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The MECTA Sigma ECT device is for use in treating catatonia or severe major depressive episode (MDE) associated with major depressive disorder (MDD) or bipolar disorder (BPD) in patients age 13 years or older who are treatment-resistant or who require a rapid response due to the severity of their psychiatric or medical condition.

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The provided document is an FDA 510(k) clearance letter for the MECTA Sigma Electroconvulsive therapy (ECT) device. It does not contain information about acceptance criteria, device performance, or studies that prove the device meets specific criteria (such as a clinical trial report or a comprehensive performance study).

The document states that the device is substantially equivalent to legally marketed predicate devices. This equivalence determination by the FDA typically means that the new device has the same intended use and the same technological characteristics as the predicate, or, if it has different technological characteristics, that the new device does not raise different questions of safety and effectiveness.

Therefore, I cannot provide the requested information based on the given text. A 510(k) clearance letter is a regulatory document, not a scientific study report detailed enough to answer the specific questions about acceptance criteria, study design, and performance metrics.

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The intended use of the MECTA spECTrum ECT device is solely for the reatment of "severe depression" or "major depressive episode with melancholia". (ref 21 CFR Part 882 Part III)

The enhanced MECTA spECTrum Models 5000 Q, 5000 M, 4000 Q, and 4000 M ECT devices* will be identical to the currently legally marketed versions in every way except they will provide the clinician with slightly different parameter range options.

The spECTrum series products continue to be the state of the art ECT devices technically. The 5000 devices offer up to six channels of monitoring of ECG and One Optical Motion Sensor while the 4000 devices are only the ECT module of the 5000 devices. As such, they are upgradeable to the 5000 series units. The 5000 Q and 4000 Q offer the user flexibility with four stimulus parameters to vary energy and charge. The 5000 M and 4000 M offer the user simplicity with one single Stimulus Intensity knob which varies frequency and duration simultaneously, again varying energy and charge.

The touch screen provides the user with an interface to set pre-treatment parameters. This provides the user with more flexibility as he can access all menus by simply touching a screen. The LCD which illuminates the touch screen provides the user with alphanumerics that lead him through self-test, treatment, and monitoring of the EEG, ECG, and OMS. The LCD/touch screen includes choices of eight set-up menus in the 5000 series and one menu in the 4000 series that can help to individualize each patient's treatment in order to enhance the efficacy of each treatment. The LCD/touch screen also provides the user with more data that can be recorded on the patient's record regarding the self test and treatment to ensure greater safety. Also, up to four channels of monitoring can be seen on the LCD-touch screen.

The two channel thermal chart recorder continues to provide the user with a hard copy of the self test and treatment results. The simplicity of the chart recorder only requires the user two gain knobs as the self test and treatment results are printed automatically. The manual on/off push button offers the user the option of manually controlling this printing also. The printout continues to provide two channels of monitoring and also provides the user with elapsed time, date, time of treatment, and patient name. The four stimulus parameters on the M series and Q series are shown on the LCD/Touch Screen and the continuous updating of the percent energy on the M series helps to increase efficacy of treatment.

Several features designed to IEC 601-2-14 standards offer the user enhanced safety during the self test and treatment and as such are an advance. The hinged cover on the Stimulus Control push button prevents the user from accidentally treating. The Stimulus Status LED is illuminated to offer the user a visual confirmation that the spECTrum is enabled, that the stimulus is being delivered and finally indicates if there is a stimulus delivery fault. The three waming tones during self test and the constant tone during treatment continue to offer the user enhanced safety during the treatment process. The continuous self-test offers the user far greater accuracy in avoiding aborted or missed seizures as this bio-feedback provides him with measurements continuously which results in far greater efficacy.

The data that can now be provided to the user with the two new features of the spECTrum series now leads to even greater patient safety. The EEG data which provides analyses on seizure adequacy** and stimulus level** allows the clinician to better assess the quality and efficacy of each individual seizure. The Optical Motion Sensor (OMS) allows the user to monitor motor movement during the seizure and provide further valuable information in assessing seizure efficacy.

The event timer, and the leads off information all provide added information for the clinician which allows him to better assess and improve clinical efficacy. The event timer is printed on the chart recorder as a permanent record. The leads off feature documents that the EEG or ECG leads are off and notifies the user by providing a message on the LCD Touch Screen.

