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TENS: The device is intended for the temporary relief of pain associated with sore and aching muscles in the lower back, upper extremities (arms) and lower extremities (legs) due to strain from exercise and/or normal household and work activities.

NMS: The device is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.

The Applicant device, XiniWave II Model ECS322P, is a precision Class II device housed in a sturdy lightweight cabinet. The keypad controls and the circuit for the Applicant device are identical to the Predicate. For a maturing user constituency, the cabinet of the Applicant device is larger than the Predicate with a bigger white paper Liquid Crystal Display (LCD), yet the weight of the device is virtually equivalent. The Applicant device is powered by 3 x 1.5V AAA alkaline batteries. The Applicant device offers the user a choice of eight (8) pre-set Transcutaneous Electro Neuro Stimulation (TENS) programs for the temporary relief of pain (80 mA Max.) and one pre-set Neuro-Muscular Electrical Stimulation (NMES) program for muscle conditioning (90 mA Max.). In the NMES mode of operation the user is able to select work/rest stimulation with pulse rates between 2-100Hz and pulse widths between 50-450uS rate may be selected. The mode of action for the Applicant device in TENS or NMES mode is identical to the mode of action to the Predicate.

The Applicant device is supplied with skin electrodes (electrode surface minimum of 25cm -), to stimulate the patient. The skin electrodes (extant for the industry) are the same ones as supplied with the Predicate and delineated in the User's Manual. The Applicant device control unit connects directly to the skin electrode by cable and plug (extant for the industry).

Sold as a kit, the XiniWave II Model ECS322P kit consists of:

One (1) Battery Powered Stimulator (Control Unit)
One (1) set of Four (4) skin electrodes
Three (3x1.5V) AAA Batteries
One (1) User's Manual
One (1) case

This document is a 510(k) premarket notification for the XiniWave II Model ECS322P, a powered muscle stimulator for both TENS and NMES applications. It claims substantial equivalence to a predicate device, XiniWave Model XW-18 (K100441). The document primarily focuses on demonstrating that the new device is as safe and effective as the predicate despite some modifications.

Here's an analysis of the provided text with respect to acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in the sense of predefined numerical performance targets for a clinical study. Instead, the performance evaluation is based on demonstrating substantial equivalence to a predicate device. The "reported device performance" is a comparison of output parameters between the applicant device and the predicate.

Below is a table summarizing the key device characteristics and their comparison, which effectively serves as the "performance" data used to support substantial equivalence.

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

The document does not describe any "test set" in the context of a clinical study with human subjects or a formal algorithm evaluation. The performance comparison is based on comparing the technical specifications and output parameters of the new device against its predicate. This is a technical, engineering-based comparison rather than a clinical one involving patient data.

• Sample Size for Test Set: Not applicable, no human test set or algorithm evaluation based on data is described.
• Data Provenance: Not applicable, no clinical data is presented. The information is derived from technical specifications and design.

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

Not applicable. No "ground truth" establishment by experts for a test set is described, as the evaluation is based on technical specifications comparison rather than interpretation of data by experts.

4. Adjudication Method for the Test Set

Not applicable. No test set or adjudication process is described.

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

No. The document does not describe an MRMC comparative effectiveness study, nor any clinical study involving human readers or AI assistance.

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

Not applicable. This device is a hardware product, a powered muscle stimulator. It does not involve an "algorithm" in the context of image analysis, diagnostics, or other applications where standalone algorithm performance would be relevant. While it has embedded "programs," these control electrical stimulation output, not information processing or interpretation for which a standalone AI performance would be assessed.

7. The Type of Ground Truth Used

Not applicable. No clinical ground truth (e.g., pathology, outcomes data, expert consensus) is used, as the evaluation is based on engineering and performance specifications.

8. The Sample Size for the Training Set

Not applicable. No "training set" is mentioned or implied, as this is a hardware device with pre-programmed functions, not a machine learning model that requires training data.

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.

Summary of the Study:

The "study" described in this 510(k) submission is not a clinical trial or an AI/algorithm validation study. It is a technical and regulatory comparison designed to demonstrate "substantial equivalence" of the XiniWave II Model ECS322P to its predicate device, XiniWave Model XW-18.

