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The AT2™ System is indicated for use in General Surgical procedures for electrocoagulation and hemostasis.

The AT2™ System consists of a RF generator and accessories, including disposable treatment electrodes.

This 510(k) summary (K082956) for the Alpha Orthopaedics AT2 System indicates that the device's substantial equivalence was established based on non-clinical performance testing, rather than a clinical study with specific acceptance criteria related to a diagnostic output or human reader performance.

Therefore, many of the requested points are not applicable to this submission.

Here's a breakdown of the available and non-applicable information based on the provided text:

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

Explanation: The 510(k) summary states, "Biocompatibility, EMC, safety testing, and software tests have been completed." This implies that the device met pre-defined acceptance criteria for these non-clinical tests, but the specific criteria (e.g., maximum current leakage, minimum insulation resistance, specific software validation metrics) are not itemized in this summary document. The "reported device performance" is a high-level statement of compliance.

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 for clinical studies. This submission relies on non-clinical performance data and a comparison to a predicate device. The sample sizes would refer to the number of units tested for biocompatibility, EMC, safety, and software, which are not detailed here. The provenance of such testing is also not specified.

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. No expert ground truth was established for a diagnostic or clinical performance study. The "ground truth" for non-clinical tests is based on engineering standards and regulatory requirements.

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

• Not applicable. No adjudication was performed as there was no expert review of clinical cases.

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

• No, an MRMC study was not done. This device is an electrosurgical cutting and coagulation system, not an AI-powered diagnostic tool. The concept of human readers improving with AI assistance is not relevant here.

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

• Not applicable. This is not an algorithm-only device. Its performance is assessed through its physical and electrical properties, not an AI algorithm.

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

• Not applicable for clinical ground truth. The "ground truth" for the non-clinical performance tests would be defined by established engineering standards (e.g., ISO standards for biocompatibility, IEC standards for EMC and safety).

8. The sample size for the training set

• Not applicable. This device does not employ machine learning or AI that would require a training set.

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

• Not applicable. No training set was used.

In summary: K082956 is a 510(k) submission for an electrosurgical device. The substantial equivalence pathway for this device focused on demonstrating that its technological characteristics and non-clinical performance (biocompatibility, EMC, safety, software) were comparable to a legally marketed predicate device. The information provided in the 510(k) summary does not include details on clinical performance studies, expert adjudication, or AI model evaluation metrics, as these were not required for this type of device and submission.

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The TivaMed Cooled RF System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.

TivaMed Cooled RF System uses radiofrequency (RF) energy to selectively heat a given volume of tissue beneath the surface, while cryogen is delivered to the inside of the treatment tip to cool and protect the surface tissue.

The provided text describes the TivaMed Cooled RF System, but it does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The document is a 510(k) summary for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data against specific acceptance criteria.

Here's a breakdown of what is and is not present in relation to your request:

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

• Not present. The document mentions "functional and performance requirements" were met, but it does not specify these requirements as acceptance criteria or provide quantitative performance metrics.

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

• Not present. The document states "representative samples of the device underwent biocompatibility, electrical, and mechanical testing," but it does not specify the sample size for these tests or the data provenance.

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/Not present. As there's no clinical performance study described, there's no mention of ground truth established by experts. The testing described (biocompatibility, electrical, mechanical) are engineering/bench tests, not clinical evaluations requiring expert interpretation of results in a diagnostic context.

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

• Not applicable/Not present. No clinical test set requiring 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/Not present. This device is an electrosurgical unit, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study and AI performance improvement are not relevant to this submission.

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

• Not applicable/Not present. This is hardware, not an algorithm.

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

• Not applicable/Not present. For the functional and safety testing, "ground truth" would be established by adherence to the specified engineering standards (e.g., IEC 60601-1, ISO 10993-1). There is no clinical "ground truth" mentioned.

8. The sample size for the training set:

• Not applicable/Not present. This is not a machine learning or AI device that would have a training set.

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

• Not applicable/Not present. See point 8.

Summary of available information regarding testing:

The device underwent:

• Functional and Safety Testing:
  • Biocompatibility testing
  • Electrical testing
  • Mechanical testing
• Standards Adhered to:
  • IEC 60601-1: Medical Electrical Equipment - General Requirements for Safety
  • IEC 60601-1-2 (Likely electromagnetic compatibility)
  • IEC 60601-1-4: Medical Electrical Equipment - General Requirements for Safety - Programmable Electrical Medical Systems (though the device itself doesn't appear to be "programmable" in a complex sense, this standard covers certain aspects)
  • IEC 60601-2-2: Medical Electrical Equipment - Particular Requirements for the Safety of High Frequency Surgical Equipment
  • AAMI/ANSI/ISO 11135-1:2007: Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
  • ISO 10993-1: Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing
  • Federal Register, Volume 43, No. 122, 1978 (likely for regulatory context or specific test methods)
  • FDA "ETO, ECH, and EG Proposed Maximum Residue Limits and Maximum Limits of Exposure" (for sterilization by-products)

The conclusion is based on the device's "similarities in principles of operation, technology, materials, and indications for use" to its predicate devices, suggesting that the compliance with these standards and functional tests provides the basis for substantial equivalence, rather than a specific clinical performance study against acceptance criteria.

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The ThermaCool TC System is indicated for use in

• . Non-invasive treatment of periorbital rhytids and wrinkles
• . Dermatologic and general surgical procedures for electrocoagulation and hemostasis.

The device as described in the above referenced Premarket Notifications has been modified to include a modified Treatment Tip.

The provided text is a 510(k) Premarket Notification for the "ThermaCool TC System." This document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way a clinical or AI performance study would.

The document states:

• "There are no applicable FDA mandated performance standards for electrosurgical cutting and coagulation device and accessories."
• "However, voluntary standards such as in-house Standard Operating Procedures and QSR based vendor qualification procedures are in place and utilized in the production of the device."

Therefore, based solely on the provided text, I cannot extract the requested information. The document serves as a regulatory submission demonstrating equivalence, not a detailed performance study with acceptance criteria.

To answer your specific questions based on the provided document:

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

   • Not available in the provided text.
   • The document implies that "voluntary standards such as in-house Standard Operating Procedures" are used, but no specific performance metrics or acceptance criteria are listed.

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

   • Not available in the provided text. This document does not describe a clinical test set or data.

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 document does not describe a study involving expert-established ground truth.

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

   • Not applicable.

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

   • Not applicable. This device is an electrosurgical system, not an AI diagnostic tool.

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

   • Not applicable. This device is an electrosurgical system, not an AI algorithm.

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

   • Not applicable.

8. The sample size for the training set:

   • Not applicable.

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

   • Not applicable.

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