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The Armory Motion is a prescription device that combines cold and compression therapy and is intended to treat postsurgical and acute injuries to reduce edema, swelling, and pain for which cold and compression are indicated.

Armory Motion is intended to be used by a licensed health care professional in rehabilitation facilities, athletic training settings, and home settings.

Armory Motion is a multimodality software-controlled device designed to provide both a muscle massage and a circulatory thermal therapy.

The Armory Motion is an AC Rechargeable Battery powered device designed to provide cold and intermittent Pneumatic Compression to a treatment site on the user. The device includes a lid with LCD panel, pump and electronics, a reservoir, tubing and a single-patient use, non-sterile, pneumatic air compression joint wrap that can also circulate water (dual bladder), to provide cold thermal therapy in addition to the compression. The Joint wrap can be used to treat the back, elbow, shoulder, foot, ankle, and knee.

The Armory Motion device contains several key parts: A cold-compression pad with a connector hose, an insulated container to hold ice and water, and a lid that contains a water pump and air pump, electronics to control the pumps, tubing, and an intuitive keypad to operate the device.

The cold-compression pads are connected to the lid tubing and are applied to the body to deliver cold and intermittent compression therapy. The cold compression pads are made of flexible materials that form two bladders. The dual bladder design allows cold water to continuously flow through one of the bladders to provide cold therapy, and air to be cyclically pumped into and released from a second bladder to provide intermittent pneumatic compression therapy.

The insulated container is filled with ice and water by the user. The water circulates through the cold compression pad to deliver cold therapy to the application site.

The lid which houses the electronics, water pump, and air pump, is sealed and not accessible by the user. The lid also houses the keypad, which controls the device and allows the user to select the therapies as directed by a healthcare professional.

This document, K213097, is a 510(k) premarket notification for a medical device called Armory Motion, which provides cold and compression therapy. The core of the submission is to demonstrate substantial equivalence to a legally marketed predicate device (Breg Polar Care Wave, K183702).

The provided text does not contain detailed acceptance criteria for a study demonstrating detailed device performance against specific metrics using a test set of data with established ground truth. Instead, the "study" demonstrating the device meets acceptance criteria is primarily a comparison with a predicate device and adherence to recognized consensus standards.

The document states:

• "No formal clinical testing was performed on the Armory Motion. The clinical testing is not applicable in this submission."
• "Test results, Risk Analysis, and FMEA analysis show that the new device Armory Motion is safe with no hazard."
• "The new device Armory Motion is designed to comply with relevant safety applicable recognized consensus standards."
• "The output characteristics of Armory Motion are similar to those of predicated device, see Table below."

Given this information, it's clear that a typical "study" proving performance against quantitative acceptance criteria for parameters like sensitivity, specificity, accuracy, or reader agreement for an AI/diagnostic device (as implied by the detailed questions) was not conducted or presented in this 510(k). The device is a therapeutic device, not a diagnostic one.

However, I can extract the information provided to address your points as best as the document allows, interpreting "acceptance criteria" as the criteria for demonstrating substantial equivalence based on technical specifications and safety standards, rather than direct performance metrics against a clinical outcome or diagnostic accuracy.

Here's a breakdown based on the provided text:

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

The document establishes "acceptance criteria" through comparison to the predicate device and compliance with recognized standards. Performance is reported through a comparative table.

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

• Sample Size: Not applicable as no formal clinical or performance study with a "test set" of data for diagnostic evaluation was performed. The "test set" in this context is the device itself being compared to the predicate device's specifications and standards.
• Data Provenance: Not applicable. The "study" is a technical comparison and demonstration of 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. Ground truth as typically understood for diagnostic AI (e.g., expert reads, pathology) was not established because no such study was conducted. The "ground truth" here is the established safety and effectiveness profile of the predicate device and the relevant consensus standards.

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

• Not applicable. No expert adjudication process for a test set was performed.

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 not an AI/diagnostic assistant for human readers.

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

• Not applicable. This is a physical therapeutic device, not a standalone algorithm. Its performance is inherent in its design and operation.

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

• The "ground truth" for this 510(k) submission is the established safety and performance of the predicate device (Breg Polar Care Wave, K183702) and compliance with recognized consensus standards (listed in the document, e.g., ANSI AAMI ES60601-1, IEC 60601-1-2, ISO 14971, etc.).

