(88 days)
The PENTAX Medical Video Duodenoscope ED34-i10T2 is intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to, Billary Tract via the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems; Esophagus, Stomach, Duodenum, Common Bile, Hepatic and Cystic Ducts. This endoscope is introduced via the mouth when indications consistent with the need for the procedure are observed in adult and pediatric patient populations.
The PENTAX Medical Video Duodenoscope ED34-i10T2 is intended to be used with a PENTAX Video Processor, documentation equipment, video monitor, endoscopic device ancillary equipment for optical visualization (via a video monitor) of, and/or therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Common Bile, Hepatic and Cystic Ducts. The ED34-i10T2 is composed of the following main parts: an insertion portion, control body and PVE connector. The insertion portion is inserted into the body cavity of patient. The insertion includes the distal end and bending section. The objective lens, light guide, instrument channel, elevator link, and air/water nozzle are located on the distal end of the insertion portion. The control body is held by the user's hand. The control body includes the angulation control knob, angulation lock knob/lever, cannula/forceps elevator control lever, air/water cylinder, suction cylinder, remote button, and instrument channel inlet. The air/water feeding valve is attached to the air/water cylinder, and the suction control valve is attached to the suction cylinder. The inlet seal is attached to the instrument channel inlet. The PVE connector is connected to the video processor via electrical contacts. The bending section is bent by the angulation control knob to operate the endoscope angulation. The angulation lock knob/lever is used to adjust the rotation torque of the angulation control knob. The cannula/forceps elevator mechanism is used to control the position of the cannula which is inserted through the Instrument Channel. The cannula/forceps elevator control lever is used to operate the cannula/forceps elevator of the Distal End Cap with Elevator (OE-A63). The air/water feeding system is used to deliver the air and water to the objective lens from the air/water nozzle. When the hole at the top of air/water feeding valve is covered, the air is delivered. When the air/water feeding valve is pushed, the water is delivered. The suction control system is used to suction the fluid and air in body cavity from the instrument channel. When the suction control valve is pushed, the fluid and air are suctioned. The remote button is used to operate the functions of the video processor and any external device from the control body, as necessary. The single use, Distal End Cap with elevator (OE-A63) is provided as a sterile product. OE-A63 is attached to the elevator link of the distal end of ED34-i10T2. It is discarded after use. Endoscopic devices such as biopsy forceps are inserted from the instrument channel Inlet into the body cavity through the instrument channel. The light guide of the distal end is used to illuminate the body cavity by light which is carried through the light carrying bundle. The light carrying bundle guides the light from light guide plug which is connected to the light source inside the Video Processor. The CCD built into the distal end receives reflected light (image data) from the body cavity, and sends the image data to the Video Processor through the video cable. The image data are converted into the image signal by the Video Processor, and the image inside the body cavity is displayed on the monitor. The PENTAX Medical Video Processors EPK-i5010 and EPK-i7010 are compatible with PENTAX Medical Video Duodenoscope ED34-i10T2.
The provided text describes the PENTAX Medical Video Duodenoscope ED34-i10T2 and its clearance via a 510(k) submission. Acceptance criteria and performance data are discussed across several categories, but it primarily focuses on device safety and functionality rather than AI performance.
Here's an analysis of the provided information based on your requested points:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a traditional medical device (endoscope), not an AI/ML device, the performance data presented is focused on safety and functional aspects, not AI accuracy metrics like sensitivity, specificity, or AUC. The "acceptance criteria" are implied by successful completion of validation studies against established standards.
| Acceptance Criterion Category | Specific Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Reprocessing Validation | Residual soil accumulation and extraction efficiency in accordance with AAMI TIR 30:2011 and FDA's 2015 Reprocessing Guidance. Effectiveness of reprocessing procedures. | All acceptance criteria were satisfied for cleaning, rinsing, and high-level disinfection, confirming effectiveness. |
| O-Ring Analysis | Compression Ratio met pre-determined criterion. | The modification demonstrated a Compression Ratio that met the pre-determined acceptance criterion. |
| Sterilization & Shelf Life (Distal End Cap with Elevator) | Product meets design specifications after irradiation at maximum acceptable dose (60kGy or more) at various storage times (immediately, 6 months, 2 years accelerated aging). | All acceptance criteria were satisfied for product performance, packing performance, and product safety qualification after irradiation and accelerated aging. |
| Biocompatibility | Acceptable biological risks based on cytotoxicity, sensitization, intracutaneous reactivity, and assessment of carbon black and titanium oxide. | Biological risks of both ED34-i10T2 and Distal End Cap with Elevator (OE-A63) were concluded to be acceptable based on test results. |
| Electrical Safety & EMC | Compliance with IEC 60601-1, IEC 60601-2-18, and IEC 60601-1-2 (4th edition). | The scope passed all testing in accordance with the specified standards. |
| Optical Testing | Optical performance is identical to the predicate device. | All items affecting optical performance are identical with the predicate device. |
| Distal End Cap (OE-A63) Performance | Attachment performance tests satisfied acceptance criteria. | All test items satisfied the acceptance criteria and were determined to be acceptable. |
| Human Factors Testing | Effectiveness of reprocessing instructions for use (RIFU) and risk management measures, without serious errors or problems. | The study validated the effectiveness of RIFU and risk management measures, indicating it would be used without serious errors or problems. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of an AI/ML device with data samples. Instead, it refers to validation studies for various aspects of the device.
- Reprocessing Validation: "Simulated use testing, cleaning and rinsing... and high level disinfection were conducted at all of evaluation sites." The specific number of devices or cycles is not provided.
- Sterilization and Shelf Life (Distal End Cap): Irradiated products were tested at different storage times. The number of products per test point is not specified.
- O-Ring Analysis, Biocompatibility, Electrical Safety & EMC, Optical Testing, Distal End Cap Performance Testing, Human Factors Testing: These studies were conducted but the sample sizes (e.g., number of O-rings, number of devices tested for electrical safety, number of participants in human factors) are not explicitly stated.
- Data Provenance: Not applicable in the context of typical AI/ML data provenance (e.g., country of origin, retrospective/prospective). These are device performance validation studies performed by the manufacturer or contracted labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The device is an endoscope, not an AI/ML diagnostic tool requiring expert ground truth for image interpretation. The performance data relates to direct device functionality and safety.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable for a non-AI medical device validation. Decisions are based on meeting predefined engineering and safety standards, not on expert adjudication of diagnostic outcomes.
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 traditional medical device (endoscope), not an AI diagnostic product. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed and is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This device is an endoscope, which is directly operated by a human user (physician) for visualization and therapeutic access. There is no standalone algorithm performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically defined for AI/ML performance (e.g., pathology, expert labels) is not directly applicable here. For the various validation studies:
- Reprocessing Validation: Ground truth is defined by objective analytical measurements of residual soil and microorganism reduction, compared against established industry standards (AAMI TIR 30:2011) and FDA guidance.
- Human Factors Testing: Ground truth is the observation of user performance of reprocessing steps against the manufacturer's Instructions For Use (IFU) and identification of critical errors, as evaluated by human factors experts.
- Other tests (e.g., O-ring, biocompatibility, electrical safety, optical performance) rely on engineering specifications, material science standards, and established laboratory testing protocols as their form of "ground truth."
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML model.
§ 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.