Search Results

Needle Stimulator is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Needle Stimulator is an electro-acupuncture device for acupuncture therapy, powered by 6 pieces of 1.5V batteries or AC 100-240V. It is composed of a console and 6 channels of electrode cables with alligator type connectors. The console has the operating controls including function knobs or buttons. Needle Stimulator does not equip with acupuncture needles. The practitioners should select legally marketed needles.

The provided text is an FDA 510(k) summary for a medical device called "Needle Stimulator." It details the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.

However, the provided text does not contain any information about a study that proves the device meets specific performance acceptance criteria for an AI/ML-based device. The information is primarily focused on electrical safety, essential performance, and electromagnetic compatibility tests as per general medical device standards, and not on the performance metrics of an AI system detecting or classifying something.

The recurring phrases like "Similar Note 1," "Similar Note 2," etc., refer to explanations for minor differences between the subject device and the predicate device in terms of hardware specifications and compliance with voluntary standards. They are not related to an AI/ML performance study.

Specifically, the section "6. Clinical Test" states, "Clinical data were not included in this submission." This strongly indicates that no clinical study was performed for this 510(k) submission, and therefore, no AI/ML performance data against ground truth or human readers would be available within this document.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML-based device based on the information provided. The document describes a standard medical device (an electro-acupuncture stimulator), not an AI/ML product requiring the detailed performance study you've outlined.

If this was a misunderstanding and you expected a generic answer for an AI/ML device based on typical FDA requirements, please clarify. But based solely on the provided text, the requested information is absent.

Ask a specific question about this device

Needle Stimulator (Model: RJNS6-1) is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Needle Stimulator (Model: RJNS6-1) is an electro-acupuncture device for acupuncture therapy, powered by 6 pieces of 1.5V batteries or AC 100-240V. It is composed of a LCD, a console and 6 channels of electrode cables with alligator type connectors. Only 3 channels at most could work together on single patient. The console has the operating elements of Channel selecting button, Setting button, Operation suspending switch button, Wave-selecting button, On/off switch, Mute button, Therapy time adjusting button, Output frequency adjusting button, Intensity adjust knobs, and Output indicator light. Needle Stimulator (Model: RJNS6-1) does not equip with acupuncture needles. The practitioners should select 510(k) cleared needles (with minimum diameter of 0.40mm and insertion depth of 16mm) for use.

The provided text describes the 510(k) submission for the "Needle Stimulator (Model: RJNS6-1)" and its substantial equivalence to a predicate device. However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/human-in-the-loop diagnostic system.

The device in question is an electro-acupuncture stimulator, and the FDA's review focuses on its electrical safety, performance parameters, and substantial equivalence to a legally marketed predicate device (K202861). The testing mentioned is related to electrical safety and electromagnetic compatibility (e.g., IEC 60601 standards), not diagnostic performance or AI assistance.

Therefore, I cannot provide a table of acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC study details, standalone performance, or ground truth establishment as these concepts are not applicable or mentioned in the context of this specific device's 510(k) submission as provided.

The document confirms the following:

• Device Name: Needle Stimulator (Model: RJNS6-1)
• Intended Use: An electro-acupuncture stimulator indicated for use in the practice of acupuncture by qualified practitioners.
• Regulatory Pathway: 510(k) Premarket Notification.
• Predicate Device: Needle Stimulator (Model: CMNS6-2), K202861.
• Performance Evaluation: Substantial equivalence based on non-clinical tests (electrical safety, EMC, etc.) according to recognized standards (ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-10).

In summary, the provided text does not contain the specific information requested about acceptance criteria and a study proving an AI-powered device meets them. The evaluation described is for a non-AI medical device and focuses on electrical and functional equivalence.

Ask a specific question about this device

Needle Stimulator is an electro-acupuncture stimulator device, which is indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Needle Stimulator is an electro-acupuncture device for acupuncture therapy powered by 6 pieces of 1.5V batteries or AC 100-240V. It is composed of a console and 6 channels of electrode cables with alligator type connectors. The console has the operating controls including function knobs or buttons. Needle Stimulator does not equip with acupuncture needles. The practitioners should select legally marketed needles.