All of the above features demand the most advanced technical design to accommodate them and to meet the most stringent domestic and international standards UL 544, CSA 22.2 125, and TUV EC IEC 601-1 (601-2-14 for electroconvulsive therapy devices), all of which result in far greater safety in the 4000 and 5000 devices to comply with these standards. These approvals are pending and in process at this time. As such they are safer as the TUV standard is the most stringent safety agency internationally. The spECTrum series include extensive redundant hardware and software testing and verification that they are operating correctly. The safety of these devices is unparalleled and as such are an advance that will impact the safety and efficacy of the ECT treatment dramatically.

As the technical advances have been a result of the field's demand for greater information, efficacy, and safety, the clinical advances have primarily been ongoing in the field over the last twenty-three years of MECTA's device history. The 5000/4000 series continues to use the constant current bi-directional square waveform, while the starter kit includes improved hand-held electrodes. Again, these have been redesigned with the redundant safety features required to meet the above mentioned standards. Patents are pending on the features identified with an asterisk.

The provided text is a 510(k) summary for MECTA's spECTrum 5000 and 4000 ECT devices. It details the device's features, intended use, and its substantial equivalence to a legally marketed predicate device (MECTA Models 5000 Q, 5000 M, 4000 Q, and 4000 M ECT devices with identical parameter ranges to the MECTA SR and JR ECT devices, identified by K960754).

The document does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or outcomes data from clinical trials. Instead, the approval is based on a determination of substantial equivalence to a previously legally marketed device, which is a different regulatory pathway than proving performance against predefined acceptance criteria for a novel device.

Therefore, many of the requested sections regarding acceptance criteria, reported device performance, sample sizes for test and training sets, ground truth establishment, expert adjudication, and comparative effectiveness studies cannot be extracted from the provided text. The 510(k) pathway focuses on demonstrating that a new device is as safe and effective as an existing, legally marketed device, rather than requiring new clinical performance studies against specific criteria.

Here's what can be extracted based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document describes a substantial equivalence determination, not a study demonstrating performance against specific acceptance criteria. Performance is inferred from the predicate device. The 510(k) summary highlights design improvements focusing on safety and enhanced information for clinicians rather than specific performance metrics against a defined standard.

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

Not applicable. No test set or clinical study for performance evaluation is described. The submission is based on engineering design, comparison to a predicate, and compliance with standards.

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

Not applicable. No ground truth establishment for a test set is described.

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

Not applicable. No test set or adjudication process 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 device is an Electroconvulsive Therapy (ECT) device, not an AI-assisted diagnostic tool. 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 algorithm-only device.

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

Not applicable. The approval is based on substantial equivalence, not a ground truth comparison in a clinical study.

8. The sample size for the training set

Not applicable. No training set for an algorithm is described.

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

Not applicable. No training set is described.

Additional Information Extracted from the Text:

Regulatory Pathway and Basis for Approval:

• Regulatory Mechanism: 510(k) Premarket Notification.
• Basis for Clearing: Substantial equivalence to a legally marketed predicate device (MECTA Models 5000 Q, 5000 M, 4000 Q, and 4000 M ECT devices with identical parameter ranges to the MECTA SR and JR ECT devices, K960754).
• Regulatory Class at Time of 510(k) clearance (March 6, 1997): Class III
• Current Regulatory Class (as of December 26, 2018, for specific indications): Reclassified to Class II (Special Controls) for specific indications, while others remain Class III.
• Product Code:
  • Previously: 84GXC
  • Currently (for reclassified indications): QGH

Intended Use (as stated in the 510(k) summary):

• "Treatment of 'severe depression' or 'major depressive episode with melancholia'." (Ref 21 CFR Part 882 Part III)
• Clinical Setting: Hospital ECT suites, Operating Rooms, or on patient wards.

Device Description (as per 510(k) summary):

