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The Thermidas IR System is for adjunctive use in addition to other clinical diagnostic procedures for diagnostic imaging for thermally significant indications of all skin regions of the human body. The system is for reviewing and reporting of temperature patterns and changes. The significance of the value of these thermal patterns is determined by professional investigation. The system is not intended for absolute temperature measurements. The Thermidas IR system is intended for use by trained technical personnel.

The Thermidas IR System consists of an off-the-shelf thermal imaging camera, a mount for the camera and a Windows workstation running the Thermidas Imager software. The Thermidas IR System is a non-invasive medical device which uses infrared radiation naturally emitted by the patient, which senses variations in temperature. The captured data is processed by software producing a quantitative image on the computer screen. The medical professional can use the image to review, analyze, investigate, and quantify the temperature of the objects that are imaged.

The Thermidas IR System (ThIR-A615) is a Class I, reserved telethermographic system. Since it is a Class I device, clinical studies were not required and were not performed. Therefore, information regarding acceptance criteria based on clinical performance, sample sizes for test and training sets, expert qualifications, ground truth establishment, adjudication methods, or multi-reader multi-case studies is not available in the provided text.

The substantial equivalence determination was based on non-clinical performance testing against several international and national standards.

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

Since clinical performance testing was not required or performed, the "reported device performance" in terms of clinical metrics (e.g., sensitivity, specificity) is not available. The acceptance criteria were met by demonstrating compliance with the following non-clinical testing standards:

Discussion on Device Features Compared to Predicate (Found in the "Predicate Device Comparison" Table):

While not formal performance metrics, the device's technical specifications and features were compared to the predicate to establish substantial equivalence. These comparisons highlight attributes that contribute to the device's functional performance:

• Resolution: Both the predicate and proposed device support high resolution (e.g., 640x480). The proposed device explicitly states it uses a "640 x 480 pixel microbolometer that detects temperature differences as small as 50 mK, for accuracy at longer distances."
• Image Frequency: Both devices offer high image frequency (e.g., 50-60 Hz) for real-time viewing. The proposed device specifies "Stream full-frame 16-bit images at 50 Hz, or in windowed mode as high as 200 Hz, for high-speed processes."
• Focus: Both offer automatic focus.
• Connectivity: Both use Gigabit Ethernet.
• Calibration: Both are factory calibrated.
• Lens: Both use a 25-degree standard lens.
• Software Features: Both provide software for capturing, displaying, and analyzing thermal patterns (e.g., patient records, image capture, visualization, ROI analysis, reporting).

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

• Not Applicable. Clinical studies were not required or performed for this Class I device. The testing involved compliance with non-clinical engineering and quality standards.

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. Clinical studies were not required or performed. There was no clinical ground truth established for a test set.

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

• Not Applicable. No clinical test set requiring adjudication was used.

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. No MRMC study was conducted. The device is a telethermographic system for adjunctive diagnostic imaging, and the provided documentation does not indicate it uses AI for image interpretation or for assisting human readers in a comparative effectiveness study.

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

• Not Applicable. Clinical studies were not performed. The device is a system for reviewing and reporting temperature patterns, with the interpretation by trained technical personnel. The software itself "makes no determination regarding what the thermal patterns or relative temperature values mean" and "The decision making is not based on the software itself."

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

• Not Applicable. No clinical ground truth was established as clinical studies were not performed. For the non-clinical testing, compliance with standards served as the "ground truth" for safety and performance according to those standards.

8. The sample size for the training set

• Not Applicable. As clinical studies were not performed, there was no clinical training set.

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

• Not Applicable. As clinical studies were not performed, there was no clinical training set or associated ground truth establishment.

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The Thermi Temperature Controlled Radiofrequency (RF) System (generator, electrodes/hanpieces and accessories) are indicated:

• for use in dermatological and general surgical procedures for electrocoagulation and hemostasis
• to create lesions in nervous tissue

The Thermi Temperature Controlled Radiofrequency (RF) System consists of a RF generator with integral temperature and impedance feedback, automatically adjusting energy delivery to maintain set temperature and percutaneous and transcutaneous electrodes accessories that deliver the RF to the targeted location on the patient's anatomy when use with Thermi RF generator. It is operating with set temperature range between 35-90° C that allows the physician to control treatment temperature to achieve the desired clinical outcome.

