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Cellinew is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

The CELLINEW generates radiofrequency(RF) energy by means of high RF at 6.78Mhz. The RF energy is delivered through the skin into the target tissue via a handpiece equipped with an electrode tip. As the RF energy passes through the tissue, it generates an electrothermal reaction with is capable of coagulation the tissue. In detail, the main body uses the "reverse thermal gradient" principle to deliver RF energy, and thus, heat is generated and selective coagulation occurs while cooling the epidermis, resulting in denaturation and contraction of collagen fibers.
The CELLINEW Device is a non-invasive device for coagulation using high frequency current. The device consists of a main body, handpiece, two disposable electrodes, a neutral electrode, neutral electrode cable, foot switch(optional) and power cord, and is controlled by software.

The provided text describes the 510(k) summary for the CELLINEW device, but it lacks the specific details required to fully address your request regarding acceptance criteria and a detailed study report. The document states that "No clinical studies were conducted as part of this submission," and the performance testing described focuses on technical aspects and an ex-vivo thermal test.

However, I can extract the available information and highlight what is missing based on your request.

Missing Information:
The document does not provide:

• A formal table of acceptance criteria and reported device performance against those criteria beyond what is inferred from the technical specifications comparison.
• Details on sample size, data provenance, number or qualifications of experts, or adjudication methods for any test set, as no clinical studies were performed.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
• Details on standalone algorithm performance, as this is a physical medical device, not an AI algorithm.
• The type of ground truth used for any clinical performance evaluation.
• Sample size for a training set or how ground truth was established for a training set, as no AI/machine learning component or related training data is mentioned.

Based on the available text, here is the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

A formal table of acceptance criteria and the device's performance against them is not explicitly provided in the document. However, implied acceptance is based on the comparison to a predicate device and technical performance tests.

Here is a summary of the technical specifications and their comparison to the predicate, which serves as an informal set of performance criteria for equivalence:

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

For the performance testing mentioned:

• Sample Size: Not specified for the "thermal testing" on porcine skin.
• Data Provenance: The thermal testing was performed on "porcine skin," indicating an ex-vivo (animal tissue) study, not human data. The country of origin for this data is not specified.

For clinical evidence:

• "No clinical studies were conducted as part of this submission."

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

Not applicable, as no clinical studies were performed and no "ground truth" for diagnostic or treatment outcome accuracy was established in the provided documentation based on human assessment. The "thermal testing" involved demonstrating the device's ability to coagulate tissue, likely measured by technical means rather than expert interpretation of images.

4. Adjudication method for the test set

Not applicable, as no clinical studies or human-interpreted test sets were reported.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The CELLINEW device is an electrosurgical device, not an AI diagnostic or assistance system. No MRMC studies were conducted.

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

Not applicable. This is a physical electrosurgical device; it does not operate as a standalone algorithm in the context of diagnostic or interpretive performance. The software controls the device, and its performance was evaluated via software verification and validation, but not as an "algorithm only" performance study.

7. The type of ground truth used

For the "thermal testing" on porcine skin, the "ground truth" was the observed ability of the device to "coagulate tissue," which is a direct physical effect. This is not comparable to expert consensus, pathology, or outcomes data typically used in diagnostic or screening device evaluations.

8. The sample size for the training set

Not applicable. The device is not an AI/machine learning system that requires a "training set" in the conventional sense.

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

Not applicable. There is no mention of a training set for an AI/machine learning component.

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The SYLFIRM X™ is intended for use in dermatologic procedures for electrocoagulation and hemostasis.

The SYLFIRM X™ includes a system main device, a hand-piece equitable with a bi-polar electrode, and a foot switch. The RF signal is generated from the main device which is then delivered to the handpiece and then to bi-polar electrode. The RF signal is delivered to the target tissue using penetrating needle electrodes in the consumable tip. The bi-polar electrode is placed in light contact with the epidermis while the hand-piece is being held at right angles to the target tissue. As the RF signal passes through the skin, it generates an electro thermal reaction which is capable of coagulating the tissue. Using the consumable tip, SYLFIRM X™ creates heat within the target skin tissue via needle electrodes from the bi-polar electrode.

