(273 days)
The HD Mediastinoscope is intended to aid the surgeon in viewing the mediastinum and facilitate the introduction and removal of surgical instruments during ENT endoscopic surgical procedures.
The components subject of this submission are: HD Mediastinoscope (Part Number: 10973HD), and the IMAGE1 S CCU. The CCU consists of the IMAGE1 S Connect Module (Model Number: TC200US) and IMAGE1 S X-Link (Model Number: TC301US).
This document describes the FDA's 510(k) clearance for the Karl Storz HD Mediastinoscope (K202272). The device is intended to aid surgeons in viewing the mediastinum and facilitating the introduction and removal of surgical instruments during ENT endoscopic procedures.
The information provided focuses on the substantial equivalence determination based on non-clinical performance data, rather than a study proving the device meets AI-specific acceptance criteria. Therefore, most of the requested information regarding AI model performance, ground truth establishment, expert review, and clinical study details is not present in the provided text.
Here is a breakdown of what can be extracted and what is not available based on the request:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria in a table format for performance. Instead, it states compliance with recognized standards and successful completion of various bench tests.
| Test Category | Acceptance Criteria (Implied by Compliance) | Reported Device Performance |
|---|---|---|
| Electrical Safety & EMC | Compliance with ANSI/AAMI ES:60601-1:2005+A1:2012 and IEC 60601-1-2:2014 | In compliance with the stated standards. |
| Biocompatibility | Compliance with ISO 10993-1, ISO 10993-5:2009/(R) 2014, ISO 10993-10:2010, ISO 10993-11:2006/(R) 2010, and FDA Guidance | Evaluation performed, tests conducted based on contact type and duration. |
| Reprocessing Validation | Compliance with AAMI TIR 12:2010, AAMI TIR 30:2011, AAMI/ANSI/ISO 11737-1:2006/(R)2011, ASTM E1837-96:2014 | Validation activities performed for cleaning and sterilization; in compliance with standards. |
| Optical Performance | Not explicitly quantified, but successful completion of tests is implied for substantial equivalence. | |
| - Color Reproduction & Contrast | (Implied successful performance for medical imaging) | Tested. |
| - Illumination Detection Uniformity | (Implied successful performance) | Tested. |
| - Instantaneous Dynamic Range (IDR) & Detection Linearity | (Implied successful performance) | Tested. |
| - Spatial Resolution & Depth of Field | (Implied successful performance) | Tested. |
| - Distortion & Field of View | (Implied successful performance) | Tested. |
2. Sample size used for the test set and the data provenance
The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications." This means there was no clinical test set in the traditional sense for assessing device performance in a human population. All testing was non-clinical bench testing. Therefore, sample size and data provenance (country, retrospective/prospective) related to a clinical test set are not applicable here.
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 or ground truth in the context of diagnostic interpretation (e.g., for an AI model) was established. The ground truth for bench testing would be metrology standards and physical measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set involving human readers or interpretation was performed.
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 mediastinoscope (a physical viewing instrument), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical bench testing, the ground truth would be based on established engineering and optical metrology standards, and potentially manufacturer specifications for the device's components. For biocompatibility and reprocessing, the ground truth is compliance with the listed ISO and AAMI standards.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device.
§ 874.4720 Mediastinoscope and accessories.
(a)
Identification. A mediastinoscope and accessories is a tubular tapered electrical endoscopic device with any of a group of accessory devices which attach to the mediastinoscope and is intended to examine or treat tissue in the area separating the lungs. The device is inserted transthoracicly and is used in diagnosis of tumors and lesions and to determine whether excision of certain organs or tissues is indicated. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel. This generic type of device includes the flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.