(35 days)
Sony Hybrid Graphic Printers UT-971AD and UP-991AD are compact, medical grode hlack and white printers that can accept both anslog and digital signal inpus. They are designed to be integrated into radiology imaging systems such as mobile c-arm, ultrasound, cardine intintion laboratory and other compaible medical imaging systems and produce hard copy prints of still images captured by these systems for the patient rocord or for referrals.
The UP-991AD and UP-971AD Hybrid Graphic Printers are compact black and white printers designed for use with both analog and digital radiology imaging systems such as mobile C-arm, ultrasound, cardiac catheterization laboratory and other compatible medical imaging systems. They provide 325 dpi high resolution hard copies of still images captured by the imaging system that can then be used as reference prints for patient record purposes or referrals.
Both the UP-991AD and UP-971AD Hybrid Graphic Printers provide a multi-picture print mode and panoramic print capability. Additionally, the UP-991AD can store images on a connected USB flash drive and print on transparent blue film media, in addition to paper media. Other conveniences offered by the UP-991AD include automatic detection of media type and an integrated media cutter.
The provided text describes a 510(k) premarket notification for the Sony UP-991AD / UP-971AD Hybrid Graphic Printers. This submission aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving the device meets specific performance criteria through clinical studies in the typical sense of AI/CADe devices.
The acceptance criteria are implicitly defined by compliance with applicable standards and a comparison of technological characteristics to predicate devices. The study proving acceptance is a non-clinical performance testing suite.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence claim for a printer, the "acceptance criteria" are the characteristics of the predicate devices. The device performance is shown by demonstrating that the proposed device is either equivalent or an upgrade in these characteristics.
| Characteristic | Acceptance Criteria (Predicate Devices - e.g., UP-701, UP-811, UP-1000/1100, UP-5000) | Reported Device Performance (Sony UP-991AD / UP-971AD) |
|---|---|---|
| Regulatory Status | K882958 (Sony UP Series Video Printers) | Proposed device claims substantial equivalence to K882958 |
| Product Code | LMC (for predicate) / KQM (for some predicates) | LMC |
| Printing Method | Direct thermal printing, Sublimation heat transfer printing | Direct thermal printing |
| High Resolution | 61 dpi to 102 dpi/132 dpi (h/w) | 325 dpi (an upgrade) |
| Gradations | 16/32 to 256 levels each | 8 bits (256 levels) processing |
| Picture Elements | Various dot/PELS specifications | Digital: 7680 x 2560 dots; Video NTSC: 720 x 504 dots; Video PAL: 720 x 604 dots (generally improved) |
| Picture Area | Various mm measurements | DIGITAL: 600 x 200 mm (Max); VIDEO: Standard NTSC: 182 x 144 mm, etc. (generally improved) |
| Paper Size | Various paper widths and sheet sizes | Paper width of 8.25 in. [210 mm] |
| Picture Memory | 128K x 4 bits to 1024K x 8bits | Digital: 2816 x 7680 x 8 bits; Video: 6 frames (720 x 608 x 8 bits for one frame) (an upgrade) |
| Interface | Various video inputs, remote ports | USB (type A), Hi-Speed USB (USB 2.0), VIDEO INPUT (BNC), VIDEO OUTPUT (BNC), REMOTE (Stereo mini jack) (digital connectivity is new functionality) |
| Power Requirements | AC 100 V to 240 V, 50/60 Hz | AC 100 V to 240 V, 50/60 Hz |
| Weight | 7lb 15oz [3.6 kg] to 102lb 12oz [46.6 kg] | 15lb 7oz [7.0 kg] |
| Digital Video Input | N/A (for predicates) | Yes (implies ability to accept digital signals) |
| Analog Video Input | Yes | Yes |
| Multi-picture Mode | Yes - 4, 9 for some predicates | Yes - 2, 4, and 6 (Analog) / 2 and 4 (Digital) (expanded functionality) |
| Panoramic Printing | N/A (for predicates) | Yes up to a maximum of 600mm in length (new functionality) |
| Printing Speed | 8.5 seconds/screen to 3 minutes | Approx. 8 seconds/image (in standard mode) |
| Storage Media | N/A (for predicates) | USB Flash drive (UP-991AD only) (new functionality) |
| Dimensions | Various width, height, depth | 12.5 (W) x 5.25 (H) x 10.5 (D) inches (compact size) |
| LCD Display Panel | N/A (for predicates) | Yes (new functionality) |
| LED Backlight | N/A (for predicates) | Yes (new functionality) |
| Function Keys | Front Panel, Operation Panel, Keypad | Front Panel |
| Settings Auto Lock | N/A (for predicates) | Yes (new functionality) |
| Contrast Knob | N/A, Yes for some predicates | Yes |
| Brightness Knob | N/A, Yes for some predicates | Yes |
| Automatic Media Cutter | N/A (for predicates) | Yes (UP-991AD only) (new functionality) |
| Automatic Detection of Media Type | N/A (for predicates) | Yes (UP-991AD only) (new functionality) |
| Print Media | Various thermal paper and film | UPT-210BL Blue Thermal Transparent Film (UP-991AD only); UPP-2010HD, UPP-210SE Thermal Print Media (new media options) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states "SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE" and "hardware and software testing." It also explicitly says "SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE: Not applicable."
This indicates that no clinical test set was used in the traditional sense for evaluating diagnostic performance with patient data. The testing was likely internal engineering and quality assurance testing of the printer's functionality, safety, and compliance with standards. Therefore, information about sample size for a test set and data provenance in a medical imaging context is not provided and not relevant to this type of device submission.
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)
Not applicable, as no clinical test set with medical imaging ground truth (e.g., diagnoses) was used. The evaluation centered on engineering specifications and adherence to safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring expert adjudication was used.
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 applicable. This device is a printer, not an AI/CADe system. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a printer, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this device would be its technical specifications and performance against industry standards for safety, electrical compatibility, and output quality (e.g., resolution, printing speed, interface functionality). These are verified through engineering tests, not clinical "ground truth" methodologies.
8. The sample size for the training set
Not applicable. This is a hardware device (printer), not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 892.2040 Medical image hardcopy device.
(a)
Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.