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The Contour Profile Tissue Expanders can be utilized for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The expander is intended for temporary subcutaneous or submuscular implantation and is not intended for use beyond six months.

The CPX™4 Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.

In order to provide these tissue expanders with elasticity and integrity, the shells are made with successive cross-linked layers of silicone elastomer. Superior and anterior reinforcement allows for directional expansion in the lower pole of the devices have integral, silicone elastomer, magnetically detected, injection ports and incorporate a BUFFERZONE® area with self-sealing technology that is attached to the inside of the anterior surface of the device to minimize and/or prevent leakage in the event of an accidental needle puncture. The textured shell provides a disruptive surface for collagen interface.

Identification of the injection port site is accomplished by use of the CENTERSCOPE® Magnetic Injection Port Locator, which is provided with the Tissue Expander. Injections into the injection dome area are made using the provided infusion needle set to inject sterile, pyrogen-free Sodium Chloride U.S.P. Solution.

Suture fixation tabs are incorporated into some models of the MENTOR® CPX™4 Tissue Expanders to give surgeons the option to attach the device to surrounding tissue for enhanced device stability. Surgeons can suture on any part of the tab surface or the suturing hole can be used for added convenience.

This document is a 510(k) summary for the Mentor CPX™4 Tissue Expander, a physical medical device, not an AI/ML powered software product. Therefore, many of the requested categories in your prompt, which are typically relevant for AI/ML device studies, are not applicable.

Here's an attempt to extract and frame the information based on the provided document, addressing the prompt's specific points where possible, and indicating "N/A" where the information is not relevant or available for a physical device submission:

Acceptance Criteria and Device Performance for Mentor CPX™4 Tissue Expander

This 510(k) summary describes modifications to an existing physical medical device, the Mentor Contour Profile Tissue Expander. The "studies" conducted are non-clinical performance tests to demonstrate substantial equivalence to the predicate device, not clinical trials or AI/ML model performance evaluations.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of Acceptance Criteria:
The document states, "All non-clinical performance testing results met their pre-determined acceptance criteria, thus demonstrating that the modified device performs as well as or better than the predicate device." The specific numerical or qualitative thresholds for these criteria are not detailed in this 510(k) summary. The overarching acceptance criterion for the submission is demonstrating "substantial equivalence" to the predicate device.

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

• Sample Size: Not explicitly stated as "test set" in the context of an AI/ML model. For non-clinical performance testing of a physical device, this would typically refer to the number of units tested per parameter. This information is not detailed in the 510(k) summary.
• Data Provenance: N/A for AI/ML data provenance. The testing was non-clinical performance testing conducted by the manufacturer, MENTOR Worldwide LLC.

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

N/A. This concept is not applicable to the non-clinical performance testing of a physical product where "ground truth" typically refers to physical measurements and adherence to engineering specifications, rather than expert interpretation of data.

4. Adjudication method for the test set

N/A. Adjudication methods (e.g., 2+1) are common in clinical studies or AI/ML ground truth establishment. For non-clinical performance testing, results are typically determined by adherence to pre-defined specification limits.

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

N/A. This is a physical medical device, not an AI/ML system, so MRMC studies involving human readers and AI assistance are not relevant.

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

N/A. This is a physical medical device, not an AI/ML algorithm.

7. The type of ground truth used

For physical device testing, "ground truth" refers to established engineering specifications, performance standards, and the physical properties of the device. The non-clinical testing was based on meeting pre-determined acceptance criteria for parameters like joint strength and leak performance, likely against internal specifications and potentially relevant industry standards.

8. The sample size for the training set

N/A. There is no AI/ML model or "training set" for this physical device.

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

N/A. There is no AI/ML model or "training set" for this physical device. The "ground truth" for physical device manufacturing and testing would be based on validated design specifications and quality control procedures.

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The Mentor NovaSilk Mesh is indicated for tissuc reinforcement and long-lasting rne Memor of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, cither as mechanical support or bridging matcrial for the fascial defect.

