MiDi-SRS is designed to provide laser energy (1550nm) for use in a variety of dermatology and general surgery procedures. The product consists of main body, a tablet PC, a foot switch, an interlock switch and a key switch. The device fires a 1550nm Er- glass Fiber laser beam which is then split into a number of microscopic beams, producing tiny dot, or pixel-like treatment zones within the selected target area of the skin, leaving the other zones within it perfectly intact.

AI/ML Overview

Here's an analysis of the provided text regarding the MiDi-SRS device's acceptance criteria and studies:

Based on the provided 510(k) summary, the device under review, MiDi-SRS, is a laser surgical unit intended for use in dermatological procedures requiring the coagulation of soft tissue. The summary focuses on demonstrating substantial equivalence to a predicate device (SellaS by Dinona Company, Ltd., K080382) rather than outlining specific, quantifiable acceptance criteria with a statistical study.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantifiable acceptance criteria for performance metrics in a table. Instead, it relies on demonstrating that the device performs "as well as the predicate device" through non-clinical bench tests and an in vivo animal study.

The primary "performance" reported are histological measurements from in vivo animal testing.

Table 1: Histological Performance of MiDi-SRS (Porcine Model)

Group / Excision days	Energy (mJ)	Measured Width (µm) (S.D.)	Measured Depth (µm) (S.D.)	Thermal Zone: Lateral (µm)	Thermal Zone: Depth (µm)
G1 (0 days)	10	17	17	151	205
	20	33	34	226	290
	30	29	36	277	325
G2 (3 days)	10	17	64	19	57
	20	13	16	42	132
	30	3	10	32	104
G3 (10 days)	10	0	0	0	0
	20	0	0	0	0
	30	0	0	0	0
G4 (15 days)	10	0	0	0	0
	20	0	0	0	0
	30	0	0	0	0

Note on Acceptance Criteria: The document states that "All the test results met pre-set criteria and support substantial equivalence to the predicate devices" for the bench tests. For the animal study, it notes that the results "supports that the subject device would perform as well as the predicate device." However, the specific numerical "pre-set criteria" for the bench tests or the comparative histological criteria against the predicate are not detailed.

Study Details

Given the nature of a 510(k) summary, which focuses on substantial equivalence rather than a detailed clinical trial, many of the requested details are not explicitly provided.

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

Test Set Sample Size: The document mentions "in vivo animal testing using porcine models." It does not specify the number of animals or the number of lesions created within those animals.
Data Provenance: The study was conducted in a porcine model. The country of origin for the data is not mentioned, though the applicant is from the Republic of Korea. The study appears to be prospective as it involves creating lesions and then observing them at specified time points (immediately, 3-5 days, 10-14 days post-treatment).

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)

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The document only states "histological data of values," implying evaluation by appropriately qualified personnel (e.g., pathologists), but their number or qualifications are not detailed.

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

Adjudication Method: Not specified. It is likely that histological assessments are typically reviewed by individual pathologists, potentially with consensus if discrepancies arise, but no specific method is described here.

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

MRMC Study: No. This device is a laser surgical instrument, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI is not applicable and was not performed.

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

Standalone Performance: Not applicable in the context of diagnostic AI. This device is a surgical tool. The performance described (histological outcomes) is the direct result of the device's action on tissue, which is its standalone performance as a surgical tool. The device functions independently in applying laser energy.

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

Ground Truth Type: Pathology (histological data). The measurements of microscopic treatment zones, measured width, depth, and thermal zones were obtained from tissue samples immediately post treatment; 3-5 days post treatment; and 10-14 days post treatment.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This document describes a medical device, not an AI/machine learning algorithm that requires a "training set." The device's performance is based on its physical and biological effects, not on being trained on a dataset.

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

Ground Truth for Training Set: Not applicable, as there is no "training set" for this type of medical device submission.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 23, 2014

SRMC Company, LTD % Ms. Priscilla Chung LK Consulting Group USA Incorporated 2651 East Chapman Avenue, Suite 110 Fullerton, California 92831

Re: K141046 Trade/Device Name: MiDi-SRS Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: ONG and GEX Dated: November 26, 2014 Received: December 2, 2014

Dear Ms. Chung:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

for

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K141046

Device Name MiDi-SRS

Indications for Use (Describe)

MiDi-SRS is intended for use in dermatological procedures requiring the coagulation of soft tissue.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary (K141046)

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date:

1. Applicant / Submitter:

SRMC CO., LTD 7F, 1130, 2 Sunhwan-ro, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do,361-825, Republic of KOREA

Tel: +82-43-255-9595 Fax: +82-43-255-5551

2. Submission Correspondent:

Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110. Fullerton, CA 92831 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com

3. Device:

Proprietary Name:	MiDi-SRS
Common Name:	Laser Surgical Unit
Classification Name:	Powered Laser Surgical Instrument
Classification:	Class II, 21 CFR 878.4810
Classification Product Code:	ONG

Predicate Device: 4.

SellaS by Dinona Company, Ltd. (K080382)

5. Device Description:

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then split into a number of microscopic beams, producing tiny dot, or pixel-like treatment zones within the selected target area of the skin, leaving the other zones within it perfectly intact.

Intended Use: 6.

MiDi-SRS is intended for use in dermatological procedures requiring the coagulation of soft tissue.

7. Performance Data(Non-Clinical):

Bench tests were performed according to EN 60601-2-22, 60601-1 and 60601-1-2 to evaluate its safety and EMC. All the test results met pre-set criteria and support substantial equivalence to the predicate devices.

In vivo animal testing using porcine models was also conducted to obtain histological data of values for depth and zone of ablation and thermal damage immediately post treatment; 3-5 days post treatment; and 10-14 days post treatment. The test results are as below and supports that the subject device would perform as well as the predicate device.

Group /Excisiondays	Microscopic treatment zones (MTZs)
	Measurement value (µm)
	Measuredwidth(S.D.)	Measureddepth(S.D.)	Thermalzone: lateral	Thermalzone: depth
G10	10mJ	17	17	151	205
	20mJ	33	34	226	290
	30mJ	29	36	277	325
G23	10mJ	17	64	19	57
	20mJ	13	16	42	132
	30mJ	3	10	32	104
G310	10mJ	0	0	0	0
	20mJ	0	0	0	0
	30mJ	0	0	0	0
G415	10mJ	0	0	0	0
	20mJ	0	0	0	0
	30mJ	0	0	0	0

8. Substantial Equivalence

The MiDi-SRS is substantially equivalent to the predicate device in terms of indication for use and technology based on technical characteristics. The two devices are similar in the following

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characteristics: intended use, spot size, wave length, aiming beam, power output, energy range, output mode, laser type, and beam mode. The major difference is in the user interface, however, the SW validation report provided in the submission supports that the touch screen tablet SW of the Midi-SRS is substantially equivalent to the predicate device in effectiveness.

9. Conclusion:

Based on the substantial equivalence discussion and testing results, SRMC CO., LTD concludes that the MiDi-SRS is substantially equivalent to the predicate devices in safety and effectiveness.

Regulation Number and Section

§ 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.