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The MC1 Plus is indicated for:
a) Therapeutic Massager:

1. Provides temporary relief of minor muscle aches and pains;
2. Relieves muscle spasms;
3. Temporarily improves local blood circulation;
4. Temporarily reduces the appearance of cellulite.
   b) Ultrasonic Diathermy:
5. Relief of pain;
6. Muscle spasms;
7. Joint contractures;
8. NOT for the treatment of malignancies.

MC1 Plus is a computerized body massager and ultrasound diathermy system. The MC1 Plus is supplied with two handpieces: one ultrasonic handpiece with two 1 MHz transducers mounted on it and one handpiece for computerized body massager.

The provided text is a 510(k) Summary for the General Project MC1 Plus device, a computerized body massager and ultrasound diathermy system. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (MC1, K091615), rather than describing a study with acceptance criteria for a novel device's performance.

Therefore, the requested information categories (1-7, 9) cannot be fully populated as they pertain to clinical studies designed to establish specific performance metrics against pre-defined acceptance criteria for a new device. This document primarily relies on engineering and electrical safety testing, and performance testing for equivalence to a predicate, not clinical trials to prove device efficacy against acceptance criteria.

However, based on the provided text, here's what can be extracted and inferred:

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

The document does not explicitly state "acceptance criteria" in the context of a clinical study for intended use. Instead, it demonstrates compliance with recognized electrical safety and performance standards, and comparison to a predicate device.

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The MC1 is indicated for: a) Therapeutic Massager: 1. Provides temporary relief of minor muscle aches and pains; 2. Relieves muscle spasms, 3. Temporarily improves local blood circulation; 4. Temporarily reduces the appearance of cellulite. b) Ultrasonic Diathermy: 1. Relief of pain; 2. Muscle spasms; 3. Joint contractures; 4. NOT for the treatment of malignancies.

The MC1 is a computerized body massager and ultrasound diathermy system. The MC1 is supplied with two handpieces: one ultrasonic handpiece with two 1 MHz transducers mounted on it and one handpiece for computerized body massage.

Here's a summary of the acceptance criteria and study information for the General Project MC1, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a "test set" in the context of patient or image data for evaluating clinical performance. The performance testing described focuses on engineering and physical performance (electrical safety, EMC, tissue heating).

• Sample Size: Not applicable in the traditional sense of a clinical test set. The evaluation compared the MC1's physical performance to a predicate device, the MED Sculpt.
• Data Provenance: Not applicable. The "data" refers to measurements from the device itself during controlled testing, not data derived from human subjects or retrospective/prospective studies on patient outcomes.

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

• Number of Experts: Not applicable. Ground truth for clinical performance was not established by experts in this context.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No human readers or adjudicators were involved in evaluating the device's technical performance against a ground truth.

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

• Was an MRMC study done? No. The submission describes technical and performance testing of the device itself, not a study evaluating human reader performance with or without AI assistance.

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

• Was a standalone study done? This question is generally relevant for AI/software devices. For this physical medical device (ultrasound and massager), a "standalone" study in the AI sense is not applicable. The performance testing was of the device operating on its own.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the device's physical performance was based on established engineering standards (IEC) for safety and electromagnetic compatibility, and a specific temperature threshold (at least 40° C) for tissue heating as a measure of therapeutic efficacy for ultrasonic diathermy. This could be considered measured physical properties and engineering standards. It was not pathology, expert consensus on clinical cases, or outcomes data.

8. Sample Size for the Training Set

• Sample Size: Not applicable. This device does not use an "AI" or "machine learning" algorithm that requires a training set. The device's function is mechanical and ultrasonic.

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

• How Ground Truth Established: Not applicable, as there is no training set for an AI algorithm.

