(80 days)
The BladderManager PCI 5000 and BladderScan BVI 5000 "project ultrasound energy through the lower abdomen of the non-pregnant patient to obtain an image of the bladder that is used to determine bladder volume non-invasively."
The BladderManager PCI 5000 is a portable, battery-powered ultrasound instrument designed for a patient to non-invasively monitor his or her bladder volume on an intermittent basis. The BladderScan BVI 5000 is similar, except that it is designed for use by the clinician with the added feature of a "docking cradle" containing an onboard computer that provides a hard copy printout of the scan images and the bladder volume.
The provided text does not contain detailed acceptance criteria or a comprehensive study report with the specific information requested in your bullet points (e.g., specific performance metrics, sample sizes for test and training sets, expert qualifications, or adjudication methods).
The document describes the submission of a 510(k) summary for the BladderManager PCI 5000 and BladderScan BVI 5000 devices, asserting their substantial equivalence to a predicate device (BladderScan BVI 2500). It mentions clinical testing but provides only a high-level summary.
Here's what can be inferred from the provided text, and where information is missing:
1. A table of acceptance criteria and the reported device performance
The document states that "clinical accuracy testing demonstrated that the subject devices are substantially equivalent to the predicate device in terms of effectiveness." It also mentions "All non-clinical testing demonstrated that the subject devices are substantially equivalent to the predicate device in terms of safety, effectiveness, and performance." However, specific quantitative acceptance criteria or reported performance metrics (e.g., accuracy percentages, sensitivity, specificity, or specific error ranges for bladder volume measurement) are not provided.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set:
- "Preliminary clinical testing of the BladderManager PCI 5000 and the BladderScan BVI 5000 was performed on adult ambulatory volunteers." (Specific number of volunteers not provided).
- "Clinical testing of the BladderManager PCI 5000 was performed at three independent clinical sites using adult spinal cord diseased patients, as well as healthy volunters." (Specific number of patients/volunteers not provided).
- Data Provenance: The location of the "three independent clinical sites" is not specified, though the company has offices in the USA, Canada, and The Netherlands. It's unclear if the participants were from the US or international, and whether the data was retrospective or prospective is not explicitly stated, although "preliminary clinical testing" and "clinical testing" generally imply prospective data collection in the context of device approval.
3. 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)
This information is not provided in the text. The document refers to "clinical accuracy testing" but does not detail how the "ground truth" for bladder volume was established (e.g., catheterization, MRI, or another method) or who performed these measurements and their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not 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
This is not applicable as the device is an "Ultrasonic Bladder Volume Instrument" which directly measures volume, not an AI-assisted diagnostic tool interpreted by human readers. It's a standalone measurement device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the device itself is a "standalone" instrument designed to measure bladder volume. The clinical testing mentioned assessed the performance of the device itself (the "algorithm" or measurement capability) against some implied standard of effectiveness.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The specific type of ground truth used for bladder volume measurement is not explicitly stated. For bladder volume measuring devices, a common "ground truth" method in clinical studies is catheterization, or using another validated imaging modality (e.g., MRI) as a reference. The document only mentions "clinical accuracy testing."
8. The sample size for the training set
This information is not provided. The text focuses on clinical testing for substantial equivalence, not on the development or training of an algorithm for the device. If the device uses an algorithm, details on its training set are not included here.
9. How the ground truth for the training set was established
This information is not provided, as details about a "training set" are absent.
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K955942 Puc 1 y3
Image /page/0/Picture/1 description: The image shows the logo and address of Diagnostic Ultrasound Corporation. The logo consists of the letters "DU" in a bold, stylized font, with the letter "X" placed below. The text "Diagnostic Ultrasound" is written in a clear, sans-serif font, followed by "CORPORATION" and the address "P.O. Box 818, Redmond, WA 98073-0818 USA".
