

   • Not applicable for clinical data. There was no clinical test set with a need for expert-established ground truth.

4. Adjudication method for the test set:

   • Not applicable for clinical data.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

   • No, an MRMC study was not done. Clinical testing was not performed.

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

   • Not explicitly stated for a clinical context. The device calculates bladder volume non-invasively using an image. While the algorithm performs the calculation, its standalone performance in a clinical setting without a human using the device on a patient was not evaluated per this summary. The "software verification and validation" tests would have assessed the algorithm's performance, but not on clinical data.

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

   • Not applicable for clinical data. For the non-clinical and software validation, the ground truth would have been based on defined specifications, simulated data, or phantoms, rather than clinical outcomes or expert consensus on patient data.

8. The sample size for the training set:

   • Not applicable for clinical data. The document does not describe any training set using patient data, as no clinical testing was performed for this submission. The software was "developed and verified according to IEC 62304:2006," implying a software development process rather than a machine learning training process on a large dataset.

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

   • Not applicable for clinical data.

Summary of Device Substantiation (as explained in the document):

The manufacturer claims substantial equivalence based on:

• Identical intended use as the predicate device.
• Similar technological characteristics, despite some differences.
• Non-clinical testing: "The function and performance of Palm Bladder Scanner - PBSV7.1 has been evaluated through non-clinical design verification and validation testing." This includes:
  • Compliance with various IEC and ISO standards (e.g., IEC 60601-1, IEC 60601-2-37, IEC 60601-1-2, IEC 62133, IEC 62359, ISO 10993-5, ISO 10993-10).
  • "Comprehensive software verification and validation."
• The conclusion that "the design changes presented with the subject device do not raise new questions of safety and effectiveness, the subject device meets design specifications, and that the subject and predicate devices are substantially equivalent."
• Improved performance over the predicate device in several key metrics (accuracy, maximum measurement, dead zone, memory capacity).

Regulation Number and Section

§ 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.