The Thermi RF System consist of:

• 1. RF Generator
• 2. Percutaneous electrodes
• 3. Disposable and re-usable transcutaneous electrodes/handpieces
• 4. Foot pedal
• 5. Power cord

Thermi RF generator produces an oscillating electric field in the antenna (electrode). The oscillating electrical field is transmitted to the surrounding soft tissue, causing heating of the tissue. A thermocouple in the electrode measures this increase in temperature and maintains a feedback loop to ensure a set point temperature in the tissue.

The provided text describes the regulatory filing for the Thermi Temperature Controlled Radiofrequency (RF) System (K173582). This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study for establishing acceptance criteria for a new clinical performance claim. As such, the information typically requested for AI/software-as-a-medical-device (SaMD) performance studies (such as sample size, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable or available in this context.

The "Performance Data" section primarily details bench testing and compliance with electrical safety and essential performance standards to ensure the device's basic functionality and safety, rather than its clinical efficacy in achieving specific medical outcomes.

Here's an attempt to populate the table and answer the questions based on the provided text, recognizing its limitations for the requested information:

Acceptance Criteria and Device Performance (Based on Bench Testing)

Additional Information Not Directly Applicable to AI/SaMD Performance Studies:

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

   • Sample Size: Not applicable. The document describes bench testing on the device itself and its components, not clinical data from patients or a test set of medical images/data.
   • Data Provenance: Not applicable. The tests were performed in a lab setting, not on patient data.

2. 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. Ground truth as typically defined for AI/SaMD (e.g., expert consensus on medical images) is not relevant to this type of device submission which focuses on the engineering and electrical safety aspects of an RF system. The "ground truth" here is the adherence to design specifications and safety standards as assessed by engineers and test equipment.

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

   • Not applicable. There was no clinical test set requiring expert adjudication.

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:

   • No. This is a medical device for electrocoagulation and lesion creation, not an AI/SaMD for assisting human readers. An MRMC study is not relevant here.

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

   • Not applicable. This device is an RF generator and accessories, not an algorithm.

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

   • The "ground truth" for this submission is adherence to engineering specifications, recognized national and international safety standards (e.g., IEC 60601 series), and internal design requirements. For example, for "Thermal effect on tissue testing," the ground truth would be the expected and measured temperature distribution and tissue changes according to the device's intended operation and safety limits, as determined by pre-defined protocols and scientific understanding of RF tissue interaction.

7. The sample size for the training set:

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

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

   • Not applicable as there is no training set for an AI/SaMD.

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The Thermi Injectable RF® Electrodes used with the Thermi RF Generator System are indicated:

• *for use in dermatological and general surgical procedures for electrocoagulation and hemostasis
• • to create lesions in nervous tissue when used in combination with Thermi RF Generator.

The Thermi Injectable RF® Electrodes are designed to provide finely-controlled radiofrequency (RF) energy in combination with the Thermi RF Generator. They are not intended to function with other RF generators or other non-Thermi branded products.
The Injectable RF® Electrodes are a combination of a RF electrode and a RF cannula to allow percutaneous application of RF energy. The RF electrode delivers the RF signal from the generator to the active tip of the cannula. The device utilizes an insulated shaft along the outside of the cannula to avoid transition of the RF signal outside of the tip area. From the active tip, the RF signal causes the tissue molecules to vibrate resulting in the formation of heat. The heated area is a function of the active tip size (length, gauge). The device is offered in different sizes to accommodate multiple anatomies and desired heating areas. The device connects to a Thermi RF Generator and requires the use of a grounding pad to complete the circuit.
The Injectable RF® Electrodes are available in different lengths, different tip exposures and different thicknesses. The lengths that are available for the Thermi Injectable RF® Electrodes range from 5 cm to 20 cm. The cannula portion is coated with an insulation layer such that only the tip will transmit the RF signal and ablate the tissue. The tip exposures available for the Thermi Injectable RF® Electrodes range from 5 mm to 10 mm. The diameters available for the Thermi Injectable RF® Electrodes range from 16 GA to 20 GA. The cannula electrodes have a blunt tip. All the RF electrodes have a 264 cm long silicone cable. The disposable cannula electrode is provided sterile in a sealed tray for single use only.

The provided text describes the Thermi Injectable RF® Electrodes, a medical device for electrosurgical cutting and coagulation, and its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving device meets acceptance criteria.

