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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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