The applicant asserts that despite some modifications (battery type, LCD size, physical dimensions, channel connector location, software program specifics, manual languages), the fundamental scientific technology and the intended use remain unchanged. The core of the evidence lies in comparing output parameters (current, pulse width, frequency, charge, power density) to show that the new device's outputs remain within clinically effective ranges and are comparable to or within acceptable variations of the predicate, and thus do not raise new questions of safety or effectiveness. The risk assessment mentioned indicates that product modifications are as safe and effective as the predicate.

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The device is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.

The Applicant device, YARLAP II, Model ECS323P, is a portable precision Class II device housed in a sturdy lightweight shock-and water-resistant cabinet with stylus. The device is battery-powered with a full color touch screen Liquid Crystal Display (LCD) and offers the user a choice of six pre-set Neuro-Muscular Electrical Stimulation (NMES) programs with four pre-set biofeedback response-based sound-enriched games. The NMES programs in the Applicant device are Work/Rest modes of operation and identical to the programs in the Predicate. The four biofeedback programs in the Applicant device are to facilitate user graduation from "muscle stimulation" to patient-initiated muscle contractions (i.e., "true exercise"). Neither the Applicant device nor the Predicate have a TENS program. Bluetooth in the Applicant device facilitates gaming and therein patientinitiated "exercise" by permitting use of a larger external Bluetooth compatible display (e.g., computer screen or television). The Bluetooth signal is out-going only. Any external Bluetooth-capable display is optional and is not supplied with the unit. The Applicant device is supplied with a vaginally inserted electrode used with the device to stimulate the muscle of the female pelvic floor (the electrode, essential technology and intended use are identical to the Predicate: K141643). The Applicant device is supplied with a biofeedback reference lead wire with a skin electrode(s). The Applicant device control unit connects directly to the vaginal electrode and reference wire by cable and plug (design extant for the industry).

This document is a 510(k) summary for a medical device called "YARLAP II, Model ECS323P", a nonimplanted electrical continence device with biofeedback. The purpose of this document is to demonstrate "substantial equivalence" of the YARLAP II device to a previously cleared predicate device, "Yarlap, Model ECS 323 (K141643)".

The document does not describe a clinical study for the YARLAP II device to explicitly prove it meets acceptance criteria with quantitative results. Instead, it argues for substantial equivalence based on the device's technical characteristics, unchanged indications for use, and a risk assessment.

Here's an breakdown of the provided information, addressing your questions where possible:

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

The document does not provide explicit "acceptance criteria" in terms of performance metrics (like sensitivity, specificity, accuracy) from a clinical study for the YARLAP II. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to the predicate device, Yarlap (K141643).

The performance data presented is a comparison of the output parameters of the YARLAP II (Applicant Device) to the predicate Yarlap (Predicate Device) for the Neuro-Muscular Electrical Stimulation (NMES) programs (programs 1-6). The "reported device performance" are these matched parameters.

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

The document does not describe a clinical test set or study with human participants for the YARLAP II alone. The "study" proving the device meets criteria is primarily a technical and risk assessment comparison to a predicate device. There is no mention of a test set sample size, country of origin, or whether any data was retrospective or prospective in a clinical sense.

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. As no clinical test set is described, there's no mention of experts determining ground truth for such a set. The risk assessment was prepared by an "independent firm" and reviewed by "independent commentators," but their specific qualifications beyond being independent are not detailed.

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

Not applicable. No clinical test set 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 an electrical stimulation device, not an AI diagnostic tool intended to assist human "readers."

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

This question is geared towards AI/software performance. While the YARLAP II has software and biofeedback, it's a physical neuromodulation device where the "human-in-the-loop" is the user. The document doesn't discuss algorithm performance in a standalone AI context. It states the biofeedback feature is an accessory that supplements the performance of the parent device (NMES programs).

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

Not applicable. For the NMES programs, the "ground truth" is that the device's electrical output parameters are identical to the predicate. For the biofeedback, the "ground truth" is that it provides a new way of using the device without changing its intended use, and its performance is defined under 21 CFR 882.5050 (which defines biofeedback devices as accessories). There's no clinical "ground truth" needed in this substantial equivalence argument for the YARLAP II modifications.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense.

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

Not applicable. As above, this is not an AI/machine learning device.

