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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.

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The Jiajian® Pointoselect Digital is intended for use in the symptomatic relief of chronic intractable pain, postoperative pain, and acute pain.

Jiajian® Pointoselect Digital is a newly designed and easy to operate hand held stimulator. It is 9V battery powered device, with an LCD in the console. which can display the selected operation mode, intensity, frequency, pulse width, and battery level of the device, and so on. The device composes of a console, a hand held probe, a hand grip electrode, and lead wires. The hand probe can be used for treatment at individual sites. When using the hand probe, the patient must hold the hand grip electrode in order to electrically ground the device.

The provided text does not describe a study that proves the device meets specific acceptance criteria in the context of clinical performance or diagnostic accuracy. Instead, it details a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device, the Jiajian® Pointoselect Digital, focusing on its substantial equivalence to a predicate device (Pointer Excel) based on technical characteristics and compliance with safety and biocompatibility standards.

Therefore, many of the requested categories (sample size, data provenance, ground truth, experts, adjudication, MRMC studies, standalone performance, training set) are not applicable or cannot be extracted from this document, as they relate to clinical studies or performance evaluations that are not present.

However, I can extract the acceptance criteria related to technical specifications and safety standards compliance and the reported performance based on the substantial equivalence discussion and safety and effectiveness section.

Here's the information that can be extracted based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" here are defined by the comparison to the predicate device and compliance with established safety/biocompatibility standards.

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

• Sample Size: Not applicable. The document describes a comparison of technical specifications and compliance with standards, not a clinical trial or performance study involving patient data.
• Data Provenance: Not applicable, as no human subject data (retrospective or prospective) is discussed. The device is manufactured in Wuxi, Jiangsu, China.

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

• Not applicable. There is no mention of "ground truth" established by experts in the context of clinical performance or diagnostic accuracy. The assessment is based on engineering specifications and adherence to standards.

4. Adjudication method for the test set

• Not applicable. No adjudication method is described as there is no clinical test set requiring it.

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.

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

• Not applicable. This is a physical medical device (TENS) for pain relief, not an algorithm or AI system.

7. The type of ground truth used

• Not applicable. The document assesses the device against technical specifications and safety/biocompatibility standards, not against a "ground truth" derived from clinical outcomes or expert consensus.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable. No training set is involved.

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Jiajian® CMN 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.

Jiajian® CMN Stimulator is an electro-acupuncture device for acupuncture therapy, powered by 6 pieces of 1.5V batteries. It is composed of 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 Wave choosing knob, Frequency adjust knob, Intensity adjust knobs, and Timer. Jiajian® CMN Stimulator does not equip with acupuncture needles. The practitioners should select 510(k) cleared needles (with minimum diameter of 0.30mm and insertion depth of 15mm) for use.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Jiajian® CMN Stimulator:

Overview:
The document provided is a 510(k) Summary for the Jiajian® CMN Stimulator, an electro-acupuncture device. The submission primarily focuses on demonstrating substantial equivalence to a predicate device (ES-130, K081943) by comparing technical characteristics and compliance with recognized safety standards. The document does not describe a clinical study for performance or effectiveness in the way an AI/ML device submission would. Instead, the "study" demonstrating it meets acceptance criteria refers to technical testing against safety standards and a comparison of its electrical output parameters to those of the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for an electro-acupuncture stimulator, the "acceptance criteria" are primarily established by compliance with recognized electrical safety and EMC standards, and by demonstrating that its operational parameters are either within established safe limits or are substantially equivalent to a legally marketed predicate device without raising new safety or effectiveness concerns.

Note on "Acceptance Criteria" for this device: For this type of electro-acupuncture stimulator pursuing 510(k) clearance, acceptance criteria are generally met by (1) demonstrating compliance with recognized safety standards (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2) and (2) showing that differences in technical specifications from the predicate device do not raise new questions of safety or effectiveness. There isn't a "performance" criterion in the sense of a clinical outcome effectiveness measure for these devices in a 510(k) context.

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

• Sample Size for Test Set: Not applicable in the context of clinical trial/performance data. The "test set" here refers to the device itself being subjected to electrical and mechanical testing for safety standards compliance. There is no mention of human subject data or a test set of data points derived from patients.
• Data Provenance: The 'data' proving compliance comes from internal testing by the manufacturer (Wuxi Jiajian Medical Instrument Co., Ltd), likely performed in China, against the specified international standards. This is not derived from patient studies, retrospective or prospective.

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

Not applicable. There is no "ground truth" established by experts in the context of a clinical test set for this 510(k) submission. The evaluation is technical and regulatory, centered on compliance with engineering standards and comparison to a predicate device.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication process described for the technical testing of the device for safety standards.

