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ATOVEN is a diode laser system designed to delivery of laser light to soft tissue during general surgery procedures. This device intended for treatment of reflux of the saphenous veins associated with varicose veins and varicosities. Non-Contact mode
ATOVEN is a diode laser system designed to delivery of laser light to soft tissue during general surgery procedures. This device intended for treatment of reflux of the saphenous veins of thigh associated with varicose veins and variosities. Non-Contact mode

ATOVEN Diode laser systems are Laser Surgery Systems that use optical energy radiated from semiconductor laser in order to cure varices. with Wave Length 1,470mm, and consists of CPU, LCD monitor, Cooling Systems, laser controller, Fiber optic pullback device included foot pedal switch. LED monitor are displaying various graphic to shows Operating Parameter, Mode, Time function, system status to user.

The provided text describes a 510(k) premarket notification for a medical device (ATOVEN) and does not contain information about a study proving the device meets specific acceptance criteria.

Instead, it focuses on demonstrating substantial equivalence to a predicate device based on common intended use, function, technology, operational principles, and performance. The document explicitly states: "No clinical standards have been established for Diode Laser, but did Safety and Performance test in accordance with below Standard." followed by a list of non-clinical safety and performance standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-2-22, IEC60825_1).

Therefore, I cannot provide a table of acceptance criteria and reported device performance directly from this document, nor can I answer questions related to sample sizes, expert qualifications, or comparative effectiveness studies, as these types of studies were not conducted or reported for this submission.

Here's a breakdown of what can be extracted and addressed:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only states that these tests were "did" (performed) and that the device is substantially equivalent, implying that it met the requirements of these standards. Specific numerical performance data or pass/fail criteria for each standard are not provided.

Regarding the other requested information:

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

  • Not applicable / Not provided. The submission relies on non-clinical safety and performance tests to standards, not a clinical test set with a sample size of patients.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

  • Not applicable / Not provided. No clinical ground truth was established by experts for performance evaluation as part of this submission. The ground truth for proving safety and performance was adherence to the listed international safety standards.

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

  • Not applicable / Not provided. No clinical test set or adjudication was performed.

• 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 / Not provided. This device is a diode laser system, not an AI-assisted diagnostic tool, and no MRMC study was conducted or reported.

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

  • Not applicable / Not provided. This is not an algorithm; it's a medical device (laser system). Its performance is inherent in its design and manufacturing, verified against safety standards.

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

  • For the non-clinical tests, the "ground truth" was compliance with the specified international safety and performance standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-2-22, IEC 60825-1).

• 8. The sample size for the training set

  • Not applicable / Not provided. There is no "training set" as this is not a machine learning or AI device.

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

  • Not applicable / Not provided. As there is no training set, this question is not relevant.

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MX-7000 CO2 laser system is indicated for use in non-fractionated mode is Incision, Excision, Ablation, Vaporization, and Coagulation of Human body soft Tissues. This system can be used in Dermatology, Plastic surgery, General surgery, Gynecology, Neurosurgery, and in Podiatry.

When used in fractionated mode, the MX-7000 CO2 system is indicated for use ablative skin re-surfacing, Wrinkle, Fine line, Rhylides, Furrow in Dermatology, Plastic surgery, and in General surgery.

MX-7000 Laser system utilize a Co2 module to generate a laser beam with wave length of 10.600 nm and used fractional or non fractional mode for different indication. The Doctor can optimize the effect for different applications by controlling the power of laser pulse and using different hand pieces.

The system are supplied with two hand pieces ( Scanned or/and Dynamic),depend the device configuration

This system consist of

Optic main Bench assembly, Articulated Arm LCD control panel, Laser Cooling system Hand pieces set, Foot Pedal switch.

The provided document is a 510(k) premarket notification for a medical device (MX-7000 MICROXEL CO2 Laser system). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study data to establish performance against acceptance criteria in the manner described in the request. Thus, much of the requested information regarding acceptance criteria, specific study design, sample sizes, expert involvement, and ground truth establishment, including MRMC studies or standalone algorithm performance, is not available in this document.

However, I can extract information related to the device's intended use and the regulatory conclusion, which are implicitly related to its "meeting acceptance criteria" in the context of a 510(k) submission.

