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The UNIDRIVE SIII System is intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue.

The HOPKINS Telescope when used with the obturator is intended to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.

The UNIDRIVE® SIII system is a motorized surgical device intended for intrauterine use to hysteroscopically resect and remove tissue. The UNIDRIVE SIII System includes the following components:
UNIDRIVE SIII Control Unit (20701020-1) Footswitch (20016230) DrillCut-X II Shaver handpiece GYN (26702050) Shaver blades (26208SA, 26208SB) HOPKINS Telescope (26208AMA) Obturator (26208OC)

The UNIDRIVE S III system has a motor control unit and can be used with the DrillCut-X II Shaver handpiece GYN which houses the shaver blades. The shaver blade upon being connected to the DrillCut-X II Shaver handpiece GYN is inserted into the working channel of the HOPKINS Telescopes. The shaver blades are activated via a one-pedal footswitch that is connected the UNIDRIVE SIII control unit. The shaver blades consist of two sheaths that fit into each other. The inner sheath oscillates within the outer sheath to enable tissue resection.

The provided text is a 510(k) summary for the UNIDRIVE SIII System. It primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing rather than presenting a study with strict acceptance criteria of the type typically used for a novel AI/software performance claim.

Therefore, the requested information specifically on acceptance criteria, reported performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, and training set details as they pertain to such a study is not available in the provided document. The document describes a comparison to predicate devices, stating that non-clinical testing was adequate to establish substantial equivalence without requiring clinical testing.

However, I can extract the types of non-clinical tests performed, which could be considered as demonstrating the device meets established safety and performance standards relevant to its design.

Regarding your specific questions, based on the provided text:

1. A table of acceptance criteria and the reported device performance:
   The document does not provide a table of acceptance criteria with specific numerical targets and reported performance values in the context of a clinical or analytical performance study of the type you're asking for. Instead, it refers to successful demonstration of performance by comparison to predicate devices and adherence to recognized standards.

   • "The cutting performance of the subject device, UNIDRIVE SIII system has been successfully demonstrated by comparing to the primary predicate device TRUCLEAR Morcellator System and TRUCLEAR Morcellators cleared in K132015." This implies the UNIDRIVE SIII System performed comparably to the predicate for cutting, but specific metrics are not given.
   • "Additional comparative bench testing between the subject and secondary predicate device was conducted to demonstrate the optical performance of the HOPKINS Telescope that is part of the subject UNIDRIVE SIII system to meet its intended use." This indicates the optical performance was deemed sufficient but lacks specific criteria or quantitative results.

2. Sample size used for the test set and the data provenance: Not applicable, as no clinical or analytical performance study (as implied by these questions) is detailed. The testing was non-clinical (bench testing).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/software evaluation (e.g., expert consensus on images) is not relevant here as it was a non-clinical bench testing and comparative analysis.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.

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. No MRMC study was conducted or mentioned. The device is 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 device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. For the non-clinical testing, "ground truth" would be the expected performance or measurements from the predicate devices and relevant engineering specifications.

8. The sample size for the training set: Not applicable. Not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

Summary of Non-Clinical Performance Testing (as described in the document):

The device underwent various non-clinical tests to demonstrate substantial equivalence and adherence to recognized standards. These standards implicitly contain "acceptance criteria" for the device's functionality, safety, and performance.

Non-Clinical Performance Data / Tests Performed:

• Hysteroscopes and Gynecologic Laparoscopes Guidance: Adherence to FDA guidance for these types of devices.
• ISO Endoscopic Standards:
  • ISO 8600-1:2015
  • ISO 8600-3:2019
  • ISO 8600-5:2020
• Biocompatibility Summary (ISO 10993 series):
  • Cytotoxicity (ISO 10993-5)
  • Acute Systemic Toxicity (ISO 10993-11)
  • Intracutaneous Irritation (ISO 10993-10)
  • Maximization Sensitization (ISO 10993-10)
• Electrical Safety and EMC (IEC 60601 series):
  • IEC 60601-1:2012 (3rd Edition)
  • IEC 60601-2-18:2009 (3RD Edition)
  • IEC 60601-1-2:2014 (4th Edition)
• Reprocessing (Cleaning and Sterilization) (AAMI and ISO standards):
  • AAMI TIR12: 2010
  • AAMI TIR30: 2011
  • AAMI TIR39: 2009
  • ANSI/AAMI ST8: 2013
  • ANSI/AAMI ST77:2013
  • ANSI/AAMI ST79:2017
  • ANSI/AAMI ST81:2004/(R)2010
  • AAMI/ISO 14937:2009
  • ANSI/AAMI/ISO 17655-1:2006/2013
  • ANSI/AAMI/ISO 17655-2:2009
  • Reprocessing Medical Device in Health Care Settings: Validation Methods and Labeling
• Software Verification and Validation Testing:
  • Guidance for the Content of Premarket Submissions for Software Contained in Medical Device
• Cutting Performance: Successfully demonstrated by comparing to the primary predicate device.
• Optical Performance: Demonstrated through comparative bench testing with the secondary predicate device for the HOPKINS Telescope.

