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Ask a specific question about this device

The ReGenesis EMS Chair is intended to provide non-invasive electromagnetic stimulation to a weak pelvic floor muscle for the purpose of rehabilitation. The procedure is intended to strengthen the pelvic floor muscle and restore the neuromuscular control for the treatment of urinary incontinence in both male and female patients.

The ReGenesis Chair is an electromagnetic muscle stimulation device. It is intended to provide non-invasive electromagnetic stimulation to a weak pelvic floor muscle for the purpose of rehabilitation. The procedure is intended to strengthen the pelvic floor muscle and restore the neuromuscular control for the treatment of urinary incontinence in both adult male and female patients. This is intended to be operated by trained professionals only.
The ReGenesis EMS Chair consists of the main unit (the chair) and a wired, color, touch screen, control Panel. The device consists of a control unit that internally houses a power supply, cooling system, user interface, and control system. The electromagnetic coil is contained in the chair applicator, which is fashioned as a seat for the patient. The subject device uses electromagnetic fields to stimulate the muscles of the pelvic floor.

This document is a 510(k) clearance letter for a medical device and does not contain the acceptance criteria or results of a study demonstrating the device meets those criteria. The primary purpose of a 510(k) summary is to establish substantial equivalence to a predicate device, not necessarily to detail comprehensive clinical performance or specific acceptance criteria.

The "Non-Clinical Testing" section mentions that "All pre-determined acceptance criteria were met," but it does not list what those criteria are nor does it provide a table of acceptance criteria versus reported performance.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated from the provided document:

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

• Acceptance Criteria: Not explicitly stated in the document. The document mentions "All pre-determined acceptance criteria were met" for non-clinical and performance bench testing, but does not provide the criteria themselves.
• Reported Device Performance: Not explicitly stated in a quantitative manner against specific acceptance criteria. The document only confirms that the non-clinical tests were "successfully completed" and "All pre-determined acceptance criteria were met."

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

• Since no clinical study results are detailed, there is no information provided on the sample size for a clinical test set or its provenance. The testing mentioned is non-clinical bench testing.

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

• Not applicable based on the provided document. The document describes non-clinical bench testing, not a study involving human experts to establish ground truth for a test set.

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

• Not applicable based on the provided document. No clinical study with adjudicated ground truth establishment 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 versus without AI assistance:

• No, an MRMC comparative effectiveness study was not done or is not reported in this document. The device is an electromagnetic muscle stimulation device, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable in the context of an "algorithm." The ReGenesis EMS Chair is a physical device that delivers electromagnetic stimulation. The "Software Verification and Validation Testing" indicates software is involved, but "standalone" performance in the sense of an algorithm making a diagnosis or prediction is not relevant here. The device's primary function is a physical intervention.

7. The type of ground truth used:

• For the non-clinical testing, the "ground truth" would be defined by engineering specifications and recognized standards (e.g., electrical safety limits, electromagnetic compatibility limits, mechanical durability expectations, temperature thresholds).

8. The sample size for the training set:

• Not applicable. The document describes a physical medical device. It does not mention any machine learning or AI components that would require a "training set" in the typical sense.

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

• Not applicable. As above, no training set for an AI algorithm is mentioned.

Summary of what is available from the document regarding acceptance criteria and study:

The document states that non-clinical testing was performed to demonstrate substantial equivalence to the predicate device. These tests included:

• Electrical Safety testing (per IEC 60601‐1: 2020)
• Electromagnetic Compatibility testing (per IEC 60601‐1-2: 2020)
• Nerve and muscle stimulator specific requirements (per IEC 60601-2-10:2016)
• Software Verification and Validation Testing (per FDA guidance)
• Performance bench data, including:
  • Service life verification test
  • Stimulation Coil Surface Temperature Rise Test

The document explicitly states: "All pre-determined acceptance criteria were met." However, the specific quantitative acceptance criteria for each of these tests and the reported quantitative performance are not detailed in this 510(k) summary. The sample size for these bench tests (e.g., how many units were tested for service life or temperature rise) is also not provided.