Specifically, the document is a 510(k) summary for FDA clearance, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing a detailed study report with specific acceptance criteria, sample sizes, expert qualifications, or comparative effectiveness study results.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Missing Information: The document states that the device "met all performance and functional testing and performed as intended," but it does not provide specific quantitative acceptance criteria for each test (e.g., "tensile strength must be >X Newtons"). It also doesn't provide specific quantitative results for each test.

Regarding the Study: The document describes "performance data" which includes electrical safety testing and bench testing. These are more akin to verification and validation activities rather than a "study" in the sense of a clinical trial or comparative effectiveness study.

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

• Sample Size: Not specified. The document generically mentions "testing" or "a series of bench testing" but does not give the number of devices or components tested for any specific test.
• Data Provenance: Not specified. The tests are bench tests, so they are likely conducted in a controlled lab environment. No information on country of origin or whether it's retrospective/prospective in the clinical sense is provided, as these are not clinical studies.

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

• Not applicable. The "ground truth" for these engineering and electrical safety tests would be the established international standards (e.g., IEC 60601 series) and internal design specifications. There's no mention of human experts establishing ground truth for individual test outcomes in the way one would for image interpretation or diagnosis.

4. Adjudication Method for the Test Set:

• Not applicable. This concept typically applies to clinical studies where multiple reviewers assess a case and their interpretations need to be reconciled. For bench testing, results are typically objective measurements or pass/fail against predetermined criteria.

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

• No. An MRMC study was not done. The document does not describe any clinical study involving human readers or comparative effectiveness for this device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Not applicable. This device is hardware (electrodes) used with a generator. It's not an algorithm or AI system. Its performance is inherent to its physical and functional characteristics when operated by a human user.

7. The Type of Ground Truth Used:

• For electrical safety: International standards (IEC 60601 series).
• For bench testing (dimensional, functional, tensile strength, etc.): Internal design specifications and validated test protocols.

8. The Sample Size for the Training Set:

• Not applicable. This is a hardware device; there is no "training set" in the context of machine learning or AI.

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

• Not applicable. As above, no training set.

In summary: The provided document is a 510(k) summary, which is a regulatory document focused on demonstrating substantial equivalence to a predicate device through engineering and electrical safety testing. It is not a detailed clinical study report and therefore lacks the specific details requested regarding clinical acceptance criteria, expert involvement, and comparative effectiveness studies.

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The Thermi RF accessories used with the Thermi RF Generator System are indicated:

• • for use in dermatological and general surgical procedures for electrocoagulation and hemostasis
• • to create lesions in nervous tissue when used in combination with Thermi RF Generator.

The Thermi RF Accessories (electrodes, cannula, adapter cable) are designed to provide finely-controlled radiofrequency (RF) energy in combination with the predicate device Thermi RF Generator (K130689).

This document is a 510(k) premarket notification for Thermi RF Accessories (electrosurgical cutting and coagulation devices and accessories). It states that the accessories are substantially equivalent to previously cleared devices. It describes performance data related to electrical safety and bench testing, but these are general engineering qualifications for device function, not specific clinical performance metrics related to diagnostic accuracy or AI performance.

Therefore, the requested information specifically regarding acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML device cannot be fully extracted as this is not an AI/ML device. The document does not describe studies with test sets, ground truth, expert consensus, or MRMC studies.

Here's what can be extracted based on the provided document:

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

2. Sample sized used for the test set and the data provenance: Not applicable. The document describes engineering and bench testing, not clinical studies with test sets of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data is not mentioned as this is not an AI/ML device.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set involving human interpretation/adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This 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 a physical electrosurgical accessory, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device's performance would be engineering specifications and standards, not clinical ground truth.

8. The sample size for the training set: Not applicable. There is no mention of a training set as this is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. There is no mention of a training set or its ground truth.

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The ThermiGen Symphony RF Generator System and the probes that are used with it are indicated

• . for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
• to create lesions in nervous tissue when used in combination with NeuroTherm . (previously Smith&Nephew) thermal/coagulation probes.