In summary:

This 510(k) notification focuses on demonstrating that the YARLAP II, Model ECS323P, is substantially equivalent to a previously cleared predicate device. The core of the "study" proving it meets acceptance criteria is a technical comparison of specifications and a risk assessment, rather than a clinical trial with performance metrics. The changes in the YARLAP II (e.g., full-color screen, Bluetooth, biofeedback) are presented as modifications that do not affect the intended use or fundamental scientific technology, and thus do not raise new questions of safety or effectiveness when compared to the established predicate. The "acceptance criteria" are effectively met by demonstrating these technical and functional equivalences, particularly the identical output parameters for the therapeutic NMES programs.

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The device is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.

The Applicant device, YARLAP, is a precision Class II device housed in a sturdy lightweight cabinet. The device is battery powered with a backlit Liquid Crystal Display (LCD) and offers the user a choice of six (6) pre-set Neuromuscular Electrical Stimulation (NMES) programs. The NMES programs are Work/Rest modes of operation. The Applicant device has no TENS programs. The Applicant device is supplied with a vaginally inserted electrode specifically designed in 2003 for the hardware, circuit and software used in device to stimulate the female pubococcvgeus (PC) muscle. The Applicant device control unit connects directly to the design-specific electrode by cable and plug (extant for the industry). Sold as a kit, the YARLAP kit consists of: One (1) Battery Powered Muscle Stimulator (Control Unit), One (1) vaginally inserted electrode specifically designed for the hardware. circuit and software used in the Control Unit to stimulate the female pubococcvgeus (PC) muscle, One (1) user's manual, One (1) case.

This document describes the Yarlap device, a non-implanted electrical continence device, comparing it to predicate devices to establish substantial equivalence for FDA 510(k) clearance. The focus is on demonstrating that Yarlap is as safe and effective as existing legally marketed devices.

Here's an analysis of the provided information concerning acceptance criteria, device performance, and the relevant study:

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

The document does not explicitly state formal acceptance criteria with numerical targets for clinical performance (e.g., a specific percentage reduction in incontinence episodes). Instead, the acceptance criteria are implicitly tied to demonstrating substantial equivalence to predicate devices. This means the Yarlap device's performance, safety profile, and technological characteristics must be comparable to already cleared devices.

The reported device performance is primarily a comparison of its technical specifications and proposed use against the predicate devices, and a usability study to support over-the-counter (OTC) use.

Here's a table summarizing the implicit acceptance criteria (based on substantial equivalence) and the reported performance:

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

• Sample Size for Usability Study (test set): The document states "racially diverse incontinent adult females unfamiliar with the device." However, a specific numerical sample size is not provided.
• Data Provenance: The country of origin and whether the study was retrospective or prospective are not specified. It can be inferred it was a prospective study, as unfamiliar users were instructed on device use and observed.

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)

• For the usability study, there is no mention of experts establishing ground truth in the traditional sense of medical diagnosis or clinical outcomes. The "ground truth" for this study was successful task completion, user understanding, and achievement of "strong tolerable pelvic floor contractions" and lack of observed hazards, which was assessed by an "observer" and "subject participants." The qualifications of the observer are not detailed.

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

• None in the context of expert adjudication for clinical ground truth. The usability study involved "the observer and subject participants" annotating possible improvements and documenting hazards. This suggests a direct observation and participant feedback method, rather than a formal expert adjudication of medical findings.

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 MRMC comparative effectiveness study was done. The Yarlap device is a therapeutic electrical stimulation device, not an AI diagnostic tool that assists human readers. Therefore, this type of study and effect size calculation is not applicable.

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

• This question is not applicable as the Yarlap device is an electrical stimulation device intended for direct human use (with a human-in-the-loop) and does not involve a standalone algorithm for diagnostic or interpretative purposes. The "standalone" performance here refers to the device itself providing the therapeutic stimulation. Its performance is characterized by its technical output parameters (current, pulse width, frequency) and its demonstrated safe and correct use by a layperson.

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

• For the usability study, the "ground truth" was related to user behavior and subjective experience: successful task completion, comprehension of instructions, appropriate intensity selection, proper storage, and the observation of "strong tolerable pelvic floor contractions" without adverse events or hazards. This is closer to process observation and participant self-reporting combined with simple physiological feedback (contractions). It is not expert consensus for diagnosis, pathology, or long-term clinical outcomes data typically seen in drug trials or complex medical device efficacy studies.

8. The sample size for the training set

• Not applicable / not explicitly mentioned. The Yarlap device is not an AI/machine learning device that requires a "training set" in the computational sense. The "training" for the device's design and functionality would come from engineering principles and the existing knowledge base of similar predicate devices, verified through testing and comparisons.