Conclusion stated: The nonclinical tests demonstrate that the subject device is as safe and effective as the primary and secondary predicate devices to support a substantial equivalence determination.

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The KARL STORZ ICG Imaging System is intended to provide real-time visible (VIS) and near-infrared (NIR) fluorescence imaging.

The KARL STORZ Endoscopic ICG System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, and at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct), using near infrared imaging. Fluorescence imaging of biliary ducts with the KARL STORZ Endoscopic ICG System is intended for use with standard of care white light and, when indicated, intraoperative cholangiography. The device is not intended for standalone use for biliary duct visualization.

Additionally, the KARL STORZ Endoscopic ICG System enables surgeon to perform minimally invasive cranial neurosurgery in adults and pediatrics and endonasal skull base surgery in adults and pediatrics > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging.

The KARL STORZ VITOM II ICG System is intended for capturing fluorescent mages for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used in plastic, micro- and reconstructive surgical procedures. The VITOM II ICG System is intended to provide a magnified view of the surgical field in standard white light.

The modified KARL STORZ ICG Imaging System includes the following components:
i) Modified 10mm and 5mm HOPKINS ICG/NIR Rigid Endoscopes (0°, 30°, 45°): have an improved optical design with the white light and NIR images in good focus simultaneously.
ii) Power LED Rubina Light Source and Footswitch: The light source has two LEDs, white light and NIR.
iii) Image1 S 4U Rubina Camera Head: uses a 2 chip 4K camera head that houses 2 CMOS sensors: one for white light and the other for NIR.
iv) Camera Control Unit: Image1 S Connect II (TC201US) and Image1 S 4U- Link (TC304US): is used with the Image1 S 4U Rubina Camera Head to output a 4K image to the monitor.

The provided text describes a 510(k) submission for the KARL STORZ ICG Imaging System. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing. Therefore, there is no information provided regarding acceptance criteria for device performance related to a clinical study, or details about such a study.

The document details various non-clinical performance data and validation tests conducted to ensure the device meets its design specifications and complies with relevant standards. Here's a breakdown based on the information provided:

1. A table of acceptance criteria and the reported device performance

The document does not present a table of specific acceptance criteria with reported device performance in a format typically used for clinical endpoints. Instead, it lists various non-clinical tests that were performed to demonstrate that the device met its design specifications and complied with standards.

Here's a summary of the non-clinical performance data categories mentioned:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

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." Therefore, there is no information about a test set sample size or data provenance from a clinical study.

The "test set" in this context refers to the methods and components used in the described non-clinical bench tests and validations (e.g., specific endoscopes, camera heads, light sources, etc., as detailed in the "Device Description" and "Technological Characteristics" sections). These are not patient data.

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)

Since no clinical study was performed or required, there is no mention of experts establishing a ground truth for a test set, nor their qualifications. The ground truth for the non-clinical tests would be defined by the technical specifications and standards against which the device's performance was measured.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical study or expert adjudication for a test set is mentioned.

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. The device is an imaging system (endoscope and related components), not an AI-assisted diagnostic tool. No MRMC study or AI assistance is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. The device is a medical imaging system intended for use by surgeons during procedures, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical performance data, the "ground truth" would be the engineering specifications and established performance parameters of the device, as evaluated through bench testing against recognized standards (e.g., IEC, ISO). No clinical ground truth (like pathology or outcomes data) was used.

8. The sample size for the training set

Not applicable. The document describes a medical imaging hardware system and its components. It does not mention any machine learning or AI components that would require a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no mention of a training set.

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