The Symphony RF is a 20 watt electro-thermal radio frequency (RF) generator with integral temperature and impedance feedback. The RF generator is the Smith&Nephew RF Delivery Device, unchanged and in clinical service since Feb 25, 2004 (K033981). The Symphony RF has software changes to allow for two types of electrode/hand-pieces. (1) percutaneous (existing Smith and Nephew thermal/coagulation probes, now owned and manufactured by Neurotherm, Inc.) and (2) the new transcutaneous thermal/coagulation probe, RFE-10-D.

The Symphony RF generator has a user interface that displays temperature set point and actual tissue temperature, procedure time, impedance, along with system error and warning codes.

The theory of operation of RF devices: The RF generator produces an oscillating electric field in the antenna (handpiece). The oscillating electrical field is transmitted to the surrounding soft tissue, causing heating of the tissue. A thermistor intrinsic to the handpiece measures this increase in temperature and in the case of the Symphony RF, a feedback loop maintains a set point temperature in the tissue.

This document is a 510(k) summary for the ThermiGen Symphony RF Generator, focusing on its substantial equivalence to predicate devices rather than a study proving the device meets specific acceptance criteria for a new clinical endpoint. Therefore, much of the requested information regarding acceptance criteria and a study meeting those criteria is not present. This device is an electrosurgical cutting and coagulation device, regulated as a Class II device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not contain a table of explicit acceptance criteria or a study that evaluates the device against such criteria in a performance-based manner (e.g., sensitivity, specificity, accuracy). Instead, it focuses on asserting substantial equivalence to predicate devices based on technical specifications and safety standards.

The criteria for demonstrating substantial equivalence are typically:

• Same intended use as predicate device.
• Same technological characteristics as predicate device, or if different, that the differences do not raise new questions of safety or efficacy.

Device Performance (as reported):

• Conformance to Standards:
  • The Symphony RF System has been third-party tested and found to conform to IEC 60601-2-2 (specific for RF devices).
  • It was also third-party tested to IEC 60601 (3rd edition) and applicable Collateral Standards (60601-1-2, 60601-1-4, 60601-1-6).
• Manufacturing and Software:
  • The Symphony RF and RFE-10-D electrode meet all manufacturing and software specifications.
• Comparison to Predicates:
  • K033981 Smith&Nephew ElectroThermal 20S: Same power, frequency, monitoring, and safety functions.
  • K000944 Thermage ThermaCool System: Same power and similar frequency, monitoring, and safety functions, as well as identical indications for use.
  • K082834 Ellman Three Button Fingerswitch Handpiece (for RFE-10D): Same diameter of skin contact, monopolar, similar materials, similar temperature ranges, and both are transcutaneous.

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

Not applicable. There was no clinical test set in the traditional sense involving patient data to evaluate performance metrics like sensitivity or specificity. The submission relies on technical testing against recognized safety standards and comparison to predicate devices, not a study of patient outcomes or expert reads.

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

Not applicable. No expert review of a test set of data was conducted as part of this 510(k) summary for performance evaluation.

4. Adjudication Method for the Test Set:

Not applicable. No test set requiring expert adjudication was described.

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

No. This 510(k) summary does not mention or present an MRMC study. The device is a physical instrument (RF generator and handpieces), not an AI algorithm that assists human readers.

6. If a Standalone (Algorithm Only) Performance Study Was Done:

No. The device is not an algorithm, and no standalone performance study in that context was performed. The "standalone" performance here relates to the device meeting technical and safety standards, which was done via third-party testing.

7. Type of Ground Truth Used:

The "ground truth" in this context is the established safety and efficacy of the predicate devices and the adherence to relevant international safety standards for electrosurgical equipment (e.g., IEC 60601 series). There is no "ground truth" derived from patient outcomes, pathology, or expert consensus on clinical cases as would be seen for diagnostic AI.

8. Sample Size for the Training Set:

Not applicable. The device is a physical electrosurgical system, not an AI model that requires a training set.

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

Not applicable for the same reasons as #8.

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Not Found

DYNA T-2000 Physical Therapy System

This document is a 510(k) clearance letter from the FDA for a device called the DYNA T-2000 Physical Therapy System. It states that the device is substantially equivalent to legally marketed predicate devices.

However, this letter does not contain the information required to answer your questions about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert qualifications. This type of information is typically found in the 510(k) submission itself, often in sections detailing performance data and clinical studies, which are not part of this clearance letter.

Therefore, I cannot provide the requested details based solely on the provided text.

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