Search Results

Secret RF Smartcure applicator is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis

Secret RF's High Frequency(=Radio Frequency) includes the system main body, a handpices with singleuse micro-needle type electrodes, footswitch and an LCD touch screen control panel.

The HF energy is delivered to the target tissue using a handpiece and disposable tip(micro needle electrode tip), the tip being placed in light contact with the epidermis and the handpiece being held at right angles to the target tissue. As the HF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating the tissue. Using the micro needle tip, the Secret RF system creates heat within the target dermal tissue via micro-needles inserted from the tip.

The Secret RF is consists of ;

• 1. Secret RF main unit (FDA cleared K170325)
• 2. Bipolar type handpieces with Bipolar type micro-needle electrodes (FDA cleared K170325)
• 3. Secret RF Smartcure applicator

The Secret RF Smartcure Applicator consists of :

• Smartcure handpiece
• Monopolar type micro-needle electrodes (MTR-AC-01 , MTR-AC-04, MTR-AC-27G, K3i)

The provided text describes a 510(k) premarket notification for the "Secret RF Smartcure Applicator" and details its substantial equivalence to predicate devices, but it does not contain information on acceptance criteria and a study proving the device meets those criteria in the context of clinical performance or effectiveness data (e.g., sensitivity, specificity, accuracy).

The document focuses on:

• Regulatory Clearance: Affirming that the device is substantially equivalent to legally marketed predicate devices for dermatologic and general surgical procedures for electro-coagulation and hemostasis.
• Technical Specifications: Comparing the proposed device's technical characteristics (e.g., frequency, max power, RF duration, electrode type) with a predicate device (SecretRF K170325) and two reference devices (AGNES K160469, EVRF K112334).
• Performance Data (Non-Clinical/Pre-Clinical): Listing performed tests, which are primarily related to safety, electrical compatibility, and basic functionality:
  • Biocompatibility testing (ISO10993-1;2009)
  • Electrical safety and essential performance (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2: 2009)
  • Animal testing (micropig models for histological data on ablation and thermal damage depth and zone at various post-treatment intervals and intensities).

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance related to clinical outcomes or diagnostic accuracy, as this information is not present. The "performance data" listed refers to design verification and validation testing for safety and basic function, not clinical efficacy or diagnostic performance metrics.
2. Sample size used for the test set and data provenance: Not mentioned, as no clinical effectiveness study is described.
3. Number of experts and their qualifications for ground truth: Not applicable, as no ground truth for labeling or diagnosing clinical conditions is discussed.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted or reported. The document explicitly states the device's substantial equivalence is based on similarities to predicate devices and performance testing related to safety and functionality.
6. Standalone performance (algorithm only): Not applicable, as this is a physical medical device, not an AI algorithm.
7. Type of ground truth used: Not applicable in the context of clinical performance data. The animal study used histological data as an endpoint for depth and zone of ablation/thermal damage.
8. Sample size for the training set: Not applicable, as this is not an AI/machine learning device.
9. How ground truth for the training set was established: Not applicable.

However, based on the provided text, I can infer a type of "acceptance criteria" related to regulatory compliance and safety, and report the "performance" in terms of meeting these standards.

Inferred Acceptance Criteria and Reported Performance (based on regulatory and safety compliance):

Study Description (as reported in the document):

The document references several types of studies performed as part of the 510(k) submission, primarily for demonstrating safety and substantial equivalence, rather than clinical efficacy or diagnostic performance.

1. Biocompatibility Testing:

   • Description: Testing of patient contact components and materials.
   • Standard: ISO 10993-1:2009.
   • Data Provenance: Not specified, but generally performed in a lab setting.
   • Sample Size: Not specified (refers to materials, not patients).
   • Ground Truth: Adherence to the ISO standard.

2. Non-Clinical (Engineering/Safety) Testing:

   • Description: Evaluation of the device's electrical safety, essential performance, and electromagnetic compatibility.
   • Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2: 2009.
   • Data Provenance: Not specified, but generally performed in a lab setting.
   • Sample Size: Not specified (typically tests on a device unit).
   • Ground Truth: Compliance with the respective IEC standards.

