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

Transcutaneous Electrical Nerve Stimulator (Model:TENS WMPS2-1) can be used for the symptomatic relief of chronic intractable pain, post traumatic pain adjunctive treatment, and post-surgical pain adjunctive treatment.

Transcutaneous Electrical Nerve Stimulator sends gentle electrical current to underlying nerves and muscle groups via electrodes applied onto the skin to relieve pain. The device has 16 programs (12 standard programs and 4 editable programs). It is a lithium battery-powered device comprising the electronic stimulatory module, the accessories of lead wires, the electrodes and the adapter. Two outlet sockets are used to connect skin electrodes by lead wires. The accessories of electrodes are 510(k) cleared devices (K192568). Size 50*50mm.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document describes the acceptance criteria in terms of compliance with various international standards for medical electrical equipment and a comparison to a predicate device. The reported performance is implicitly stated by asserting compliance with these standards and the substantial equivalence to the predicate.

Ask a specific question about this device

The Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) 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, the TENS WMPS6-1 is indicated for use for symptomatic relief of chronic intractable pain and adjunctive treatment in the management of post-surgical and post traumatic pain.

Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) 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. The device has 18 programs (13 standard programs and 5 editable programs), powered by 6 pieces of 1.5V batteries or AC 100-240V, comprising electronic stimulatory module and accessories of lead wires, electrodes. Six outlet sockets are used to connect skin electrodes by lead wires. The accessories of electrodes is 510(k) cleared device (K192568), Size: 50*50mm.

The provided text is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulator (TENS) device. It details the device's technical specifications and a comparison to a predicate device to establish substantial equivalence for regulatory clearance. This document does not describe an AI-powered medical device or an associated study for complex acceptance criteria like those involving AI performance metrics (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by experts).

Therefore, I cannot extract the requested information regarding AI device acceptance criteria and study details from the provided text. The device is a physical medical device (TENS) and the "study" referred to in the document is a series of non-clinical bench tests to compare it to a predicate device, and to verify safety and performance standards.

Here's a breakdown of why I cannot fulfill your request based on the provided text:

• No AI Component: The device is a Transcutaneous Electrical Nerve Stimulator, a physical product that applies electrical current. There is no mention of any AI or machine learning component.
• No Diagnostic/Interpretive Task: The device is for pain relief, not for image analysis, diagnosis, risk prediction, or any other task that would typically involve acceptance criteria like sensitivity, specificity, or the need for ground truth established by experts.
• No Human-in-the-Loop Study: Since there's no AI component, there's no MRMC (Multi-Reader Multi-Case) study described for human readers improving with AI assistance.
• No Standalone Algorithm Performance: There is no algorithm to assess in a standalone capacity.
• No Training Set/Test Set (in the AI context): The concepts of training and test sets as they apply to machine learning models are not relevant to the clearance of this physical device. The "test set" here refers to the device itself undergoing bench tests.
• No Ground Truth Establishment by Experts: Ground truth for AI models is often established by expert consensus (e.g., radiologists reviewing images). For this TENS device, "ground truth" would refer to its physical and electrical properties meeting specified standards, validated through engineering tests, not human interpretation.

Summary of what the document DOES describe in terms of performance and comparison:

The document describes acceptance criteria in the context of substantial equivalence to an existing predicate device and compliance with voluntary standards for electrical medical equipment.

• Acceptance Criteria (Implicit via Comparison to Predicate and Standards Compliance): The acceptance criteria are primarily demonstrated by showing that the new device's specifications (e.g., power source, output channels, waveform, voltage, current, safety features) are either identical, similar with acceptable differences (justified by safety and effectiveness analyses), or meet the requirements of relevant electrical safety and performance standards (ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-10). The reported device performance is presented as compliance with these standards and the specific electrical output values listed in the comparison table.

• Study That "Proves" Compliance: The "study" here is a series of non-clinical bench tests.

  • Sample Size: This is not a study with a "sample size" in the statistical sense of patient data. It refers to testing the physical device itself.
  • Data Provenance: Not applicable as it's not a data-driven AI study. The tests are bench tests performed on the device.
  • Experts and Ground Truth: Not applicable in the way you've defined them for an AI study. Electrical engineers and regulatory compliance experts would be involved in setting and verifying the test standards.
  • Adjudication Method: Not applicable.
  • MRMC Comparative Effectiveness Study: No.
  • Standalone Performance: The "standalone" performance here refers to the device successfully passing all required electrical and safety tests independently (i.e., not reliant on human interpretation for its function).
  • Type of Ground Truth: The "ground truth" is compliance with established engineering and medical device safety standards for TENS devices (e.g., maximum current density limits, electrical isolation, waveform characteristics).
  • Training Set/Ground Truth for Training: Not applicable.

If you have a document describing an AI medical device, please provide that, and I will be able to answer your questions with the level of detail you are seeking.

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 Transcutaneous Electrical Nerve Stimulator 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 of post surgical and post traumatic pain.