• Device Name: spECTrum 5000 Q, 5000 M, 4000 Q, 4000 M.
• Key Features Highlighted:
  • Slightly different parameter range options compared to predicate.
  • 5000 devices offer up to six channels of monitoring (ECG and One Optical Motion Sensor).
  • 4000 devices are ECT modules upgradeable to 5000 series.
  • 5000 Q and 4000 Q: Four stimulus parameters for varying energy/charge.
  • 5000 M and 4000 M: Single Stimulus Intensity knob varying frequency and duration simultaneously.
  • Touch screen interface for setting pre-treatment parameters, accessing menus, and displaying alpha-numerics for self-test, treatment, and monitoring (EEG, ECG, OMS).
  • Choices of eight setup menus (5000 series) and one menu (4000 series) for individualizing patient treatment.
  • Two-channel thermal chart recorder for hard copy of self-test and treatment results, elapsed time, date, time, and patient name.
  • Continuous updating of percent energy (M series) to increase efficacy.
  • Safety Features (designed to IEC 601-2-14 standards, UL 544, CSA 22.2 125, TUV EC IEC 601-1):
    • Hinged cover on Stimulus Control push button.
    • Stimulus Status LED (enabled, stimulus delivered, stimulus delivery fault).
    • Three warning tones during self-test, constant tone during treatment.
    • Continuous self-test.
    • Redundant hardware and software testing.
  • Clinical Data/Monitoring Capabilities:
    • EEG data for seizure adequacy and stimulus level analysis.
    • Optical Motion Sensor (OMS) for monitoring motor movement during seizure.
    • Event timer.
    • Leads off information (message on LCD Touch Screen).
  • Waveform: Constant current bi-directional square waveform.
  • Electrodes: Improved hand-held electrodes (redesigned with redundant safety features).

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The intended use of the MECTA spECTrum device is solely for the treatment of Severe depression "SE" and Clinical setting is in hospitla ECT suites, Operating Rooms, or on patient wards.

The intended use of the MECTA spECTrum ECT device is solely for the treatment of "severe depression" or "major depressive episode with melancholia". (ref 21 CFR Part 882 Part III) The clinical setting is in hospital ECT suites, Operating Rooms, or on patient wards.

The MECTA spECTrum 5000 and 4000 ECT devices are the fourth generation of MECTA ECT devices and continue to be the state of the art ECT devices technically, while continuing to offer even more safety and efficacy clinically. The 5000 devices offer up to six channels of monitoring of ECG and EEG and one Optical Motion Sensor while the 4000 devices are only the ECT module of the 5000 devices. As such, they are upgradable to the 5000 series units and are identical to the SR JR series in their modularity (i.e.JR upgrade to SR, 4000 upgrade to 5000). The 5000 Q and 4000 Q offer the user flexibility with four stimulus parameters to vary energy and charge. The 5000 M and 4000 M offer the user simplicity with one single Stimulus Intensity knob which varies all four stimulus parameters simultaneously, again varying energy and charge.

The touch screen provides the user with an interface to set pre-treatment parameters. This provides the user with more flexibility as he can access all menus by simply touching a screen. The LCD which illuminates the touch screen provides the user with alphanumerics that talk him through through self-test, treatment, and monitoring of the EEG,ECG,and OMS. The LCD/touch screen includes choices of eight set-up menus in the 5000 series and one menu in the 4000 series that can help to individualize each patient's treatment in order to enhance the efficacy of each treatment. The LCD/ touch screen also provides the user with more data that can be recorded on the patient's record regarding the self test and treatment to ensure greater safety. Also, up to four channels of monitoring can be seen on the LCD-touch screen.

The two channel thermal chart recorder continues to provide the user with a hard copy of the self test and treatment results. The simplicity of the chart recorder only requires the user to set two gain knobs as the self test and treatment results are printed automatically. The manual on/off push button offers the user the option of manually controlling this printing also. The printout continues to provide two channels of monitoring and also provides the user with elapsed time, date, time of treatment, and patient name. The four stimulus parameters on the M series and Q series are also shown on the LCD/Touch Screen and the continuous updating of the percent energy on the M series also helps to increase efficacy of treatment.

Two features that offer the user enhanced safety during the self test and treatment are IEC 601-2-14 standards and as such are an advance. The hinged cover on the Stimulus Control push button prevents the user from accidentally treating. The Stimulus Status LED is illuminated to offer the user a visual confirmation that the spECTrum is enabled,that the stimulus is being delivered and finally indicates if there is a stimulus delivery fault, The three warning tones during self test and the constant tone during treatment continue to offer the user enhanced safety during the treatment process. The continuous self-test offers the user far greater accuracy in avoiding aborted or missed seizures as this bio-feedback provides him with acceptable ranges continuously which results in far greater efficacy.

The data that can now be provided to the user with two new MECTA features affecting the safety and effectiveness of the treatment, now leads to even greater patient safety. The EEG data which provides analyses on seizure adequacy and stimulus level will allow the clinician to better assess the quality and efficacy of each individual seizure. The predicate device that has been marketing seizure indices for a number of years is the Thymatron DGx marketed by Somatics Inc.(K#852069). The Optical Motion Sensor (OMS) will allow the user to monitor motor movement during the seizure and provide further valuable information in assessing seizure efficacy. The predicate device that has been marketing a motor monitor (EMG) for a number of years is the Thymatron DGx marketed by Somatics Inc. (K#852069).