Based on the provided text, the device in question is a "Needle Stimulator," an electro-acupuncture stimulator. The document is a 510(k) Summary, which aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This type of submission relies on comparisons to demonstrate safety and effectiveness rather than conducting extensive clinical studies typically associated with novel devices.

Therefore, the acceptance criteria and the "study" proving the device meets them are primarily based on equivalence to a predicate device through engineering and performance testing, rather than a clinical efficacy study with human subjects.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the parameters of the predicate device (K130768) and compliance with relevant safety standards. The reported device performance is presented as a comparison to these predicate specifications.

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

The document does not describe a "test set" in the context of clinical data for performance evaluation. Instead, the "testing" refers to engineering and compliance testing of the device prototypes themselves. Therefore, the "sample size" is the manufactured device unit or units tested for compliance.

• Sample Size: Not applicable in the context of a clinical test set. The testing was performed on the device models themselves (CMNS6-1 and CMNS6-2).
• Data Provenance: Not specified as clinical data. The tests were likely conducted by the manufacturer in China, given their location. The studies are retrospective in the sense that they are proving equivalency to a device already on the market, but the testing on the new device would have been done prospectively for this submission.

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

This information is not applicable as the ground truth for this type of submission is established through:

• Engineering specifications and design requirements.
• Compliance with recognized national and international safety standards (ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-10).
• Demonstration of substantial equivalence to a legally marketed predicate device.

No human expert interpretation of clinical data (like radiology reads) is involved in establishing "ground truth" for this device's safety and performance claim.

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

This is not applicable as there is no clinical test set requiring human adjudication. The "adjudication" is done through engineering measurements and conformity assessments to established standards and predicate specifications.

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 is not applicable. The device is an electro-acupuncture stimulator, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or required for this type of device.

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

This is not applicable. The device is a physical medical instrument, not a software algorithm. Its performance is inherent in its electrical and mechanical properties, not an algorithm's output.

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

The "ground truth" for this submission is:

• Engineering specifications and performance characteristics of the predicate device (K130768).
• International and national safety standards (ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-10), which define acceptable limits for various electrical and physical parameters, ensuring patient and user safety.
• The premise that if the new device operates within the same safety and performance parameters as a previously cleared predicate and complies with relevant standards, it is "safe and effective."

8. The sample size for the training set

This is not applicable. This is not an AI/ML device that requires a "training set."

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

This is not applicable. As it is not an AI/ML device, there is no training set or associated ground truth establishment process.

Ask a specific question about this device

The AXUS ES-5 Electro Acupuncture Device is an electro-acupuncture device indicated for use in the practice of acupuncture by qualified professionals of acupuncture as determined by the states.

The AXUS ES-5 is an electro-acupuncture device indicated for use in the practice of acupuncture by qualified professionals of acupuncture as determined by the state. The AXUS ES-5 is a battery operated prescription use only electro-acupuncture device used for applying electric stimuli to areas of preferred delivery (APD). The device uses a low-intensity, low-frequency pulse multimode generator through microalligator clips attached to commercially available and FDA-cleared stainless steel acupuncture needles. The device can also deliver stimulation with the included probe.

The provided text is a 510(k) summary for the AXUS ES-5 Electro-Acupuncture Device. It describes the device, its intended use, and its similarities to a predicate device (ES-130). However, the document does not contain any information about acceptance criteria or a study proving the device meets those criteria, especially in the context of AI/ML performance evaluation.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, primarily through:

• Technological characteristics: Comparing waveform shapes, maximum frequency, output voltage/current, power density.
• Performance testing: Stating that the device conforms to applicable technical standards, including electrical safety, electromagnetic compatibility, and biocompatibility.

There is no mention of a study involving AI, machine learning, human readers, or any metrics like sensitivity, specificity, or AUC related to diagnostic performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets the acceptance criteria, as the provided text does not contain such information for this medical device clearance. The device is a physical electro-acupuncture device, not an AI/ML-driven diagnostic tool.

If you have a document describing the testing for an AI/ML medical device, I would be happy to analyze it according to your criteria.