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The Medical Video Endoscope is designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney.

The image processor is used with the specified endoscope designed by SEPLOU during minimally invasive surgery.

The image processor provides power and processes the images for medical electronic endoscope.

The Medical Video Endoscope system is designed to provide image solution for endoscopy and endoscopic surgery, and perform procedures in the urinary tract and interior of the kidney using appropriate accessory devices (e.g. laser fibers, forceps baskets).

The Medical Video Endoscope is a sterile Medical Video Endoscope. The Image Processor for Endoscopy is a reusable monitor.

The Medical Video Endoscope is comprised of a control body with articulation controls and accessory access ports, and a flexible insertion tube with an on-tip camera module and LED lighting source. The Image Processor processes the images from the Endoscope and outputs video signals to a display.

This document describes the FDA 510(k) clearance for the Seplou (ZHUHAI) Co., Ltd. Medical Video Endoscope System. It is important to note that this is a medical device clearance, not an AI/ML device clearance. Therefore, the information regarding AI-specific criteria like training sets, expert ground truth, and MRMC studies will not be present in this document. The provided text does not describe an AI/ML device.

Here's an analysis based on the provided document for the Medical Video Endoscope System:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a medical device and not an AI/ML system, the "acceptance criteria" discussed are related to physical, electrical, and performance standards rather than metrics like sensitivity or specificity. The "reported device performance" refers to the device's adherence to these standards.

2. Sample Sizes Used for Test Set and Data Provenance

This is not applicable as the clearance is for a physical medical device (endoscope system) and not an AI/ML algorithm that processes data. The "test set" in this context refers to the physical units and their components undergoing various engineering and performance tests, not a dataset of medical images. The data provenance would be laboratory testing data generated during the device's development and validation.

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

This is not applicable for a non-AI medical device clearance. Ground truth, in the context of AI/ML, refers to definitively labeled data. For this device, "ground truth" would be established through adherence to engineering standards, validated measurement techniques, and industry best practices by qualified engineers and technicians.

4. Adjudication Method for the Test Set

Not applicable for a non-AI medical device clearance. Adjudication methods like 2+1 or 3+1 are used for reconciling expert disagreements in AI ground truth labeling. For a physical device, testing outcomes are typically definitive measurements against established standards.

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

Not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. This device is an endoscope system, not an AI diagnostic tool.

6. Standalone (i.e. algorithm only without human-in-the loop performance) Study

Not applicable. This device is a physical endoscope system, not a standalone algorithm.

7. Type of Ground Truth Used

The "ground truth" for this medical device's performance is established by:

• International Standards: Adherence to ISO, ASTM, and IEC standards for biocompatibility, sterilization, electrical safety, EMC, optical performance, and packaging.
• Engineering Specifications: The device's measurable physical and optical properties meeting predefined design specifications.
• Comparison to Predicate Device: Demonstrating substantial equivalence to a legally marketed predicate device, implying similar performance characteristics.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable for the same reason as above.

Summary of Device and Performance:

The Seplou (ZHUHAI) Medical Video Endoscope System aims to provide an image solution for endoscopy and endoscopic surgery within the urinary tract and interior of the kidney. It consists of multiple models of flexible endoscopes and an image processor.

The device's performance has been demonstrated through a series of non-clinical tests to meet established regulatory and industry standards. This includes:

• Biocompatibility: Evaluated according to ISO 10993-1, covering cytotoxicity, sensitization, irritation, acute systemic toxicity, and material-mediated pyrogens.
• Sterilization and Shelf Life: Validated via ISO 11135:2014 for sterilization, ISO 10993-7:2008 for EO/ECH residuals, and ASTM F1980-21 for accelerated aging to support a 3-year shelf life. Package validation was also done per ISO and ASTM standards.
• Electrical Safety and EMC: Complies with IEC 60601-1 (general medical electrical equipment safety), IEC 60601-2-18 (endoscopic equipment specific safety), and IEC 60601-1-2 (electromagnetic compatibility).
• Software Verification and Validation: Conducted and documented as per FDA guidance.
• Bench Performance Testing: Included optical performance (according to ISO 8600 series, color reproduction, geometric distortion, resolution, depth of field, image intensity uniformity, noise, dynamic range compared to the predicate device) and mechanical tests (use-life of bending section, control knob, connection strength, tensile force, and corrosion resistance).

