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When used in combination with a listed stimulator, such as the NT2000 manufactured by Bio-Medical Research Ltd., the Midwest Development FT2000 Sequencer provides electrical neuromuscular stimulation for the purposes of relaxation of muscle spasm, prevention or retardation of disuse muscle atrophy, muscle re-education, increase local blood circulation, or to maintain or increase range of motion.

Sequencing provided by the FT2000 directs the stimulator signal from the stimulator device to selected patient electrode sites without modifying the original signal characteristics.

The FT2000 permits treatment in user selected time sequences of up to 24 pairs of electrodes by having 12 pairs on each side of the body. The C12000 Software allows the user to set treatment times for each electrode pair.

The FT2000 is a prescription device.

A sequenced system for transcutaneous muscle stimulation consists of a stimulator, a sequencer for programmable timed channel selection, patient cable, and electrodes applied to the skin.

Various types of time-variable waveforms may be output to generate the desired effect on the muscle(s) to be treated, and the patient is given control of the signal intensity for personal safety and comfort. Sequenced systems may have more than one output channel in order to operate bilaterally on the body or to treat multiple regions simultaneously or serially in a prescribed sequence.

The FT2000 is a sequencing device only - it does not generate stimulation signals, but directs the signals from the stimulator to the patient, applying a physician prescribed sequence to the treatment. Sequenced treatment has several advantages, including patient convenience and controlled treatment of specific sites.

The FT2000 Sequencer is designed to mechanically and electrically mate with the NT2000, manufactured by Bio-Medical Research, Ltd., a 510(k) listed device which provides muscle stimulation signals.

The FT2000 embodies similar technological characteristics as the predicate devices. Both devices employ embedded microcontrollers to store and provide treatment profiles to the user. Both have a means for the patient to easily control or suspend treatment. Both devices are battery operated to ensure that treatment is isolated.

As stated in (4), the FT2000 is a sequencing device only - it does not generate stimulation signals, but directs the signals from the stimulator to the patient via a bank of relays per a prescribed treatment profile.

The CI2000 PC software allows the physician to set up a treatment profile for the patient and store it in the FT2000. Treatment profiles cannot be modified by the patient.

The provided document describes a 510(k) premarket notification for the FT2000 Sequencer for Muscle Stimulator. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval).

Therefore, the structure of the provided information is not a typical acceptance criteria and study report format you would see for a novel device undergoing extensive clinical validation. Instead, the "study" is a demonstration of the device's adherence to relevant standards and its functional equivalence to the predicate.

Here’s a breakdown based on the information provided, tailored to the context of a 510(k) submission:

Acceptance Criteria and Device Performance for FT2000 Sequencer for Muscle Stimulator

The FT2000 Sequencer for Muscle Stimulator is a sequencing device that directs existing muscle stimulation signals to various electrode sites. Its regulatory pathway is a 510(k) premarket notification, which establishes substantial equivalence to a legally marketed predicate device (NT2000, Bio-Medical Research, Ltd.). The acceptance criteria for this type of submission are primarily focused on demonstrating that the device meets applicable safety standards, performs as intended without modifying the core signal characteristics, and possesses similar technological characteristics to its predicate.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable in the context of a clinical test set. The non-clinical tests involved testing the device itself against various engineering and safety standards.
• Data Provenance: The tests conducted were non-clinical, hardware, and software verification/validation tests. There is no mention of patient data or clinical data provenance (country of origin, retrospective/prospective) for these tests, as no clinical studies were performed.

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

• Number of Experts: Not applicable. For non-clinical tests described (electrical safety, EMC, software V&V, risk analysis), the "ground truth" is defined by established engineering standards, regulatory requirements, and the device's design specifications. This does not involve clinical experts establishing ground truth for diagnostic accuracy, for example.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The tests performed were objective assessments against defined standards and specifications (e.g., "passed" or "failed" particular tests), not subjective interpretations requiring adjudication.

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

• No. A MRMC comparative effectiveness study was not performed. The device is a sequencer, not a diagnostic or therapeutic tool where human reader performance would be a primary metric. No clinical studies were submitted.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done

• Yes, implicitly, for its core function. The FT2000 is a "sequencing device only" and "does not generate stimulation signals." Its primary function is to direct signals. Non-clinical tests, including waveform testing in combination with the stimulator, were performed to ensure it performs this sequencing function accurately and according to specifications, without human intervention in the signal path, effectively acting as a standalone component in the system.

7. The Type of Ground Truth Used

• For the non-clinical tests:
  • Engineering Standards: For electrical safety, EMC, and nerve/muscle stimulator safety.
  • Device Specifications: For software verification and validation, ensuring the software meets its design requirements and intended use.
  • Predicate Device Characteristics: For demonstrating substantial equivalence in technological characteristics.

8. The Sample Size for the Training Set

• Not applicable. This device is not an AI/ML product that undergoes a "training" phase with a dataset. Its software is programmed based on deterministic logic and specifications.

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

• Not applicable. As it's not an AI/ML device, there is no training set or associated ground truth establishment for a training phase. Software functionality is verified against its own requirements and validated against intended use.

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SEQUENCER is to be used to facilitate the delivery of defined radiotherapy treatment plans. SEQUENCER verifies the settings on a radiotherapy treatment machine prior to treatment and records the actual parameters after treatment. SEQUENCER can be used whenever radiotherapy treatment is prescribed.

The primary function of SEQUENCER is to assist in setting up the patient for treatment and verifying that the treatment setup is correct for a patient undergoing radiation therapy. SEQUENCER may be used to help in the setup of geometric and console parameters and verify the set parameters on the treatment machine with the planned values. After treatment the actual values can be recorded. This assists in tracking the dose given to the specified location.

This document is a 510(k) Pre-market Notification for a device called "SEQUENCER." It describes the intended use and development process of the software. However, the provided text does not contain any information about specific acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.

The document focuses on:

• Intended Use: To assist in setting up and verifying radiation therapy treatment parameters and recording actual values after treatment.
• Context: Used in radiation therapy to reduce setup errors and track dose delivery.
• Development Process: Developed under IMPAC's Quality System, adhering to 21 CFR 820, with Software Requirements Specifications, Design Descriptions, and Hazard Analysis.
• Regulatory Status: A 510(k) clearance (K981313) from the FDA, indicating substantial equivalence to a predicate device.

Therefore, I cannot fulfill the request to describe acceptance criteria and the study that proves the device meets them because this information is not present in the provided text.

The document is primarily a regulatory submission outlining the device's purpose and compliance with quality systems, not a clinical or performance study report.

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