NovaSilk is a permanent, synthetic knitted polypropylenc mesh that is square in shape. It is a sterile, single use device which will be available in quantitics of three.

The provided text describes a medical device, the Mentor NovaSilk™ Mesh, and its clearance process through the FDA 510(k) pathway. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than explicit performance against predefined acceptance criteria for AI/ML devices or diagnostic accuracy. Therefore, much of the requested information for an AI/ML device is not applicable or not present in this document.

Here's an analysis based on the information provided and what is typically sought for AI/ML device evaluations:

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

For this device (surgical mesh), the "acceptance criteria" are not reported in terms of specific performance metrics like sensitivity, specificity, accuracy, or AUC that would be relevant for an AI/ML diagnostic or predictive device. Instead, acceptance for 510(k) clearance is primarily based on demonstrating substantial equivalence to a legally marketed predicate device and meeting general safety and effectiveness requirements through various tests.

The document lists the following characteristics assessed for NovaSilk:

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

This information is not provided. The testing described appears to be bench testing for material characteristics and biocompatibility, not a clinical study with patient "test sets" in the context of AI/ML evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. The device is a surgical mesh, not a diagnostic tool requiring expert interpretation for ground truth.

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

This is not applicable. The device is a surgical mesh, not a diagnostic tool requiring adjudication of interpretations.

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 a surgical mesh, not an AI-assisted diagnostic tool.

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

This is not applicable. The device is a surgical mesh, not an algorithm.

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

This is not applicable. The "ground truth" for this device would be its physical and biological properties conforming to established standards and demonstrating safety. The biocompatibility tests for pyrogenicity and cytotoxicity provide a form of "ground truth" regarding its biological safety.

8. The sample size for the training set

This is not applicable. The device is a manufactured medical product, not an AI/ML model that requires a training set.

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

This is not applicable.

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The Mentor Self-Cath® HydroGel™ Intermittent Urethral Urinary Catheter is intended for use in male, female and pediatric patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode

The Mentor Self-Cath® HydroGel™ catheter (hereafter referred to as SCHG) is an extension of the existing Mentor Self-Cath product line. The device is a modification of the Mentor Self-Cath® Plus catheter and the Mentor Self-Cath Closed System catheter.

The SCHG is intended to be used to drain urine from the bladder. It is provided sterile and is for single-use only. It consists of a prelubricated catheter with an introducer tip on the proximal end which is designed to reduce patient contact and potential contamination while advancing the catheter into the urethra. The catheter is prelubricated with a water-soluble hydrophilic water-based lubricant. The catheter is packaged inside a thin flexible telescoping sleeve that is designed to extend from the catheter to the urine collection device or toilet during bladder voiding. The distal end of the sleeve includes a drainage port with a suction cup for attachment to the toilet, thus stabilizing the sleeve during the voiding process. The SCHG also has a reduced package size for ease of transport.

The SCHG is available singly or as a kit with the following accessories included: non-latex gloves, a paper poly towel, PVP swabs, and a BZK towelette.

The provided text describes a medical device, the Mentor Self-Cath® HydroGel™ Intermittent Urethral Urinary Catheter, and its path to FDA clearance via a 510(k) submission (K050008). However, it does not include information about acceptance criteria or a study that proves the device meets those criteria in the context of performance metrics like sensitivity, specificity, accuracy, or similar measures typically used for diagnostic or AI-based devices.

This submission focuses on substantial equivalence to predicate devices and biocompatibility testing rather than performance in terms of diagnostic effectiveness or clinical outcome improvement through a P-value or specific statistical analysis commonly found in clinical trials. As such, many of the requested fields cannot be filled from the provided text.

Here's a breakdown based on the given information:

1. A table of acceptance criteria and the reported device 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 Test Set: Not specified for biocompatibility tests (e.g., number of units tested, number of animals). This information is usually detailed in the full test reports, which are not included in this summary.
• Data Provenance: Not specified. The tests are general biocompatibility tests, not clinical studies in humans or specific geographical data.

