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The TOF-Watch S device can be used as an objective monitor using accelerometry for measuring the muscle contraction following stimulation of the respective motorneuron, as a peripheral nerve stimulator (without the objective measuring function) for subjective monitoring or as a nerve location device.

The TOF-Watch S device is a neuromuscular transmission monitor capable of estimating the degree of neuromuscular block in anesthetized patients. It can be used as an objective monitor using accelerometry for measuring the muscle contraction following a stimulation of the respective motorneuron, as a peripheral nerve stimulator (without the objective measuring function) for subjective monitoring and as a nerve location device utilizing a needle electrode. The TOF - Watch S device is packaged individually in a neutral carton box. The complete package contains a TOF-Watch S, an acceleration transducer, a surface electrode cable and a multilingual manual.

This 510(k) submission for the TOF-Watch S electric nerve stimulator does not contain a detailed study demonstrating its performance against specific acceptance criteria. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical trial data with predefined acceptance criteria.

The document states:
"In summary, the TOF-Watch S described in this submission is substantially equivalent to the predicate device based on the following similarities:

• Have the same indicated use.
• Use the same operating principle.
• Incorporate the same basic design.
• Incorporate the same materials ●
• Packaged the same using the same materials and process."

Given this, I cannot provide the requested information. The document focuses on comparing technological characteristics to a predicate device (TOF-Watch) rather than presenting a performance study with acceptance criteria.

Therefore, for the specific questions:

1. A table of acceptance criteria and the reported device performance: Not provided in the document.
2. Sample size used for the test set and the data provenance: Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in the document.
4. Adjudication method: Not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical device for direct patient use, not an AI algorithm.
7. The type of ground truth used: Not applicable, as no dedicated performance study is described.
8. The sample size for the training set: Not applicable, as this is a medical device, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

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The TOF-Watch SX device can be used as an objective monitor using accelerometry for measuring the muscle contraction following stimulation of the respective motorneuron, as a peripheral nerve stimulator (without the objective measuring function) for subjective monitoring or as a nerve location device.

The TOF-Watch SX device is a neuromuscular transmission monitor capable of estimating the degree of neuromuscular block in anesthetized patients. It can be used as an objective monitor using accelerometty for measuring the muscle contraction following a stimulation of the respective motorneuron, as a peripheral nerve stimulator (without the objective measuring function) for subjective monitoring and as a nerve location device utilizing a needle electrode. The TOF - Watch SX device is packaged individually in a neutral carton box. The complete package contains a TOF-Watch SX, an acceleration transducer, a surface electrode cable and a multilingu manual.

This 510(k) submission (K992598) for the TOF-Watch SX does not contain detailed information about acceptance criteria or a specific study proving the device meets those criteria in the way a modern AI/ML device submission would. This document is from 1999, and the regulatory requirements and types of evidence provided for device equivalence were different then.

The submission focuses on demonstrating substantial equivalence to a predicate device (TOF-Watch) based on functional and technological characteristics, rather than on detailed performance metrics with acceptance criteria derived from clinical studies.

Therefore, much of the requested information cannot be found in the provided text. I will indicate where information is not available.

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text, as the submission focuses on substantial equivalence based on feature comparison rather than detailed performance metrics with specific acceptance criteria. The document lists features of the new device (TOF-Watch SX) and compares them to the predicate device (TOF-Watch), implying that if the features are similar or enhanced, the performance is also considered equivalent.

A summary characteristic comparison is provided:

The "reported device performance" is essentially the "TOF-Watch SX" column, indicating the features and specifications it possesses, which are either identical or enhanced compared to the predicate device.

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

Not available. The submission relies on technological comparison for substantial equivalence, not on specific clinical or performance test data on a "test set" in the context of modern AI/ML device evaluations.

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/available. No "ground truth" establishment by experts is described for a test set in this 510(k) submission.

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

Not applicable/available. No test set or adjudication method 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

Not applicable. This is not an AI/ML device and no MRMC study is mentioned.

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

Not applicable. This is not an AI/ML device. The TOF-Watch SX functions as a standalone monitoring device, but the "standalone performance" concept here refers to AI algorithm performance which is not relevant.

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

Not applicable/available. No explicit ground truth is mentioned. The equivalence is based on the device's functional characteristics and operating principles being similar to a legally marketed predicate device.

8. The sample size for the training set

Not applicable/available. This is not an AI/ML device, so there is no training set mentioned.

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

Not applicable/available. There is no training set for this device.

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The TOF-Hatch device can be used as an objective monitor using accelermetry for masclear The TOP-Match device as an objective monton as a periodal nerve contraction following a stimulation of the respective monitoring or as a newe location stimulator (with and the electrone device utilizing a needle electrode.

TOF Watch® device is a neuromuscular transmission monitor capable of estimating the degree of neuromuscular block in anesthetized patients. It can be used as an objective monitor using accelerometry for measuring the muscle contraction following a stimulation of the respective motorneuron, as a peripheral nerve stimulator (without the objective measuring function) for subjective monitoring and as a nerve location device utilizing a needle elctrode (needle electrode not supplied by Organon Teknika).

The provided text describes the TOF-Watch® device, a peripheral nerve stimulator and neuromuscular transmission monitor. The information about acceptance criteria and the study that proves the device meets them is primarily focused on nonclinical testing for substantial equivalence.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of specific numerical acceptance criteria (e.g., accuracy percentages, output ranges with defined limits) for performance and then directly report the device's measured performance against each. Instead, it refers to general analyses and adherence to standards.

However, we can infer some "acceptance criteria" related to functionality and safety, and the "reported performance" is that the device meets these.

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

The document explicitly states that clinical tests were "Not Applicable" for this 510(k) submission. Therefore, there is no information provided about a "test set" in the context of clinical data. The testing was nonclinical (bench testing and software review).

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

As clinical tests were not performed and no human-reviewed test set was created, this information is not applicable. The ground truth for the nonclinical tests would be defined by engineering specifications and international safety standards.

4. Adjudication Method for the Test Set

Since no clinical test set requiring human review or expert consensus was used, an adjudication method is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states "Not Applicable" for clinical tests. The evaluation was based on nonclinical testing and substantial equivalence to predicate devices.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device itself, the TOF-Watch®, is a standalone device in its operational use for monitoring neuromuscular transmission. The evaluation described in the 510(k) summary is based on standalone nonclinical performance (functionality analysis, software checking, safety testing). There is no mention of an algorithm in the sense of AI or a software-only evaluation, but rather a holistic assessment of the physical device and its embedded software.

7. The Type of Ground Truth Used

For the nonclinical tests, the ground truth was based on:

• Engineering Specifications: For functionality analysis of output current at different simulated skin resistances.
• Software Requirements/Specifications: For internal checking of software.
• International Safety Standards: EN60601 series, IEC 601-2-10, and Medical Device Directive (93/42/EEC) for safety testing.

8. The Sample Size for the Training Set

Since there is no mention of AI or machine learning algorithms that would require a training set in the modern sense (e.g., for image classification or prediction), this concept is not applicable to this 1997 medical device submission. The "software" mentioned in the document refers to embedded control software rather than a learning algorithm.

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

As there was no training set for an AI/ML algorithm, this information is not applicable.

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