Ask a specific question about this device

The ANSiStim-PP is an electro-acupuncture device for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

The ANSiStim®-PP is a wearable, battery-operated device that is designed to administer continuous low-level electrical pulses to the ear over four days / 96 hours from the time of activation of the device. The electrical pulse from the device will be delivered to the stimulation point on the ear through a set of wire assembly and Stimulation needles. Three zinc air batteries with 1.4 V each provides the required stimulation energy for a maximum of 96 hours. There are three Stimulation needles and one ground electrode - which constitute of a needle and lead/ wire with the snap-fit ring. The stimulation needles are inserted at three specific points, which have the ability to stimulate the auricular cranial nerves. The ground electrode is inserted at one specific point (constant in all treatments) which forms the functional earthing to the device is also provided with a bottom ground.

There are three options available for using the ground terminal in the device. Either the ground electrode or the bottom ground can be used. Or both the ground electrode and bottom ground can be used together.

This constant current source guarantees equivalent stimulation energy regardless of the individual impedance of the skin. The treatment period varies based on the severity of the pain in the individual.

The stimulation pattern consists of 1 Hz single pulses with square waveform. The current direction is inverted every second pulse, which is intended to avoid polarization effects. To minimize the risk of adaption or tolerance to the electrical stimulation is applied for 3 hours, followed by a pause of 3 hours.

A 3-pin connector is provided, which is used to check the output voltage of the device once it is activated and before applying to the patient with any one of the voltage measuring devices available in the market with the appropriate regulatory compliance.

This document, a 510(k) summary for the ANSiStim-PP device (K170391), describes the device and its comparison to a predicate device (ANSiStim, K141168). However, it does not contain the level of detail typically found in a clinical study report that would address many of the specific questions about acceptance criteria and study design for a device's performance.

The focus of this 510(k) is demonstrating substantial equivalence to a legally marketed predicate device through performance testing, indicating that the new device meets the same safety and effectiveness standards without requiring a new clinical study. It is not a clinical study proving performance against specific clinical acceptance criteria for an AI or diagnostic device in the way your prompt describes.

Therefore, I cannot provide a direct answer to most of your questions as the information is not present in the provided text. The document refers primarily to bench testing, compliance with standards, and non-clinical testing to demonstrate equivalence.

Here's what I can extract and address based on the provided text, and where the information is not available:

Acceptance Criteria and Study Details (Based on the provided K170391 510(k) Summary):

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The document implies that the acceptance criteria for the ANSiStim-PP device are that its "Performance specifications" are equivalent to the predicate device (ANSiStim K141168). This is assessed through "Performance testing" and "functional test" for 96 hours.

• Reported Device Performance:
  "The ANSiStim®-PP has equivalent Performance specifications when compared to the predicate device."
  "The functional test is performed for 96 hours to monitor the 3 hours ON state followed by 3 hours OFF state. The pulse duration, amplitude and current values are captured for the ANSiStim®-PP device."
  "The bench test has been performed and found that the ANSiStim®PP met all the requirements specifications and standards requirements."

  Specific performance values (e.g., exact pulse duration, amplitude, current ranges) are not detailed in this summary for the ANCIStim-PP, nor are the specific numerical targets for "equivalence" to the predicate. It states they are "equivalent" and "met all requirements."

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

• Not Applicable / Not Provided. This document describes non-clinical bench testing, not a clinical test set with patient data. The "test set" would be the manufactured devices themselves that undergo performance testing. There is no information on the number of units tested.

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

• Not Applicable. This is not a study that uses expert review for ground truth establishment. The performance testing is against engineering specifications and compliance standards.

4. Adjudication method for the test set

• Not Applicable. No human adjudication of results is described as this is not a diagnostic device with subjective outputs requiring expert consensus.

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 is an electro-acupuncture device, not an AI-assisted diagnostic imaging device. No MRMC study was performed or is relevant here.

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

• Not Applicable. This is a hardware device that delivers electrical pulses. Its performance is measured by its output characteristics (current, frequency, waveform, duration). It does not have an "algorithm-only" mode in the context of AI.

