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The bite away® neo is indicated for use to provide temporary relief of the pain and itching from insect stings and bites such as bees, wasps and mosquitoes.

The bite away® neo device is a light weight, portable, hand-held, battery powered, user- operated device that produces mild heat for direct contact with the affected areas of the skin. The heat is initiated by the user through the activation of the unit by depressing a non-locking button. The device is provided with two (2) side-by-side buttons. The user has the choice of a short 3 second heat treatment or a 5 second heat treatment depending on which button is depressed. The activation of the unit is signified with the illumination of an LED light and an audible chirp through the use of an electronic buzzer. An audible alarm is activated when there is a user error. The device is not connected to the user as the user is in complete control of the heat treatment and as such, self-delivers the heat treatment to themselves by contacting the device to their own anatomy / treatment site. The short duration of 3 and 5 seconds of heating the device's heated ceramic plate that contacts the patient further alleviates risk of overheating the skin as the device automatically stops heating the element after 3 or 5 seconds; limiting the maximum amount of heat to be delivered to the site.

The bite away® neo device utilizes two AA batteries (1.5 volts each) that power a resistor that heats a 7mm ceramic disc to approximately 50°C when activated by the user through the use of one of the two electro-mechanical NOC (normal open contact) buttons (3 seconds of heating). The device consists of a few major components: a hard plastic outer case, a printed circuit board, an activation button. AA batteries, and a heated ceramic plate that contacts the printed circuit board consists of the following components: electro-mechanical NOC buttons, microcontroller with programmed firmware, MOSFET transistor heating element, ceramic pad, resistors, coils, capacitor, thermistor temperature sensor and buzzer. The bite away® neo device is approximately 7 inches long and weighs approximately 40 grams.

This document is a 510(k) Premarket Notification from MibeTec, GmbH to the FDA for their device, the bite away® neo. The device is a powered heating pad intended for the temporary relief of pain and itching from insect stings and bites.

Since this document is a 510(k) submission, the study performed is a non-clinical performance study to demonstrate substantial equivalence to a predicate device, not a comparative effectiveness study with human readers (MRMC study) or a standalone algorithm performance study. The core of this submission is comparison to a predicate device and demonstration that the new device is as safe and effective.

Here's an breakdown of the requested information based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical thresholds for clinical efficacy in this document, as this is a 510(k) submission demonstrating substantial equivalence based primarily on non-clinical performance and design characteristics, rather than de novo clinical efficacy trials. The implicit acceptance criterion is that the device is as safe and effective as the predicate device and meets relevant safety and performance standards.

The document demonstrates this by:

• Identical Indications for Use: The bite away® neo and the predicate device (Riemser Bite Away, K160943) are indicated for the same purpose.
• Similar Design Principles: Both are user-operated, hand-held, battery-powered, reusable devices that deliver mild heat to the skin via a ceramic disc.
• Compliance with Safety Standards: The device underwent and passed electrical safety, EMC, software verification/validation, and usability testing according to international standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62366, IEC 60601-1-6) and FDA guidance for biocompatibility (ISO 10993-1).

Table of Acceptance Criteria (Implicit) and Reported Device Performance:

2. Sample Size for the Test Set and Data Provenance

The document explicitly states: "No clinical studies were performed to support safety or effectiveness of the subject device."

Therefore, there is no "test set" in the traditional sense of a clinical data set used to prove efficacy. The "testing" refers to non-clinical bench testing (biocompatibility, electrical safety, software validation, usability) against established standards. The data provenance is from laboratory testing and engineering analysis conducted by the manufacturer, MibeTec, GmbH (Germany), as part of their premarket notification submission.

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

N/A. As no clinical studies were performed, there was no "ground truth" derived from expert consensus on medical images or patient outcomes. The "ground truth" for the non-clinical tests is adherence to engineering and safety standards, which are defined by international bodies and regulatory agencies like the FDA. The experts involved would be the engineers, quality assurance personnel, and regulatory affairs specialists at the manufacturer and the testing laboratories.

4. Adjudication Method for the Test Set

N/A. There was no clinical test set requiring adjudication. Adjudication methods (e.g., 2+1, 3+1) are typically used for establishing ground truth in clinical image interpretation studies or clinical trials, which were not conducted here.

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

No. The document explicitly states: "No clinical studies were performed to support safety or effectiveness of the subject device." Therefore, no MRMC study was conducted, and no effect size for human readers improving with or without AI assistance is provided. (Note: This device is a heating pad, not an AI-powered diagnostic tool, so an MRMC study would generally not be applicable in this context).

