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KSH-4 Kronner Low Profile Scope Holder: For abdominal and thoracic endoscopic surgical procedures
HPL2-CRL High pressure* Gas Line Set: For abdominal and thoracic endoscopic and arthroscopic surgical procedures
KSHSA-3 Standard Arm Assembly: For abdominal and thoracic endoscopic surgical procedures
C-1 Control: For abdominal, thoracic, arthroscopic, endoscopic surgery and holding manual surgical instruments
ECB-2 Electronic Control Box: For abdominal, thoracic, arthroscopic, nasal endoscopic surgical procedures and holding manual surgical instruments
GLW-1 Gas line wrench: For abdominal, thoracic, arthroscopic, nasal endoscopic surgical procedures and holding manual surgical instruments
SEAH-1 Small Endoscope Accessory with Handle: For nasal endoscopic surgical procedures
HPL1-BL1-CRL High pressure* Branched Gas Line Set: For nasal endoscopic surgical procedures and holding manual surgical instruments

• Tolerates pressures to 150 PSI, do not use with pressures over 150 psi.

The Kronner Low Profile Scope Holder with Electronic Control and Control Box is the same as the Kronner Low Profile Scope Holder (K973543) with mechanical control except that it has an electronic control, momentary button, and electronic control box with solenoids to control gas output.

This document is an FDA 510(k) summary for the Kronner Low Profile Scope Holder and accessories. It's a premarket notification, which means it asserts that the device is substantially equivalent to a legally marketed predicate device, rather than providing or requiring new clinical studies to prove effectiveness. Therefore, the information requested about acceptance criteria, detailed study results, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance studies is not typically found in this type of submission.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as performance metrics in this 510(k) summary. The primary "acceptance criteria" for a 510(k) is demonstrating substantial equivalence to a predicate device.
• Reported Device Performance: The document does not contain quantitative performance data or traditional clinical study results with metrics like sensitivity, specificity, accuracy, etc. It focuses on functional descriptions and comparison to a predicate device.

2. Sample sized used for the test set and the data provenance

• Not applicable. This 510(k) relies on establishing substantial equivalence to a predicate device (K973543), not on a new clinical test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. Ground truth for a test set is not established in this type of submission.

4. Adjudication method for the test set

• Not applicable. No test set requiring adjudication 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

• No MRMC study was done. This device is not an AI-assisted diagnostic tool for human readers; it's a mechanical surgical instrument holder.

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

• Not applicable. This device is a physical instrument holder, not an algorithm.

7. The type of ground truth used

• Not applicable. No ground truth in the context of diagnostic accuracy is established or used for this submission. The "ground truth" for a 510(k) is the safety and effectiveness of the legally marketed predicate device to which substantial equivalence is claimed.

8. The sample size for the training set

• Not applicable. This device does not involve a training set as it is not an AI/ML algorithm.

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

• Not applicable. This device does not involve a training set.

Summary based on the document:

The document describes a 510(k) premarket notification for the "Kronner Low Profile Scope Holder" and associated accessories. The core of the submission is to demonstrate substantial equivalence to a previously cleared predicate device (K973543).

• Device Description: The device is an endoscope holder with various components like control mechanisms, gas line sets, and arm assemblies for different surgical procedures (abdominal, thoracic, arthroscopic, nasal endoscopic, and for holding manual surgical instruments). The newly introduced device (K000663) is an electronic version, replacing the mechanical control of the predicate (K973543) with an electronic control and control box with solenoids for gas output.
• Proof of Equivalence: The document explicitly states: "The Kronner Low Profile Scope Holder with Electronic control and Electronic Control Box is essentially equivalent to the Kronner Low Profile Scope Holder (K973543) except that the mechanical control has been replaced with an electronic control and electronic control box with solenoids to control gas output." This is the primary "study" or justification for its clearance under the 510(k) pathway.
• Acceptance Criteria for 510(k): The implied acceptance criteria for this 510(k) filing is that the modified device (with electronic control) does not raise new questions of safety and effectiveness compared to the predicate device (K973543) and shares the same intended use and similar technological characteristics. The FDA's letter (page 1) confirms that the FDA "determined the device is substantially equivalent... to legally marketed predicate devices."

Therefore, this document does not contain the kind of detailed performance study data requested as it pertains to a different regulatory pathway (510(k) substantial equivalence rather than a PMA or De Novo with new clinical data).

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The Kronner Low Profile Scope Holder is used to hold rigid endoscopes during endoscopic surgery and to allow rapid position changes by the pressing of a control button by the operator.
KLH-100 Kronner Low Profile Scope Holder For abdominal, thoracic, arthroscopic and nasal endoscopic surgical procedures.
HPL-2-30 High pressure flexible gas line set, double output For abdominal, thoracic, arthroscopic endoscopic surgical procedures.
HPL-3-30 High pressure flexible gas line set, triple output For nasal endoscopic surgical procedures.
KLH-200 Arm assembly For abdominal, thoractic, arthroscopic and nasal" endoscopic surgical procedures. *requires the Small Endoscope Accessory
C-100 Arm assembly For abdominal, thoracic, anthroscopic and nasal endoscopic surgical procedures.
C-101 Control strap, replacement For abdominal, thoracic, arthroscopic and nasal endoscopic surgical procedures.
SG-101 Scope grip strap, replacement For abdominal, thoracic, anthroscopic and nasal endoscopic surgical procedures.
SMA-100 Small Endoscope Accessory For nasal endoscopic surgical procedures

The Kronner Low Profile Scope Holder consists of mechanical linkages that connect between the operating table side rail and the shaft or head of a rigid endoscope. A telescoping arm distinguishes the device from other endoscope holders. Inert nitrogen gas at 100-150 psi is used to provide the energy to multiple joints to lock the holder in position when a control button is released by the operator.

The provided text describes a 510(k) submission for the "Kronner Low Profile Scope Holder," a medical device designed to hold rigid endoscopes during surgery. However, the document does not contain any information regarding specific acceptance criteria, a study proving device performance against those criteria, or details about sample sizes, expert involvement, or ground truth establishment.

The document is a regulatory submission for substantial equivalence to a predicate device (Leonard Arm, K951854). It focuses on describing the device, its intended use, and comparing its technological characteristics to the predicate device. The FDA's response confirms substantial equivalence, allowing the device to be marketed, but this process does not inherently involve detailed performance studies against explicitly stated acceptance criteria in the way a clinical trial or algorithm validation study would.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: No such criteria or performance data are provided.
2. Sample sized used for the test set and the data provenance: No test set is described or analyzed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment process is mentioned.
4. Adjudication method for the test set: No test set is described.
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 device is a mechanical endoscope holder, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: As above, this is a mechanical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No ground truth is mentioned in the context of device performance.
8. The sample size for the training set: No training set is relevant or mentioned for this type of mechanical device.
9. How the ground truth for the training set was established: No training set or ground truth is mentioned.

In summary, the provided 510(k) summary document focuses on demonstrating substantial equivalence to a predicate device and does not include the type of detailed performance criteria, study design, and results typically found for AI/software devices or clinical studies that would generate the information you requested.

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