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

• The "ground truth" for this device's performance testing would be the engineering specifications and established standards (e.g., IEC 60601-1, ISO 10993 series) for electrical characteristics, biocompatibility, and sterilization, as well as the performance values of the legally marketed predicate device.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. As above, no training set for an AI/ML model.

In summary, this 510(k) notification focuses on demonstrating substantial equivalence through engineering and laboratory testing (bench testing, functional testing for 96 hours, biocompatibility, sterilization, electrical safety, EMC) against a predicate device and relevant international standards. It does not involve a clinical study with patient data, expert review, or AI performance metrics as typically required for more complex diagnostic or AI-driven medical devices.

Ask a specific question about this device

Stivax is an electro-acupuncture device for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

The Stivax is a single use, battery-powered, electrical nerve stimulator which is used for the stimulation of the vagus nerve via the ear. The device connects an electrode cable to two sterile (radiation) acupuncture needles that have been applied by a healthcare practitioner. The stimulator connects to a clip holder on medical grade adhesive tape. The stimulator (with tape) adheres to the patient, behind the ear.

The STIVAX and the sterile (radiation) stimulation double needle are intended for single use.

The device consists of the stimulator and a stimulation double needle. The device cannot be recharged. The device has no connection to any external devices except the electrode.

The stimulator is housed in plastic. It is connected through a plug to the stimulation double needle (needles made of titanium, insulated wire). The power is supplied by a 3 V battery (type CR1220).

The dimensions of the device are W x H x D 34 x 7 x 20 mm, the weight is 4.41 g with battery.

The device is activated by connecting the stimulation double needle.

This document is a 510(k) premarket notification for the Stivax System, an electro-acupuncture device. The core of this submission is to demonstrate substantial equivalence to a predicate device, the Biegler P-Stim System (K140788), rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria and performance studies for an AI/algorithm-based device is not directly applicable or available in this document.

However, I can extract the information that is present concerning the device's technical specifications and the non-clinical testing performed for its substantial equivalence claim.

Here's the breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present "acceptance criteria" in the typical sense for an AI/algorithm where specific metrics (e.g., sensitivity, specificity) are defined and then performance against those metrics is reported. Instead, it relies on demonstrating that the subject device (Stivax) has equivalent or comparable specifications and performance to its legally marketed predicate device (P-Stim).

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

No test set for evaluating algorithm performance (clinical or otherwise) is mentioned. This is a medical device 510(k) submission, not an AI/ML algorithm submission that requires such a test set. The submission relies entirely on non-clinical (bench) testing and comparison to a predicate device.

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

Not applicable. No ground truth establishment by experts for an algorithm's performance is mentioned.

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

Not applicable.

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.

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

Not applicable.

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

Not applicable. The "ground truth" here is compliance with electrical safety and performance standards, and comparison to the predicate device's established safety and effectiveness.

8. The sample size for the training set:

Not applicable. This device is a hardware electrical stimulator, not an AI/ML algorithm requiring a training set.

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

Not applicable.

Ask a specific question about this device

The ANSiStim™ is an electro-acupuncture device for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

The ANSiStim™ is a wearable battery-operated device that is designed to administer continuous low-level electrical pulses at the ear over four days. The stimulation needles are inserted at three specific points, which have the ability to stimulate the acupoints in the human body. Three zinc air batteries with 1.4 V provide the required stimulation energy for a maximum of 96 hours. This constant current source guarantees equivalent stimulation energy regardless of the individual impedance of the skin. The stimulation pattern consists of 1 Hz single pulses with square waveform. The current direction is inverted every second pulse, which is intended to avoid polarization effects. To minimize the risk of adaption or tolerance to the electrical stimulation, stimulation is applied for 3 hours, followed by a pause of 3 hours.

Here's a breakdown of the acceptance criteria and study information for the ANSiStim™ device based on the provided text:

Acceptance Criteria and Device Performance

The ANSiStim™ device demonstrates substantial equivalence to its predicate device (P-STIM, K050123) through performance, biocompatibility, and sterilization testing.

