(64 days)
This 27HJ713S is intended to provide color video displays and images from medical equipment which include laparoscopy and endoscopy systems for surgery and various medical imaging systems. This product does not support 3D.
The 27HJ713S is a color video monitor intended to display viewable medical images transmitted by standard video signals. In particular, the device is intended for use as part of a visualisation system in endoscopic surgery.
Based on the provided document, the device in question is a medical display monitor (27HJ713S) intended to display color video from medical equipment like laparoscopy and endoscopy systems. The document is a 510(k) summary, which establishes substantial equivalence to a predicate device rather than providing extensive de novo clinical or performance studies for a novel AI-powered device.
Therefore, the information typically associated with acceptance criteria and a study proving an AI device meets those criteria (such as specific performance metrics like sensitivity, specificity, or AUC, sample sizes for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance) is not present in this document. This filing is for a display monitor, not an AI diagnostic or assistance tool.
However, I can extract the acceptance criteria related to the device's functionality and safety as a display monitor, and how its performance was proven.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
For this device (a medical display monitor), "performance" is primarily defined by its technical specifications and compliance with safety and EMC standards. The comparison is made against a predicate device to establish substantial equivalence.
| Acceptance Criteria Category | Specific Criteria (Implicitly Accepted) | Reported Device Performance and Compliance |
|---|---|---|
| Display Technology | TFT LCD | TFT LCD (Matches Predicate) |
| Resolution | Ability to display medical images clearly at a specified resolution. | 3,840 x 2,160 pixels (Higher than Predicate: 1920 x 1080) |
| Pixel Pitch | Appropriate pixel density for medical imaging display. | 0.1554 x 0.1554 mm (Smaller than Predicate: 0.3114 x 0.3114 mm, indicating higher pixel density) |
| Physical Dimensions | Appropriate size and weight for clinical environments. | 654.4 x 410.9 x 58.0 mm (Comparable to Predicate: 650.0 x 419.0 x 58.0 mm) |
| Weight | Manageable weight for installation and use. | 7.7 kg (Lighter than Predicate: 8.5 kg) |
| Electrical Safety | Compliance with electrical safety standards for medical devices. | Complies with AAMI ES60601-1 |
| Electromagnetic Compatibility (EMC) | Compliance with EMC standards to ensure no interference with other medical devices. | Complies with IEC 60601-1-2 |
| Software Validation | Software designed, developed, verified, and validated according to FDA guidance (for "MODERATE level of concern software"). | Software was designed and developed according to a software development process and was verified and validated according to FDA quidance “The content of premarket submissions for software contained in medical devices, on May 11, 2005.” |
| Indications for Use | Ability to provide color video displays and images from medical equipment including laparoscopy and endoscopy systems and various medical imaging systems (non-3D). | Stated Indications for Use match this criterion. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of an AI device's performance study. The document describes bench tests for electrical safety, EMC, and software validation for a hardware display monitor. There is no "test set" of medical images or patient data in the sense of an AI algorithm evaluation.
- Data Provenance: Not applicable. The "study" here consists of engineering tests on the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. Ground truth as typically defined for AI algorithms (e.g., disease presence/absence in an image) is not relevant for a display monitor's electrical and mechanical performance. The "ground truth" for these tests are the established industry standards (e.g., AAMI ES60601-1, IEC 60601-1-2) which expert engineers and regulatory bodies define.
4. Adjudication Method for the Test Set
- Not applicable. There is no human reading or image interpretation involved that would require adjudication.
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
- No. This is a display monitor, not an AI-powered diagnostic or assistance tool. Therefore, an MRMC study related to human reader performance with or without AI assistance was not performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a display monitor, not a standalone algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this device's evaluation is primarily compliance with established electrical safety and electromagnetic compatibility (EMC) standards, and verification of software functionality against design specifications. These are technical standards, not clinical outcomes or expert consensus on medical images.
8. The Sample Size for the Training Set
- Not applicable. This device is a hardware display monitor, not an AI algorithm developed using a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI algorithm, no ground truth was established in this context.
§ 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.