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Endomat Select is intended to:
· provide the infusion of the sterile irrigant solutions into the ureter and upper urinary tract, as well as to suction off the irrigation fluids, bodily fluids, secretions, tissue and gas during diagnostic and operative endoscopic urological procedures
· provide the infusion of the sterile irrigant solutions into the uterus, as well as to suction off the irrigation fluids, bodily fluids, secretions, tissue and gas during diagnostic and operative endoscopic hysteroscopic procedures
· provide the infusion of the sterile irrigant solutions into organs and operating diagnostic and operative procedures in laparoscopic and open general surgery
· provide sustained liquid irrigation of joint or intra-articular spaces during all phases of arthroscopic surgery
· provide the infusion of the sterile irrigant solutions in order to enable the Lens Cleaning during endoscopically assisted Functional Endoscopic Sinus Surgery and endoscopically assisted transnasal pituitary gland surgery

The Endomat Select is a multi-functional, pressure-controlled, combined irrigation and suction pump. It can be used for irrigation and, where appropriate dilation, during Hysteroscopic (HYS), Arthroscopic (ART), Urological (URO) and General Surgical or Laparoscopic (SURG) interventions. The device can be used for suction during Urological (URO) and Hysteroscopic (IBS) interventions. In addition, the device can function in an oscillatory mode (ENT/Neuro) providing a fluid means to maintain lens clarity during use in Transnasal procedures. The device has a modern LCD display with touch screen user interface. The tubing sets are encoded so that they can be identified by the device, which selects the appropriate operating modes based on the tubing set connected. The device can also be connected to other Karl Storz devices using the proprietary Storz Control Bus (SCB) [K994348].

The device protects the patient from overpressure via software means. The software-controlled pressure measurement system can stop the actuator (roller pump) should the pressure rise beyond the pre-determined limit and will immediately reverse the pump roller direction to depressurize the fluid system if required. Additionally, the device has high pressure alarms to alert the operating room staff of a high-pressure situation. The device also requires positive action from the user to increase pressures above 100mmHg; the user is prompted to confirm their choice on the user interface.

The accessories for this device are provided separately. All of the accessories for use with this device are already marketed in the U.S. and are either Class I, Class II 510(k) exempt or Class II previously cleared devices. The generic tubing sets for use with this device are single use, sterile Class I accessories.

The provided text describes a 510(k) submission for the "Endomat Select" device and its substantial equivalence to predicate devices, but it does not contain the detailed acceptance criteria for a specific study, nor does it present the results of a study designed to prove the device meets such criteria.

The document primarily focuses on establishing substantial equivalence through a comparison of the Endomat Select's indications for use, technological characteristics, and non-clinical performance data against two predicate devices (KARL STORZ Endomat Select (K180735) and KARL STORZ HAMOU Endomat (K936231)).

However, I can extract information related to the performance data and "acceptance criteria" in a general sense, as implied by the "Pass" status for various verification tests.

Here's the information based on the provided document, addressing your numbered points where possible, and indicating where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide explicit numeric acceptance criteria. Instead, it lists "Verification Tests" and indicates they "Pass," implying that the device met pre-defined internal specifications.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified. The tests are described as "bench testing," which implies laboratory or engineering testing, but the number of units or test runs is not mentioned.
• Data Provenance: Not specified, but generally, bench testing would originate from the manufacturer's R&D or testing facilities (Germany, given the applicant's address). The data is retrospective (i.e., conducted before the 510(k) submission).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

• Not Applicable. This type of information (experts establishing ground truth) is typically relevant for studies involving subjective human interpretation, such as image analysis for diagnostic accuracy. The reported tests are objective performance verification tests for a medical device (a pump).

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations, again, relevant to subjective assessments rather than objective device performance tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices." MRMC studies are clinical studies involving human readers.

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

• Not Applicable/Not a software algorithm device. The Endomat Select is a hardware device (a pump) with software control for pressure measurement and operation modes. The performance tests are for the physical device's function, not a standalone diagnostic algorithm.

7. The Type of Ground Truth Used

• Objective Device Specifications/Design Requirements. For performance tests like flow rate and pressure, the "ground truth" would be the pre-defined target values and tolerances specified in the device's design and engineering documents. For safety and usability, it would involve adherence to relevant standards and risk analyses.

8. The Sample Size for the Training Set

• Not Applicable. This concept is relevant for machine learning algorithms. The Endomat Select is a electromechanical medical device; it does not "train" on a dataset in the way an AI algorithm does. Its software logic is programmed based on engineering principles and design specifications.

9. How the Ground Truth for the Training Set was Established

• Not Applicable. As noted above, there is no "training set" for this type of device. The functional specifications and safety parameters are established through engineering design, risk assessment, and compliance with medical device standards.

Summary of Device and Study:

The Endomat Select is a multi-functional, pressure-controlled, combined irrigation and suction pump intended for various endoscopic surgical procedures. The substantial equivalence documentation highlights its expanded hysteroscopy suction mode compared to a primary predicate, while maintaining similarity to a secondary predicate's features.

The "study" to prove the device meets acceptance criteria was a series of non-clinical bench tests. These tests verified and validated that the Endomat Select met its design specifications for operating mode activation, software installation, flow rate performance, pressure performance, accessory compatibility, error detection, and usability. The results showed that all these tests passed, leading to the conclusion that the device is as safe and effective as its predicate devices, rendering clinical testing unnecessary for this 510(k) submission.

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