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Mjolnir Pro. With single-electrode plasma tip is used in the removal and destruction of skin lesions and coagulation of tissue.

Mjolnir Pro. With Multi-electrode plasma tip is intended for use in dermatologic and general surgical procedures for coagulation and hemostasis.

Mjolnir Pro. With single-electrode plasma tip is used in the removal and destruction of skin lesions and coagulation of tissue. With Multi-electrode plasma tip is intended for use in dermatologic and general surgical procedures for coagulation and hemostasis. Under the controllable way, the device utilizes a treatment method called plasma sublimation, which causes controlled skin damage through the generation of an electrical arc. The arc between the electrode tip and the skin is created by a radio frequency generator housed in an electrosurgical unit (handpiece) that ionizes the gas particles in the air. A straight active electrode made of 316 stainless steel is available with the system.

The provided document describes the Mjolnir Pro. (Multi-electrode plasma) device and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of clinical performance or diagnostic accuracy.

The document focuses on demonstrating substantial equivalence based on:

• Intended Use and Technological Characteristics Comparison: Highlighting similarities in indications for use, product code, classification regulation, mode of operation, and maximum output power with predicate devices (pages 6-7).
• Non-Clinical Testing: Including compliance with electrical safety (ANSI/AAMI ES60601-1, IEC 60601-2-2), EMC (IEC 60601-1-2), and biocompatibility (ISO 10993-5, ISO 10993-10, ISO 10993-23) standards.
• Performance Testing for Tissue Thermal Effect: "The tests were conducted on freshly ex vivo pig tissue. Histological evaluation with Hematoxylin-Eosin (H&E) demonstrated the tissue damages by the subject device are less than 0.25mm, which is considered superficial and substantially equivalent to the tissue damages." (page 9)
• Software Verification and Validation Testing: Conducted per FDA guidance, with a moderate level of concern (page 9).

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details on sample sizes for test sets (as no clinical test set for diagnostic accuracy or clinical effectiveness is mentioned), number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, or ground truth types related to a clinical study demonstrating performance against specific clinical acceptance criteria.

The document's scope is primarily a non-clinical evaluation to support substantial equivalence for a 510(k) submission for an electrosurgical device, not a clinical trial with performance metrics like sensitivity, specificity, accuracy, or reader agreement.

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PLAXPOT™ MULTI PLASMA is intended for the removal and destruction of skin lesions and coagulation of tissue.

PLAXPOT™ MULTI PLASMA is a device that consists of a handpiece which is the main body and a charger (charging cradle, and power adapter). The high frequency current is exposed to the air and the air is ionized. The electrode tip can perform treatment without direct contact with the tissue. After the power is applied through the internal battery, the mode is set and the Shot button is pressed, a high voltage alternating current pulse is released according to the set value, and the air is ionized to form a plasma arc. This device uses plasma energy. This causes excess skink and sublimate (direct passage from the solid to the gaseous state of matter) without affecting the deeper skin layers. The difference in potential distance between device's handpiece and the skin represents the area where the voltaic arc will take place. In this gap, the gases in the air are ionized, thus Plasma is generated. The tissues touched by plasma "sublime" without heat transfer to other unwanted tissues.

The provided text is an FDA 510(k) clearance letter and an associated 510(k) summary for the PLAXPOT™ MULTI PLASMA device. This documentation primarily focuses on establishing "substantial equivalence" of the device to legally marketed predicate devices, rather than a detailed study proving the device's clinical performance against specific acceptance criteria for a novel AI/ML device.

Therefore, the document does not contain information regarding acceptance criteria for an AI/ML device, nor does it describe a study that proves the device meets such criteria. The device in question, an electrosurgical device, is not an AI/ML product.

The 510(k) summary (specifically sections 5.8 and Table 2) outlines performance bench tests designed to demonstrate the device's functional requirements and safety as an electrosurgical device, but these are not the type of studies (e.g., MRMC, standalone AI performance) you've inquired about for AI/ML device validation.

Here's an explanation of why the requested information is not present based on the provided text:

• Acceptance Criteria for AI/ML Performance: The document does not mention any AI/ML components. The device operates on the principle of generating plasma through high-frequency current to remove/destroy skin lesions and coagulate tissue. Its "Performance Testing" relates to electrical safety, EMC, and thermal effects, which are standard for electrosurgical devices, not AI/ML performance metrics like sensitivity, specificity, AUC, or F1-score.
• Study Proving Device Meets Acceptance Criteria: No study in the document describes the formal validation of an AI/ML algorithm against specified performance thresholds. The "Performance Testing" section mentions "bench tests" and "functional requirements," which are engineering and electrical safety checks, not clinical performance studies for an AI/ML diagnostic or therapeutic aid.
• Table of Acceptance Criteria and Reported Performance: No such table exists for AI/ML performance. The table (Table 2) lists "Performance Testing Summary" for bench tests with "Pass" results, indicating compliance with electrical safety and other engineering standards.
• Sample Size for Test Set and Data Provenance: Not applicable as there's no AI/ML test set defined.
• Number of Experts and Qualifications for Ground Truth: Not applicable, as there's no AI/ML ground truth generation process described.
• Adjudication Method: Not applicable.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned, as it's not an AI/ML device requiring human-in-the-loop performance evaluation.
• Standalone (Algorithm Only) Performance: Not applicable, as there's no standalone algorithm.
• Type of Ground Truth Used: Not applicable.
• Sample Size for Training Set: Not applicable.
• How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided document details the FDA clearance process for an electrosurgical device (PLAXPOT™ MULTI PLASMA) based on substantial equivalence to existing predicate devices. It covers safety, electrical standards, and intended use as an electrosurgical device, but it does not contain any information about an AI/ML component or studies related to AI/ML device performance.

