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The InnoVoyce VYLO is intended for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. Suggested applications include:

General Surgery: Vaporizing, coagulating, incising, debulking, and ablating of soft tissue as well as in endoscopic (e.g., laparoscopic) or open surgeries.

Gastroenterology: Tissue ablation and hemostasis in the gastrointestinal tract; esophageal neoplastic obstructions, including squamous cell carcinoma and adenocarcinoma; gastrointestinal hemostasis (including varices, espohagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, angiodysplasia, stomal ulcers, non-bleeding ulcers, gastrointestinal tissue ablation (benign and malignant neoplasm, angiodysplasia, polyps, ulcer, colitis, hemorrhoids).

Gynecology: Vaporizing, incising, or coagulating tissue associated with treatments of conditions such as: endometriosis; cervical, vulvar, and vaginal intraepithelial neoplasia; condyloma acuminata; uterine septum; intrauterine adhesions; submucosal fibroids.

Head and Neck/ Otorhinolaryngology (ENT): Tissue incision, ablation, and vessel hemostasis.

Neurosurgery: Incising, excising, coagulating, and vaporizing neurological tumors of the firm textured type.

Ophthalmology: Post-vitrectomy endophotocoagulation of the retina.

Plastic Surgery: Vaporizing, coagulating, incising, excising, debulking, and ablating of soft tissue in endoscopic and open procedures.

Spinal Surgery: Percutaneous lumbar diskectomy.

Thoracic Surgery: Vaporizing, coagulating, incising, excising, debulking, and ablating of soft tissue, including lung tissue in thoroscopic or open procedures.

Urology: Cutting, coagulating, or vaporizing urologic soft tissues. Open endoscopic minimally invasive urological surgery (ablation, vaporization, excision and coagulation of soft tissue) including treatment of: bladder, urethral & ureteral tumors; condylomas; lesions of external genitalia; urethral & penile; hemangioma; urethral strictures; bladder neck obstructions; and vaporization of prostate tissue for men suffering from benign prostate hyperplasia (BPH).

InnoVoyce VYLO is a solid-state laser device with laser energy generated by internal diodes. The laser output energy of the device is in the blue spectrum at wavelength of 445-465nm.

The system is intended to be used by professional practitioners (specialized physician/ authorized technical personnel) in the medical field. The system is intended for use in professional healthcare facility environments.

The VYLO's base unit is a console with a graphical touch screen user interface and a footswitch, and single-use, disposable LOFs. The system has four laser emission modes: Continuous Wave (CW), Pulsed Wave (PW), Quasi Pulsed Wave (QPW), and Quasi Continuous Wave (QCW).

The provided text is a 510(k) Premarket Notification from the FDA, asserting the substantial equivalence of the InnoVoyce VYLO laser surgical instrument to a legally marketed predicate device (Greenlight XPS Laser System). It discusses indications for use, device description, electrical safety, electromagnetic compatibility, software, and performance testing.

However, the document does not describe a study that involves human readers, AI assistance, ground truth established by medical experts (other than potentially for the histology review, which is not explicitly detailed), or acceptance criteria related to diagnostic performance metrics for an AI/software device. The performance testing described is a bench test comparing the VYLO device's tissue interaction to the predicate device, not an AI or software performance study.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable in this context, as they relate to the evaluation of an AI/software diagnostic device, which the InnoVoyce VYLO is not.

Based on the information provided, here's what can be extracted and what cannot:

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

The document describes "Performance Testing" which is a comparison of tissue effects (Coagulation and Ablation Zones - CAZs) between the subject device (InnoVoyce VYLO) and the predicate device (Greenlight XPS). The acceptance criterion implicitly seems to be "comparable performance" in terms of tissue effects, with a note that smaller CAZs at max power for the subject device indicate a "safer and more controlled way."

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

• Sample Size: For the histology testing, the document states: "All settings mentioned above were triplicated in all three types of tissues (liver, kidney, and muscle)." This means for VYLO, 3 power/mode settings (30W CW for 300 & 600 µm, 20W CW for 600 µm, 20W Q-CW for 600 µm) x 3 tissues x 3 repetitions = 27 tissue samples. For the Predicate, 2 power levels (30W, 180W) x 3 tissues x 3 repetitions = 18 tissue samples. The total number of tissue samples is 45.
• Data Provenance: The tissues used were liver, kidney, and muscle. The document does not specify the origin (e.g., animal, human, specific country) or whether the study was retrospective or prospective, but it's clearly a bench/pre-clinical study.