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device requiring a training set.

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

• Not applicable. No training set was used.

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TENS stands for Transcutaneous Electrical Nerve Stimulation. The Ultima NEO TENS system is used to provide symptomatic pain relief for chronic, acute or post-operative pain.

EMS stands for Electrical Neuromuscular Stimulator. The Ultima NEO EMS system is indicated for:

• Relaxation of muscle spasm; .
• Increasing local blood circulation and muscle re-education; ' .
• Prevention or retardation of disuse atrophy; .
• Prevention of venous thrombosis of the calf muscles immediately . after surgery;
• Maintaining or increasing range of motion. .

MIC stands for Microcurrent Stimulation. The Ultima NEO MIC system is used to provide symptomatic pain relief for chronic intractable pain, post traumatic pain or post surgical pain.

IF stands for Interferential Stimulation. The Ultima NEO IF system is indicated for:

Symptomatic relief of chronic intractable pain. .

A portable TENS/EMS/MIC/IF combo device for pain relief or muscle re-education.

Features:

• Innovative design
• · Large LCD display
• · Dual output isolated channels
• · One rechargeable lithium battery
• · Adjustable frequency, pulse width, and timing parameters
• 18 different modes
• · Timer option
• · Doctor lock/unlock facility
• · Open circuit detectors
• Non-volatile

The Ultima NEO is a multi-system electrotherapy device, combining TENS, EMS, MIC, and IF functionalities. The document provided is a 510(k) summary, which focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a performance study with acceptance criteria and results in the typical academic sense.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be fully provided as this type of detailed clinical study information is generally not included in a 510(k) summary for devices demonstrating substantial equivalence through technological comparison to predicates.

Instead, the submission relies on the assertion that its technological characteristics, intended use, and safety comply with relevant standards and are substantially equivalent to already marketed and cleared devices.

Here's an attempt to address the prompt based on the provided text, highlighting what is implicitly or explicitly stated and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) summary for substantial equivalence, formal acceptance criteria and a detailed comparison table of quantitative performance metrics against these criteria are not provided. The "performance" assessment is based on the device's functional equivalence and compliance with established safety standards.

The document implicitly "accepts" the performance of the predicate devices as a benchmark. The reported device performance is described qualitatively as being "almost the same substantially" or "very similar" to the predicate devices in terms of features and operational parameters.

No quantitative performance metrics (e.g., sensitivity, specificity, accuracy, or other clinical outcomes) are presented.

2. Sample Sizes and Data Provenance

• Test Set Sample Size: Not applicable/not provided. No clinical "test set" in the traditional sense was used to evaluate the device's performance against specific clinical outcomes. The evaluation is primarily based on technological comparison and compliance with standards.
• Data Provenance: Not applicable. The "data" here refers to the design specifications, software logic, and electrical characteristics of the Ultima NEO and its predicate devices. The information is derived from the device designs and established standards.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable/not provided. There was no explicit "ground truth" derived by experts for a clinical test set in this context. The review process involves regulatory bodies and their internal experts assessing the submission's claims of substantial equivalence.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not provided. No clinical test set requiring adjudication was conducted.

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

• Was an MRMC study done? No. This type of study is not relevant for this device, which is an electrical stimulator.
• Effect Size: Not applicable.

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

• Was a standalone study done? Not applicable in the context of an "algorithm-only" or AI device. The device is a physical electrotherapy unit. The "performance" is assessed through engineering testing and comparison to the predicate devices' specifications and intended use.
• The document states that the new device passes "the same tests of applicable recognized international consensus standards" as the predicate devices, indicating that its standalone (physical/electrical) functionality meets established safety and performance benchmarks.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable for clinical efficacy. For device safety and functional performance, the "ground truth" is derived from:
  • Compliance with recognized international consensus standards: The document lists several IEC, ISO, and UL standards (e.g., IEC 60601 series for medical electrical equipment, ISO 14971 for risk management).
  • Substantial equivalence to predicate devices: The functional specifications, intended use, and safety profiles of the already cleared predicate devices serve as the benchmark for "truth."

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device does not involve machine learning or AI that would require a "training set" in the conventional sense. The "training" for this type of device is the engineering design and manufacturing process that ensures it meets specifications.

