(53 days)
This instrument is indicated for use to view the larynx, bronchi, and trachea, and, using additional accessories, to perform various diagnostic and therapeutic procedures.
The KSEA DCI Endoscope is comprised of a rigid, panoramic telescope which utilizes rod lens technology. The body contact portions of the K.SEA DCI Endoscope are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
The provided text is a 510(k) Summary of Safety and Effectiveness for the KSEA DCI Endoscope. This document is a pre-market notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
Key takeaway: This is not a study proving device performance against acceptance criteria in the way one would describe an AI/ML device study.
Instead, this document asserts substantial equivalence based on the device's design, materials, and intended use being similar to existing, legally marketed devices. It does not contain information about "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the context of performance metrics for an AI/ML algorithm.
Therefore, I cannot extract the requested information as it is not present in the provided text. The questions asked are typically relevant for demonstrating the performance of novel AI-driven medical devices, which this endoscope is not.
To directly answer your request based on the provided text, many fields will be "Not Applicable" or "Not Provided," as the document focuses on regulatory equivalence rather than performance metrics from a controlled study.
Here's how I would answer if I were forced to interpret the spirit of your questions within the context of a 510(k) for a non-AI device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (Implied by Substantial Equivalence and Device Description) |
|---|---|
| Intended Use: To view larynx, bronchi, trachea, and perform diagnostic/therapeutic procedures with accessories. | The KSEA DCI Endoscope is "designed to be used by qualified surgeons and physicians to view the larynx, bronchi, and trachea, and, using additional accessories, to perform various diagnostic and therapeutic procedures." This matches the predicate. |
| Design & Features: Utilizes rod lens technology, rigid, panoramic telescope. | The KSEA DCI Endoscope "is comprised of a rigid, panoramic telescope which utilizes rod lens technology." This matches the predicate. |
| Materials: Body contact portions composed of surgical grade stainless steel. | The KSEA DCI Endoscope's "body contact portions... are composed of surgical grade stainless steel, which is commonly used in medical devices... and has a long history of biocompatibility for human use." This matches the predicate. |
| Safety & Effectiveness: Raises no new issues of safety and effectiveness compared to predicate devices. | "The minor differences between the KSEA DCI Endoscope and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices." |
| Biocompatibility: Materials are biocompatible for human use. | "[Surgical grade stainless steel] has a long history of biocompatibility for human use." |
| Substantial Equivalence: Basic features, design, and intended uses are the same as predicate devices. | "The KSEA DCI Endoscope is substantially equivalent to the predicate devices since the basic features, design and intended uses are the same." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is a traditional medical device (endoscope), not a machine learning algorithm that requires a "test set" in the sense of a dataset for performance evaluation. Substantial equivalence is based on comparison to existing device designs and materials, not clinical performance data from a specific "test set."
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. See above. "Ground truth" in this context refers to regulatory assessment by the FDA, based on engineering, materials science, and clinical equivalence, rather than expert annotation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See above.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Implicit "Ground Truth": Regulatory standards and the characteristics of legally marketed predicate devices. The "ground truth" for substantial equivalence is that the device's design, materials, and intended use align with established devices and accepted medical practices/safety standards.
8. The sample size for the training set
- Not Applicable. This is not a machine learning device.
9. How the ground truth for the training set was established
- Not Applicable. This is not a machine learning device.
§ 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.