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

• Not applicable. As explained above, there isn't a "training set" or corresponding ground truth in the AI sense for this device. The design and validation relied on comparison to established predicate devices and standard engineering and safety testing.

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A. TENS: The device is intended to be used for the temporary relief of pain associated with sore and aching muscles in the lower back, upper extremities (arms) and lower extremities (legs) due to strain from and/ or norrmal non-commercial household work activities.
B. NMS: The device is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

The "XINIXWAVE" is a portable combined TENS and NMS dual channel device for OTC use. Housed in sturly but lightweight cabinet, the device is battery powered. The same circuitry is used to for both TENS and NMS.

The provided text does not contain detailed acceptance criteria or a study that precisely describes how the device meets those criteria with specific performance metrics. It mainly focuses on the device's substantial equivalence to a predicate device and its indications for use.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not include a table of acceptance criteria or specific performance metrics like sensitivity, specificity, accuracy, or any quantitative measures.

Instead, the "Performance Studies" section (Section 5.0) vaguely states: "Performance testing was conducted on the "XINIXWAVE" combined TENS & NMS device to demonstrate the integrity, suitability and substantial equivalence of the device." This implies that the 'acceptance criteria' were likely functional and safety benchmarks inherent in demonstrating substantial equivalence, rather than specific performance targets for, e.g., pain relief efficacy or muscle stimulation improvement through objective measures.

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

The document does not mention any specific sample size for a test set. It refers to "Performance testing," but provides no details on the study design, number of participants, or the origin of any data (e.g., country of origin, retrospective or prospective).

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

The document does not mention any experts used to establish ground truth or their qualifications. Given the nature of the device (TENS and NMS for OTC use) and the focus on substantial equivalence based on technical characteristics rather than clinical performance (in terms of disease diagnosis or treatment efficacy studies with human subjects), it's highly unlikely that "ground truth experts" in the typical sense (e.g., radiologists, pathologists) were involved in evaluating a test set of data.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method. This is consistent with the lack of a defined test set and expert evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The document does not describe any study involving human readers or the AI-assisted improvement effect. The "XINIXWAVE" is a physical medical device (Transcutaneous Nerve Stimulator combined with Neuromuscular Stimulator), not an AI algorithm for interpreting medical images or data.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, a standalone (algorithm-only) performance study was not done. This device is not an AI algorithm.

7. The Type of Ground Truth Used:

The concept of "ground truth" as typically used in AI/diagnostic device evaluation (e.g., pathology, expert consensus, outcome data) is not applicable here in the same way. The performance studies mentioned were likely focused on:

• Bench testing: Verifying electrical safety, output parameters (frequency, intensity, pulse width), battery life, durability, etc.
• Comparison to predicate device: Ensuring similar physiological effects and safety profile, likely through technical specifications rather than specific clinical outcomes in a trial.

The "ground truth" for showing "integrity, suitability and substantial equivalence" would be compliance with recognized standards for electromedical devices and verification that its technical specifications align with those of the predicate device for its intended use.

8. The Sample Size for the Training Set:

The concept of a "training set" is not applicable as the "XINIXWAVE" is a hardware medical device, not a machine learning algorithm.

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

This question is not applicable for the same reason as above; there is no training set for this type of device.

Summary of what the document does indicate about "performance studies":

The document uses the term "Performance Studies" to refer to testing that demonstrated the integrity, suitability, and substantial equivalence of the "XINIXWAVE" device to its predicate, the Endurance Therapeutics' T-1040 (K-060846).

• Substantial Equivalence: The primary "performance" aspect highlighted is that the device is "simply 'two products in one' as is the cited predicate device," offering choices of programs for both TENS and NMS, similar to the predicate. It also notes that the device comes with a garment belt for electrode pads, similar to the predicate.
• Integrity and Suitability: These terms generally imply tests for electrical safety, biocompatibility (if applicable to materials in contact with skin), mechanical durability, and verification that the device functions according to its technical specifications within safe limits. These types of tests are typically conducted in a laboratory setting, not on human test sets with "ground truth" in the diagnostic sense.

In conclusion, the K100441 submission for the "XINIXWAVE" does not present performance data in the typical format of acceptance criteria, test set, ground truth, and expert evaluation as would be expected for a diagnostic AI device. Instead, it relies on demonstrating substantial equivalence through technical characteristics and basic safety/functional performance testing to an already approved predicate device.

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