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The PLASONIC with PLAPASS handpiece (Radiofrequency) is intended for the removal and destruction of skin lesions and coagulation of tissue.

The PLASOINC with SONOPASS handpiece (Ultrasound) is intended for pain relief, reduction of muscle spasms, localized increase in blood flow, increase range of motion of contracted jointed using heat and stretch techniques.

The device is an instrument used for tissue coagulation by means of high-frequency current. It consists of the main unit, two handpieces, foot switch, LCD touchscreen and power cable.

The PLASONIC has two systems (two handpieces) :

• 1. Radiofrequency (PLAPASS Handpiece) The device is intended for the removal and destruction of skin lesions and coagulation of tissue. The system is intended for use by trained healthcare professionals in a clinical setting to provide controlled radiofrequency therapy through non-invasive procedure.
• 2. Ultrasound (SONOPASS Handpiece)

The device is intended for pain relief, reduction of muscle spasms, localized increase in blood flow, increase range of motion of contracted jointed using heat and stretch techniques. The device is designed to deliver therapeutic ultrasound waves, promoting tissue relaxation and aiding in the recovery process for improved patient well-being

The provided text describes a 510(k) submission for a medical device called "PLASONIC." It does not contain information about the acceptance criteria or a study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on non-clinical tests.

Therefore, I cannot provide the requested table or answer questions about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as this information is not present in the given text.

The text does state the following regarding studies:

• Non-clinical tests:
  • Compliance with several IEC and ISO standards for electrical safety, electromagnetic compatibility, usability, software lifecycle processes, and risk management (listed in section 7).
  • An ex vivo model study where handpieces were applied to analyze temperature change via thermal imaging, and tissue coagulation length, width, and depth via photography and histological evaluation.
• Clinical tests: "No clinical test was performed."

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The SILKRO with RM. RN. RC. RV. PS handpieces is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis.

The SILKRO with RN handpieces is intended for the removal and destruction of skin lesions and coagulation of tissue.

This device is an instrument used for tissue coagulation by means of high-frequency current. It consists of the main unit, five handpieces, GP Cable, foot switch, LCD touch screen, ground pad and power cable.

The SILKRO has two operating modes: monopolar mode and bipolar mode. In the monopolar mode. RF energy flows from the main unit and a patient loop is formed by pairing the active electrode tip with the neutral electrode pad. Heat is not generated in the neutral electrode pad due to its low contact resistance, but heat is generated in the active electrode tip which has higher contact resistance. The higher contact resistance heats up the tissue resulting in coagulation. In the bipolar mode, RF energy is delivered between adjacent needles in the electrode tip without use of the neutral electrode pad. The user can select the mode and adjust parameters through the touch screen user interface of electrosurgical device.

RF(HF) enerqy is delivered to the target tissue using a handpiece (RM, RN, RC, RV, PS) and 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 RF(HF) energy passes through the skin, it generates an electro RF reaction which is capable of coagulating the tissue.

• Electrosurgical Unit Main body
• Five different handpieces
• Neutral electrode pad and neutral electrode pad cable, cleared under K092761
• Handpiece stands
• Foot switch
• Power cord

I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) summary for a medical device (SILKRO), primarily focusing on demonstrating substantial equivalence to predicate devices based on technological characteristics and adherence to various safety and performance standards. It mentions non-clinical ex vivo animal testing for histological data but does not present this data as acceptance criteria or a study proving device performance against such criteria. The document explicitly states, "No clinical test was performed."

Therefore, I cannot extract the requested information.

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This device is intended for use in dermatologic and general surgical procedures for electro-coagulation.

This device is an instrument used for tissue coagulation by means of high-frequency current. It consists of the main unit, Four handpieces, GP Cable, foot switch, LCD touchscreen, ground pad and power cable. The SILKRO has two operating modes: monopolar mode and bipolar mode.

The provided text does not contain information about acceptance criteria and reported device performance from a clinical study for the SILKRO device. Instead, it focuses on non-clinical tests and a comparison of technological characteristics with predicate devices to demonstrate substantial equivalence for regulatory clearance.

Specifically, the document lists:

• Non-clinical tests submitted (Section 7): These are primarily related to electrical safety, electromagnetic compatibility, usability, risk management, software validation, and biocompatibility, conducted according to various IEC and ISO standards.
• Ex vivo animal testing (Section 7): This was conducted to evaluate the thermal effect of the handpieces on tissue, observing depth and zone of coagulation and thermal damage.
• Biocompatibility testing (Section 8): Confirmed that materials met biocompatibility requirements for skin contact, following ISO 10993 standards.
• Sterilization and shelf-life testing (Section 9): Demonstrated a sterility assurance level and a three-year shelf-life through accelerated aging tests.

Therefore, I cannot provide the requested information for the following points as they are not present in the given text:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The document's conclusion (Section 11) states that "Results of performance testing demonstrated substantial equivalence of the subject device to the predicate," but it refers to the non-clinical tests mentioned earlier, not a clinical study involving human patients or a complex diagnostic performance evaluation.