The conclusion states that these performance tests and compliance with voluntary standards confirm the substantial equivalence of the proposed Medical Video Endoscope system to its predicate device (K172098). No clinical studies were deemed necessary for this clearance.

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The ClearTip FNA and FNB Types are intended for Ultrasonically Guided Fine Needle Aspiration, (FNA) of submucosal and extraluminal lesions of the Gastrointestinal Tract, (e.g., lymph nodes, abnormal tissue in the mediastinum).

The ClearTip is a manually operated endoscopic instrument intended to obtain tissue specimens of gastrointestinal tract (=digestive tract). The subject device mainly consists of a handle unit with an insertion part, a syringe, a stopcock, and a connector. ClearTip is offered in various needle gauges for insertion and aspiration. The available needle gauge sizes of 19, 22, and 25 gauge. The Needle which is dimpled for ultrasonic visualization is advanced into the target site for aspiration. The device allows for adjustment of the length of the coil sheath and the needle to enable the user to adjust for the working length of the endoscope and to control needle insertion depth. It is preloaded with a stylet to aid in inserting the Needle which is removed for injection and aspiration. This device passes through the working channel of endoscope, and the average contact time with mucosa of the human gastrointestinal tract is less than 1 hour. This device is supplied sterile for single-patient use and shall be not reused or re-sterilized.

This FDA 510(k) clearance letter pertains to a medical device, and as such, it does not detail acceptance criteria or a study that would demonstrate the device meets those criteria in the way typically seen for AI/software-as-medical-device (SaMD) products. This document describes a traditional medical device (a biopsy instrument), not an AI system.

The "acceptance criteria" and "device performance" mentioned in your request are usually quantifiable metrics (e.g., sensitivity, specificity, AUC) for SaMD products, often against a ground truth for diagnostic accuracy. For a physical device like the ClearTip FNA and FNB Types, acceptance criteria typically relate to physical properties, functionality, safety, and compatibility, which are assessed through non-clinical (engineering, bench) tests rather than clinical performance studies against a diagnostic "ground truth."

Therefore, I will extract the information provided based on the context of a physical medical device submission, focusing on the nearest equivalents to your requested categories.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical device, the "acceptance criteria" are implied by the performance standards for the non-clinical tests conducted. The reported "device performance" is typically that the device met these standards. The document does not provide specific numerical acceptance criteria or performance metrics for each test, but rather lists the types of tests performed.

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

This document does not describe a "test set" in the context of clinical data for diagnostic performance. The "tests" mentioned are non-clinical (bench/engineering) tests conducted on the physical device itself. Therefore, information on sample size for a "test set" or "data provenance" (country of origin, retrospective/prospective) is not applicable or provided given the nature of the device and the submission.

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

Not applicable. This is not an AI/SaMD product requiring expert-established ground truth for diagnostic accuracy. The "ground truth" for a physical device's performance often relates to engineering specifications and regulatory standards.

4. Adjudication Method for the Test Set

Not applicable. No "test set" requiring adjudication in a clinical context is described.

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

No. An MRMC study is typically for evaluating diagnostic performance of imaging or AI systems with human readers. This clearance is for a physical biopsy instrument.

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

No. This is not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on engineering specifications, material standards, and regulatory requirements (e.g., for sterility, biocompatibility, mechanical strength). It is not pathology, outcomes data, or expert consensus in the diagnostic sense.

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 system.

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

Not applicable. There is no training set for this device.

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