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

• How Ground Truth Established: Not applicable. As there is no training set, there is no ground truth for a training set. The design principles and safety considerations are based on established medical device regulations and engineering best practices.

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The Ultima Five™ external, non-invasive, non-narcotic, electrotherapy device is indicated for use as an adjunctive therapy in providing symptomatic pain relief for chronic, acute, or post-operative pain.

The Ultima Five consists of electrodes, the lead wires, and the signal generator. The Stimulator is portable, battery operated and rechargeable. The Lead wires connect the electrodes to the stimulator. These electrodes complete an electrical circuit allowing current to flow. The stimulator produces a pulsed electrical signal through the lead wires and electrodes at the treatment site.

The provided text is a 510(k) summary for the Ultima Five™ Transcutaneous Electrical Nerve Stimulator (TENS) device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a standalone study as would be done for a novel device or a device with new intended uses.

Therefore, many of the requested elements for a detailed study description, such as sample sizes for test and training sets, expert qualifications, ground truth establishment, and MRMC studies, are not present in this 510(k) summary.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The acceptance criteria for a 510(k) submission are largely implicit in the concept of "substantial equivalence." The device must be as safe and effective as a legally marketed predicate device. For TENS devices, this primarily constitutes demonstrating equivalent electrical performance and similar intended use. The "study" here is a comparative analysis of technical specifications between the proposed device and the predicate.

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

• Sample Size for Test Set: Not applicable. There was no "test set" in the traditional sense of a clinical or retrospective data study aimed at evaluating diagnostic accuracy or treatment efficacy against a specific outcome. The submission relies on a technical comparison to a predicate device.
• Data Provenance: Not applicable in the context of a dataset. The data provenance is from the technical specifications of the Ultima Five™ and the predicate device, the Easy Med TN-28C.

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

• Not applicable. Ground truth as typically understood (e.g., expert consensus on medical images or pathology results) is not relevant for this type of submission focused on technical equivalence for a TENS device.

4. Adjudication Method for the Test Set:

• Not applicable. There was no test set requiring expert adjudication.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. TENS devices are not typically evaluated using MRMC studies, which are common for diagnostic imaging AI. The aim here is to show equivalent electrical output and intended use to a predicate, not to assess a human reader's improvement with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Yes, in a way. The "performance" being assessed is the inherent electrical output characteristics of the device itself, independent of a human operator's actions beyond setting the parameters. This is a "standalone" technical performance evaluation. However, it's not an algorithm-only performance in the context of AI, but rather the device's physical output.

7. The Type of Ground Truth Used:

• Technical Specifications and Intended Use: The "ground truth" for this submission is the established technical specifications of the predicate device (Easy Med TN-28C) and its legally marketed intended use. The Ultima Five™ is compared directly against these documented characteristics.

8. The Sample Size for the Training Set:

• Not applicable. There was no "training set" in the context of machine learning or AI algorithm development.

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

• Not applicable. As no training set was used, no ground truth needed to be established for one.

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The J-Stim 1000 is indicated for use as an adjuctive therapy in reducing the level of pain and symptoms associated with Osteoarthritis of the knee and Rheumatoid Arthritis of the Hand.
The J-Stim 1000 external, non-invasive, non-narcotic, electrotherapy system is indicated for use as an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee and for overall improvement of the knee.
The J-Stim 1000 is also indicated for use as an adjunctive therapy in reducing the level of pain, and stiffness associated with pain, from rheumatoid arthritis of the hand.

The J-Stim 1000 consists of electrodes, the lead wires, and the signal generator. The Stimulator is portable, battery operated and rechargeable. The Lead wires connect the electrodes to the stimulator. These electrodes complete an electrical circuit allowing current to flow. The stimulator produces a pulsed electrical signal through the lead wires and electrodes at the treatment site.

The provided text is a 510(k) summary for the J-Stim 1000™, a Transcutaneous Electrical Nerve Stimulator (TENS) device. The document primarily focuses on establishing substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics.

Based only on the provided text, here's what can be extracted and what information is not available:

1. Table of acceptance criteria and the reported device performance:

The document does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., specific pain reduction percentages, range of motion improvements, or statistical significance levels) for the J-Stim 1000™.