3. Animal Testing:

   • Description: In vivo study to obtain histological data on depth and zone of ablation and thermal damage.
   • Species: Micropig models.
   • Purpose: To assess immediate, 7-day, and 14-day post-treatment effects.
   • Data Provenance: Animal study. Country of origin not specified.
   • Sample Size: Not specified (number of micropigs or treatment sites).
   • Ground Truth: Histological analysis of tissue samples.
   • Experts: Not specified, but typically includes pathologists.
   • Adjudication: Not specified.

Missing Information:

Crucially, the document explicitly states this is a substantial equivalence determination for a medical device. For such submissions, extensive clinical efficacy studies with predefined acceptance criteria for patient outcomes (like those you’d expect for an AI diagnostic device's sensitivity/specificity or a pharmaceutical drug's effectiveness) are often NOT required if the device is sufficiently similar to legally marketed predicate devices. The focus is on ensuring basic safety and functional equivalence.

Therefore, the requested details related to clinical performance metrics, ground truth establishment for a diagnostic output, training sets, or human-AI comparative effectiveness studies are not present in this regulatory summary because they were likely not part of the 510(k) submission for this type of device.

Ask a specific question about this device

SECRET RF is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis.

Secret RF's High Frequency(=Radio Frequency) includes the system main body, a bipolar handpiece(Two type) with disposable micro-needle type electrodes, footswitch and an LCD touch screen control panel. The HF energy is delivered to the target tissue using a handpiece and disposable tip(micro needle electrode tip), the tip being placed in light contact with the epidermis and the handpiece being held at right angles to the target tissue. As the HF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating the tissue. Using the micro needle tip, the Secret RF system creates heat within the target dermal tissue via micro-needles inserted from the tip.

The provided text describes a 510(k) summary for a medical device called "Secret RF". This document focuses on demonstrating substantial equivalence to a predicate device, "FRAXIS DUO_RF PART" (K160312), rather than providing detailed acceptance criteria and studies for independent device performance.

Therefore, many of the requested categories cannot be directly addressed from this document because it's a submission for substantial equivalence based on similar technology and intended use, not a clinical trial evaluating specific performance metrics against pre-defined acceptance criteria.

However, I can extract information related to the device's technical specifications and the non-clinical testing performed to establish safety and effectiveness for a 510(k) submission.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the "performance" demonstrated is that the device's technological characteristics and non-clinical test results are comparable or compliant with established standards, supporting its substantial equivalence to the predicate device.

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

• Non-Clinical Testing (IEC Standards): Not applicable for "sample size" in the conventional sense of a clinical test set. These are engineering and electrical safety tests typically performed on a device unit.
• Animal Testing: Micropig models were used. The document does not specify the number of animals (sample size).
• Data Provenance: The document implies these tests were conducted by the manufacturer or accredited labs for the purpose of the 510(k) submission. No country of origin for the "test set" data is explicitly stated beyond the manufacturer being in Korea. The animal study results are not presented in a way that would indicate retrospective or prospective, but animal studies for regulatory submissions are typically prospective.

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

This is not applicable to the non-clinical and animal testing described. Ground truth in a clinical context (e.g., expert consensus on image interpretation) is not part of this 510(k) summary, which focuses on device safety and technical equivalence. The animal study generated histological data, which would typically be analyzed by veterinary pathologists, but this detail and the number of experts are not provided.

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

This is not applicable. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple human readers, which is not described here.

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 510(k) submission for a non-AI electrosurgical device, not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device is an electrosurgical tool, not an algorithm. Its performance is directly tied to its physical and electrical characteristics and how it interacts with tissue.

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

• For Non-Clinical Testing (IEC standards): "Ground truth" is compliance with the defined parameters and limits of the specific international standards (e.g., electrical safety, EMC).
• For Animal Testing: The ground truth for evaluating tissue effects was histological data obtained from micropig models, presumably interpreted by pathologists.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

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

Ask a specific question about this device