Transcutaneous Electrical Nerve Stimulator 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. The device has standard programs and edit programs. It is a battery-powered portable device, comprising electronic stimulatory module and accessories of lead wires, electrodes and battery. Two outlet sockets are used to connect skin electrodes by lead wires. The accessories of electrodes is 510(k) cleared device (K192568), Size: 50*50mm.

This document is a 510(k) Premarket Notification for a Transcutaneous Electrical Nerve Stimulator (TENS) device. The purpose of this submission is to demonstrate that the new device, "TENStem eco basic," is substantially equivalent to a legally marketed predicate device (K112288), also a TENS device manufactured by the same company, Wuxi Jiajian Medical Instrument Co., Ltd.

Here's an analysis of the provided information regarding acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the parameters of the predicate device (K112288) and the relevant IEC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10). The reported device performance is presented as a comparison between the proposed device ("Modified Device") and the predicate device in the "Substantially Equivalent Comparison Conclusion" table.

Ask a specific question about this device

The Self-adhesive electrode is intended to be used to transmit electrical stimulation current to the patient's skin. Example electrical stimulations for current applications of the electrodes are: TENS and EMS.

The Self-adhesive electrode, lead wire type and snap button type, are non-sterile flexible structures, composed of materials commonly used in this application: First layer: Non-woven fabric tape Second layer: Polyurethane (PU) electrically conductive carbon cloth (Hebei Kangshengda Electronic Technology Co., Ltd) Third layer: Biocompatible conductive hydrogel coupling media (ValueTrode Carbon, K970426), which has passed the required skin sensitivity testing criteria as specified in ISO 10993-10 and cytotoxicity testing criteria as specified 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 nine shapes of round, rectangle, elliptical, calabash, butterfly, saddle shape, rhombus, meniscus shape and palm shape. For the electrical connection, Jiajian provides lead wire type and snap button type: Lead wire assembly - at least 40mm long wire with 2mm/2.5mm diameter female socket. Snap button assembly - with 2.5~5mm diameter male socket. The lead wire assembly is in compliance with the requirements of FDA performance standard 21 CFR part 898 by testing under ANSI/AAMI ES60601-1, subclause 8.5.2.3.

The provided document is a 510(k) summary for the Jiajian Self-Adhesive Electrode, which is a medical device. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance criteria through clinical studies in the same way a PMA (Premarket Approval) would require.

Therefore, many of the requested points, particularly those related to clinical studies, MRMC studies, training set details, or complex ground truth establishment, are not applicable to this type of regulatory submission (a 510(k)). The manufacturer's conclusion explicitly states: "Clinical data was not including in this submission."

Instead, the submission relies on bench testing and a comparison to an existing predicate device to demonstrate substantial equivalence, focusing on technical specifications, materials, and non-clinical performance.

Here's an analysis based on the available information:

1. Acceptance Criteria and Reported Device Performance (as demonstrated by testing and comparison):

The document doesn't present a formal table of "acceptance criteria" paired with "reported performance" in the way one might expect from a clinical study. Instead, it outlines the tests performed to show the device's adherence to relevant standards and its substantial equivalence to a predicate device. The implicit acceptance criterion is that the device performs as well as or similarly to the predicate device across key parameters and meets relevant safety standards.

Here's a table summarizing the relevant data points and how they compare to the predicate, as presented in the "Substantially Equivalent Comparison Conclusion" table:

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

• Test Set Sample Size: For the bench tests (e.g., impedance, conformability, fluid tolerance, peel strength, shelf life, reuse), the document states: "All test samples were drawn from batches, with 3 samples for each specification."
• Data Provenance: The tests were conducted internally by Wuxi Jiajian Medical Instrument Co., Ltd. in China, as indicated by the submitter/manufacturer address. The data is retrospective, as it's part of a premarket submission.

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

• This is Not Applicable (N/A). For a 510(k) submission based on bench testing and substantial equivalence, "ground truth" established by human experts (like radiologists for image analysis) is not relevant. Performance is measured against engineering specifications and industry standards.

4. Adjudication method for the test set:

• N/A. As there are no human experts establishing a "ground truth" for a medical imaging/AI dataset, no adjudication method is performed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• N/A. The document states "Clinical data was not including in this submission." MRMC studies apply to performance of diagnostic devices often involving human interpretation of results, which is not the case for this external electrode.

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

• N/A. This device is a passive electrode, not an algorithm or AI. Standalone performance refers to the accuracy of an AI algorithm.

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" or reference was based on engineering specifications, established industry standards (e.g., AAMI/ANSI ES 60601-1, IEC 60601-2-2), and the performance characteristics of the legally marketed predicate device (K090198). Essentially, the device's performance was compared against these defined benchmarks.

8. The sample size for the training set:

• N/A. This is not an AI/ML device requiring a training set.

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

• N/A. This is not an AI/ML device requiring a training set or its associated ground truth establishment.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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 (

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)

Ask a specific question about this device

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.

Ask a specific question about this device