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

• The document mentions "Histology testing was conducted." While histology implicitly involves expert review (pathologist), the number of experts, their qualifications, or their role in establishing "ground truth" (e.g., measurement of CAZs) is not specified.

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

• Not applicable or Not specified. Adjudication methods are typically for human reader studies with multiple interpretations. For histology, it's usually either a single expert or a consensus process which is not detailed here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No. An MRMC study was not done. This device is a laser surgical instrument, not an AI or software diagnostic tool intended to assist human readers. The clinical evidence section explicitly states: "Clinical Evidence – N/A. No clinical studies were conducted as part of this submission."

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

• Not applicable. This is not an AI algorithm. Its performance is evaluated through its interaction with tissue, not as a standalone diagnostic algorithm.

7. The type of ground truth used:

• The ground truth for evaluating the device's performance was the dimensions of the Coagulation and Ablation Zones (CAZs) in ex vivo tissue samples, as determined by histology. This is primarily a pathology/histology-based ground truth for physical tissue effects.

8. The sample size for the training set:

• Not applicable. This device does not involve a training set as it is not an AI/machine learning model.

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

• Not applicable. This device does not involve a training set.

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InnoVoyce Laser Fiber is intended for use in incision, vaporization, ablation, and coagulation of soft tissue.

The InnoVoyce Laser Fibers are sterile, single use, disposable laser delivery devices designed to deliver laser energy at 532 nm (KTP) for use in incision/excision, vaporization, ablation, and coagulation of soft tissue. The laser fibers are used as an accessory to the Aura KTP medical laser. They are 12 feet (3.66m) long glass fibers in flexible jackets, and they are available in three sizes 300, 400, and 600 Microns. The choice of the fiber diameter is dependent upon the surgical procedure, the desired tissue effects, and the personal preference of the surgeon. Fibers with small core diameters minimize lateral tissue damage, are more flexible, and tend to cut faster when used in contact than larger diameter fibers. The InnoVoyce Laser Fibers have a proprietary connector meeting the Aura XP surgical laser console interface requirements which includes: custom bayonet-style engagement to the system, and fiber model recognition. The InnoVoyce Laser Fibers transmit maximum power available from the Aura XP at 15w. This fiber within the surgical laser system will be operated by a surgeon and a laser safety officer.

This device is a Laser Surgical Instrument. The device is a Class II device with product code GEX.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail table format common for AI/ML devices. Instead, the performance is demonstrated through non-clinical performance testing against recognized consensus standards, which essentially serve as the acceptance criteria for safety and effectiveness for this type of device.

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

• Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of an AI/ML device. For this type of medical device (laser fiber), the "test set" would encompass the physical units subjected to the non-clinical performance and biological evaluation tests. The document indicates that "Non-clinical testing was performed on InnoVoyce Laser Fiber."
• Data Provenance: Not applicable in the same way as AI/ML software. The data provenance would refer to the materials and methodology used in the laboratory and bench testing, which are governed by the listed ISO and USP standards. This is not retrospective or prospective patient data.

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

• Number of Experts: Not applicable. The "ground truth" for this device is established by adherence to recognized international and FDA standards for medical device safety and performance (e.g., biocompatibility limits, sterilization efficacy, material properties). These standards are developed through consensus by experts in various fields. The testing itself is conducted by qualified personnel in accredited laboratories.
• Qualifications of Experts: Not explicitly stated for specific individuals involved in this submission, as the "experts" are the collective bodies that establish the standards and the qualified personnel performing the laboratory tests.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. This is not a study requiring expert adjudication of interpretations (like imaging studies). Compliance with the performance standards is typically determined by objective measurements and analyses performed during bench and laboratory testing.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a physical surgical tool, not an AI/ML diagnostic aid that would involve human readers interpreting cases.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Standalone Study: Not applicable. This is not an algorithm or software device. The "performance" is inherent to the physical device's characteristics and its ability to deliver laser energy safely and effectively as intended.