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JETT PLASMA Medical II is used in the removal and destruction of skin lesions and coagulation of tissue.

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I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance.

The document is an FDA 510(k) clearance letter for the "JETT PLASMA Medical II" device. It primarily discusses:

• The FDA's determination of substantial equivalence to a predicate device.
• Regulatory requirements the manufacturer must follow.
• The indications for use of the device: "removal and destruction of skin lesions and coagulation of tissue."

It does not include:

• A table of acceptance criteria or reported device performance metrics.
• Details on specific studies, sample sizes, data provenance, or ground truth establishment.
• Information about expert adjudication, MRMC studies, or standalone algorithm performance.

To provide the information you've requested, I would need a different type of document, such as a clinical study report, a performance validation report, or a summary of safety and effectiveness from the 510(k) submission itself (which often contains more technical details than the clearance letter).

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The Plasma MD or Plasma + is intended for the removal and destruction of skin lesions and coagulation of tissue.

The Plasma Pen utilizes a treatment method called plasma sublimation, which causes controlled skin damage through the generation of an electrical arc. The arc between the disposable tip and the skin is created by a radio frequency generator housed in an electrosurqical unit (handpiece) that ionizes the gas particles in the air. A straight disposable tip is available with the system. The handheld device is cordless and is charged in a docking/charging station prior to use.

The system components include the following:

1. Plasma Pen (Plasma MD (with 2 level switch) and Plasma+ (without switch)
2. Docking station for Plasma Pen
3. Cable for Plasma Pen
4. Power bank battery
5. Cable for power bank battery
6. Charging Block

The provided text describes a 510(k) premarket notification for the Plasma Pen (Plasma MD and Plasma +) device. It details the device's characteristics, its intended use, and a comparison to a predicate device to establish substantial equivalence. However, the document does not contain the specific information requested regarding acceptance criteria, a study that proves the device meets those criteria, or details about test sets, ground truth establishment, or expert involvement.

The document focuses on demonstrating substantial equivalence to an existing predicate device (SubNovii Advanced Plasma Technology, K201738) based on similar indications for use, mode of operation, and performance characteristics. The "performance data" mentioned refers to non-clinical bench testing, not a clinical study involving human patients or complex AI-driven analysis.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be extracted from the provided text:

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

The document doesn't explicitly state "acceptance criteria" in the format of a clinical study with metrics like sensitivity, specificity, or AUC. Instead, it compares characteristics and performance benchmarks against a predicate device to claim substantial equivalence. The closest to "acceptance criteria" are the "SAME" or "DIFFERENT" conclusions for various characteristics and the damage depth for thermal effects.

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

• Sample size for bench testing: Not specified. The thermal effects testing mentions "4 porcine tissues," but not the number of samples or repetitions.
• Data provenance: Not applicable in the context of clinical data for AI performance. The performance testing is "bench/performance testing" and involves "porcine tissues" for thermal effects, not human data.

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

• Not applicable. This device is an electrosurgical tool, not an AI-driven diagnostic device requiring expert interpretation for ground truth. The "ground truth" for its performance is derived from physical measurements (e.g., damage depth, electrical safety compliance) and comparison to a predicate device's established performance.

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

• Not applicable. No expert adjudication process for image interpretation or diagnosis.

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. This is not an AI-assisted diagnostic device. The study described is non-clinical bench testing.

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

• No. This is a hardware device.

7. The type of ground truth used:

• Bench test measurements and compliance with electrical safety standards. For thermal effects, the ground truth is the measured damage depth in porcine tissues. For electrical safety, the ground truth is compliance with the specified IEC standards. Substantial equivalence relies on comparing these performance characteristics to the predicate device.

8. The sample size for the training set:

• Not applicable. This device does not involve machine learning or AI that requires a training set.

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

• Not applicable. No training set for AI.

In summary, the provided document describes a 510(k) submission for an electrosurgical device, focused on demonstrating substantial equivalence based on physical characteristics and non-clinical bench testing. It does not involve an AI component or complex clinical study with human patients, which are the typical contexts for the detailed acceptance criteria and study designs outlined in your request.

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