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The Suture-TOOL System is intended for abdominal wall closure after laparotomy in patients 18 years old and older.

The Suture-TOOL System is a single-use, sterile, suture applicator with a polydioxanone resorbable suture pre-mounted to the needle. The polydioxanone monofilament synthetic absorbable sutures are prepared from polyester, poly(p-dioxanone). The empirical molecular formula of the polymer is as follows: -(0-CH2-CH2-O-CH2-CO)n- The sutures are dyed with D&C Violet No. 2 (21CFR§ 74.3602) and are available in size 2. The Suture-TOOL System includes the following: - Polydioxanone resorbable suture pre-mounted on the needle -1020S (Suture&Needle). - Suture-TOOL 1018S (suture applicator) Before use, the user must follow the instructions to attach the needle, preloaded with the suture, to the applicator.

The provided text describes the regulatory clearance of a medical device, the "Suture-TOOL System," and compares it to predicate and reference devices. However, it does not contain the specific information required to answer the questions about acceptance criteria and a study proving the device meets those criteria, particularly in the context of an AI/human-in-the-loop study.

This document focuses on the substantial equivalence of a physical surgical device (suture and applicator) based on material properties, performance testing (tensile strength, diameter, needle attachment), biocompatibility, and human factors testing related to its physical use. It does not describe an AI medical device or a study involving human readers and AI assistance for diagnostic or interpretative tasks.

Therefore, I cannot provide the requested information from the given text. The text does not provide:

1. A table of acceptance criteria and reported device performance: While it mentions USP criteria were met or exceeded for physical tests, it doesn't present these as specific acceptance criteria in a table format.
2. Sample size, data provenance, number of experts, adjudication method, MRMC study effect size, standalone performance, type of ground truth, training set size, or how ground truth for training was established. These are all concepts relevant to AI/diagnostic studies, which are not described in this regulatory submission for a physical surgical device.

The study referenced ("Börner and Montgomery, 2020; and Börner et al., 2022") appears to be a nonclinical performance study related to the physical surgical technique (SL/WL ratio, reducing needle stick injuries), not an AI performance study measuring diagnostic accuracy.

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Secret Line up and i-Thread (Sterile single use absorbable polydioxanone suture with needle) comprised of dyed polydioxanone suture with a sterile needle. It is indicated for use in soft tissue approximation where use of absorbable suture is appropriate. The suture is not intended for body cavity applications, nor is it intended for lifting and supporting tissues; it is intended for dermatological use only.

Secret Line up and i-Thread (Sterile single use absorbable polydioxanone suture with needle) consist of a cannula type needle which is straight and hollow (pre-loaded on the suture), a needle cap, a hub, a sponge and polydioxanone (PDO) suture which is sterilized by ethylene oxide (EO) gas. The pigment for the violet dye is D&C Violet No.2. PDO Sutures are characterized by their bidirectional barbs along axis of the monofilament. The bidirectional barbs of barbed suture are precisely lodged in tissue, making it feasible to anchor in the tissue and prevent movement in both directions without the need for a surgical knot. As a result, the barbed suture improves the effectiveness of treatment.

The provided document is a 510(k) premarket notification for a medical device called "Secret Line up" and "i-Thread," which are absorbable polydioxanone sutures with needles. The document asserts that the subject device is substantially equivalent to a previously cleared predicate device (K240389).

However, the document does not contain any acceptance criteria or study results that prove the device meets specific performance criteria related to AI or algorithm-only performance. This is because the device described is a physical surgical suture, not an AI/algorithm-driven device.

Therefore, I cannot fulfill the request for information regarding AI/algorithm acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies, as these types of studies are not applicable to the non-AI medical device described in the input.

The document primarily focuses on demonstrating substantial equivalence of the subject suture to a predicate suture based on material, manufacturing, sterilization, and physical performance tests, not on any AI or software-related functional performance.

Therefore, many parts of your request for information related to AI/algorithm performance studies cannot be answered based on the provided document.

Here’s what can be extracted and inferred from the document regarding the physical medical device:

Acceptance Criteria and Device Performance (Not for AI, but for the physical suture)

The document does not present a formal table of "acceptance criteria" for the device's main performance as a suture with corresponding "reported device performance" in a quantitative manner as one might expect for an AI algorithm. Instead, it lists the types of performance tests conducted and states that they "Pass." The acceptance criteria are implicitly the successful completion of these tests as per relevant standards.