Here's a breakdown of what can be extracted and what cannot:

Information Not Available in the Document:

• A table of acceptance criteria and the reported device performance: This document does not establish specific quantitative performance metrics or acceptance criteria for a clinical study comparing the device's output to a predefined standard or clinical endpoint. The "performance" is implicitly tied to its substantial equivalence to predicate devices, which are already deemed safe and effective for their intended uses.
• Sample sizes used for the test set and the data provenance: No test sets or associated sample sizes are mentioned for performance evaluation in a clinical study context.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as a clinical study with ground truth establishment is not detailed.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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. The device is a CO2 laser system, not an AI-assisted diagnostic tool.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Information Related to "Acceptance Criteria" (in the context of a 510(k)):

In the context of a 510(k) submission the "acceptance criteria" are primarily established by demonstrating substantial equivalence to legally marketed predicate devices in terms of intended use, main function, technology, principal operation, and performance. The "study" that proves this is the 510(k) submission itself, where the applicant provides comparative information and justifications.

Here's the closest approximation of the requested table and relevant details based on the provided text:

1. Table of Acceptance Criteria (as implied by 510(k) substantial equivalence) and Reported Device Performance

• IEC 60601 Medical Electrical equipment part 1. General requirement for safety amend 2 1995
• IEC60601-1-2 Electro magnetic compatibility test ED 2001 EMC test
• IEC60601-1-22-22: 1996 Particular requirement for the safety and Diagnostic of Therapeutic laser Equipment. |
  | Conclusion of Equivalence | Predicate devices are considered safe and effective for their stated indications. | "The D.S.E, MX-7000 Co2 system, in this submission, is substantially equivalent to several already cleared predicate device in respect to Intended use, Main function, Technology, Principal operation and performance. So, it does not raise any additional concerns regarding safety and effectiveness." (Bio-Med USA)
  FDA's conclusion: "the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." |

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

• Not applicable for a typical clinical test set in this 510(k) submission. The "test" is a comparison to predicate devices based on design and technical specifications, not a clinical trial with a defined patient sample size.
• Data provenance: The submission originates from Bio-Med USA Inc. (U.S.) and the manufacturer is Dae Shin Enterprise (Seoul, Korea). The data provided in the 510(k) is a compilation of device specifications and comparisons to predicate devices, not patient data from a specific country of origin. This is a retrospective submission to the FDA.

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

• Not applicable. No clinical test set requiring expert ground truth is described. The "experts" involved are the regulatory reviewers at the FDA who assess the substantial equivalence claim, and the engineers/scientists at Dae Shin Enterprise who designed and tested the device to meet its specifications and relevant standards.

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

• Not applicable.

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 device is a surgical laser, not an imaging or diagnostic AI-assisted device subject to MRMC studies.

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

• Not applicable.

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

• Not applicable. The "ground truth" for a 510(k) is the established safety and effectiveness of the predicate devices based on a demonstration that the new device is functionally and technologically equivalent and therefore "as safe and effective" as the predicates.

8. The sample size for the training set:

• Not applicable. This device does not use machine learning or AI that would require a "training set."

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

• Not applicable.

In summary, the provided document is a regulatory submission demonstrating substantial equivalence, not a clinical study report with detailed performance metrics and acceptance criteria in the typical sense of a diagnostic or interventional efficacy trial.

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Single use, sterile, intended use for the subcutaneous injection of U 100 Insulin only.

"Bio-Med® Soft" Insulin syringe are sterile, single use, disposable hypodermic syringes with a permanently affixed lumen needle to the tip of syringe. The syringe consists of a barrel, a plunger rod with Synthetic Rubber Gasket, and an orange colored end-cap over the needle to preserve sterility of the fluid path. In addition the "Bio-Med® Soft" Insulin syringe are non-toxic and pyrogenic free "Bio-Med® Soft" Insulin syringe are available 1.0cc (100units), 0.5cc (50units), 0.3cc (30 units) with 29G, 30G, 31G, needle thickness, 1/2:'', 5/16'' needle length, and meet the following standard: ISO 7864 Sterile, Hypodermic Needles for single use ISO 8537: 1991/Amendment 1: 2000 Sterile, Single use Syringe with/without needle For insulin

This document does not contain an AI/ML device. The provided text is a 510(k) premarket notification for the "Bio-Med® Soft Insulin Syringe," which is a traditional medical device (a piston syringe) and not an AI/ML product.

Therefore, I cannot extract information related to AI/ML device acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement as requested. The document focuses on demonstrating substantial equivalence to predicate insulin syringes based on design, materials, manufacturing processes, and intended use, rather than algorithmic performance.

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