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To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (e.g., arm and/or leg) and lower back due to strain from exercise or normal household and work activities.

The 5000Z/Firefly is a portable, single channel TENS device with two pre-programmed operational modes. It is powered by 2 standard AAA alkaline or rechargeable batteries. All operational modes produce the Prizm Medical Bi-Sourced waveform. The user selects a pre-programmed mode by using the program buttons to select one of two program options. The user is able to adjust the intensity up or down. The 5000Z/Firefly is intended for Over-the-Counter sale. The 5000Z/Firefly battery icon on the LED will flash when the batteries need replacement.

This document is a 510(k) summary for the Prizm Medical 5000Z/Firefly Transcutaneous Nerve Stimulator (TENS) system. The purpose of this document is to demonstrate "substantial equivalence" to a predicate device, not to present a study proving the device meets specific acceptance criteria in the typical sense of a clinical trial for a new therapeutic claim.

Therefore, the requested information about acceptance criteria, study design, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is largely not applicable in the context of this 510(k) submission. This document focuses on demonstrating that the new device has similar technological characteristics and performance to already cleared predicate devices.

However, I can extract information related to non-clinical testing that verifies the device meets its own product specifications, which could be considered its internal "acceptance criteria."

Here's the breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in a quantitative, pass/fail manner for clinical efficacy. Instead, it provides a comparison of technological characteristics of the subject device (Prizm Medical 5000Z/Firefly) against several predicate devices. The "reported device performance" in this context refers to the technological specifications of the subject device.

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

• Test Set (for clinical efficacy): Not applicable. The document explicitly states: "The Prizm Medical 5000Z/Firefly TENS System does not require clinical testing in order to determine substantial equivalence to the predicate unmodified device because the programs and electrical output characteristics of the two devices are the same." Therefore, there was no clinical "test set" in the sense of patient data.
• Data Provenance: The "data" presented is largely engineering and technical specifications of the device and its predicates, not patient data.

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

• Not applicable. As no clinical "test set" was used for efficacy, there was no ground truth to be established by experts in a clinical context. The "ground truth" here is the technical specifications of the device, established through engineering design and testing.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No. This type of study is for evaluating human performance (e.g., radiologists diagnosing images) with and without AI assistance. This device is a TENS unit, not an AI diagnostic tool, so an MRMC study is completely irrelevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. This device is a TENS unit that directly delivers electrical stimulation to a user. It is not an algorithm that performs a standalone function without human interaction in the sense of diagnosis or interpretation. The "algorithm" here refers to the device's electrical output programs, which are inherent to its function. The non-clinical testing verifies that these programs perform according to specifications.

7. Type of Ground Truth Used

• For the non-clinical testing mentioned, the "ground truth" would be the engineering design specifications and recognized electrical safety standards. The device was tested to ensure it met these predetermined, objective, and measurable criteria (e.g., output voltage, current, frequency, timing, safety features).

8. Sample Size for the Training Set

• Not applicable. As this is a TENS device and not an AI/machine learning algorithm that requires a "training set" of data, there is no training set sample size.

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

• Not applicable. No training set for an AI algorithm.

Summary of the Study that Proves the Device Meets its (Internal) Acceptance Criteria (Product Specifications):

The document describes Non-clinical Testing which includes:

• Software verification: Carried out according to FDA guidance for software in medical devices. This ensures the software embedded in the device functions as intended and safely.
• Electrical and mechanical tests: These tests were performed to demonstrate that the device meets its product specifications (the "acceptance criteria" in this context) across a range of operating and storage conditions. This would involve rigorous bench testing of the device's output (voltage, current, frequency, waveform), timer accuracy, button functionality, display indicators, battery life, and physical durability.
• Validation testing: This was conducted to show that the device meets user needs according to marketing requirements. This implies usability testing and confirmation that the device effectively delivers the intended stimulation.

The conclusion states: "The non-clinical testing demonstrates that the Prizm Medical 5000Z/Firefly TENS System performs as well as the predicate device(s). There are no new safety or effectiveness issues concerning the new device." This indicates that the results of the non-clinical tests confirmed that the device's performance aligns with its specifications and is comparable to previously cleared devices, thus deeming it substantially equivalent.

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The 5000Z System (OTC) is intended for the symptomatic relief and management of pain in the upper and lower extremities (arms and legs).
"To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities."