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The PICOHI is indicated for the following at the specified wavelength:

• · 1064nm: Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.
• · 532nm: Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
• · Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

The PICOHI is a solid-state laser capable of delivering energy at wavelengths of 1064nm, 532nm at extremely short duration in the range of 275-300ps. The laser system contains one 1064nm (Nd:YAG) laser head which is used to create the 1064nm picosecond wavelength which can be frequency-doubled to 532nm as desired. The outputs of the two lasers are designed to be colinear on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either the 1064nm or 532nm wavelengths. All these energies are delivered through an articulated arm and corresponding handpiece.

The provided text is a 510(k) summary for the PICOHI laser device. It does not present any clinical study data or acceptance criteria for AI/ML performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device (PICOWAY) primarily through non-clinical testing and a comparison of technological characteristics.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study that proves the device meets those criteria, specifically regarding AI/ML performance, because the document explicitly states:

"8. Clinical tests submitted - 807.92(b)(2) No clinical performance testing was performed." (Page 7)

And the entire document is about a laser surgical instrument, not an AI/ML device.

To address your prompt based on the provided document:

The acceptance criteria and study proving the device meets them, as presented in this 510(k) submission, are centered on non-clinical performance and a comparison to a predicate device, not on AI/ML.

Here's a breakdown of what the document does provide regarding the device's acceptance (which is substantial equivalence through non-clinical means):

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):

The acceptance criteria are implied by the standards and characteristics the device must meet to be deemed substantially equivalent to the predicate. The "reported device performance" is essentially that the device passed these non-clinical tests and exhibits comparable technological characteristics.

• Wavelength: 532/1064 nm (Same)
• Max. Fluence: 16.00 J/cm² (PICOHI) vs. 12.5 J/cm² (PICOWAY) - Different, but deemed acceptable for substantial equivalence.
• Pulse Width: 275-300 ps (PICOHI) vs. 375-450 ps (PICOWAY) - Different, but deemed acceptable for substantial equivalence.
• Max. Repetition: 10 Hz (Same)
• Spot Size: 1.5-13 mm (PICOHI) vs. 2-10 mm (PICOWAY) - Different, but deemed acceptable for substantial equivalence.
• Rated Input: 220-240 VAC, 50/60 Hz, 20 A (PICOHI) vs. 200-240 VAC, 50/60 Hz, 30 A (PICOWAY) - Different, but deemed acceptable for substantial equivalence. |
  | Intended Use & Indications for Use: Same as/similar to predicate. | Same intended use; similar indications for use, with PICOHI having a slightly narrower range of indications (e.g., no 730/785nm wavelengths, no acne scar or wrinkle treatment indications as listed for predicate). |

2. Sample Size for Test Set and Data Provenance:

• Sample Size: Not applicable in the traditional sense of a clinical trial or AI/ML test set. The "test set" for this device's acceptance consists of the device itself undergoing various laboratory and engineering tests (bench testing, electrical safety, EMC, software V&V, etc.). No patient samples were used for performance evaluation for this 510(k).
• Data Provenance: Not applicable as no clinical or patient data was used for performance testing. The "data" comes from the results of the non-clinical engineering and safety tests conducted on the device.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Experts: Not applicable. Ground truth, in the context of an AI/ML device, is established by human experts or definitive diagnostic tests. For this laser device, the "ground truth" for its safety and performance is established by its adherence to recognized engineering standards and a comparison of its physical and operational characteristics to a legally marketed predicate device.
• Qualifications: Not specified, as it's not a human-data-driven evaluation. The experts performing the non-clinical tests would be engineers, physicists, and quality assurance personnel with expertise in medical device safety and performance testing.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. There's no human interpretation or disagreement on results to adjudicate in the context of the non-clinical tests described. The results are quantitative measurements against defined standards.

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

• MRMC Study: No, there was no MRMC comparative effectiveness study, as this is not an AI/ML device, and no clinical data was submitted for performance evaluation.

6. Standalone (Algorithm Only Without Human-in-the Loop) Performance:

• Standalone Performance: Not applicable. This is a physical laser device, not an AI/ML algorithm.

7. Type of Ground Truth Used:

• Ground Truth: For this type of device and submission, the "ground truth" for acceptance is successful completion of non-clinical engineering and safety standards (e.g., IEC standards) and a demonstration of substantial equivalence in technological characteristics and intended use to a predicate device.

8. Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This device does not use an AI/ML algorithm that requires a training set.

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

• Ground Truth Establishment for Training Set: Not applicable, as there is no AI/ML training set.

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The SLIMUS is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, and thighs.

Vibrator installed inside each hand-piece and operable only in non-laser output condition is intended for relief from minor muscle aches and pains.