Table 1: Acceptance Criteria and Reported Device Performance

Study Details

The provided document describes a summative report for a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a previously cleared predicate device (P-STIM, K050123). This is primarily achieved through bench testing for performance, biocompatibility, and sterilization, rather than clinical trials involving human participants or elaborate AI model evaluation.

Regarding the specific questions:

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

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

   • Test Set Sample Size:
     • Performance Testing: Not explicitly stated but refers to "each unit" for functional tests and "the ANSiStim™ and its predicate device" for comparative analysis. This implies multiple units or components were tested.
     • Biocompatibility Testing:
       • Acute Systemic Toxicity: Swiss albino mice (number not specified).
       • Subcutaneous Implantation: Wistar rats (number not specified).
       • Skin Sensitization: Guinea pigs (number not specified).
       • Intracutaneous Reactivity: New Zealand White rabbits (number not specified).
       • In vitro cytotoxicity: Cell cultures (number not specified).
       • 3M Material Testing: Performed by 3M, details not specified but likely involves standard biological testing methodologies.
     • Sterilization Testing: "Each batch of needle assembly" is subjected to tests. Specific number of samples per batch not provided.
   • Data Provenance: The document states DyAnsys, Inc. is located in San Mateo, CA, USA, and refers to "DyAnsys India Pvt Ltd" in the biocompatibility conclusion. This suggests testing may have occurred in multiple locations or been managed by the Indian subsidiary. The testing is prospective in the sense that the device was specifically tested to demonstrate equivalence for this submission.

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 in the context of this 510(k) submission. The "ground truth" here is compliance with established engineering, electrical, and international biocompatibility/sterilization standards, as well as demonstrating comparable function to a legally marketed predicate device. This is evaluated by technical experts in those fields (e.g., toxicologists, microbiologists, electrical engineers) typically working for testing labs, consistent with the reference to "the test lab concluded." The document does not describe a clinical study requiring expert consensus on diagnoses or outcomes.

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

   • None. This type of adjudication is typically relevant for clinical studies or image-based diagnostic AI, where multiple human readers assess cases and discrepancies need resolution. This 510(k) predominantly relies on objective measurements from bench testing and adherence to published standards.

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, an MRMC comparative effectiveness study was not done. This device is an electro-acupuncture stimulator, not an AI-powered diagnostic or assistive tool for human readers. Its substantial equivalence is based on its physical properties, electrical performance, and safety (biocompatibility, sterilization), not on improving human interpretation of medical data.

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

   • No. This device is a hardware electro-acupuncture stimulator, not an algorithm. Its "standalone performance" is demonstrated through its functional tests and comparison of its electrical output to the predicate device.

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

   • The "ground truth" for this submission is primarily objective measurements against engineering specifications and international standards, along with demonstrated equivalence to the performance and safety profiles of the predicate device.
     • Performance: Measured electrical parameters (pulse width, duration, amplitude, current) against design specifications and comparison to predicate.
     • Biocompatibility: Biological responses (toxicity, irritation, sensitization, cytotoxicity) measured against acceptance criteria defined by ISO 10993 standards.
     • Sterilization: Microbiological tests (bio-burden, sterility), and chemical indicator checks against ISO 11135 and related standards.

8. The sample size for the training set:

   • Not applicable. This device is a physical stimulator, not an AI/machine learning algorithm requiring a "training set" in the conventional sense.

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

   • Not applicable. As a non-AI physical medical device, there is no "training set" or corresponding ground truth establishment process in the context of machine learning. The device's design and manufacturing are based on established engineering principles and prior validated devices.

Ask a specific question about this device

The Pantheon Research Electrostimulator 4c.Pro, 8c.Pro, 12c.Pro, & 9c3i are for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

The Pantheon Research Pro Series electro-acupuncture stimulators are electrical stimulators that introduce calibrated and controlled electrical impulses into acupuncture needles inserted into patients for therapeutic purposes. These devices are built in 5 models: the 4c.Pro. 6c.Pro. 12c.Pro. and 9c3i models. The Pantheon electro-acupuncture stimulator series does not come equipped with acupuncture needles. The practitioners should select 510(k) cleared needles

This document is a 510(k) Pre-market Notification for the Pantheon Electrostimulator Models 4c.Pro, 6c.Pro, 8c.Pro, 12c.Pro, and 9c3i. It aims to demonstrate substantial equivalence to a predicate device.