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

• Not applicable. This submission concerns the biocompatibility and substantial equivalence of a physical medical device, not a diagnostic algorithm requiring expert-established ground truth.

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

• Not applicable. This type of adjudication is typically used for image-based diagnostics or clinical studies where subjective interpretation is involved.

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 study was done. This is not an AI-assisted device.

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

• Not applicable. This is not an algorithm.

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

• For biocompatibility, the "ground truth" is established by the results of standardized biological tests (e.g., observation of cellular reactions, animal responses to extracts, genotoxicity assays) and comparison against acceptance criteria defined by relevant ISO standards or regulatory guidelines.
• For substantial equivalence, the "ground truth" is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI device that requires a training set.

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

• Not applicable.

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The Mentor ObTape Trans-obturator Surgical Kit consists of an implantable, suburethral support tape and introducers. It is indicated for the surgical treatment of all types of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or sphincter deficiency.

The Mentor ObTape Trans-obturator Surgical Kit consists of two components: the Mentor ObTape Trans-obturator Tape and a set of Introducer Needles.

The Mentor ObTape Trans-obturator Tape is an implantable, suburethral, support tape indicated for the surgical treatment of all types of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency. The tape is made from non-woven polypropylene fibers. This structure gives the ObTape resistance to traction, allows tissue colonization and facilitates positioning during surgery.

A set of sterile, disposable Introducer Needles (one flat curved introducer and a pair of helical introducers) necessary for implantation of the tape are also included in the Kit.

The provided text describes a 510(k) submission for the Mentor ObTape™ Trans-obturator Surgical Kit. This is a medical device clearance process, not a study evaluating an AI algorithm, and therefore many of the requested elements (like sample size for test sets, number of experts, MRMC studies, standalone performance of an algorithm, and training set details) are not applicable to this type of regulatory submission.

The "study" in this context refers to the pre-clinical and mechanical testing performed to demonstrate that the device is substantially equivalent to a previously cleared predicate device.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Additional Information (Not applicable for AI algorithms)

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

• Not applicable. This submission focuses on the substantial equivalence of a physical medical device (surgical tape and introducers), not an AI algorithm. The testing involved mechanical and biocompatibility assessments of the physical components, not a "test set" of data in the AI sense. The text does not provide sample sizes for these tests. Data provenance in this context would refer to the origin of the materials and manufacturing standards, which are not detailed in the summary.

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 "ground truth" establishment in the AI sense for this device. The tape component's equivalence is based on it being identical to a previously cleared device. The introducers' performance is based on mechanical and biocompatibility testing against predefined standards, likely conducted by qualified engineers and toxicologists/biologists, but not "experts" establishing a "ground truth" for a test set.

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

• Not applicable. No adjudication method is relevant as there is no "test set" or human interpretation of data in the AI context.

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

• Not applicable. This is not an AI-assisted device.

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

• Not applicable. This is not an AI device.

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

• Not applicable. For the tape, the "ground truth" is that it is identical to a predicate device already deemed safe and effective. For the introducers, the "ground truth" is adherence to established mechanical performance specifications and demonstrated biocompatibility as per relevant standards. These are not "ground truths" in the diagnostic AI sense.

8. The sample size for the training set:

• Not applicable. This is not an AI device with a training set.

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

• Not applicable. This is not an AI device.

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The Mentor Genesis Penile Prosthesis is designed for the management of impotence stemming from a variety of causes, including epispadias; pelvic fracture; spinal cord injury or disease; prostatectomy; abdominal-perineal resection; multiple sclerosis; diabetes mellitus; alcoholism; arteriosclerosis and hypertensive vascular disease; priapism; and Peyronie's disease. The Prosthesis may also be used in selected patients with psychogenic impotence.