The provided text describes the Sylfirm X, an electrosurgical cutting and coagulation device. The document is a 510(k) summary submitted to the FDA for market clearance. It doesn't contain information about AI or machine learning algorithms, so there are no acceptance criteria, performance metrics, or study details related to such technologies.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (also Sylfirm X, K200185) for its intended use in dermatologic procedures for electrocoagulation and hemostasis.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert ground truth, or MRMC studies because the provided text is for a medical device that does not involve AI/ML.

However, I can extract information regarding the device's performance testing for general safety and efficacy:

Device Performance Testing (Preclinical):

• Study Design: The study evaluated the safety and effectiveness of SYLFIRM X™ as a radiofrequency (RF) heating device to treat dermal conditions and hemostasis.
• Sample Size: Three (3) Yucatan Mini-pigs were used.
• Observation Periods:
  • Animal G1: Euthanized 3 hours after treatment on Day 1.
  • Animal G2: Euthanized on Day 5.
  • Animal G3: Euthanized on Day 22.
• Findings:
  • Gross Observations: No erythema or edema formation observed within 1-hour post-treatment or at any other scheduled time points on any animals.
  • Microscopic Findings:
    • Animals euthanized on Days 1 and 5: Minimal to moderate, multifocal deep dermal collagen necrosis.
    • Animal euthanized on Day 22: Minimal to mild multifocal deep dermal fibrosis.
• Conclusion: Test results, including histology data, demonstrated that the subject device is substantially equivalent to the predicate devices in the market for its intended use.

Additional Tests Conducted to support substantial equivalence (not AI/ML related):

1. Sterilization Validation Test: Verified sterility assurance level (10-6) for EO sterilization using the biological indicator (BI) overkill method, in accordance with ISO 11135-1, ISO 10993-1, ISO 10993-7, ISO 11138-1, ISO 11138-2, ISO 11737-1, ISO 11737-2, AAMI TIR 15, and ISO 13485:2016.
2. Shelf-life Validation Test: Conducted using the accelerated aging method in accordance with ASTM F1980-07 (2011) and referenced standards ISO 11607-1, ISO 11607-2, ISO 11737-2, ASTM F1929, ASTM F 88, and USPNF.
3. Biocompatibility Test: Performed on the patient-contacting component (J25BM) in accordance with ISO 10993-5, ISO 10993-10, ISO 10993-11, and USP 38 .
4. Software Validation Test: Performed for the device's firmware, which was determined to have a "moderate" level of concern.
5. EMC & Electrical Safety Test: Evaluated according to IEC 60601-1:2005, IEC 60601-1:2012, IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013, IEC 60601-2-2:2017, CISPR 11:2009/AMD1:2010, and IEC 60601-1-2:2014.
6. Verification (for new accessories): Performance tests were done to confirm the same performance for added bi-polar tips (J25BM, J25BS, J18BS).

Note: The document only lists the types of tests performed and their general conclusions (e.g., "demonstrated that the subject device is substantially equivalent"). It does not provide specific numerical acceptance criteria (e.g., "sensitivity must be >X%") or quantitative results. The standard for a 510(k) clearance is to demonstrate substantial equivalence to a predicate device, not necessarily to meet specific quantitative performance benchmarks as would be expected for a novel AI/ML device.

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The SYLFIRM X™ is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

The SYLFIRM X™ includes a system main device, a probe equitable with a consumable tip, and a foot switch. The RF signal is generated from the main device which is then delivered to the probe and then to consumable tip. The RF signal is delivered to the target tissue using penetrating needle electrodes in the consumable tip. The consumable tip is placed in light contact with the epidermis while the probe is being held at right angles to the target tissue. As the RF signal passes through the skin, it generates an electro thermal reaction which is capable of coagulating the tissue. Using the consumable tip, SYLFIRM X™ creates heat within the target skin tissue via needle electrodes from the consumable tip.

The provided text describes the 510(k) summary for the SYLFIRM X™ device, which is an electrosurgical cutting and coagulation device and accessories. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm-driven device for diagnostic or prognostic purposes, which is what your query implies with terms like "ground truth," "multi reader multi case," and "standalone performance."

