(174 days)
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
| "Acceptance Criteria" Category (Implied by 510(k)) | Predicate Device Performance / Characteristics (Implicit Baseline) | MX-7000 MICROXEL Reported Performance / Characteristics |
|---|---|---|
| Intended Use | Incision, Excision, Ablation, Vaporization, and Coagulation of Human body soft Tissues in non-fractionated mode, and ablative skin re-surfacing, Wrinkle, Fine line, Rhylides, Furrow in fractionated mode. (as per legally marketed predicate devices). Used in Dermatology, Plastic surgery, General surgery, Gynecology, Neurosurgery, and Podiatry. | Non-fractionated mode: Incision, Excision, Ablation, Vaporization, and Coagulation of Human body soft Tissues. Used in Dermatology, Plastic surgery, General surgery, Gynecology, Neurosurgery, and in Podiatry. |
| Fractionated mode: Ablative skin re-surfacing, Wrinkle, Fine lines, Rhylides, Furrow. Used in Dermatology, Plastic surgery, and General surgery. | ||
| Technology | CO2 module generating a laser beam with a wavelength of 10,600 nm. | CO2 module to generate a laser beam with a wavelength of 10,600 nm. |
| Principal Operation | Utilizes fractional or non-fractional mode; Doctor can optimize effect by controlling power of laser pulse and using different hand pieces. | Utilizes fractional or non-fractional mode for different indications; Doctor can optimize the effect for different applications by controlling the power of laser pulse and using different hand pieces. Two hand pieces (Scanned or/and Dynamic) supplied. |
| Safety Standards Compliance | Compliance with relevant industry and medical device safety standards (e.g., IEC standards). | Manufactured in accordance with: |
- 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.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.