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

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

The document does not explicitly state "acceptance criteria" for performance metrics in a numerical or target-based format. Instead, it demonstrates performance by comparing technical characteristics to the predicate device and by complying with relevant safety and EMC standards. The implicit acceptance criteria are that the device's technical characteristics are comparable or safer than the predicate, and that it passes the specified electrical safety, EMC, and biocompatibility tests.

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 describes non-clinical testing for electrical safety, EMC, and biocompatibility. These types of tests typically use a sample of the manufactured device itself and do not involve patient data or study subjects in the way a clinical trial would. Therefore, there is no mention of a "test set" in the context of patient data, nor its provenance, as this submission is for an electro-acupuncture stimulator supported by technical and safety standards rather than a disease-detection or diagnostic device.

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 section is not applicable as the submission relies on technical and safety standard compliance, and a comparison of technical characteristics to a predicate device, rather than a clinical study with a "test set" requiring expert-established ground truth.

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

This section is not applicable for the same reasons as #3.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an electro-acupuncture stimulator, not an AI-powered diagnostic or assistive device for "human readers."

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

This section is not applicable. The device is an electro-acupuncture stimulator, and it does not contain an "algorithm" in the sense of a decision-making or diagnostic AI algorithm. Its performance is evaluated based on its electrical output characteristics and safety compliance, not a standalone algorithm's accuracy.

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

The "ground truth" for this device's performance relies on compliance with established international electrical safety and electromagnetic compatibility (EMC) standards, and biocompatibility standards (ISO 10993-1). Additionally, the technical specifications (voltage, current, frequency, pulse width, etc.) are compared to those of a legally marketed predicate device to demonstrate substantial equivalence. No patient-specific outcomes data, pathology, or expert consensus on clinical findings are mentioned as ground truth for this type of device submission.

8. The sample size for the training set

This section is not applicable as this device does not involve machine learning or AI that would require a "training set."

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

This section is not applicable for the same reasons as #8.

Ask a specific question about this device

The EAD is an electro acupuncture device for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

The EAD system is a battery-operated, single-use device that has a preprogrammed frequency, pulse and duration for the stimulation of auricular point nerve stimulation for pain. The device power supply connects via four (4) stainless steel wires, sheathed in a plastic over-molding, to three (3) needle arrays comprised of four (4) needles each and one (1) needle array comprised of only 1 needle.

The device is powered by one 3 Volt lithium ion battery.

The device modulates a duty cycle between 2 hours on and 2 hours at rest. The maximum performance time frame is 5 days or 120 hours (5 days X 24 hours). Weight is 4 grams including batteries. The power supply dimensions are 36 mm x 17 mm x 7 mm. The needle dimensions are 0.5 mm width x 2 mm length.

The provided document is a 510(k) Summary for a medical device called the "Electro Auricular Device" (EAD). This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a predicate device already legally marketed. As such, it focuses on comparing the new device to existing ones rather than presenting a detailed clinical study demonstrating the device's performance against specific acceptance criteria in the way a clinical trial might for a novel device.

Therefore, much of the requested information about acceptance criteria and studies that prove the device meets them, especially regarding clinical performance, is not present in this type of regulatory submission. The document primarily focuses on non-clinical aspects to establish substantial equivalence.

Here's a breakdown of what can be extracted and what is not available from the provided text, based on your request:

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

This information is not provided in the document in the format requested. The document emphasizes substantial equivalence to predicate devices rather than meeting specific performance acceptance criteria for a novel clinical claim. The "Performance" row in the comparison table on page 6 describes operational characteristics (e.g., "2 hours on/2 hours off; pulses with modulating frequency (1 to 10 Hz)"), but these are not presented as acceptance criteria against which a study directly measured clinical performance.

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

This information is not provided. The document describes non-clinical testing (biocompatibility, electrical safety, EMC, software verification, sterilization, shelf life), but these do not typically involve patient "test sets" or data provenance in the way clinical studies do. No clinical performance testing with human subjects is mentioned.