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

N/A. This device is a powered heating pad, not an AI algorithm. There is no software or algorithm whose performance is being evaluated in a standalone manner. The software mentioned is for the device's internal control (e.g., heating duration, temperature regulation), verified as "moderate" level of concern.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is established through:

• Engineering and Safety Standards: Compliance with international standards (IEC 60601 series, ISO 10993, IEC 62366).
• Predicate Device Equivalence: The legally marketed predicate device (K160943) serves as the primary benchmark for demonstrating safety and effectiveness. The premise of a 510(k) is that if the new device is substantially equivalent to a legally marketed predicate, it is considered safe and effective.

8. The Sample Size for the Training Set

N/A. As this is not an AI/machine learning device, there is no "training set" in the conventional sense. The device's design (e.g., microcontroller firmware) would be developed and refined through engineering iterations, but not trained on a distinct dataset like an AI model.

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

N/A. See #8.

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The Bite Away is indicated for use to provide temporary relief of the pain and itching from insect stings and bites such as bees, wasps and mosquitoes by temporarily increasing localized blood flow.

The Riemser Pharma Bite Away device is a light weight, portable, hand held, battery powered, user-operated device that produces mild heat for direct contact with the affected areas of the skin. The heat is initiated by the user through the activation of the unit by depressing a non-locking button. The device is provided with two (2) side-by-side buttons. The user has the choice of a short 3 second heat treatment or a 6 second heat treatment depending on which button is depressed. The activation of the unit is signified with the illumination of an LED light and an audible chirp through the use of an electronic buzzer. An audible alarm is activated when there is a user error. The device is not connected to the user as the user is in complete control of the heat treatment and as such, self-delivers the heat treatment to themselves by contacting the device to their own anatomy / treatment site. The short duration of 3 and 6 seconds of heating the device's heated ceramic plate that contacts the patient further alleviates risk of overheating the skin as the device automatically stops heating the element after 3 or 6 seconds; limiting the maximum amount of heat to be delivered to the site.

The Riemser Pharma Bite Away device utilizes two AA batteries (1.5 volts each) that power a resistor that heats a 9mm ceramic disc to 51.5℃ +/- 1% when activated by the user through the use of one of the two electro-mechanical NOC (normal open contact) buttons (3 seconds or 6 seconds of heating). The device consists of a few major components: a hard plastic outer case, a printed circuit board, an activation button, AA batteries, and a heated ceramic plate that contacts the patient. The printed circuit board consists of the following components: electro-mechanical NOC buttons, microcontroller with programmed firmware, MOSFET transistor heating element, ceramic pad, resistors, coils, capacitor, thermistor temperature sensor and buzzer.

The Riemser Pharma Bite Away device is approximately 6 inches long and weighs approximately 25 grams. The Bite Away device is provided in 2 shapes, both of which are identical in every way except for the shape. One product is an elongated configuration called "Cobra" and the other configuration is an oblong configuration called "Mouse". Although these products have different shapes and names, the products are identical in every way to include raw materials, subcomponents, electronic circuits, electronic components, and imbedded software code, fabrication processes, etc., and only differs in the shape of the outer case (elongated Cobra model versus the oblong Mouse model).

This document describes the marketing authorization for the "Bite Away" device, a powered heating pad intended for temporary relief of pain and itching from insect stings and bites. The study provided focuses on clinical data to support the device's indications for use.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" is not explicitly defined as a numeric threshold in the document for the clinical study's primary endpoint. Rather, the study aims to demonstrate a statistically significant reduction in pain, itching (pruritus), and swelling as measured by a Visual Analog Scale (VAS) after using the Bite Away device. The reported performance shows significant improvement across these metrics.

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The Heated Eye Pad ophthalmic warmer is a powered heating pad for the application of localized heat therapy. Use for treatment when the current medical community recommends the application of a warm compress to the eyelids. Such applications would include Meibomian Gland Dysfunction (MGD), Dry Eye, Blepharitis, Stye, or Chalazia.

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The provided document is an FDA 510(k) clearance letter for a device called "Heated Eye Pad." This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

The content is a regulatory clearance stating that the device is "substantially equivalent" to legally marketed predicate devices. It outlines:

• The device name, regulation number, regulatory class, and product code.
• General controls provisions of the Act that apply.
• Contact information for further guidance.
• Indications for Use: The Heated Eye Pad is a powered heating pad for localized heat therapy, recommended for conditions like Meibomian Gland Dysfunction (MGD), Dry Eye, Blepharitis, Stye, or Chalazia, and is approved for Over-The-Counter use.

Therefore, I cannot fulfill your request for information on acceptance criteria and device performance studies based on the provided text. The document is strictly a regulatory clearance, not a technical report detailing performance studies.

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The AVACEN 100 is a heat therapy system indicated for the temporary relief of minor muscle and joint pain and stiffiess; the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains; muscular relaxation; and the temporary increase of local circulation where applied.