Table of Acceptance Criteria (Inferred from standards and tests listed) and Reported Device Performance (Summary)

Information Not Applicable or Not Found (Relevant to AI/Algorithm Studies):

1. Sample sizes used for the test set and data provenance (e.g., country of origin of the data, retrospective or prospective): This information is not provided as the tests are for a physical device, not an AI algorithm. The document mentions "in vivo testing in Sprague-Dawley Rat" for animal studies, but doesn't specify sample sizes for these, nor does it detail human subject data for an AI test set.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical suture's performance (e.g., tensile strength) is established by direct measurement and compliance with engineering standards, not by expert consensus on interpretations of data.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This pertains to expert review for AI ground truth.
4. 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 a surgical suture, not an AI assistance tool for human readers. The document explicitly states "no Clinical Studies were performed nor required."
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this physical device is established by bench testing against ISO, USP, and ASTM standards, and animal studies for in-vivo performance (absorption, barb holding, tensile strength over time).
7. The sample size for the training set: Not applicable, as this is not an AI device with a training set.
8. How the ground truth for the training set was established: Not applicable, as this is not an AI device.

In summary, the provided document is a 510(k) submission for a traditional physical medical device (a surgical suture) and, therefore, does not contain any of the specific information requested regarding acceptance criteria and study designs pertinent to AI/algorithm performance. The 'acceptance criteria' for this device are implicitly derived from the successful execution of a range of standard physical, chemical, biological, and sterilization tests.

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The Cypris eXact Suture Placement Device is indicated for use in general soft tissue approximation when used with sutures.

The Cypris eXact Suture Placement Device is for use in general soft tissue approximation by surgeons, and it is single-use and provided sterile. It is a hand-held device used for the placement of a surgical suture, and the device consists of a handle, needle driver, and tissue capture port. The handle is designed for manual manipulation of the suture placement device, allowing the surgeon to advance the device to the desired deployment site. The needle driver functions to pass the suture when it is advanced and retracted. The tissue capture port consists of a capture chamber, needle, and hook assembly, and holds the tissue to be sutured during either manual palpation or vacuum-assisted palpation of tissue into the tissue capture port. Suture placement is achieved by advancing and retracting the needle driver.

{
"1. A table of acceptance criteria and the reported device performance": {
"Acceptance Criteria": [
"Biocompatibility endpoints evaluated (cytotoxicity, sensitization, irritation, acute systemic toxicity, and material-mediated pyrogenicity)",
"Integrity of the sterile barrier and functionality of the device after 3 years of real-time aging",
"Performance as expected",
"Use of vacuum-assisted palpation equivalent to manual palpation by the predicate device",
"Peak suction force measurement at 25.0 inHg"
],
"Reported Device Performance": [
"Device underwent testing for cytotoxicity, sensitization, irritation, acute systemic toxicity, and material-mediated pyrogenicity.",
"Testing demonstrated integrity of the sterile barrier and functionality after 3 years of real-time aging (shelf-life is 3 years).",
"Testing demonstrated that the subject device performs as expected.",
"Testing demonstrated that the use of vacuum-assisted palpation is equivalent to the use of manual palpation by the predicate device.",
"At a vacuum level of 25.0 inHg, the minimum, maximum, and average measured peak suction force achieved was 0.753 lbf, 1.052 lbf, and 0.904 lbf, respectively."
]
},
"2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The provided text describes non-clinical testing. It does not mention specific sample sizes for a test set in the context of clinical data or human subjects. The data provenance is not specified, but the testing appears to be laboratory-based (non-clinical).",
"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. This is a non-clinical study for a manual surgical instrument, not an AI/imaging device requiring expert ground truth establishment for a test set.",
"4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable. This is a non-clinical study for a manual surgical instrument, not an AI/imaging device requiring an adjudication method.",
"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 a non-clinical study for a manual surgical instrument, not an AI/imaging device. No MRMC study was conducted or mentioned.",
"6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Not applicable. This is a non-clinical study for a manual surgical instrument. No algorithm or standalone performance testing was mentioned.",
"7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "Not applicable. For this non-clinical study, ground truth was established by adherence to performance specifications and established biocompatibility standards.",
"8. The sample size for the training set": "Not applicable. This is a non-clinical study for a manual surgical instrument, not an AI/machine learning device requiring a training set.",
"9. How the ground truth for the training set was established": "Not applicable. This is a non-clinical study for a manual surgical instrument, not an AI/machine learning device. No training set was used or ground truth established for one."
}

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1. PINION™ PDO Knotless Sutures are indicated for use in general soft tissue approximation where use of an absorbable suture is appropriate.

2. PINION™ PGA-PCL Knotless Sutures are indicated for use in general soft tissue approximation where use of an absorbable suture is appropriate.