Instead, the document focuses on demonstrating substantial equivalence to predicate devices for a radiofrequency heating device used in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The "performance data" section details various preclinical tests and validations required for this type of medical device, such as:

• Sterilization validation test: To verify sterility assurance level (10-6) for EO sterilization using the biological indicator (BI) overkill method, in accordance with ISO 11135-1, ISO 10993-1, ISO 10993-7, ISO 11138-1, ISO 11138-2, ISO 11737-1, ISO 11737-2, AAMI TIR 15, and ISO 13485:2016.
• Shelf-life validation test: Conducted using the accelerated aging method in accordance with ASTM F1980-07 (2011), ISO 11607-1, ISO 11607-2, ISO 11737-2, ASTM F1929, ASTM F 88, and USPNF.
• Biocompatibility test: For the patient-contacting consumable tip, in accordance with ISO 10993-5, ISO 10993-7, ISO 10993-10, ISO 10993-11, and USP 39 .
• Software validation test: For software (firmware) of moderate level of concern.
• EMC & Electrical safety test: Per IEC 60601-1:2005, IEC 60601-1:2012; IEC 60601-1-6:2010, IEC 60601-1-6:2010/AMD1:2013; IEC 60601-2-2:2017, CISPR 11:2009/AMD1:2010, IEC 60601-1-2:2014.
• Preclinical (Animal) test: Three Yucatan Mini-pigs were used to evaluate safety and effectiveness as an RF heating device to treat dermal conditions and hemostasis. Animals were euthanized at different time points (3h, Day 4, Day 21). Microscopic findings included minimal to moderate, multifocal deep dermal collagen necrosis and minimal to mild multifocal deep dermal fibrosis.

None of the provided information aligns with the specific points you requested for an AI/algorithm-driven device (e.g., acceptance criteria for diagnostic accuracy, sample size for AI test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details). The SYLFIRM X™ is a physical medical device, not an AI software intended for diagnosis or prediction.

Therefore, I cannot provide the requested table and details based on the given document as it describes a different type of device validation.

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The SCARLET SRF is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

The SCARLET SRF includes a system main device, a hand-piece equipped with a tip, and a footswitch. The RF signal is generated from the main device which is then delivered to the handpiece and then to consumable tip. The RF signal is delivered to the target tissue using penetrating needle electrodes in the tip. The tip is placed in light contact with the epidermis while the handpiece is being held at right angles to the target tissue. As the RF signal passes through the skin, it generates an electro thermal reaction which is capable of coagulating the tissue. Using the consumable tip, SCARLET SRF creates heat within the target skin tissue via needle electrodes from the consumable tip.

The provided document is a 510(k) summary for the SCARLET SRF device, an electrosurgical cutting and coagulation device. This type of FDA submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical efficacy studies with specific acceptance criteria as you might see for novel devices.

Therefore, the information you've requested about acceptance criteria and a study proving the device meets those criteria, particularly in the context of diagnostic performance (e.g., sensitivity, specificity, F1 score), MRMC studies, or multi-reader ground truth establishment, is not present in this document. The document describes pre-clinical performance testing related to safety and foundational operational aspects.

However, I can extract the information that is available about the performance data.

Here's the breakdown of the information provided in the document:

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

The document does not provide a formal table of "acceptance criteria" and "reported device performance" in the traditional sense of diagnostic or clinical outcome metrics. Instead, it lists various performance tests and states that the device "met the pre-set criteria" or that "all results were passing."

Important Note: The "acceptance criteria" here are largely inferred from the testing standards and the statement that the tests were successful. They are not quantifiable performance metrics like accuracy, sensitivity, or specificity.

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

• Test Set Sample Size:
  • Preclinical Animal Study: Three (3) Yucatan Mini-pigs.
  • For other tests (Sterilization, Shelf-life, Biocompatibility, EMC, Electrical Safety, Max Output Energy, Software), the specific sample sizes are not explicitly stated for each test, but standard procedures for these tests would involve appropriate sample sizes of the device/components.
• Data Provenance: The document does not specify the country of origin for the data (e.g., where the animal study was conducted, or where the other tests were performed). It is presumed to be conducted by or for VIOL Co., Ltd., based in South Korea, or their designated testing facilities.
• Retrospective/Prospective: The preclinical animal study was prospective in design (monitoring animals over time after treatment). Other tests are typically prospective (i.e., conducted anew for this device).

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 in the document. The preclinical animal study involved histopathology evaluation, which would typically be performed by veterinary pathologists, but the number or qualifications of these experts are not mentioned. For the other technical tests, "ground truth" as you might define it for AI or diagnostic devices does not directly apply; rather, it's about adherence to engineering standards and objective measurements.

