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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.

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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.

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The BW685/BW685 S blood / fluid warming system is intended to deliver warm blood, blood products, and liquids to adult and pediatric patients.

The BW685 and BW685S are blood and infusion fluid warmers designed to reduce complications associated with the infusion of blood or other liquids. They warm the fluid by means of an aluminum heat exchanger which is adjacent to an I.V. extension set through which the liquid to be heated flows. The electrically powered heat exchanger has a spiral groove through which the I.V. extension set is wrapped. There is no direct contact between the heat exchanger and infusate, the infusate only contacts the I.V. extension set. The BW685 and BW685S operate on 120 VAC and are controlled by an on-off switch on the plastic face of the instrument. Above the on-off switch is an LED indicator which indicates the temperature setting as well as the measured temperature. The set temperature is selectable in increments of 0.5° C between 37 and 41°C. The default temperature is 38.5° C. The infusate is warmed to approximately the set temperature as it travels a path around the constantly monitored and regulated heat exchanger. The temperature is measured at the end of the extension set, where it leaves the spiral groove. The BW685 / BW685 S weigh 1.9 and 2.0 kg respectively and are equipped with a dual knob clamp at the back of the devices for attachment to an I.V. pole; the devices may also be clamped to a bedrail. The BW685 and BW685S are identical except that the BW685 S has provision and additional circuitry for connection to an additional heating element that can be placed nearer the patient. The additional heating element is called the TubeFlow and fits over the I.V. line to the patient. The TubeFlow is electrically powered from the BW685S and contains a display indicative of the heating status (green for heating) or over-temperature (red). The TubeFlow does not contain software.

The provided document is a 510(k) summary for the Biegler GinbH BW685/S fluid warmer, a medical device. It does not describe a study involving an algorithm or AI, nor does it present acceptance criteria and performance data in the context of such a study.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Biegler BW385L K954769) to gain market clearance. The "acceptance criteria" discussed are largely related to direct comparisons of device specifications and functional properties to the predicate device, or adherence to general safety standards.

Therefore, I cannot extract the requested information concerning a device performance study, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these are not relevant to this type of regulatory submission for this particular device.

Here's an analysis of the "acceptance criteria" and "performance" as presented in this 510(k) summary, reframed to align with the provided content:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a comparison to a predicate device to establish substantial equivalence. The "acceptance criteria" in this context are effectively the specifications and operational characteristics of the predicate device, which the new device aims to meet or exceed without raising new questions of safety or effectiveness.

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 in the 510(k) summary. The document mentions "Heater testing at various flow rates" and "Fault testing" but does not detail the sample sizes, test conditions (e.g., number of units tested, duration), or data provenance. The tests performed are listed as:

• Leakage testing
• Heater testing at various flow rates
• Fault testing
• Testing to the requirements of ASTM F2172-02 Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers

These tests are typically performed on a limited number of manufactured units in a controlled lab environment.

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 and not provided. This device is a fluid warmer, not a diagnostic imaging device or an AI algorithm that requires expert interpretation for a "ground truth" reference. The "ground truth" for a fluid warmer would be objective measurements of temperature, flow rates, and safety parameters, typically collected by engineers or technicians.

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

This information is not applicable and not provided. As explained above, there's no diagnostic or interpretive task that would require 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

This information is not applicable and not provided. An MRMC study is relevant for AI-powered diagnostic tools or decision support systems. The BW685/S is a physical medical device (fluid warmer), not an AI system, and therefore, an MRMC study is not relevant to its regulatory submission.

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

This information is not applicable and not provided. The BW685/S is a physical medical device; it does not contain a standalone algorithm in the context of an AI-powered diagnostic or therapeutic system.

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

The implied "ground truth" for this device would be:

• Objective physical measurements: Accurate temperature readings (e.g., from calibrated thermometers), confirmed flow rates, electrical safety measurements, and leak detection.
• Compliance with standards: Adherence to established performance and safety standards like ASTM F2172-02.

There is no "expert consensus," "pathology," or "outcomes data" ground truth referenced, as these are typically associated with diagnostic or therapeutic efficacy studies, not the functional performance of a fluid warmer.

8. The sample size for the training set

This information is not applicable and not provided. A training set is used for machine learning models. This document describes a physical medical device.

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

This information is not applicable and not provided. As above, there is no training set for this device.

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