The 5000Z System (OTC) is a compact battery operated transcutaneous electrical stimulator that delivers a micro-current to the surface area of our patented conductive Silver-Thera E.M. garment electrodes to provide electrical stimulation for pain. It is designed not to exceed 100 volts across the garment electrodes. The technical Specifications for the 5000Z Stimulator can be found in Exhibit E. It is microprocessor controlled, allowing for easy setup of the treatment parameters and precise control of each setting, with a garment electrode dedicated to the upper or lower extremities. The system incorporates a proprietary connection from the stimulator to the electrodes that renders the device unusable without the dedicated electrodes. It is designed for ease of patient use with clearly marked intensity buttons.

The provided text is a 510(k) Summary for the Prizm Medical, Inc. 5000Z System (OTC), a Transcutaneous Electronic Nerve Stimulator (TENS). This summary describes the device, its intended use, and indicates its substantial equivalence to a predicate device.

However, the submission does not contain a study or data proving the device meets acceptance criteria in the way a clinical trial or performance study would for a novel medical device. Instead, the 510(k) process relies on demonstrating "substantial equivalence" to a legally marketed predicate device.

Therefore, many of the specific questions regarding acceptance criteria, study data, sample sizes, expert ground truth, and comparative effectiveness related to a performance study cannot be answered from the provided document.

Here's a breakdown of what can be inferred and what is not available:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as pass/fail criteria for a new performance study. The core "acceptance criteria" for a 510(k) submission is demonstrating substantial equivalence to a predicate device.
• Reported Device Performance: The document states: "The primary function of the 5000Z System (OTC) is the same as the Micro-ZTM Stimulation System, Axelgaard Mfg. Co. UltraStim Kit and Woodside Biomedical ReliefBand® and raises no new questions of safety and effectiveness." This is the "performance" claim in the context of a 510(k) – that its performance is equivalent to established devices in terms of safety and efficacy for its intended use. Specific quantitative performance metrics (e.g., pain reduction scores, error rates) from a new study are not provided.

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

• Not applicable/Not provided. There is no mention of a test set or associated data from a performance study for the 5000Z System.

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/Not provided. Ground truth for a performance study is not discussed.

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

• Not applicable/Not provided. Adjudication for a performance study is not discussed.

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. The device is a Transcutaneous Electronic Nerve Stimulator (TENS) for pain relief, not an AI-assisted diagnostic or imaging device for human readers.

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

• Not applicable. The device is a physical TENS unit, not an algorithm. Its function is to deliver electrical stimulation for pain.

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

• Not applicable/Not provided. Ground truth for a performance study is not discussed. The "truth" in a 510(k) is the demonstration of substantial equivalence to a predicate, meaning it performs as safely and effectively as an already legally marketed device.

8. The sample size for the training set

• Not applicable/Not provided. There is no mention of a training set as this is not an AI/Machine Learning device requiring such data.

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

• Not applicable/Not provided. Same as above.

Summary based on the document:

The provided document details a 510(k) premarket notification for the Prizm Medical, Inc. 5000Z System (OTC). The mechanism for "proving" the device meets acceptance criteria in this context is through demonstrating substantial equivalence to existing, legally marketed predicate devices (Micro-ZTM Stimulation System, Axelgaard Mfg. Co. UltraStim Kit, and Woodside Biomedical ReliefBand®).

The document explicitly states: "The primary function of the 5000Z System (OTC) is the same as the Micro-ZTM Stimulation System, Axelgaard Mfg. Co. UltraStim Kit and Woodside Biomedical ReliefBand® and raises no new questions of safety and effectiveness." This declaration serves as the basis for its "acceptance."

The FDA's letter (APR 1 5 2005) confirms that they "have determined the device is substantially equivalent... to legally marketed predicate devices." This is the "proof" required for a 510(k) pathway, rather than a clinical study with detailed performance metrics against pre-defined acceptance criteria. The FDA, however, did add specific warnings/limitations to the labeling regarding potential underlying serious conditions that the device should not be used for without physician consultation.

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Thera-Cream™ is a conductive cream, which increases skin conductivity for electrotherapy treatment and was developed for use with the Prizm brand electrotherapy units and the Intelligent Textiles® brand of garment electrodes.

The Prizm Medical Inc.'s Thera-Cream™ product is used prior to electrode placement to reduce the impedance (resistance to alternating current), which increases the skin conductivity during electrotherapy treatment. Electrotherapy treatment includes the use of TENS (Transcutaneous Electrical Nerve Stimulators) and NMES (Neuromuscular Electrical Stimulators).