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

No. An MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic imaging devices or devices where human interpretation/performance is augmented by AI. This device is a therapeutic stimulator, and its clearance relies on technical safety and equivalence to an existing device, not a comparison of human interpretation.

6. Standalone (Algorithm Only) Performance Study

No. This is not an AI/ML device, so a standalone algorithm performance study is not applicable. The "standalone" performance here would refer to the device operating according to its technical specifications.

7. Type of Ground Truth Used

The "ground truth" for this submission are the established international safety standards (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2) and the technical specifications of the cleared predicate device (ES-130, K081943). The device's performance is compared against these benchmarks to establish substantial equivalence.

8. Sample Size for the Training Set

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

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

Not applicable. There is no AI/ML training set.

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Jiajian® Electro-acupuncture Stimulator, Model WQ-10D1 and WQ-6F are electro-acupuncture stimulator devices, which are indicated for use in the practice of acupuncture by qualified practitioners of acupuncture as determined by the states.

Jiajian® Electro-acupuncture Stimulator, Model WQ-10D1, is a battery powered instrument with 3 channel outputs for acupuncture needle stimulation. The predicate device is ES-130, K081943. The output frequency and intensity for stimulation are adjustable. The stimulation time can be set. The 3 channels can output stimulation simultaneously. The device is powered by DC 9V battery, Type 6F22. When the battery has insufficient voltage (<8.5V), the light goes out. The user should replace battery. WQ-10D1 does not equip with acupuncture needles. The practitioners should select 510(k) cleared needles (with minimum diameter of 0.30mm and insertion depth of 15mm) for use. Jiajian® Electro-acupuncture Stimulator, Model WQ-6F, is an electro-acupuncture device, composed of a main unit and seven separate lead wires which represent 7 output channels. 4 output channels are grouped in Section A and 3 output channels are grouped in Section B. Section A and B have separate intensity and frequency adjusting knobs. The 4 channels in Section A can output waveforms simultaneously, and the 3 channels in Section B can output waveforms simultaneously but Section A and Section B can not output waveforms simultaneously. The main unit is powered by DC4.5V battery (three No 1 battery, Size "D"). When the battery has insufficient voltage (<4.1V), the light goes out. The user should replace battery. WQ-6F does not equip with acupuncture needles. The practitioners should select 510(k) cleared needles (with minimum diameter of 0.30mm and insertion depth of 15mm) for use. The predicate device of WQ-6F is ES-130, K081943.

The provided document describes the Wuxi Jiajian Medical Instrument Co., Ltd.'s Electro-acupuncture Stimulators (Model WQ-10D1 and WQ-6F) and its 510(k) summary for substantial equivalence to a predicate device. This submission focuses on comparing the new device's technical specifications and safety standards to those of the predicate device, not on clinical performance or specific acceptance criteria met through clinical studies with human subjects.

Therefore, many of the requested categories related to clinical study design (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set) are not applicable to this type of regulatory submission, which primarily relies on engineering performance testing and comparison to a legally marketed predicate device.

However, the document does list product specifications and safety standard compliance, which could be considered criteria for acceptance in a technical and regulatory context.

Here's the information that can be extracted from the provided text according to your request categories:

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

Since this is a 510(k) submission for substantial equivalence based on technical characteristics and safety standards, the "acceptance criteria" are generally that the new device's parameters and safety performance are equivalent to or within the acceptable limits established by the predicate device and relevant standards. The "reported device performance" refers to the new device's measured specifications. The tables below synthesize this information for key parameters, highlighting where differences exist and how they are addressed in the substantial equivalence discussion.

Jiajian® Electro-acupuncture Stimulator, Model WQ-10D1 vs. Predicate Device ES-130 (K081943)

Jiajian® Electro-acupuncture Stimulator, Model WQ-6F vs. Predicate Device ES-130 (K081943)

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 document. The submission is based on engineering and performance testing against safety standards, not a clinical trial with a test set of patients or medical images. The device was manufactured in China.

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 there was no test set requiring expert ground truth in the context of a clinical study. The "ground truth" for this submission are the established safety standards (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2) and the technical specifications of the predicate device.

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

This information is not provided as there was no clinical test set requiring 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

An MRMC comparative effectiveness study was not done. This device is an electro-acupuncture stimulator, not an AI-assisted diagnostic or treatment planning system.

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

This information is not applicable. This is a physical medical device, not a software algorithm.

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

The "ground truth" for this submission consists of:

• Compliance with international safety standards: IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2.
• The technical specifications and established safety profile of the predicate device, ES-130 (K081943).
• Regulatory guidance from the FDA regarding safety limits.

8. The sample size for the training set

This information is not applicable as there was no training set in the context of machine learning or clinical trials.