The event timer, and the leads off information all provide added information for the clinician which allows him to better assess and improve clinical efficacy. The event timer is printed on the chart recorder as a permanent record. The leads off feature documents that the EEG or ECG leads are off and notifies the user by providing a message on the LCD Touch Screen.

All of the above features demanded the most advanced technical design to accommodate them as did the commitment to design to the most stringent domestic and international standards UL 544, CSA 22.2 125, and IEC 601- 1 (601-2-14 for electroconvulsive therapy devices), all of which resulted in far greater safety in the 4000 and 5000 devices to comply with these standards. The predicate devices SRJR were UL, CSA listed and approved and partially approved to the IEC 601-1 standards. The spECTrum 5000/4000 devices are designed to the above UL,CSA, and TUV CE (IEC 601-1) standards. These approvals are pending and in process at this time. As such they are safer as the TUV standard is the most stringent safety agency internationally. These new devices include extensive redundant hardware and software testing and ventication that they are operating correctly. The safety of these devices is unparalleled and as such are an advance that will impact the safety and efficacy of the ECT treatment dramatically.

As the technical advances have been a result of the field's demand for greater information, efficacy, and safety, the clinical advances have primarily been ongoing in the field over the last twenty-three years of MECTA's device history. Therefore, the MECTA 5000,4000 series will be used in a clinical setting with modified ECT that is identical to the setting that was used for the SR/JR,D, and C devices. Therefore, the clinical application of treating with the MECTA will remain the same. The 5000/4000 series continues to use the constant current bi-directional square waveform and the starter kit items accompanying these devices remains the same with the exception of the hand-held electrodes Again, these have been redesigned with all of the redundant safety that was designed into the new devices. The patents that are pending on the above features are identified with an asterik. * US PATENT PENDING: **US PATENT PENDING

The provided text describes the reclassification of Electroconvulsive Therapy (ECT) devices and mentions a 510(k) submission (K960754) for the MECTA Spectrum 5000 Q, 5000 M, 4000 Q, 4000 M. However, this document does not contain a study proving the device meets acceptance criteria in the typical sense of a clinical trial with specific performance metrics.

Instead, the 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (MECTA Models SR JR and Thymatron DGx) and highlights design features intended to enhance safety and efficacy based on existing clinical understanding and regulatory standards.

Therefore, I cannot fulfill all parts of your request as the provided text does not contain a study with detailed acceptance criteria, reported performance, sample sizes, ground truth establishment, or expert adjudication.

However, I can extract the information available from the document regarding the device and its intended use, and the basis for its clearance, noting where information is explicitly absent.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are primarily related to meeting safety and performance aspects of legally marketed predicate devices and relevant regulatory standards, rather than specific performance metrics from a dedicated clinical study as might be seen for novel technologies.

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

The document does not describe a clinical evaluation or "test set" in the context of a prospective study for the MECTA Spectrum 5000/4000 devices. The 510(k) process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device through technical and performance comparisons. Therefore, there is no information on sample size, data provenance, or study design for a test set.

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)

No test set requiring expert ground truth establishment is described in this 510(k) summary.

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

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

No such study is described. ECT devices are therapeutic devices, and the document describes design specifications and comparison to predicate devices, not an AI-assisted diagnostic or interpretative tool that would typically involve MRMC studies.

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

This request is not applicable. The MECTA Spectrum 5000/4000 is an ECT device, not an algorithm, and is used with a human in the loop (a clinician).

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

For 510(k) substantial equivalence, the "ground truth" implicitly refers to the established safety and effectiveness of the predicate devices (MECTA SR/JR, Thymatron DGx) and the general understanding of ECT efficacy and safety in the medical community at the time based on clinical outcomes for the intended indications. The device's features are designed to enhance these known parameters (e.g., by providing more detailed monitoring of seizure activity via EEG and OMS, which are recognized proxies for treatment effectiveness). No specific "ground truth" studies for the Spectrum 5000/4000 itself are mentioned.

8. The sample size for the training set

No training set is mentioned in the context of this 510(k) submission. Design verification and validation would have been performed on the device itself, but not a "training set" of data for an algorithm.

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

Not applicable as no training set is mentioned.

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