The SLIMUS device incorporates a laser system that emits a 1060 nm wavelength using a diode laser. Laser radiation is emitted from the laser main unit to the device's handpieces through the handpiece fibers. The device is used to noninvasively reduce the size of the waist of overweight patients with a Body Mass Index (BMI) of less than 30 (kg/m²). A vibrator function is installed inside of each hand-piece and operable only in non-laser output mode. The device's handpieces are fixed to a belt which then combined provide mechanical vibration to the patient in order provide relief from minor muscle aches and pains.

This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It is a 510(k) premarket notification summary for the SLIMUS device, primarily demonstrating its substantial equivalence to a predicate device (SculpSure™).

Specifically, the document states in section 8: "No Clinical performance testing was performed." This means there isn't a study proving the device's performance against specific acceptance criteria in a clinical setting provided in this document.

Therefore, I cannot provide the requested information in the table or answer the questions related to clinical study design, as no such study is presented in this document. The provided text focuses on non-clinical testing and technological comparisons to establish substantial equivalence.

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Main Hand Piece For use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue, Treatment of back acne Treatment of atrophic acne scars Treatment of facial wrinkles Treatment of mild to moderate acne vulgaris Treatment of Sebaceous Hyperplasia

Radio Frequency Hand piece The RF Hand piece energy is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.

A-FIT consists of Laser diode and high-frequency (RF) stimulator. It can be used for incision, destruction and removal of skin tissue by illuminating a 1450 nm wavelength laser on the skin tissue. In addition, the RF energy can be used to relieve pain.

Laser surgical unit, diode: Specifically, a 1450 nm wavelength laser is absorbed into the skin to be transformed into thermal energy, which then induces incision, destruction and removal of skin tissues. Laser is sent out through the power unit equipped inside the Main Body to oscillate the laser diode, and the user uses the touch LCD in the Main Body to set the output parameters while controlling laser radiation through the foot switch. At this point, a coolant is sprayed from the end of the hand piece to protect skin from the heat generated by the radiated laser, resulting in a reduction in skin irritation and pain.

Electrosurgical system, general-purpose: The operating concept of the electrosurgical unit is to let the high frequency (RF) energy flow through the electrodes of the hand piece to use the load or heat generated by contact resistance, resulting in a coagulant activity on the cell tissues.

The provided text is a 510(k) Summary for the A-FIT device, which combines a laser and radiofrequency (RF) handpiece. This document focuses on demonstrating substantial equivalence to predicate devices based on technical characteristics and adherence to performance standards, rather than presenting a clinical study with detailed acceptance criteria and performance metrics for specific clinical indications.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be fully extracted in the way typically found in a clinical trial report. However, I can summarize the information provided about the device's performance data and its regulatory compliance.

Here's a breakdown of what can be gathered from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with numerical performance metrics for the device's clinical efficacy (e.g., success rate for acne treatment). Instead, it states that the device was tested against recognized performance standards for safety and essential performance. The "reported device performance" is essentially its compliance with these standards, indicating it meets safety and basic functional requirements.

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

The document does not describe a clinical test set in terms of patient numbers or demographic data. The "test set" in this context refers to the device itself being subjected to various engineering and safety tests according to the listed consensus standards. Therefore, specific sample sizes for a clinical test set and data provenance (country of origin, retrospective/prospective) are not applicable or provided.

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

This information is not provided. The "ground truth" for the non-clinical tests described is the established requirements of the referenced industry standards (e.g., IEC, ISO). There is no mention of external human experts establishing a clinical ground truth for device performance in this summary.

4. Adjudication Method for the Test Set:

Not applicable, as this refers to a clinical study methodology. The tests conducted were against technical standards, not adjudicated clinical outcomes.

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

No, an MRMC comparative effectiveness study is not mentioned or described. This document is a 510(k) summary, which generally relies on demonstrating substantial equivalence to a predicate device based on technical characteristics and safety, rather than providing comparative effectiveness data or human reader improvement with AI assistance. The A-FIT is a physical medical device, not an AI-assisted diagnostic tool in the sense of image interpretation.

6. Standalone Performance:

The document describes the performance of the A-FIT device in a standalone manner, meaning the device itself (laser and RF handpiece) was tested against various safety and performance standards. It does not refer to an "algorithm only (without human-in-the-loop performance)" because the A-FIT is a therapeutic device operated by a human, not an AI algorithm.

7. Type of Ground Truth Used:

The ground truth used for the reported performance data is the consensus international and national standards (e.g., IEC 60601-1, IEC 60825-1, ISO 14971, 21 CFR 1040.11) outlining safety, essential performance, EMC, usability, risk management, software validation, and biocompatibility for such medical devices. There is no mention of expert consensus derived from clinical cases, pathology, or outcomes data in this summary.

8. Sample Size for the Training Set:

This information is not applicable and not provided. The A-FIT is not an AI/machine learning model whose performance is dependent on a 'training set'. Its design and functionality are based on established engineering principles and its manufacturing processes adhere to quality systems.

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

This question is not applicable, as there is no training set in the context of this device.

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