The provided text describes a 510(k) premarket notification for the Thera-Cream™ device. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document focuses on:

• Device identification: Trade name, common name, classification, product code.
• Intended Use: "Thera-Cream™ is a conductive cream, which increases skin conductivity for electrotherapy treatment and was developed for use with the Prizm brand electrotherapy units and the Intelligent Textiles® brand of garment electrodes."
• Predicate devices: A list of previously marketed devices to which Thera-Cream™ is compared for substantial equivalence.
• Similarities and Differences to Predicate Devices: Thera-Cream™ shares the same intended use and incorporates "conductive copper salts" like the predicate Conduct-Mist™. The primary difference highlighted is Thera-Cream™'s "moisturizing cream base" versus Conduct-Mist™'s liquid/water base.
• FDA determination: The FDA's letter indicating substantial equivalence to legally marketed predicate devices, allowing the device to be marketed.

Therefore, I cannot provide the requested information as it is not present in the given text.

To answer your request, the text would need to include:

1. Specific performance metrics (e.g., impedance reduction levels, conductivity values) along with thresholds that define "acceptance."
2. Details of a study (e.g., number of subjects, experimental design, results) demonstrating that the device achieved these performance metrics.

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The Prizm Medical, Inc. Micro-Z™ Stimulation System is intended for the symptomatic relief and management of chronic (long-term) intractable (not easily controlled) pain and to help with the management of post surgical and post-traumatic acute pain problems.

The Prizm Medical, Inc. Micro-Z™ Stimulation System is also used for Neuromuscular Electrical Stimulation for the purposes of relaxation of muscle spasm, prevention or retardation of disuse muscle atrophy, muscle re-education, increase local blood circulation, maintain or increase range of motion, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. These uses were previously cleared under K951727.

Prizm Medical, Inc. Micro-Z™ Stimulation System is a compact battery operated transcutaneous electrical stimulator that delivers a micro-current to the surface area of our patented conductive Silver-Thera E.M. garment electrodes to provide electrical stimulation for chronic or intractable pain (see indications for use statement). It is designed not to exceed 100 volts across the garment electrodes. The technical Specifications for the Micro-ZTM Stimulator can be found in Appendix A. The stimulator is wearable with the Velcro® strip that attaches the device to the Velcro® arm/leg strap. It is microprocessor controlled, allowing for easy setup of the treatment parameters and precise control of each setting with a garment electrode dedicated to the upper or lower extremities. The system incorporates a proprietary connection from the stimulator to the electrodes that renders the device unusable without the dedicated electrodes. It is designed for ease of patient use with clearly marked patient intensity buttons.

The provided text is a 510(k) summary for the Prizm Medical, Inc. Micro-Z™ Stimulation System, which is a Transcutaneous Electronic Nerve Stimulator (TENS) device. This document does NOT contain information about acceptance criteria or a study that proves the device meets those criteria, as it is a regulatory submission for substantial equivalence to a predicate device, not a performance study report.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document focuses on regulatory classification, indications for use, device description, and claiming substantial equivalence to a legally marketed device (Empi Focus). It does not present data from performance studies with acceptance criteria, sample sizes, expert ground truth, or MRMC studies.

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The Prizm Medical, Inc. ThermoTrace™ Infrared Thermometer Models 15004 and 15007 are intended for use in clinical settings for the intermittent measurement and monitoring of surface skin temperature on people of all ages.

The Prizm Medical, Inc. ThermoTrace™ Infrared Thermometer Models 15004 and 15007 are a hand held instrument that measures skin temperature based on measuring infrared radiation. It is designed for ease of patient use with clearly marked patient intensity buttons. The indications for use are to measure and monitor the patient's skin temperature. It is intended for use on people of all ages.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided 510(k) summary does not contain a specific table of acceptance criteria or detailed device performance metrics beyond stating that the device is "substantially equivalent" to predicate devices. The document explicitly states: "The primary function of the ThermoTrace™ Infrared Thermometer Models 15004 and 15007 are the same as the J & J Engineering, Inc. Thermistor Thermometer and the Exergen Corporation DermaTemp DT 1001 and raises no new questions of safety and effectiveness." This implies that the acceptance criteria for this device are met by demonstrating equivalence to the legally marketed predicate devices, which would have themselves met their respective performance standards.

Without specific performance data, it's impossible to create a table. However, if performance data were present, it would typically look something like this (hypothetical example):

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