The PINION™ PDO Knotless Suture consists of barbed suture material armed with a surgical needle on each end. Barbs allow for tissue approximation without the need to tie surgical knots. PINION™ PDO Knotless Suture is a sterile, synthetic, absorbable monofilament suture comprised of Poly (p- Polydioxanone). The empirical molecular formula of which is (G.HგO3)x. PINION™ PDO Knotless Sutures are available in undyed or dyed with D & C violet No.2 (21 CFR 74. 3602) at a level not exceeding 0.3 % by weight of the suture in sizes USP (EP) 3-0 (2), 2-0 (3) & 0 (3.5). It is supplied with the attached stainless steel surgical needles. Polydioxanone has been found to be nonantigenic, nonpyrogenic and to elicit only a slight tissue reaction during absorption. The PINION™ PDO Knotless Suture is designed with small unidirectional and bidirectional barbs along the length of the device. It consists of an absorbable thread with unidirectional anchors, equipped with a surgical needle at one end and a fixation tab at the other while the bidirectional anchors equipped with a surgical needle at both end. The anchors and fixation tab design allows for tissue approximation without the need to tie surgical knots.

The PINION™ PGA-PCL Knotless Suture consists of barbed suture material armed with a surgical needle on each end. Barbs allow for tissue approximation without the need to tie surgical knots. PINION™ PGA-PCL Knotless Suture is a sterile, synthetic, absorbable monofilament suture comprised of poly (glycolide-co-caprolactone). PINION™ PGA-PCL Knotless Suture is provided undyed or dyed with D & C violet No.2 (21 CFR 74. 3602) at a level not exceeding 0.25 % by weight of the suture in sizes USP (EP) 4-0 (1.5), 3-0 (2) & 2-0 (3). It is supplied with the attached stainless steel surgical needles. The polymer has been found to be nonantigenic, nonpyrogenic and eliciting only a slight tissue reaction during absorption. The PINION™ PGA-PCL Knotless Suture is designed with small unidirectional and bidirectional barbs along the length of the device. It consists of an absorbable thread with unidirectional anchors, equipped with a surgical needle at one end and a fixation tab at the other while the bidirectional anchors equipped with a surgical needle at both end. The anchors and fixation tab design allows for tissue approximation without the need to tie surgical knots.

The provided text describes the acceptance criteria and the studies performed for two medical devices: PINION™ PDO Knotless Suture and PINION™ PGA-PCL Knotless Suture.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The main acceptance criteria are based on comparison to predicate devices and adherence to USP (United States Pharmacopoeia) and ISO standards. The "Reported Device Performance" column reflects whether the subject device meets these criteria. Since the document states "No change," "Identical," or indicates the subject device provides "more safety" than the predicate device, it implies successful meeting of the criteria.

PINION™ PDO Knotless Suture

PINION™ PGA-PCL Knotless Suture

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 details performance testing for both sutures, including:

• Diameter USP <861>
• Tensile strength USP <881>
• Needle attachment USP <871>
• Suture Length
• Number of barbs per linear length of suture
• Barb size (length)
• Barb size Direction
• Barb Angle
• Barb holding strength
• Sterility USP <71>
• Biocompatibility as per ISO 10993-1

However, the specific sample sizes used for each of these performance tests are not explicitly stated in the provided document.

The document mentions "implantation studies in animals" for the predicate devices to establish in-vivo tensile strength retention and absorption profiles. For the subject devices, it explicitly mentions "The results of in vitro study using PINION™ PDO Knotless Suture" and "PINION™ PGA-PCL Knotless Suture retains approximately 62 % of its original strength 7 days post implantation," implying similar in-vitro or animal studies were conducted for the subject devices to demonstrate equivalent performance.

The data provenance is related to the manufacturing country, which is India (M/s. Meril Endo Surgery Private Limited, Gujarat, India). The studies would therefore likely align with standard regulatory practices and be conducted to meet FDA requirements for prospective testing to demonstrate device performance and safety. The document does not specify if any retrospective data was used for direct performance comparison of the subject device, beyond referencing predicate device characteristics.

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 section is not applicable to this type of medical device submission. The devices are surgical sutures, and their performance is evaluated through measurable physical and biological properties against established standards (USP, ISO) and comparison to predicate devices, not through expert-reviewed interpretations of images or clinical outcomes that require "ground truth" established by human experts in the same way an AI diagnostic device would.

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

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving human readers and AI for diagnostic or screening tasks to establish a consensus "ground truth." For surgical sutures, the assessments are based on objective physical measurements and biological tests, not subjective interpretations requiring adjudication.

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 section is not applicable. MRMC studies are relevant for diagnostic or screening devices, particularly those involving AI assistance for human readers. These sutures are physical medical devices, not diagnostic software.

