The Ceralas Fiber-Coupled Diode Laser family 980nm (and their delivery accessories used to deliver optical energy) are indicated for use in general surgical applications for incision, excision, ablation, cutting, vaporization, hemostasis, and coagulation of soft tissue contact or non-contact, open or closed endoscopic applications where incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue vaporization, hemostasis and/or coagulation may be indicated.

Added Indication for Use:

Percutaneous Lumbar Disc Decompression/ Diskectomy in soft and cartilaginous tissue.

Device Description

Ceralas Fiber-Coupled Diode Laser 980 nm Family

AI/ML Overview

The request implicitly asks for a detailed description of acceptance criteria and the study proving the device meets them, but the provided text (K100726 Biolitec Inc.'s Ceralas Fiber-Coupled Diode Laser 980nm Family) does not contain typical acceptance criteria tables or detailed study results like those found in clinical efficacy trials for AI/ML devices.

Instead, this 510(k) summary focuses on demonstrating substantial equivalence to existing predicate devices for an additional indication of use (Percutaneous Lumbar Disc Decompression/Diskectomy). The performance "data" discussed is not about numerical accuracy or sensitivity/specificity but about confirming the safety and efficacy of the 980nm laser for a new application, primarily by comparing its technological characteristics to already-cleared devices.

Therefore, many of the requested categories (like sample size, ground truth, experts, MRMC study, standalone performance) are not applicable to the type of submission presented here.

Here's a breakdown of what can be extracted and why other parts are not present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety and Efficacy for Percutaneous Lumbar Disc Decompression/Diskectomy	Substantially Equivalent to predicate devices (Ceralas G15 532nm, Ceralas D1950, Quanta System Polysurge, Quanta System Model 30, INTERmedic 810nm & 980nm families) for this added indication. The 980nm family demonstrates "no significant difference" in performance compared to cleared Ceralas G15 532nm and D1950 lasers for this use.
Technological Characteristics	The Ceralas 980nm family has "substantially similar technological characteristics" compared to predicate devices for the intended use and added indications. Minor technological differences are stated to raise "no new issues of safety or effectiveness."
General Surgical Applications (incision, excision, ablation, cutting, vaporization, hemostasis, coagulation of soft tissue)	The device is indicated for these uses, presumably based on prior clearances and the substantial equivalence to predicate devices which also have these indications. No specific performance metrics or acceptance criteria for these general uses are provided in this document, as the focus is on the added indication.

Explanation: The "acceptance criteria" here are implicitly meeting the standards of safety and effectiveness as demonstrated by the predicate devices for the target anatomical location and procedure. "Device performance" is stated as being "substantially equivalent" rather than reporting specific metrics like sensitivity or accuracy.

2. Sample size used for the test set and the data provenance

Not Applicable. This submission is for substantial equivalence based on technological characteristics and prior clearances, not a clinical study involving a "test set" of patients or data in the typical sense for AI/ML device evaluations. No patient-specific data or cohorts are mentioned for this particular submission.

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

Not Applicable. As no specific data "test set" requiring ground truth by external experts is detailed in this 510(k) summary, this information is not provided. The assessment of substantial equivalence is done by the manufacturer (Biolitec) and reviewed by the FDA, based on engineering data, technological comparisons, and established principles of laser surgery.

4. Adjudication method for the test set

Not Applicable. There is no "test set" discussed in the context of clinical data requiring an adjudication method.

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 laser surgical instrument, not an AI/ML-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study and AI-related performance metrics are irrelevant to this submission.

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

Not Applicable. This is a hardware device (laser), not an algorithm.

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

Not Applicable. For this type of 510(k) – substantial equivalence for an added indication for a physical device – "ground truth" as typically defined for diagnostic or AI/ML devices is not explicitly stated or required in this summary. The "truth" is based on the established safety and efficacy of the predicate devices and the technological comparison demonstrating the new device performs similarly for the new indication.

8. The sample size for the training set

Not Applicable. This is a physical medical device (laser), not an AI/ML algorithm that requires a "training set."