Instead, the core of the submission revolves around establishing substantial equivalence to a predicate device, the Bionicare Stimulator, Model Bio 1000 (K030332). The "performance" reported is that the J-Stim 1000™ has identical electrical output compared to the predicate device.

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

The provided document does not describe any new clinical study or test set with human subjects that directly tested the J-Stim 1000™. The submission hinges on the established performance of the predicate device (Bionicare Stimulator, Model Bio 1000). Therefore, there is no sample size for a test set, nor is there data provenance mentioned for such a study in this document.

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

Since no new clinical study or test set for the J-Stim 1000™ is described, there is no information on experts used to establish ground truth.

4. Adjudication method for the test set:

As no new clinical study or test set for the J-Stim 1000™ is described, there is no information on an adjudication method.

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:

This question is not applicable to the J-Stim 1000™ TENS device. AI assistance and human reader improvement are concepts typically associated with diagnostic imaging or decision support systems, not with a TENS device.

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

This question is not applicable to the J-Stim 1000™ TENS device. It is a physical device that delivers electrical stimulation, not an algorithm.

7. The type of ground truth used:

For the purpose of this 510(k) submission, the "ground truth" for demonstrating the J-Stim 1000™'s effectiveness is established by the prior approval of the predicate device (Bionicare Stimulator, Model Bio 1000). The assumption is that because the J-Stim 1000™ is "electrically identical" to the predicate, it will have comparable therapeutic effects for the stated indications.

8. The sample size for the training set:

There is no mention of a training set in this document as it does not describe the development or testing of an algorithm, but rather a medical device seeking substantial equivalence based on its physical and electrical characteristics.

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

As no training set is mentioned, there is no information on how its ground truth was established.

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The PMT Soft-Touch™ external TENS Electrodes are indicated for use with transcutaneous electrical stimulation devices as a non-sterile, disposable device for single patient use only. The PMT electrodes provide the conductive interface between the TENS generator and the patient's skin.

The PMT TENS electrode Soft-Touch™ are designed for, and to be used with marketed and FDA approved TENS stimulators.

The PMT Soft-Touch™ electrodes are high quality carbon electrodes.

The provided text is a 510(k) Summary for a medical device (TENS electrodes) and a letter of clearance from the FDA. This type of document, particularly for Class II devices, typically focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device) rather than presenting a full study with acceptance criteria and performance data in the format you've requested for AI/software-as-a-medical-device (SaMD).

Here's why a direct answer to your request isn't possible based on the provided text:

• Device Type: The "Soft-Touch TM TENS electrode" is a passive medical device, a physical product, not a software algorithm or AI. Your request for "acceptance criteria," "test set," "ground truth," "MRMC," and "standalone performance" are concepts primarily applicable to evaluating the performance of AI/Machine Learning systems or diagnostic tools, not a conductive electrode.
• 510(k) Process: For this type of device, a 510(k) submission generally relies on demonstrating that the new device has the same intended use, technological characteristics, and safety/effectiveness profiles as a predicate device. This often involves bench testing (physical and chemical properties), biocompatibility testing, and electrical performance testing to show it performs equivalently to the predicate, rather than meeting specific quantitative diagnostic performance metrics.
• Missing Information: The document explicitly states "Refer to NAMSA Reports (Attachments 3, 4, 5)" for summaries of pre-clinical and clinical studies, and conclusions. These attachments, which would contain the detailed study data if any existed beyond predicate comparison, are not included in the provided text.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or MRMC studies because the provided document does not contain this information for a device of this nature.

Instead, the document highlights:

• Predicate Devices: K915333 and K912643 electrodes are the predicate devices.
• Substantial Equivalence: The primary conclusion is that the PMT Soft-Touch™ electrodes are "substantially equivalent" in design and performance characteristics to the predicate devices.
• Safety and Performance: This was established through "similarities in design and performance characteristics as well as performance testing" and comparison of "Materials, performance specifications and essential design characteristics." The details of this "performance testing" are not in the provided text.

If this were an AI or SaMD device, the "NAMSA Reports" would be crucial for your request. Without them, we only have the conclusion of equivalence, not the detailed data or methodology usually associated with performance studies for AI/diagnostic devices.

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