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 provided. As no clinical test set for performance is mentioned, there is no discussion of experts establishing ground truth for such a set.

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

This information is not provided. As no clinical test set for performance is mentioned, there is no adjudication method described.

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 information is not provided. MRMC studies are typically used for imaging or diagnostic devices where human readers interpret results, often with AI assistance. The EAD is an electro-acupuncture device, and the document describes no such study.

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

This information is not provided. The EAD does not appear to be an algorithmic diagnostic device, but rather a therapeutic device, so standalone performance in the context of an algorithm is not applicable or discussed. The software verification and validation are for the device's operational control, not for a diagnostic algorithm.

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

This information is not provided. Similarly to question 3, there is no mention of ground truth as it pertains to clinical performance outcomes.

8. The sample size for the training set

This information is not provided. The device is an electro-acupuncture stimulator, not an AI/ML-based diagnostic device that typically employs training sets for machine learning models. The software mentioned is for device control, not for learning from data.

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

This information is not provided. As there is no mention of a training set, there's no discussion of how ground truth for it would be established.

Summary of available information related to performance and testing from the document:

While the document does not present clinical acceptance criteria or studies in the traditional sense, it outlines non-clinical performance data to support the device's safety and substantial equivalence to predicate devices:

• Biocompatibility Testing:
  • Acceptance Criteria/Goal: To show the EAD adhesive is safe for tissue contact and that other patient-contacting materials are unchanged from the predicate.
  • Study/Testing Done: Conducted in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1. Included tests for Cytotoxicity, Sensitization, and Irritation.
  • Reported Performance: The adhesive is considered tissue contacting for less than 30 days. The other patient-contacting materials are unchanged from the P-Stim predicate device.
• Electrical Safety and Electromagnetic Compatibility (EMC) Testing:
  • Acceptance Criteria/Goal: Compliance with recognized international standards for safety and EMC.
  • Study/Testing Done: Testing conducted on the EAD device.
  • Reported Performance: The system complies with IEC 60601-1 and IEC 60601-2-10 (safety) and IEC 60601-1-2 (EMC).
• Software Verification and Validation Testing:
  • Acceptance Criteria/Goal: To ensure the software functions as intended and does not pose a significant risk.
  • Study/Testing Done: Testing conducted and documentation provided as recommended by FDA guidance.
  • Reported Performance: Software considered a "minor" level of concern, as failure would not directly result in serious injury or death.
• Sterility/Shelf Life:
  • Acceptance Criteria/Goal: To demonstrate the device can be sterilized and maintain its integrity and performance over time.
  • Study/Testing Done: Sterilization Validation using VDMAX25 method (ISO 11137-2 and ISO 11737-2). Packaging validation (ISO 11607-1), Accelerated aging (ASTM F1980-07), and machine qualifications for sealing (ISO 11607-2).
  • Reported Performance: Validation conducted according to specified standards.

Conclusion stated in the document: "The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that the EAD device should perform as well as the predicate device in the specified use conditions." This highlights that the "performance" shown is largely about safety, functionality, and equivalence to existing devices, not a direct clinical efficacy study.

Ask a specific question about this device

P-Stim is an electro-acupuncture device for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

P-Stim is an electro-acupuncture device

I am sorry, but the provided document does not contain information on acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for the P-Stim System, an electro-acupuncture device. It states that the device is substantially equivalent to legally marketed predicate devices and outlines general controls and regulations.

The document includes:

• The device name: P-Stim System
• Regulation Name: Electro-Acupuncture Stimulator
• Regulatory Class: Unclassified
• Product Code: BWK
• Indications for Use: "P-Stim is an electro-acupuncture device for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states."
• Type of Use: Prescription Use

However, there is no mention of specific acceptance criteria (e.g., performance metrics, thresholds) or any study details such as sample sizes, ground truth establishment, expert qualifications, or adjudication methods for demonstrating performance against such criteria. The letter confirms clearance based on substantial equivalence, not on the presentation of a performance study with detailed acceptance criteria.

Ask a specific question about this device