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

This section is not applicable. This question pertains to AI/software device performance, which is not relevant to surgical sutures.

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

For these surgical sutures, the "ground truth" or reference standards are:

• United States Pharmacopoeia (USP) standards for properties like diameter, tensile strength, and needle attachment.
• ISO 10993-1 standards for biocompatibility.
• Established performance profiles of the legally marketed predicate devices (e.g., STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device and STRATAFIX™ Spiral MONOCRYL™ Knotless Tissue Control Device) for characteristics like tensile strength retention and absorption rates.

These are objective, quantitative and scientifically established benchmarks or comparisons.

8. The sample size for the training set

This section is not applicable. "Training set" refers to data used to train machine learning models. Surgical sutures are physical devices, not AI/ML systems, and therefore do not have training sets.

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

This section is not applicable for the same reason as above.

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Secret Line up and i-Thread (Sterile single use absorbable polydioxanone suture) comprised of dyed polydioxanone suture with a sterile needle. It is indicated for use in soft tissue approximation where use of absorbable suture is appropriate. This device is not intended for body cavity applications or lifting and is intended for dermatological use only.

Secret Line up and i-Thread (Sterile single use absorbable polydioxanone suture with needle) consist of a cannula type needle which is straight and hollow (pre-loaded on the suture), a needle cap, a hub, a sponge and polydioxanone (PDO) suture which is sterilized by ethylene oxide (EO) gas. The pigment for the violet dye is D&C Violet No.2. Secret Line up/i-Thread Sutures are characterized by their bidirectional barbs along the long axis of the monofilament. The bi-directional barbs of barbed suture are precisely lodged in tissue, making it feasible to anchor in the tissue and prevent movement in both directions without the need for a surgical knot.

This document is a 510(k) Pre-market Notification for a medical device, specifically absorbable polydioxanone surgical sutures. The purpose of this document is to demonstrate that the new device, "Secret Line up / i-Thread," is substantially equivalent to existing legally marketed predicate devices.

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

The document implicitly uses the performance of the predicate devices as its acceptance criteria and demonstrates that the subject device meets or is similar to these criteria through various tests. Explicit numerical acceptance criteria are not presented in a direct table with reported performance. However, the "Substantially Equivalent (SE) Comparison Chart" (page 6) serves this purpose by comparing various attributes of the subject device to the predicate device. All "SE" remarks indicate that the device meets the implied acceptance criteria.

Key performance tests and their outcomes (reported device performance):

Differences noted and justified:

• Suture Size (USP): Predicate: 4-0, 3-0, 2-0, 0. Subject: 2-0, 2, 0. (Similar - predicate has more sizes but subject still equivalent).
• Suture Length: Predicate: 90, 110, and 150 mm. Subject: 150, 160 mm. (Similar - predicate has various lengths but subject still equivalent).
• Barb Angle: Predicate: 2 - 45 degrees. Subject: 50 - 80 degrees. (Justified by barb holding performance test).

The overall conclusion states: "Despite the differences, the test results submitted in this 510k show that the subject device is substantially equivalent to In almost all aspects, the subject device is substantially equivalent in its capacity and function to the predicate device." (Page 7)

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

The document references several performance tests, but it does not explicitly state the sample sizes used for each test. The tests include:

• Bench Tests (Non-clinical):

  • Suture measurements (Length, Diameter, Hub)
  • Bending test
  • Barb Holding strength
  • Flexural test
  • Pulling out (or) Extraction Test
  • USP standards: Sutures Diameter (<861>), Sutures Needle Attachment (<871>), Sutures Tensile Strength (<881>).
  • ASTM F1874-98 9 bending test.

• Biocompatibility Tests (in vitro and in vivo):

  • ISO 10993 series tests for various aspects (cytotoxicity, hemolysis, systemic toxicity, irritation, sensitization, local effects after implantation, genotoxicity).
  • Ethylene Oxide Sterilization Results (ISO 10993-7, ISO 11135).

• Animal Study (In Vivo):

  • Biodegradability evaluation in Sprague-Dawley Rats.
  • Comparing "absorption", "Tensile strength test" and "Barb holding strength test" over time.

Data Provenance: The document does not explicitly state the country of origin of the data. The studies and tests appear to be retrospective, conducted in support of the 510(k) submission.

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

This information is not provided within the document. The document describes laboratory and animal studies, not studies involving human experts establishing ground truth for a diagnostic interpretation.

4. Adjudication method for the test set:

This information is not applicable as the studies described are laboratory, animal, and biocompatibility tests, not studies requiring expert adjudication of results like image interpretation.