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The Axiom Intense Pulsed Light System is a medical device emitting light radiation in the range from 590 nm to 1200 nm. It is intended for use in:

• Removal of unwanted hair from all skin types and to effect stable long-term or permanent, hair reduction
• Treatment of mild to moderate inflammatory acne (acne vulgaris) .
• Treatment of benign pigmented epidermal and cutaneous lesions including warts, scars, striae, lentigines, nevi, melasma and cafè-au-lait

The Axiom Intense Pulsed Light System is a medical device emitting light radiation in the range from 590 mm to 1200 mm. The Axion Intense Fullood Eight Oyel Cyell is based on a quick power discharge of Capacitors in a Xenon ramp, mountou on a hanspires include the charge intense Fulsed Eight. The four philopal pairol panel, and a handpiece with exchangeable lamp box

The provided text is a 510(k) summary for the AXIOM Intense Pulsed Light System. It states explicitly that no performance data was required or submitted for this Class II device by the Food and Drug Administration (Office of Device Evaluation).

Therefore, the following information cannot be extracted from the document:

• A table of acceptance criteria and the reported device performance: No acceptance criteria or performance data is presented.
• Sample sized used for the test set and the data provenance: No test set or data provenance is mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
• Adjudication method for the test set: No adjudication method is mentioned.
• 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 MRMC study was conducted.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is an Intense Pulsed Light System, not an algorithm, so this is not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth is mentioned.
• The sample size for the training set: No training set is mentioned.
• How the ground truth for the training set was established: No ground truth for a training set is mentioned.

The document focuses on demonstrating substantial equivalence to predicate devices (Flash1, Med FlashII, SpaTouch, IPL Quantum SR, Clareon Pulsed Light System, Photosilk Plus) based on shared indications for use and similar technological characteristics, controls, displays, and light sources. The FDA concluded that the device is substantially equivalent, allowing it to be marketed.

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The MED Sculpt Computerized Body Massager and M-Sonic Ultrasound Diathermy is indicated for:
a. Therapeutic Massager:
i. Provides temporary relief of minor muscle aches and pains . -
ii . Relieves muscle spasms
iii. Temporarily improves local blood circulation
iv. Temporarily reduces the appearance of cellulite
b. Ultrasonic Diathermy:
i. Relief of pain
ii. Muscle spasms
III. Joint contractures
iv. NOT for the treatment of malignancies

The MED SCULPT Computerized Body Massager and M-Sonic Ultrasound Diathermy system has massage and ultrasound diathermy components. The massage portion of the device uses a specially designed membrane, made up of elastomeric material. This membrane, fastened onto the handbiece, moves in an alternate way due to changeable depression created by a vacuum pump; such movement is due to the opening and closing of two electronically controlled electrovalves. The unit also includes an ultrasonic handpiece that can be used to perform ultrasound diathermy. Ultrasound is a particular form of mechanical energy which leads to an increase in the molecular vibration of the tissue resulting in heat generation and according to this principle the ultrasonic handpiece of the unit, using an ultrasound wave at the fixed frequency of 3 MHz, produces thermal changes in the areas of the body where it is applied.

Here's an analysis of the provided 510(k) summary regarding the MED Sculpt Computerized Body Massager and M-Sonic Ultrasound Diathermy, focusing on acceptance criteria and study information:

Based on the provided document, there is no performance data or clinical study detailed. The 510(k) summary explicitly states under "6. Performance Data": "None presented."

This type of 510(k) submission typically relies on substantial equivalence to a predicate device without requiring new clinical performance data if the new device's technology and intended use are similar enough to an already legally marketed device. In this instance, the MED Sculpt device is deemed substantially equivalent to the Dermosonic manufactured by Sybaritic, Inc. (K024307).

Therefore, most of the questions regarding acceptance criteria, study design, and performance metrics cannot be answered from the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document explicitly states "None presented" for performance data. There are no acceptance criteria or reported device performance metrics provided in this 510(k) summary. The submission relies on substantial equivalence to a predicate device.

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

Not applicable. No test set was used to generate performance data for this submission.

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

Not applicable. No test set requiring ground truth establishment was conducted or reported.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring adjudication was conducted or reported.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this 510(k) summary.

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

Not applicable. This device is a physical medical device (massager and ultrasound diathermy), not an algorithm or AI system, so the concept of standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

Not applicable. No ground truth data was used, as no performance study was conducted or reported.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI or algorithm-based system that uses a training set.

