(170 days)
Jedmed ORL Video Nasopharyngo-Laryngoscopes are intended to examine the larynx, nasal cavity and nasal pharynx. They are used between the upper respiratory tracts of the nasal passage and vocal cords.
This flexible scope is designed with the insertion tube with its bendable distal tip w/camera, the handle, the umbilical unit which has the leakage tester, and connection for light source port and power/video port The handle incorporates the control lever to bend the distal tip.
The provided text describes a 510(k) premarket notification for the "ORL Video Nasopharyngo-Laryngoscope." It references a study conducted to demonstrate substantial equivalence to predicate devices, but it does not describe an AI medical device or a study involving AI. Therefore, I will respond to the prompt by extracting the relevant information about the non-AI device's acceptance criteria and study, indicating where certain AI-specific questions are not applicable.
Here's the information extracted from the provided text, formatted to address your questions:
Acceptance Criteria and Device Performance Study for the ORL Video Nasopharyngo-Laryngoscope
This document describes a 510(k) premarket notification for a medical device that does not involve Artificial Intelligence (AI). The study conducted was to demonstrate substantial equivalence to predicate devices based on functional performance and cleaning/disinfection validation.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly list "acceptance criteria" for the functional tests with specific numerical targets. Instead, it states that the device was "found to be comparable" to the predicate device in several functional areas. The table below compares the specifications of the device under review with its predicate devices. The "acceptance criteria" here implicitly means that the performance values should be similar to or within acceptable ranges of the predicate devices for achieving substantial equivalence.
| Feature | Predicate Device (K132039) Performance / Criteria | Device Under Review Performance |
|---|---|---|
| Field of View | 90° | 90° |
| Depth of View | 10mm-55mm | 10mm-55mm |
| Angulation (Up/Down) | 130° Up / 130° Down | 130° Up / 130° Down |
| Working Length | 310mm | 310mm |
| Tube Diameter | 4mm | 4mm |
| Video Format | NTSC---PAL | NTSC---PAL/NTSC |
| Resolution | 320x240 & 500x582/510x492 | 320x240 500x582 510x492 |
| Cleaning/Disinfection | Significant microbial reduction (implied) | Fully met validation requirements |
Predicate Device (K102733) Differences Noted:
- Working Length: 300mm (Device under review: 310mm)
- Depth of View: 3mm-50mm (Device under review: 10mm-55mm)
- Tube Diameter: 3mm (Device under review: 4mm)
- Angulation: 140° Up / 140° Down (Device under review: 130° Up / 130° Down)
- Product Code: EOB and HRX and GCJ (Device under review: EQN)
- Resolution: (Not explicitly stated for K102733, but K132039 provides a direct comparison)
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 does not specify a "sample size" in terms of number of patients or cases for the functional comparison. Instead, the "test set" consisted of the ORL Video Nasopharyngo-Laryngoscope itself and the predicate device (ErgoFlex Naso-Pharyngo-Laryngoscope K132039) which were tested in a controlled environment.
- Sample Size for Functional Test: Two devices (the new device and one predicate).
- Sample Size for Cleaning/Disinfection Test: The ORL Video Naso-Pharyngo-Laryngoscope.
- Data Provenance: The testing appears to have been conducted by the manufacturer (JEDMED Instrument Company) or a contracted laboratory (Geneva Laboratories for disinfection). The location is implied to be in the USA (St. Louis, Missouri). This was a prospective test conducted for the purpose of this 510(k) 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)
For the functional testing, the comparison was performed by "knowledgeable field staff." The document does not specify the exact number of staff or their detailed qualifications (e.g., years of experience, specific certifications). For the cleaning and high-level disinfection test, it was performed by "Geneva Laboratories per the IFU," implying qualified laboratory personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable as the study described is a technical comparison of device specifications and functional performance, not a clinical trial requiring ground truth adjudication by multiple experts for diagnostic outputs.
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 question is not applicable as the device is not an AI medical device, and no MRMC study was conducted. The study was a comparison of device specifications and a validation of cleaning/disinfection.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is not an AI medical device. The functional comparison focuses on the device's inherent physical and optical characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the functional tests (Field of View, Depth of View, Angulation, Color Output, Clarity, Tip Diameter), the "ground truth" was established by direct measurement and observation of the device's technical specifications and performance against the known specifications of the predicate device.
For the cleaning and high-level disinfection test, the ground truth was microbiological reduction efficacy, validated against established standards for sterilization/disinfection (implied by "significant level of microbial reduction must result from tests for both vegetative microorganisms and mycobacteria").
8. The sample size for the training set
This question is not applicable as the device is not an AI medical device and does not involve a training set.
9. How the ground truth for the training set was established
This question is not applicable as the device is not an AI medical device and does not involve a training set.
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.