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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Jiajian® TENS is an electrical nerve stimulator indicated for use for pain relief by applying an electrical current to electrodes on a patient's skin to treat pain. In particular, this device is indicated for use for symptomatic relief of chronic intractable pain and adjunctive treatment in the management of post surgical and post traumatic pain.

Jiajian® TENS, is Transcutaneous Electrical Nerve Stimulator for pain relief. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. It is a battery-powered portable device, comprising electronic stimulatory module and accessories of lead wires and 9 volt type 6F22 battery. When using this device, the physician should select and use 510(k) cleared electrodes. The area of electrodes must be larger than 8cm2. The electronic stimulatory module has the operating elements of (1) Display screen, 2 Menu keys, 3 Modification keys, 4 On/Off key, 5 Battery compartment and (6) Outlet socket. The display screen can show (a) battery power, (b) selected program, (c) lasting time or left time of a program, (d) current intensity for each channel, (e) program phase and (f) locking state. The menu key "P" is for selecting standard program or user-program, and for locking; the menu key "E" is for editing program when the device is not being locked. The modification key "3A" and "3B" are for intensity level adjustment during stimulation. The outlet socket is used to connect skin electrodes by lead wires. The device has 12 selectable programs, which can be grouped into 4 output modes, i.e. Normal mode (P1, P2, P3, P4, P5, P6), Burst mode (P7, P12), Rate & width modulation (P8), and Intensity modulation (P9, P10, P11).

The provided document is a 510(k) summary for the Jiajian® TENS device and primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study of the device's performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not available in the provided text.

However, based on the information provided, here's what can be extracted and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in terms of clinical performance metrics (e.g., pain reduction scores, patient satisfaction). Instead, it focuses on demonstrating technical equivalence and compliance with safety standards as a basis for being "substantially equivalent" to a predicate device.

The table below summarizes the comparison of technical specifications between the new device and the predicate device. While not acceptance criteria in the sense of clinical study endpoints, these indicate the technical specifications that the new device meets and how they compare to the predicate.

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

• Not applicable. This document is a 510(k) submission for a TENS device, which typically relies on demonstrating substantial equivalence to a predicate device through technical and safety comparisons, rather than a clinical trial with a "test set" of patient data. The safety testing mentioned (IEC standards) would involve hardware testing, not human subjects.

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

• Not applicable. As above, no clinical "test set" with ground truth established by experts is described in this document.

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

• Not applicable. No clinical "test set" or adjudication method is 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

• Not applicable. This device is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, not an AI-assisted diagnostic or imaging interpretation tool. Therefore, an MRMC comparative effectiveness study involving human "readers" and AI assistance is entirely irrelevant to this device type.

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

• Not applicable. This device is a physical TENS unit, not an algorithm. Its "performance" is measured by its electrical output characteristics and compliance with safety standards, not by an algorithm's classification accuracy.

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

• Not applicable. Since this is a TENS device and the submission focuses on substantial equivalence and safety standards, the "ground truth" relates to compliance with engineering and electrical safety specifications defined by standards like IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-10. This is verified through objective testing against these standards, not against clinical expert consensus or pathology.

8. The sample size for the training set

• Not applicable. There is no "training set" for this device as it does not involve machine learning or AI models.

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

• Not applicable. As there is no training set, there is no ground truth for it.

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Jiajian Acupuncture Needle is intended to piece the skin in the practice of acupuncture therapy by qualified practitioners or acupuncture doctors as determined by the states.

Jiajian brand Acupuncture Needle consists of a stainless steel wire (ASTM 304) as the needle body, with a stainless steel wire handle, a copper wire handle or polystyrol handle. The handles make the needles easier to manipulate and place. The acupuncture needle is sterilized and disposable. The diameter of the needle is 0.140.80mm; the length of the needle is 7100mm; the invasive length is 2~47mm.

The provided text is a 510(k) Premarket Notification Summary for the Jiajian Acupuncture Needle. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than robust clinical studies with acceptance criteria and statistical analysis typical of software or AI/ML medical devices. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics is not present.

Here's an analysis based on the available information:

1. Table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or detailed performance metrics. The primary "performance" demonstrated is the substantial equivalence to predicate devices. This means the device is considered as safe and effective as the predicate devices.

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

No test set for performance evaluation in the typical sense (e.g., a dataset of images for an AI model) is described. The device is a physical acupuncture needle.

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

Not applicable, as no such test set or ground truth determination process is described for this physical medical device.

4. Adjudication method 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. This is not an AI/ML device, and no MRMC study was conducted.

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

Not applicable. The "ground truth" for this submission is establishing that the device's design, materials, and intended use are similar enough to existing legally marketed devices.

8. The sample size for the training set

Not applicable, as this is a physical device and not an AI/ML model requiring a training set.

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

Not applicable.

