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510(k) Data Aggregation
(138 days)
Transtimulation Research, Inc
Patch-TEA is an Over-The-Counter device to be used by adults only for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, arm, and leg, due to strain from exercise or normal household work activities and suitable for home use.
The Patch-TEA device is a non-invasive, battery-operated, over-the-counter transcutaneous electrical nerve field stimulator indicated for use in adult patients for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, arm, and leg, due to strain from exercise or normal household work activities and suitable for home use.
The system includes the following components: Patch-TEA device, charging case, electrode pads, USB charging cable, and Patch-TEA app. The device can be used in clinical environments (i.e., outpatient clinics and hospitals) and/or at home.
The Patch-TEA device is powered by an internal rechargeable lithium polymer battery and uses a microprocessor to control the working modes, the waveform and strength of the output pulse. The electric pulse generator is based on a current source circuit. The power management module contains a DC-DC boost conversion circuit that provides the required voltage for the electric pulse generator. The Patch-TEA device is able to connect with the Patch-TEA app, which is located on a smartphone. The user interface is available on both the Patch-TEA device and Patch-TEA app. The user can power on/off the device, adjust treatment time and treatment intensity.
Treatment time is adjustable within the of range 5~240 minutes per treatment session. In addition, there is over-load, over-current and no-load protection as well as an automatic shut-off function. The Bluetooth transceiver module is responsible for communication between the Patch-TEA device and Patch-TEA app located on a smartphone.
The provided FDA 510(k) Clearance Letter for Patch-TEA (Model TRI-21) and its accompanying 510(k) Summary do not contain any information about a study involving human subjects or AI performance analysis. The summary focuses entirely on the "technological comparison" of the device's physical and electrical characteristics against predicate devices, and non-clinical testing for safety and compliance with standards.
Therefore, I cannot fulfill the request to build a table of acceptance criteria and reported device performance related to AI or human studies, nor can I provide details on sample sizes, ground truth establishment, or multi-reader multi-case studies, as this information is not present in the provided text.
The closest information available is related to non-clinical testing and technical conformance to standards, which are summarized below, but these are not in the context of human performance or AI-driven evaluation.
Summary of Device Acceptance Criteria and Performance (Based on provided text - Note: This does NOT relate to AI or human-in-the-loop performance, as no such data is supplied):
The acceptance criteria and performance data described in the 510(k) Summary are primarily focused on the device's technical specifications, safety, and compliance with recognized standards, demonstrating substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and the Reported Device Performance
As there is no data provided regarding acceptance criteria for clinical performance or AI performance, the table below reflects the technical comparison and non-clinical testing aspects as described in the 510(k) Summary. The "Reported Device Performance" column reflects the subject device's characteristics as compared to predicates.
| Acceptance Criteria Category | Acceptance Criteria (as implied by comparison to predicate/standards) | Reported Device Performance (Patch-TEA Model TRI-21) |
|---|---|---|
| Intended Use | Same as predicate device | Same as predicate (temporary pain relief) |
| Patient Population | Same as predicate device (Adults only) | Same as predicate (Adults only) |
| Treatment Areas | Same as predicate device (shoulder, waist, back, neck, arm, leg) | Same as predicate |
| Use Environment | Same as predicate device (clinical and/or home use) | Same as predicate |
| Mode of Action | Same as predicate device (Transcutaneous electrical nerve stimulation) | Same as predicate |
| Device Design | Similar to predicate (one output channel, safety features, rechargeable battery, similar size/weight) | Similar to predicate |
| Electrode Design | Similar to predicate (reusable, round-shaped, self-adhesive conductive hydrogel) | Similar to predicate |
| Safety Standards Conformance | Compliance with specified IEC, ANSI/AAMI, ISO standards | Compliance demonstrated for IEC 60601-1-2, 62133-2, ISO 14971, 10993-5, 10993-10, 10993-23, AAMI TIR57, etc. |
| Output Parameters | Similar to predicate (frequency, pulse width, voltage, current, charge/phase, ACD, APD) | Frequency: 1-50 Hz (Predicate: 1-100 Hz), Pulse Width: 50-750 μs (Predicate: 50-500 μs), Max. Voltage: 5-55V (Predicate: 6.25-65V), Max. Current: 5.5-10mA (Predicate: 6.5-12.5mA), Max. Charge/Phase: 7.5 μC (Predicate: 6.25 μC), Max. ACD: 0.95 mA/cm² (Predicate: 0.49-1.70 mA/cm²), Max. APD: 4.8 mW/cm² (Predicate: 0.035-3.1 mW/cm²) |
| Net Charge/Pulse | Identical to predicate (0) | 0 |
| Max. Treatment Time | Similar to predicate (adjustable within range) | 90 min, adjustable (Predicate: 240 min, adjustable) |
| Waveform | Identical to predicate (Biphasic, Rectangular alternating) | Biphasic, Rectangular alternating |
| Power Source | Identical to predicate (Rechargeable battery) | Rechargeable battery |
| Patient Leakage Current | Identical to predicate (N/A - battery operated) | N/A (Battery operated) |
| Automatic Shut-off | Yes | Yes |
| Automatic Overload Trip | Yes | Yes |
| Automatic Over-current Trip | Yes | Yes |
| Automatic No-load Trip | Yes | Yes |
| Battery Safety | Battery passed IEC 62133-2 test | Passed IEC 62133-2 test |
| Software Verification & Validation | Compliance with ANSI/AAMI/IEC 62304:2006+A1:2016, ANSI/AAMI SW96:2023 | Demonstrated Compliance |
| Cybersecurity | Compliance with AAMI TIR57:2016, FDA Guidance | Demonstrated Compliance |
| Biocompatibility | Compliance with ANSI/AAMI/ISO 10993-5, 10993-10, 10993-23 | Demonstrated Compliance |
| EMC | Compliance with FCC 47 CFR Part 15 Subpart C | Demonstrated Compliance |
Regarding the other requested information, the provided text does not contain:
- Sample sizes used for the test set and the data provenance: No information on a test set involving human subjects is provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no human subject test set or ground truth establishment process is described.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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. The device is a Transcutaneous Electrical Nerve Stimulator, not an AI-powered diagnostic or assistive tool for human "readers."