The AVACEN 100 consists of a control panel, temperature-controlled raised thermal transfer pad, and a vacuum chamber. The AVACEN 100 is designed to comfortably and noninvasively apply dry heat to the hand for the temporary relief of minor aches and pains. The user places their hand into the AVACEN 100 for approximately 10-30 minutes per treatment session. A vacuum pump creates a slight vacuum (25-35 mm Hg) on the hand, which accelerates the transfer of heat.

The provided text does not describe a study involving acceptance criteria for device performance in the context of an AI/ML algorithm. Instead, it is an FDA 510(k) summary for a medical device called "AVACEN 100," which is a heat therapy system.

This document focuses on demonstrating substantial equivalence to a predicate device (Shenzhen Anpan FIR Heat Therapy Systems) for regulatory clearance. It outlines the device description, indications for use, comparison with the predicate device, and compliance with nonclinical safety standards (electrical safety, electromagnetic compatibility, and biocompatibility).

Therefore, I cannot provide the requested information about acceptance criteria, device performance from a study, sample sizes, ground truth establishment, or multi-reader multi-case studies, as none of this pertains to the content of the provided document. The device in question is a physical heat therapy system, not an AI/ML algorithm.

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The FIR Heat Therapy Systems are indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis, muscle spasms, minor strains and sprains and minor muscular back pain; muscular relaxation; and the temporary increase of local circulation where applied.

The FIR Heat Therapy Systems provide infrared heat to different areas of the patient's body. The Systems consist of an outer application cover with adjustable pads that enclose the infrared heating elements to treat different areas of the body. The pad's covers are fabricated of nyloncotton blend. Velcro fasteners on the cover allow for adjusting the cover and pads for optimum contact to the patient's body areas.

Here's a breakdown of the acceptance criteria and study information for the FIR Heat Therapy Systems, based on the provided document:

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

The document doesn't explicitly state "acceptance criteria" in a quantitative performance metric sense for clinical efficacy. Instead, the acceptance criteria are largely based on demonstrated equivalence to a predicate device and adherence to relevant safety and performance standards. The performance testing focuses on physical characteristics supportive of its intended use and safety.

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 detail a clinical "test set" in the sense of a patient population for evaluating clinical outcomes. The performance testing described (skin temperature, infrared energy/spectrum) appears to be laboratory-based testing of the device itself, not human subjects. Therefore, sample size and data provenance relating to human subject data are not applicable here.

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)

This information is not applicable. The ground truth for the performance tests (e.g., infrared spectrum, temperature measurements) would be established by standard scientific measurement techniques and instrumentation, not expert human assessment.

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

This information is not applicable, as there was no clinical test set requiring expert adjudication.

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 was conducted or mentioned. This device is a heat therapy system, not an AI-assisted diagnostic tool.

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

This information is not applicable. This device is a physical therapy device with a direct effect, not an algorithmic diagnostic tool.

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

For the performance tests mentioned:

• Infrared spectrum and energy: Ground truth would be established by calibrated scientific instruments (e.g., spectrometers, thermal cameras/sensors) and physical principles.
• Temperature measurements: Ground truth would be established by calibrated thermometers or thermal probes.

8. The sample size for the training set

This information is not applicable. There is no indication of a "training set" as this device does not involve machine learning or AI models. This is a traditional medical device demonstrating substantial equivalence through standard performance testing and comparison to a predicate.

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

This information is not applicable, as there was no training set.

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The Bio-Mat is indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis; the temporary relief of muscle spasms, minor sprains and strains, and minor muscular back pain; the relaxation of muscles; and the temporary increase of local circulation where applied.

The Bio-Mat is an electrically powered mattress pad that applies infrared heat to the user's body for the temporary relief of minor body aches and pains. A control panel allows the user to turn the product on/off, modify the temperature, and set the product's timer.

The provided document is a 510(k) summary for the RichWay International, Inc.'s Bio-Mat 2000, an infrared heat pad. The performance data section refers primarily to safety and functionality testing, not a clinical study proving therapeutic effectiveness against specific acceptance criteria for a medical condition.

Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not applicable or estimable from this document. The document focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and safety testing.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for therapeutic efficacy for specific clinical endpoints (e.g., pain reduction scores, range of motion improvements). Instead, it relies on the device functioning "as intended" and passing safety/durability tests.

Study Information

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

   • Sample Size: "A total of 70 Bio-Mats were eventually sent to the Underwriters Laboratories which indicates how complete the testing was." This sample size refers to the number of devices tested for safety and functionality, not a patient test set for therapeutic efficacy.
   • Data Provenance: The testing was conducted by Underwriters Laboratories (UL). The document doesn't specify the country of origin of the data beyond this. It's an engineering/safety test, not a clinical study on human subjects, so retrospective/prospective distinction for a patient test set is not applicable.