Summary of Device and Substantial Equivalence Information (from the provided text):

The Jiajian Acupuncture Needle is a single-use acupuncture needle made of stainless steel wire with various handle options. It is sterilized by Co-60 irradiation and intended for use by qualified practitioners for acupuncture therapy.

The manufacturer claims substantial equivalence to two predicate devices:

• DN Acupuncture Needles (K983800)
• Singer Acupuncture Needles (K974616)

Similarities claimed between the Jiajian Acupuncture Needle and predicate devices:

1. Similar materials composition and structure.
2. Same intended use.
3. All are sterile.
4. All are used as prescription.

Differences:

1. Different sizes scale (This difference was not deemed significant enough to preclude substantial equivalence).

The FDA concurred with the substantial equivalence determination.

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The self-adhesive electrode is intended to be used to apply electrical stimulation current to the patient's skin. Example electrical stimulations for current applications of the electrodes are: TENS (Transcutaneous Electrical Nerve Stimulation) EMS (Electrical Muscular Stimulation)

Jiajian branded Self-adhesive Electrodes, wire type, are non-sterile flexible structures, composed of materials commonly used in this application: First layer: Nonwoven fabric tape Second layer. Electrically conductive carbon cloth (ValueTrode® Carbon, K970426) Third layer: Biocompatible conductive hydrogel coupling media (ValueTrode GEL, K970426), which has passed the required skin sensitivity testing criteria as specified in ISO 10993-10 and cytotoxicity testing criteria as specifeid in ISO ISO 10993-5. The electrodes are designed for single patient / multiple application use. It can be used for low-frequency or medium-frequency nerve or muscle stimulators, as the conduction film adhered to body skin. There are six shapes of round, rectangle, oval, gourd, butterfly and saddle of the electrodes. For the electrical connection, Jianjian provides wire type: Lead wire assembly - at least 40mm long wire with 2.5mm diameter female socket, connected to one side of the wire. The lead wire assembly is in compliance with the requirements of FDA performance standard 21 CFR Part 898 by testing under IEC 60601-1. subclause 56.3(c).

This document is a 510(k) Premarket Notification for the Jiajian Self-adhesive Electrode. It's a submission to the FDA to demonstrate that the device is substantially equivalent to legally marketed predicate devices, not a study reporting on specific acceptance criteria and device performance in the way a clinical trial or detailed engineering report would.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance cannot be directly extracted from this document, as this type of information is generally NOT part of a 510(k) summary for this class of device.

510(k) submissions for devices like a self-adhesive electrode typically focus on demonstrating substantial equivalence in terms of:

• Intended Use: The purpose of the device.
• Technological Characteristics: How the device works and its materials.
• Performance Data: This usually involves non-clinical bench testing (e.g., biocompatibility, electrical performance, adhesive strength) to show it meets recognized standards or performs similarly to the predicate. It does not typically involve extensive clinical trials or human-in-the-loop studies.
• Biocompatibility: Showing materials are safe for human contact.

Based on the provided text, here's what can be gathered, addressing the spirit of your request where possible, and noting what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not provide a table of quantitative acceptance criteria with corresponding performance data in the way you might expect from a detailed validation report. Instead, it relies on demonstrating compliance with recognized standards and similarity to predicate devices.

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

• Sample Size for Test Set: Not specified in this 510(k) summary. For devices of this nature, testing typically involves bench-top studies on a certain number of manufactured units rather than large clinical test sets with human subjects.
• Data Provenance: Not explicitly stated as "country of origin" for tests, but the manufacturer is Wuxi Jiajian Medical Instrument Co., Ltd in China. The testing itself is referenced against international standards (ISO, IEC) and FDA regulations. It is not specified if tests were retrospective or prospective, but typically bench testing would be considered prospective for the submission.

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

• Experts and Qualifications: Not applicable/not specified in this type of 510(k) submission. "Ground truth" in the clinical imaging or diagnostic sense is not relevant for this device. The assessment is primarily based on engineering and biocompatibility testing against established standards.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable/not specified.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

• MRMC Study: No, this type of study is not relevant or reported for a self-adhesive electrode. An MRMC study is typically for evaluating diagnostic imaging devices or AI algorithms that assist human readers in interpretation.

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

• Standalone Performance: Not applicable. This device is a passive electrode, not an algorithm.

7. The Type of Ground Truth Used:

• Ground Truth: For this device, "ground truth" equates to established international standards (ISO 10993, IEC 60601) and FDA regulations (21 CFR Part 898) for biocompatibility, electrical performance, and safety. The device's performance is measured against the requirements of these standards.

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This device is not an AI algorithm that requires a training set. The "design" or "development" of the product is distinct from machine learning training.

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

• Training Set Ground Truth Establishment: Not applicable, as there is no training set for this device.

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