7. The Type of Ground Truth Used:

• Type of Ground Truth: The ground truth for this device is established by objective measurements against predefined scientific and engineering specifications and consensus standards. This includes physical properties, biological safety (e.g., lack of irritation, endotoxin levels), and sterilization efficacy, as outlined by the ISO and USP standards. It is not expert consensus on interpretations of images or pathology.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This is not an AI/ML device; therefore, there is no "training set."

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

• Ground Truth for Training Set: Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for it.

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The INNOVO® is a transcutaneous electrical stimulator indicated for the treatment of stress urinary incontinence in adult females.

The INNOVO® is a powered transcutaneous electrical continence device intended for the treatment of stress urinary incontinence. The device is provided with an internally wired garment which locates eight conductive electrodes around the pelvic area. An electronic controller, which is attached to the garment using a leadwire, delivers an amplitude modulated symmetric biphasic stimulation current to the electrode array to evoke timed muscle contractions in the pelvic floor muscles. A neck strap clips to the unit to allow it to be worn around the neck. The neck strap contains a safety clip which pops open if there is a forceful pull on the neck strap The current amplitude is adjusted by the patient using a push-button intensity control. A treatment lasts for 30 minutes and is self-administered by the patient at home. The electronic controller operates from rechargeable batteries and a mechanical interlock is provided to prevent simultaneous connection to the patient and the charger. The INNOVO® is supplied with a non-sterile, electrically conductive, electrolyte spray.

The provided text describes a 510(k) summary for the INNOVO® device intended for treating urinary incontinence. While it details non-clinical performance testing and general acceptance criteria like compliance with electrical safety and EMC standards, it does not contain information about a study proving the device meets specific performance acceptance criteria for its effectiveness in treating urinary incontinence.

The document primarily focuses on demonstrating substantial equivalence to a predicate device, adherence to safety standards (e.g., IEC 60601 series, ISO 14971, ISO 10993), and usability testing for over-the-counter use.

Therefore, I cannot provide the requested information regarding:

1. A table of acceptance criteria and the reported device performance: This document does not present quantitative performance metrics for treating urinary incontinence for the INNOVO® device.
2. Sample size used for the test set and the data provenance: No clinical test set data for performance is presented. The usability study involved 15 subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no performance study (e.g., diagnostic accuracy for an AI/CAD system) is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a medical device for treatment, not an AI/CAD diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not described for device efficacy. Usability testing ground truth was expert observation.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set in the conventional sense.
9. How the ground truth for the training set was established: Not applicable.

The "Summary of Non-Clinical Performance Testing" in section VII details testing against various electrical safety, usability, and biological compatibility standards. For example, usability testing involved 15 subjects to assess suitability for safe over-the-counter use, and its findings relate to users understanding instructions and applying treatment safely. However, this is not a clinical study proving the treatment efficacy of the device for urinary incontinence.

The document states: "Performance testing has demonstrated that the INNOVO® is substantially equivalent to the predicate INNOVO®." This implies that the effectiveness is established by comparison to a previously cleared device, not necessarily by new clinical efficacy data for this specific submission, especially when the changes are primarily related to making it available as an Over-The-Counter device (which required Human Factors testing).

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The Innovo is a transcutaneous electrical stimulator indicated for the treatment of stress urinary incontinence in adult females.

The Innovo is indicated for prescription use only.

The Innovo is a single channel, rechargeable, non-implanted electrical stimulator that is intended for the treatment of stress urinary incontinence.

The Innovo is comprised of the following main components, along with accessories:

• Controller
• Body Garments (right and left)
• Gel Pads (8 surface electrodes)
• Battery Charger
• Lead Wire
• Neck Strap

The Controller generates the electrical stimulation patterns for coupling the stimulation signals to the body when sued with the Gel Pad electrodes and lead wire. The Body Garments, equipped with 8 surface electrodes, are worn by the patient and cover the buttocks, lateral pelvis, and upper thighs. The electrodes have a skin conductive adhesive hydrogel laver, a current dispersing layer, and a garment conductive adhesive hydrogel layer.