MAR 1 5 1996
510(k) SUMMARY
Diagnostic Ultrasound Corporation's BladderManager™ Personal Care Instrument PCI 5000 BladderScan™ Bladder Volume Instrument BVI 5000
This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Diagnostic Ultrasound Corporation 18109 NE 76th Street Redmond, WA 98052
| Phone: | (206) 867-1348 |
|---|---|
| Facsimile: | (206) 883-2896 |
| Contact Person: | Gerald McMorrow, MSEE |
Date Prepared: December 22, 1995
Name of Devices and Name/Address of Sponsor:
BladderManager™ Personal Care Instrument PCI 5000 (PCI 5000) BladderScan™ Bladder Volume Instrument BVI 5000 (BVI 5000)
Diagnostic Ultrasound Corporation 18109 NE 76th Street Redmond, WA 98052
Common or Usual Name
Ultrasonic Bladder Volume Instrument
Classification Name
System, Imaging, Pulsed Echo, Ultrasonic
Predicate Device
Diagnostic Ultrasound Corporation's BladderScan™ BVI 2500 (K 915436)
Cornorate Hear 18109 NF 76th Redmond I 906 867-134 200 221-0317
Canadian Office
3500 Maycrest Way, Suite 140
Richmond, BC V6V 2N8
CANADA
604 244-5814
800 765-7733
European Office
Lagedijk 14
3401 RG Ijsselstein
THE NETHERLANDS
31 3068 70570
31 3068 70510 Fax
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Device Description
The BladderManager PCI 5000 is a portable, battery-powered ultrasound instrument designed for a patient to non-invasively monitor his or her bladder volume on an intermittent basis. The BladderScan BVI 5000 is similar, except that it is designed for use by the clinician with the added feature of a "docking cradle" containing an onboard computer that provides a hard copy printout of the scan images and the bladder volume.
Intended Use
The BladderManager PCI 5000 and BladderScan BVI 5000 "project ultrasound energy through the lower abdomen of the non-pregnant patient to obtain an image of the bladder that is used to determine bladder volume non-invasively."
This statement of intended use is identical to that of the predicate device.
Technological Characteristics Comparison
The BladderManager PCI 5000 and BladderScan BVI 5000 are substantially equivalent to the other currently marketed BladderScan BVI 2500 which is referenced above. The BladderManager PCI 5000 and BladderScan BVI 5000 and their predicate device are all pulsed echo ultrasonic imaging instruments dedicated to non-invasive measurement of urinary bladder volume. Although there are some technological differences between the BladderManager PCI 5000, the BladderScan BVI 5000, and their predicate device, these differences are minor and raise no new questions of safety and effectiveness. In addition, accepted scientific methods exist for assessing the effects of the technological differences. The BladderManager PCI 5000 and BladderScan BVI 5000 differ from the BladderScan BVI 2500 in scanhead shape, patient contact materials, scan angle, ultrasonic coupling material, lateral resolution, acoustic output, and transducer model number. However, accepted scientific methods for biocompatibility testing, ultrasonic acoustic output testing, and clinical testing demonstrated that the subject devices are substantially equivalent to the predicate device in terms of safety. Also, accepted scientific methods for clinical accuracy testing demonstrated that the subject devices are substantially equivalent to the predicate device in terms of effectiveness.
Performance Data
Non-clinical testing included acoustic output testing, thermal, mechanical, and electrical safety testing, electromagnetic emissions and immunity testing, and biocompatibility testing. All non-clinical testing demonstrated that the subject devices are substantially equivalent to the predicate device in terms of safety, effectiveness, and performance.
Preliminary clinical testing of the BladderManager PCI 5000 and the BladderScan BVI 5000 was performed on adult ambulatory volunteers. No significant adverse effects or complications were noted. The results demonstrated that the device is substantially equivalent to the predicate device in terms of safety and effectiveness.
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Clinical testing of the BladderManager PCI 5000 was performed at three independent clinical sites using adult spinal cord diseased patients, as well as healthy volunters. No significant adverse effects or complications were noted. The results demonstrated that the device is substantially equivalent to the predicate device in terms of safety and effectiveness.
Conclusion
Non-clinical and clinical testing methods demonstrate that the device is as safe, as effective, and performs as well as the legally marketed predicate device. The BladderManager PCI 5000 and the BladderScan BVI 5000 are substantially equivalent to the BladderScan BVI 2500 with respect to intended use, technological characteristics, and performance.
§ 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.