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

Not applicable. As a physical device, there is no training set or ground truth establishment relevant to an algorithm's training.

In summary: The provided 510(k) submission for the MED Sculpt Computerized Body Massager and M-Sonic Ultrasound Diathermy relies on the concept of substantial equivalence to a predicate device (Dermosonic, K024307) rather than presenting new performance data or clinical studies for the device itself. Therefore, the document does not contain information about acceptance criteria, study design, sample sizes, expert involvement, or ground truth establishment for performance data.

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The MED flash II Intense Pulsed Light System is indicated for use in:

• Removal of unwanted hair from all skin types and to effect stable long-term or permanent, hair reduction
• Treatment of inflammatory acne (acne vulgaris)
• Treatment of benign pigmented epidermal and cutaneous lesions including warts, scars, striae, lentigines, nevi, melasma and café-au-lait
• Treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins
• The integrated cooling handpiece is intended to provide pre-cooling of the epidermis, to reduce thermal injury to the epidermis, and to reduce patient pain, & discomfort associated with light applications.

The MED flash II Intense Pulsed Light System is a medical device emitting light radiation in the range from 590 nm to 1200 nm. The system is based on a quick power discharge of capacitors in a Xenon lamp, mounted on a handpiece. This generates a rapid and Intense Pulsed Light.
The Med flash II system contains five principal components:

• Charge system of the capacitors .
• Electronic control system .
• Control panel .
• Handpiece with exchangeable lamp box ●
• Handpiece cooling system .

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and supporting study for the MED flash II Intense Pulsed Light System:

1. Table of Acceptance Criteria and Reported Device Performance

• Treatment of inflammatory acne (acne vulgaris)
• Treatment of benign pigmented epidermal and cutaneous lesions including warts, scars, striae, lentigines, nevi, melasma and café-au-lait
• Treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins
• Integrated cooling handpiece intended to provide pre-cooling of the epidermis, to reduce thermal injury to the epidermis, and to reduce patient pain, & discomfort associated with light applications. | The device is deemed acceptable for these indications based on its substantial equivalence to predicate devices that have similar indications and technological characteristics. |
  | Technical Specifications (Implicit Acceptance for Equivalence) | - Emitting light radiation in the range from 590 nm to 1200 nm.
• Based on quick power discharge of capacitors in a Xenon lamp.
• Handpiece with exchangeable lamp box.
• Handpiece cooling system. | These technical specifications are presented in the device description, implying that they align with or are sufficiently similar to the predicate devices to support substantial equivalence. |

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

The document explicitly states "None presented" under the "Performance Data" section. This indicates that no specific test set data, sample size, or information on data provenance (country of origin, retrospective/prospective) was provided or required for this 510(k) submission. The approval was based on demonstrating substantial equivalence to predicate devices, not on new clinical performance data from a specific test set.

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

Not applicable. Since no specific performance data or test set was presented, there was no ground truth to be established by experts in the context of this 510(k) summary.

4. Adjudication Method for the Test Set

Not applicable. As no test set data was presented, no adjudication method was mentioned or required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document explicitly states "None presented" for performance data. There is no mention of an MRMC study, or any comparative effectiveness study with or without AI assistance. This type of study would typically be part of a robust performance data section, which is absent here.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable/No. This device is an Intense Pulsed Light System, a physical medical device, not a software algorithm. Therefore, "standalone" algorithm performance without human interaction is not relevant to its type. The 510(k) summary does not mention any software or AI components that would require such a study.

7. The Type of Ground Truth Used

No specific ground truth type was used or reported in the context of a new performance study. The basis for clearance is substantial equivalence to predicate devices. This implies that the safety and effectiveness of the device are inferred from the established safety and effectiveness of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. As the approval is based on substantial equivalence to existing predicate devices and no new performance study data was presented, there are no references to a training set for an algorithm.

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

Not applicable. Since no training set was mentioned in this 510(k) summary, there is no information on how a ground truth for a training set would have been established.

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