The Genesis Penile Prosthesis is a flexible silicone elastomer device designed to be implanted into the penis for the management of erectile dysfunction (commonly known as impotence). The Prosthesis (used in pairs) is inserted into the corpora cavernosa. Each Prosthesis consists of a r roothed in panel in panel is a silver wire coil and silver wire coil and silver wire core in the flexible center section and a trimmable proximal section. The distal end is shaped to provide an anatomical fit under the glans penis. The silver wire coil and core in the flexible center section anatelinear in antost the gost into an erect position for intercourse, and then moved into a lowered position for concealment under clothing. Placed within the corpus cavernosum and crus of the penis, the Prosthesis will fit firmly at the ischial tuberosity. The ends fit the proximal culde-sacs of the cavernosa and provide support to the Prosthesis.

All components of the Genesis Penile Prosthesis incorporate a hydrophilic coating on all external surfaces.

Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing that this is a 510(k) summary for a penile prosthesis and not an AI/ML device. Therefore, many standard AI/ML study components will not be present.

Device: Mentor Genesis™ Penile Prosthesis

Device Type: Penile Rigidity Implant (not an AI/ML device)

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document does not specify the sample sizes (number of units/samples) used for each physical, mechanical, or biocompatibility test. It only states that "Physical and Mechanical testing" and "Biocompatibility testing" were conducted.
• Data Provenance: Not applicable in the context of this device. The testing describes lab-based performance verification, not data from human subjects or clinical populations.

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

• Not applicable. The "ground truth" here refers to the pre-defined engineering specifications and biocompatibility standards that the device had to meet. The determination of whether a test result "met all specifications" would typically be done by qualified testing personnel and reviewed by engineering/quality control teams, not "experts establishing ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set

• Not applicable. Performance was assessed against pre-defined specifications for each test, not by adjudication of different evaluations.

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

• No, a MRMC comparative effectiveness study was not done. This is a physical medical device (penile prosthesis), not a diagnostic algorithm or AI system. Such studies are not relevant for this type of product.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone performance study was not done. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

• Engineering Specifications and Biocompatibility Standards: The "ground truth" for this device's performance was established by internal engineering design specifications for physical and mechanical properties (e.g., specific thresholds for column strength, desired lubrication properties) and recognized international standards for biocompatibility (ISO 10993-5).

8. Sample Size for the Training Set

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

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

• Not applicable. As above, no training set was used.

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Mentor ObTape Trans-obturator Tape is an implantable, suburethral, support tape indicated for the surgical treatment of all types of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Mentor ObTape Trans-obturator Tape is an implantable, suburethral, support tape indicated for the surgical treatment of all types of stress urinary incontinence (SUI), for female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

ObTape is made from non-woven polypropylene fibers. This structure gives the ObTape resistance to traction, tissue colonization and facilitates positioning during surgery. Disposable and re-usable Introducer Needles necessary for the implantation are also available with the device.

The provided text is a 510(k) summary for a medical device (Mentor ObTape Trans-obturator Tape and Introducers). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and a detailed performance evaluation in the way an AI/software device would.

Therefore, many of the requested categories for a study proving device acceptance against specific criteria are not applicable or cannot be extracted from this document, as it describes a physical surgical mesh and its introducers.

Here's an attempt to answer the questions based on the available information:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

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

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

This information is not provided in the 510(k) summary. The document describes tests against established standards for materials and biocompatibility, but it does not detail the specific sample sizes used for these tests, nor the data provenance in terms of country of origin or whether the tests were retrospective/prospective. This type of detail is typically part of the underlying test reports, not the summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to the type of device and testing described. The "ground truth" for this device is determined by physical and biological testing against recognized industry standards (EDANA, USP, ISO, EN), not by expert interpretation of clinical data in the same way an AI device would require.

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

This is not applicable to the type of testing described. Adjudication methods are typically used when interpreting subjective data (like medical images), which is not the case for mechanical properties or biocompatibility testing. The compliance is determined by objective measurements against predefined thresholds within the standards.

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. An MRMC study is relevant for evaluating the clinical performance of diagnostic or assistive AI technologies. This submission is for a surgical implant (mesh), not an AI-powered diagnostic tool.

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 surgical implant, not an algorithm.

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

The "ground truth" is based on established industry and regulatory standards for material properties and biocompatibility.