The four electrodes on the right side are combined into a single equivalent electrode (and similarly as are the electrodes on the left side). The electrical stimulation current is passed across the pelvic area (from the right side to the left site), thereby stimulating the pelvic floor muscles.

Innovo Device Acceptance Criteria and Study Analysis

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Innovo device are primarily derived from the "Summary of Clinical Information" and "Benefit-Risk Determination" sections, particularly an observed meaningful clinical improvement for the target condition.

2. Sample Sizes and Data Provenance

The primary clinical evidence supporting the Innovo device comes from two studies:

• Study 1 (Germany - Sham Controlled Trial):
  • Sample Size: N=50 women (N=24 in treatment arm, N=26 in control/sham arm completed 12 weeks of treatment). This study was "prematurely stopped."
  • Data Provenance: Germany, prospective, randomized, double-blinded, sham-controlled.
• Study 2 (USA - Randomized Non-Inferiority Study):
  • Sample Size: N=180 subjects (N=89 in Innovo group, N=91 in iTouch Sure group).
  • Data Provenance: USA (12 US sites), prospective, multicenter, randomized, non-inferiority clinical study.

3. Number of Experts and their Qualifications for Ground Truth

The document does not explicitly state the number or specific qualifications of experts used to establish ground truth for the clinical studies. However, the patient population for both studies consists of "women clinically diagnosed with stress urinary incontinence." This implies that the diagnoses were made by qualified medical professionals (e.g., urologists, gynecologists, or primary care physicians with relevant expertise), who would have established the initial inclusion criteria and therefore the "ground truth" of the SUI diagnosis for enrollment.

For objective measures like the 1-hour and 24-hour pad weight tests, the "ground truth" is established by the quantifiable weight of leaked urine, measured according to standardized protocols rather than a subjective expert assessment of individual cases. Similarly, questionnaires like iQoL and MESA rely on patient self-assessment.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for determining the "ground truth" of the test set beyond the initial clinical diagnosis for enrollment and the objective measurements of the primary and secondary endpoints. For quantitative outcomes like pad weight tests, the measurement itself serves as the ground truth. For patient-reported outcomes (QOL questionnaires), the patient's response is the ground truth.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The studies described are clinical trials evaluating the device's effectiveness and safety directly on patients, not AI-assisted reader performance. Therefore, there is no mention of the effect size of how much human readers improve with AI vs. without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The Innovo device is a physical transcutaneous electrical stimulator, not an AI algorithm. Its "performance" refers to its efficacy in treating SUI in patients, not a standalone algorithm's diagnostic or predictive accuracy. Therefore, a standalone (algorithm only) performance study was not conducted or applicable to this device. The software in the controller manages stimulation patterns but is not described as an AI algorithm.

7. Type of Ground Truth Used

The ground truth used in the clinical studies was based on a combination of:

• Clinical Diagnosis: Women "clinically diagnosed with stress urinary incontinence" (for patient enrollment).
• Objective Outcome Measures:
  • Pad Weight Tests: 1-hour and 24-hour pad weight tests (quantifiable leakage in grams). This could be considered a form of "objective measurement" or "outcomes data" rather than expert consensus on retrospective images.
• Patient-Reported Outcome (PRO) Measures:
  • Incontinence Quality of Life Questionnaire (iQoL)
  • Medical Epidemiologic and Social Aspects of Aging Urinary Incontinence (MESA) Questionnaire
  • Global Impression of Improvement (PGI-I)

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of an AI algorithm or machine learning. The clinical studies (Study 1 and Study 2) served as the primary data for evaluating the device's performance, but these are "test sets" in the clinical trial sense, not an AI training set. Therefore, a sample size for a training set is not applicable here.

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

As noted above, there is no mention of a "training set" for an AI algorithm. If "training set" is instead interpreted as data used to inform the device's design or initial performance parameters, these would likely come from pre-clinical research, feasibility studies, and possibly literature reviews, but the specific methods for establishing ground truth for such development phases are not detailed in this regulatory summary. The "series of smaller feasibility studies conducted during the development of the device" hint at such activities, but specific ground truth establishment for these is not provided.

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