(261 days)
SP-900:
The FUJIFILM Ultrasonic Processor SP-900 is intended to be used in combination with FUJIFILM Ultrasonic Probe, video processor, light source, monitor, recorder, and various peripheral devices. The product is intended to provide ultrasonic images of the gastrointestinal tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree for observation, recording and to aid in diagnosis during endoscopic evaluation.
PB2020-M:
This product is a medical ultrasonic probe. It is intended for the observation and diagnosis of the gastrointestinal tract, biliary and pancreatic ducts and surrounding organs, airways and tracheobronchial tree under the management of physicians at medical facilities.
The FUJIFILM Ultrasonic Processor SP-900 and Ultrasonic Probe PB2020-M consists of five components: 1) processor (SP-900), 2) probe (PB2020-M), 3) control pad (CP-900), 4) scanner (RS-900), and 5) power cord. The SP-900 generates ultrasound waves into the body cavity by driving the ultrasonic transducer installed in the PB2020-M, which is inserted through the forceps channel of an endoscope. The SP-900 processes the reflected ultrasound signals which the PB2020-M receives in the body cavity and further converts the processed electrical signals into video signals to relay to a monitoring system. The SP-900 can acquire and display real-time ultrasound data in B-mode. The CP-900 is used to control operational features of the RS-900 provides the mechanical scanning for acquiring a two-dimensional image. The power cord supplies power to the SP-900.
The provided document is a 510(k) summary for the FUJIFILM Ultrasonic Processor SP-900 and Ultrasonic Probe PB2020-M. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study or performance efficacy study with a test set, ground truth, or expert readers.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes for test/training sets, expert involvement, and ground truth establishment are not present in this document. The document outlines bench testing to ensure the device functions as intended and meets established specifications, particularly regarding image quality and performance, but it does not describe a study involving human readers or a defined set of diagnostic tasks.
Based on the information provided, here's what can be extracted and what is missing:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in terms of specific performance metrics for diagnostic accuracy (e.g., sensitivity, specificity) against a ground truth. Instead, it focuses on demonstrating substantial equivalence to an existing predicate device (Olympus EU-ME2 and UM-S20-17S). The "performance" reported is primarily the device's conformance to safety and performance standards, and its ability to produce images and function as intended during bench testing.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Safety and Essential Performance: | |
| Compliance with IEC 60601-1 | Met (listed as compliant in the "Performance Data" section) |
| Compliance with IEC 60601-1-1 | Met (listed as compliant) |
| Compliance with IEC 60601-1-2 (EMC) | Met (listed as compliant, states "All predetermined testing criteria were met, and the device functioned as intended in all instances.") |
| Compliance with IEC 60601-2-37 | Met (listed as compliant) |
| Compliance with IEC 62359 (Acoustic Output) | Met (listed as compliant, and specific values for ISPTA.3, MI, and TI are provided and noted as less than or equal to predicate device's values, implying meeting safety limits.) |
| Image Quality and Performance: | |
| Meeting internally established specifications (for image quality and performance) | Tested and met ("Testing was conducted on the SP-900 in combination with PB2020-M to ensure that the image quality and performance met all internally established specifications.") |
| Functional equivalence to predicate device | Demonstrated through comparison of technological characteristics (frequency, scanning method, display range, measuring functions, etc.), with an assertion that differences do not raise new safety/effectiveness concerns. |
| Software Validation: | |
| Compliance with IEC 62304 | Met ("Testing of the SP-900 consisted of software validation in accordance with IEC 62304.") |
| Biocompatibility: | |
| Compliance with ISO 10993 (for PB2020-M) | Tested and met ("Ultrasonic Probe PB2020-M was tested for biocompatibility according to ISO 10993.") |
| Cleaning, Disinfection, Sterilization: | Evaluated ("Cleaning, disinfection, and sterilization were also evaluated.") No specific acceptance criterion or outcome from this evaluation is provided beyond the statement of evaluation. |
Study Details (Based on available information):
-
Sample size used for the test set and the data provenance:
This document describes bench testing and software validation, not a clinical or performance study with a "test set" of patient data in the typical sense for evaluating diagnostic accuracy. No sample size for a patient data test set is mentioned. The data provenance is not applicable in the context of device function testing rather than diagnostic performance evaluation. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No "ground truth" establishment for diagnostic accuracy is described, as the evaluation was of device functionality and safety, not diagnostic performance on patient cases. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There was no test set requiring expert adjudication for diagnostic ground truth. -
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:
No. This document does not mention any MRMC study or AI assistance. The device is an ultrasonic processor and probe, not an AI-powered diagnostic tool requiring human-in-the-loop performance studies. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is hardware (ultrasonic processor and probe), not an algorithm that performs standalone diagnostic functions. Its performance was tested as a system. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. No ground truth for diagnostic accuracy was used. The "ground truth" for the engineering tests would be the established performance specifications and safety standards defined in the relevant IEC and ISO standards (e.g., acoustic output limits, electromagnetic compatibility, software integrity). -
The sample size for the training set:
Not applicable. There is no mention of machine learning or an AI model requiring a training set. -
How the ground truth for the training set was established:
Not applicable, as there was no training set for an AI/ML model.
In summary: This 510(k) summary focuses on demonstrating the substantial equivalence of a new ultrasonic imaging device to existing legally marketed devices, primarily through engineering and safety testing. It attests that the device meets relevant performance and safety standards and its functionality is comparable to its predicate. It does not include details about clinical performance studies, diagnostic accuracy, or human reader involvement, as these types of studies are typically required for devices with more subjective or interpretative outputs, or for AI-based diagnostic tools.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.