• For mechanical testing: The ground truth for compliance is whether the measured Tear Strength, Tensile Strength, and Elongation meet the specified values within the EDANA standards.
• For biocompatibility: The ground truth for compliance is whether the results of tests for Cytotoxicity, Genotoxicity, Hemolysis, Implantation, Pyrogenicity, Intracutaneous Reactivity, Sensitization, and Systemic Toxicity adhere to the requirements of USP, ISO 10993, or EN standards.

8. The sample size for the training set

This is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

This is not applicable. As there is no training set for a physical device, this question is irrelevant.

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The Mentor Contour Genesis System is indicated for the liquefication and aspiration of soft tissues in General Surgery, Plastic and Reconstructive Surgery and Gynecological Surgery applications. It is also indicated for the liquefication and aspiration of localized subcutaneous fatty deposits for the purposes of aesthetic body contouring.

The Mentor Contour Genesis System consists of the following components: ultrasonic generator, infiltrator, aspirator, ultrasonic handpiece, foot pedal(s), cannulae and cannulae sheaths, system cart, irrigation tubing set, infiltration tubing set, and aspiration tubing set.

The provided text describes a 510(k) premarket notification for the Mentor® Contour Genesis System, a device for ultrasound-assisted lipoplasty. It references a clinical study conducted to demonstrate substantial equivalence to a predicate device. However, the document does not present specific acceptance criteria in a table format with reported device performance against those criteria. It also doesn't detail the study information in the structured way requested.

Based on the information provided, here's what can be extracted and inferred, along with the limitations:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria in a quantitative or tabular format. Instead, it compares the new device (UAL) to a predicate device (SAL) based on safety and effectiveness measures.

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

• Sample Size for Test Set:
  • Total subjects enrolled: 366
  • UAL patients (test group): 180
  • SAL patients (control group): 186
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a clinical study comparing two treatments for a 510(k) submission, it is highly likely to be a prospective study. The country of origin is not specified, but typically for FDA submissions, studies are often conducted in the US or follow international clinical trial standards.

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

• The document mentions "a masked reviewer" assessed body contour measurements.
• It does not specify the number of experts (beyond "a masked reviewer"), their qualifications (e.g., radiologist with X years of experience), or how they established the 'ground truth' for other measures like satisfaction or self-esteem (which are patient-reported outcomes).

4. Adjudication Method for the Test Set:

• The document does not describe any specific adjudication method (e.g., 2+1, 3+1). For patient-reported outcomes like satisfaction and self-esteem, adjudication is typically not applicable as the patient's report is the primary data. For body contour measurements, "a masked reviewer" implies a single assessment, not a consensus or adjudication process.

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

• This study was a clinical comparative effectiveness study, but specifically comparing device performance (UAL vs. SAL lipoplasty), not a multi-reader multi-case study comparing human readers with and without AI assistance.
• Therefore, an effect size of how much human readers improve with AI vs. without AI assistance is not applicable to this document as it's not an AI device.

6. Standalone (Algorithm Only) Performance:

• This is not an AI device, so standalone algorithm performance is not applicable. The study evaluates the performance of a medical device (Mentor® Contour Genesis System) used by a surgeon.

7. Type of Ground Truth Used:

• Primary Safety Measures: Adverse events (patient-reported and/or clinician-observed).
• Secondary Effectiveness Measures:
  • Patient-reported overall satisfaction.
  • Patient-reported feelings towards each body area treated.
  • Patient-reported self-esteem (using Rosenberg Self-Esteem scale and Body Esteem scale).
  • Body contour measurements as assessed by a masked reviewer.

8. Sample Size for the Training Set:

• The document describes a clinical study to compare the device, which serves as the test set for demonstrating equivalence. It does not mention a separate training set for the device itself. This device is a physical medical system (ultrasonic generator, handpiece, etc.), not a machine learning algorithm that requires a training set.

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

• As this is not an AI/ML device, a separate training set and its associated ground truth establishment are not applicable.

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