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 information is not applicable as the device is a surgical suture, not an AI-powered diagnostic device, and no MRMC studies are mentioned.

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

This information is not applicable as the device is a surgical suture, not an algorithm.

7. The type of ground truth used:

For the performance and biocompatibility studies, the "ground truth" is established by adherence to recognized international and FDA standards, and comparison to the performance of legally marketed predicate devices.

• Bench Test Ground Truth: Defined by the specifications and performance characteristics of the predicate device, as well as established industry standards (USP, ASTM). The goal is to show the subject device performs similarly or within acceptable limits.
• Biocompatibility Ground Truth: Defined by the requirements of the ISO 10993 series of standards, which assess the biological safety of medical devices.
• Animal Study Ground Truth: The observed biological response in the Sprague-Dawley Rat model (absorption, tensile strength, barb holding strength) is compared against the expected performance based on the predicate device and established knowledge of polydioxanone sutures.

8. The sample size for the training set:

This information is not applicable as the device is a surgical suture, not a machine learning model that requires a training set.

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

This information is not applicable for the same reason as above.

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The Symmed Elite Aesthetic is intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation.

The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.

The Symmed Elite Aesthetic device is a radiofrequency generator that is used for a number of pain related applications such as" to relieve pain, muscle spasms and increase local circulation through electrical and thermal stimulation of the treated tissues". In addition, it contains a massage function that provides temporary improvement in the appearance of cellulite. The Symmed Elite Aesthetic consists of a console plus 2 handpieces, each with 3 different size electrodes. Each handpiece is capable of being fitted with the optional massager. This allows for flexible treatment parameters throughout the working range and handpieces.

The provided document, a 510(k) summary for the Symmed Elite Aesthetic, does not describe an AI medical device. Instead, it details a radiofrequency generator for topical heating and a massage device for cellulite reduction. Therefore, the questions related to AI device acceptance criteria, ground truth, expert adjudication, MRMC studies, and training/test set data are not applicable.

However, I can extract the relevant performance testing information for the described device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Indiba Diathermia RF, K161458) through comparison of specifications and direct performance testing. While explicit "acceptance criteria" for each performance metric are not listed as pass/fail thresholds in a table, the performance testing section describes what was evaluated and the comparison table highlights areas of similarity or difference with the predicate.

Key Performance Testing Conducted (General Acceptance Criteria Implied):

• Electrical Safety & Performance:
  • IEC 60601-1:2005 (Third Edition) + A1:2012 (General requirements for basic safety and essential performance)
  • IEC 60601-1-2:2014 (Electromagnetic compatibility requirements and tests)
  • IEC 60601-2-2:2017 (Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories)
• Biocompatibility:
  • ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (Implies components in contact with the body are safe)
• Software Verification & Validation:
  • IEC 62304:2006/A1:2016 (Implies software functions as intended and is safe)
• Specific Device Functionality:
  • Performance testing to show that frequency, impedance, voltage output, and output power all performed within the accepted range (Implies these electrical parameters were measured and found compliant).
  • Tissue Heating Capability: The device "can maintain a skin surface temperature of 40°C for 10 minutes of treatment." (This is a specific functional acceptance criterion and was met).

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

The document states: "The Symmed Elite Aesthetic device has been validated through an in-house study to demonstrate that the device can maintain a skin surface temperature of 40°C for 10 minutes of treatment."

• Sample Size: Not specified. It's an "in-house study," which typically implies a limited number of test subjects or a bench test setup simulating skin.
• Data Provenance: "In-house study," likely conducted by the manufacturer, Termosalud, in Spain (Ataulfo Friera Tarfe, 8 - 33211 Gijón, Spain). It is a prospective test of the device's performance.

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

N/A for this type of device. There is no "ground truth" established by experts in the context of diagnostic interpretation as there would be for an AI device. The validation is based on physical measurements (temperature, electrical parameters, safety standards).

4. Adjudication Method for the Test Set:

N/A. This is not an interpretive diagnostic study requiring adjudication. Performance is measured against predefined technical specifications or the ability to achieve a physical outcome (e.g., maintaining a specific temperature).

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

No, an MRMC study was not done. This is not an AI device, and its performance is not assessed in terms of human reader improvement.

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

N/A. This is a physical device, not an algorithm. The device's performance is inherently standalone in its function (e.g., it heats by itself).

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance is based on engineering specifications, international consensus standards (IEC, ISO), and direct physical measurements (e.g., temperature, electrical outputs). For the tissue heating study, the ground truth was the measured attainment of 40°C for 10 minutes on the skin surface.

8. The Sample Size for the Training Set:

N/A. This is not an AI/machine learning device that requires a training set.

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

N/A.

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