4. Adjudication method for the test set

This information is not provided and is generally not applicable to the types of technical and preclinical (animal) tests described in this 510(k) summary. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessment where discrepancies between readers need to be resolved for ground truth establishment.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done and is not described. This type of study is relevant for AI-powered diagnostic devices comparing human performance with and without AI assistance, which is not the nature of the SCARLET SRF device.

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

No, a standalone algorithm-only performance study was not done and is not described. The SCARLET SRF is an electrosurgical device, not an AI or diagnostic algorithm, so this type of study is not applicable.

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

• For the Preclinical Animal Study: Histopathology evaluation was used to assess the tissue changes.
• For other engineering and safety tests: The "ground truth" is adherence to established international and national standards (e.g., ISO, ASTM, IEC, EN, USP) and the device's own pre-set design specifications. This is based on objective measurements and standard compliance.

8. The sample size for the training set

This information is not applicable and not provided. The SCARLET SRF is an electrosurgical device; it does not involve machine learning algorithms that require a "training set" in the context of AI development.

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

This information is not applicable as there is no "training set" for this device in the context of AI.

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The CELFIRM™ is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

The CELFIRM™ includes a system main device, a hand-piece equipped with a tip, and a footswitch. The RF signal is generated from the main device which is then delivered to the hand-piece and then to consumable tip. The RF signal is delivered to the target tissue using penetrating needle electrodes in the tip. The tip is placed in light contact with the epidermis while the hand-piece is being held at right angles to the target tissue. As the RF signal passes through the skin, it generates an electro thermal reaction which is capable of coagulating the tissue. Using the consumable tip, CELFIRM™ creates heat within the target skin tissue via needle electrodes from the consumable tip.

The provided text describes a 510(k) premarket notification for the CELFIRM™ device, which is an electrosurgical cutting and coagulation device. The document primarily focuses on demonstrating substantial equivalence to a predicate device (INFINI Radiofrequency System) through various non-clinical performance tests.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria with corresponding performance metrics for the CELFIRM™ device. Instead, it describes various non-clinical tests conducted and generally states that the "test results met the pre-set criteria" or that the device is "substantially equivalent."

However, we can infer some criteria and reported performance from the "Performance Tests (Non-clinical)" section:

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

• Sample Size for Test Set: The document explicitly mentions "Yucatan Mini-pigs" for the preclinical (animal) test. However, it does not specify the number of mini-pigs used as the sample size. It refers to "Animal were euthanized 3 h after application on Day 1, Day 4, and Day 22," implying multiple animals or multiple applications on different animals over time points, but no precise count is given. For other tests (sterilization, shelf-life, biocompatibility, software, EMC/electrical safety, max output energy), the sample sizes of the components or units tested are not specified.
• Data Provenance: The preclinical animal study was conducted as part of the device's development by VIOL Co., Ltd., based in South Korea. Therefore, the data provenance is likely prospective (generated specifically for this submission) and from South Korea (or the location where the animal study was conducted under the company's purview).

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

The document does not provide any information regarding the number or qualifications of experts used to establish a "ground truth" for the test set. The evaluation of test results (e.g., histology data from the animal study) would implicitly involve experts (e.g., veterinary pathologists), but these details are not provided.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set. The results appear to be based on direct measurements and observations from the non-clinical tests.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a non-clinical evaluation of the device's safety and performance characteristics, primarily against standards and a predicate device. It does not involve human readers interpreting cases with or without AI assistance.

6. Standalone Performance Study

Yes, the studies described are essentially standalone evaluations of the algorithm/device (CELFIRM™) without a human-in-the-loop performance component in the context of diagnostic interpretation. The tests assess the device's physical, electrical, and biological effects independently.

7. Type of Ground Truth Used

For the preclinical animal test, the ground truth was established through:

• Direct observation of tissue responses (erythema, necrosis).
• Histology data (microscopic examination of tissue samples).

For other tests (sterilization, shelf-life, biocompatibility, EMC/electrical safety, max output energy), the ground truth is based on established scientific and engineering standards and specifications (e.g., ISO, ASTM, IEC, EN standards).

8. Sample Size for the Training Set

The document does not mention any training set or machine learning model. The CELFIRM™ is an electrosurgical device, not an AI or imaging device that would typically involve a "training set" in the context of machine learning. The studies described are hardware and bio-compatibility related.

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

As there is no mention of a training set or machine learning in the provided document, this question is not applicable.

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