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as there is no mention of an algorithm or AI component for which standalone performance would be measured.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no human study or clinical ground truth is mentioned.
- The sample size for the training set: Not applicable, as there is no mention of a training set for an AI/algorithm.
- How the ground truth for the training set was established: Not applicable.
In conclusion, the FDA 510(k) clearance letter and its summary for Patch-TEA (Model TRI-21) pertain to a physical medical device (Transcutaneous Electrical Nerve Stimulator) and establish substantial equivalence based on technical specifications, safety testing (non-clinical), and compliance with electrical, mechanical, and biocompatibility standards. The document does not describe any AI component, human-in-the-loop studies, or clinical performance trials that would require the type of acceptance criteria and study details outlined in your comprehensive request.
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(199 days)
Transtimulation Research, Inc.
The Transcutaneous Electrical Applicator (TEA) is a transcutaneous electrical nerve field stimulator system intended to be used in adult patients with functional abdominal pain associated with irritable bowel syndrome (IBS) through application to Cranial Nerves V, VI, IX and X, and the occipital nerves, as an aid in the reduction of pain when combined with other therapies for IBS. TEA device is intended to be used for 7-120 hours per week up to 3 consecutive weeks.
The TEA Device is a non-invasive, battery-operated, prescription-based transcutaneous electrical nerve field stimulator indicated for use in adult patients with functional abdominal pain associated with the irritable bowel syndrome (IBS). The system includes the following components: TEA Device, lead cable, USB charging cable, USB power adapter, electrode pads, holding clip, and TEA IBS app. The device can be used in clinical environments (i.e., outpatient clinics and hospitals) and/or at home. The TEA Device is powered by an internal rechargeable lithium polymer battery and uses a microprocessor to control the working modes, the waveform and strength of the output pulse. The electric pulse generator is based on a current source circuit. The power management module contains a DC-DC boost conversion circuit that provides the required voltage for the electric pulse generator. The TEA Device is able to connect with the TEA IBS app, which is located on a smartphone. The user interface is available on both the TEA Device and TEA IBS app. The user can power on/off the device, adjust treatment time and treatment intensity. Treatment time is adjustable within the of range 5~240 minutes per treatment session with a maximal operating time of 8.6 hours per day. In addition, there is over-load, over-current and no-load protection as well as an automatic shut-off function. The Bluetooth transceiver module is responsible for communication between the TEA Device and TEA IBS app located on a smartphone.
The provided document describes the Transtimulation Research Inc.'s Transcutaneous Electrical Applicator (TEA) Device (Model: SNM-FDC01) and its substantial equivalence to a predicate device, the IB-Stim.
The acceptance criteria are derived from the special controls for devices under 21 CFR 876.5340, as well as general performance requirements for medical devices. The study provided focuses on the clinical effectiveness of the device.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Patient-contacting components must be demonstrated to be biocompatible (ISO 10993-1, G95-1). | Biocompatibility evaluation conducted (Cytotoxicity, Irritation tests). The TEA pads and Device were evaluated for skin contact for prolonged use (>24 hours to 30 days). Outcome: Testing demonstrated compliance. |
| Electrical Safety & EMC | Electromagnetic compatibility, electrical, mechanical, and thermal safety testing must be performed (IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10, IEC 60601-1-2). | Electrical safety and EMC testing conducted. Outcome: The system complies with IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10 for safety and IEC 60601-1-2 for EMC. |
| Battery Safety | Battery evaluation must be performed (IEC 62133-2). | Battery evaluation conducted. Outcome: Compliance demonstrated to IEC 62133-2. |
| Wireless/Radio Testing | Radio and wireless testing (FCC 47 CFR Part 15 Subpart C, ANSI IEEE C63.27). | Compliance demonstrated to FCC 47 CFR Part 15 Subpart C, ANSI IEEE C63.27 for radio and wireless testing. Outcome: Compliance demonstrated. |
| Electrical Performance | Electrical performance testing of the device and electrodes must be conducted to validate specified electrical output and duration of stimulation. | "The TEA Device and its components were tested to validate the safety and effectiveness of the device. The TEA Device has equivalent performance specifications when compared to the predicate device." "The Model SNM-FDC01 has been previously cleared under K212377 with the identical design and performance specification." Outcome: Implicitly satisfied through testing and previous clearance of a device with identical design/performance. |
| Software Verification & Validation | Software verification, validation, and hazard analysis must be performed (FDA Guidance for Industry and FDA Staff). | Software verification and validation testing conducted, documentation provided. Outcome: Software considered "moderate" level of concern and testing performed as per guidance satisfied requirements. |
| Shelf Life | Shelf-life testing of the electrode pad must be performed to demonstrate continued package integrity and device functionality over labeled shelf life. | Shelf life of the TEA electrode pad demonstrated to be 2 years. Outcome: Satisfied. |
| Clinical Efficacy (for Indication of Use) | Reduction of functional abdominal pain and constipation associated with IBS. | Complete Spontaneous Bowel Movements (CSBMs) per week: TEA group tripled (2.8 ± 2.2) vs. sham (0.9 ± 0.9), P |
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