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

   • Not applicable as this was not a clinical study involving experts establishing ground truth for patient outcomes. The "ground truth" for the device's functional and safety performance relied on UL's testing protocols and standards.

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

   • Not applicable as this was not a clinical study involving human assessment or adjudication of patient outcomes.

4. 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 document is for an infrared heat pad, not an AI-assisted diagnostic or therapeutic device that would involve human readers.

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

   • Not applicable. This is not an algorithm-only medical device. The "performance" refers to the device's electrical, thermal, and mechanical safety/functionality.

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

   • The "ground truth" for the performance data in this submission is compliance with established safety and functional standards, specifically those of Underwriters Laboratories (UL). This is a technical/engineering ground truth, not a clinical one.

7. The sample size for the training set:

   • Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device or a clinical trial with a training phase.

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

   • Not applicable for the reasons stated above.

In summary: The provided 510(k) summary for the Bio-Mat 2000 focuses on demonstrating the device's safety, functionality, and substantial equivalence to legally marketed predicate devices through technical testing by Underwriters Laboratories. It does not present detailed clinical study data with specific acceptance criteria, patient test sets, or ground truth establishment relevant to therapeutic efficacy, which is often a feature of submissions for different types of medical devices or higher-risk classifications.

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The PT-Pac is a portable heating pad. It is a non-significant risk device similar to predicate devices (powered heating pads 890.5740) in providing sustained electrical powered heat to a defined body region. As with approved heating pads, the skin contacts only a biocompatible (100% cotton) cover. The PT-Pac claims the ability to provide soothing warmth in the temperature range of predicate devices. PT-Pac differs from alternating current powered devices in that it is powered by low-voltage, direct-current batteries, making it portable as well as safer than conventional heating pads. The PT-Pac uses highly reliable thermoelectric tiles to transfer heat. These are microprocessor-controlled, providing strict temperature regulation. The redundancy of two safety circuits, together with the finite time that the batteries can power the unit, make the safety of this device more robust than that of predicate devices.

This is a 510(k) summary for a portable heating pad (PT-Pac). It does not contain information about acceptance criteria, device performance metrics, or study designs typically associated with AI/ML-driven diagnostics or complex medical devices requiring such detailed evaluations.

The provided text focuses on:

• Device Description: A portable heating pad, battery-powered, using thermoelectric tiles and microprocessor control.
• Predicate Comparison: Similar to existing powered heating pads (890.5740), but portable and safer due to low-voltage DC batteries and safety circuits.
• Intended Use: Providing soothing warmth in the temperature range of predicate devices.
• Safety Features: Low-voltage DC, two safety circuits, finite battery life.

Therefore, I cannot answer your specific questions because the provided input is for a relatively simple, low-risk device where the evaluation criteria are fundamentally different from those for a device requiring extensive clinical studies, AI performance metrics, or expert reviews as implied by your questions.

To elaborate, for a device like the PT-Pac, acceptance criteria would likely revolve around:

• Temperature Range: Does it consistently output heat within a specified safe and effective range (e.g., 38°C to 45°C)?
• Temperature Uniformity: Is the heat distributed evenly across the pad's surface?
• Over-temperature Protection: Do the safety circuits reliably prevent the device from exceeding a maximum safe temperature?
• Battery Life: Does it operate for a reasonable duration on a single charge/set of batteries?
• Biocompatibility: Is the cover material safe for skin contact?
• Electrical Safety: Does it meet relevant standards for low-voltage devices (e.g., current leakage, insulation)?
• Durability: Does it withstand typical use and handling?

However, the provided summary does not include any data or study results demonstrating that the PT-Pac meets these or any other specific acceptance criteria. It merely describes the device and its intended function and safety features relative to predicate devices.

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Use wherever hot applications are desirable for personal comfort, and wherever recommended by your physician, dentist or health care professional for the relief of minor muscular or joint pain.

Electric Heating Pad, 11.5" x 14.5" conforming to ANSI / UL Standard #130, Electric Heating Pads, operating on standard 110-120V household current. The units are supplied with removable covers and sponge inserts for moist heat applications, with instructions, in conventional 4-color printed boxes, and are marketed through consumer retail channels.

This document is a 510(k) summary for electric heating pads (Models EHP2, EHP3). It details the product's classification, description, and intended use. However, it does not contain any information about acceptance criteria, device performance, sample sizes, expert involvement, or study methodologies that would typically be found in a clinical or performance study report.

The document's purpose is to claim "substantial equivalence" of the new heating pads to existing, legally marketed devices. It explicitly states that "Substantial equivalence is claimed because: the power source, manufacturing technology, operating principles, intended uses and safety standards are the same for all models. Differences are primarily cosmetic."

Therefore, I cannot extract the requested information as it is not present in the provided text. This type of submission relies on demonstrating similarity to already approved devices rather than presenting novel performance data.

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