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

Not Applicable. As above, no training set or its ground truth is relevant or discussed for this device.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as per this 510(k) Summary):

The "study" presented in this 510(k) summary is not a traditional clinical trial with patient cohorts and statistical outcomes. Instead, it is a design and performance comparison study demonstrating the Ceralas Fiber-Coupled Diode Laser 980nm Family's substantial equivalence to legally marketed predicate devices for the added indication of Percutaneous Lumbar Disc Decompression/Diskectomy.

Key components of this "study":

Technological Characteristics Comparison: The submission details that the Ceralas 980nm family has "substantially similar technological characteristics" (e.g., wavelength, power output, delivery accessories, fundamental principle of operation) to several predicate devices already cleared for similar applications, including other Ceralas models (G15 532nm, D1950) and lasers from Quanta System and INTERmedic.
Performance Data Assessment: The document states that "Performance testing of the Ceralas 980nm family demonstrates no significant difference as compared to the cleared Ceralas G15 532nm Frequency-Doubled Nd:YAG and D1950 lasers." While the specifics of this "performance testing" are not detailed in this summary, it would typically involve bench testing (e.g., power output stability, beam profile, tissue ablation rates in ex vivo models, thermal effects) to confirm the new device performs within expected parameters and similarly to the predicates for the intended use.
Safety and Effectiveness Argument: The core of the submission is the argument that because the technological characteristics are similar and performance testing shows no significant difference, the Ceralas 980nm family is as safe and effective for Percutaneous Lumbar Disc Decompression/Diskectomy as its predicate devices, which are already deemed safe and effective for similar uses. The minor technological differences are argued not to raise new issues of safety or effectiveness.

Conclusion from the document: The FDA's review agreed with this assessment, issuing a letter stating that the device is "substantially equivalent" to legally marketed predicate devices for the stated indications for use. This substantial equivalence determination is the primary "proof" for this type of regulatory submission, rather than a clinical trial report with numerical performance metrics.

Summary

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510(k) SUMMARY: K100726 Biolitec Inc.'s Ceralas Fiber-Coupled Diode Laser 980nm Family for an Additional Indication of Use

Submitter's Name, Facility/ Manufacturing Address, Telephone/ Fax Number, Contact Person:

Biolitec Inc. 515 Shaker Road East Longmeadow, MA 01028 Phone: (413) 525-0600 Facsimile: (413) 526-0611

SEP 1, 5 2010

Contact Person: Harry Hayes, Ph.D. - Regulatory Consultant, Biolitec Inc. - cell: (413) 250-0779 Email: harry.hayes@biolitec.com Or Nancy Foley - Manager of Regulatory Affairs, Biolitec Inc. Email: nancy.foley@biolitec.com

Date Prepared: March 8, 2010

i. Name of Device and Name/ Address of Sponsor/ Establishment Reg. Number:

Ceralas Fiber-Coupled Diode Laser 980 nm Family

Biolitec, Inc. 515 Shaker Road East Longmeadow, MA 01028

Establishment Registration Number: 1222625

ii. Common or Usual Name: Diode Laser

iii. Classification Name:

Laser, Surgical Diode Laser System

Classification Panel: iv.

The General Surgery Devices Branch has classified Diode Lasers as Class II devices pursuant to 21 C.F.R. § 878.4810

v. Predicate Devices:

Ceralas 50W Ceralas D1950 (K072682) Ceralas G15 532 Frequency Doubled Nd:Yag (K002296) Quanta System Polysurge Diode Laser Family (K083613) Quanta System Diode Medical Laser Family (K072034) INTERmedic Diode Laser family 810nm & 980nm (K053540)

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Intended Use/ Indications for Use vi.

Added Indication for Use:

Percutaneous Lumbar Disc Decompression/ Diskectomy in soft and cartilaginous tissue.

vii. Technological Characteristics

The Ceralas 980nm family have substantially similar technological characteristics as compared to the Ceralas G15 532nm Frequency-Doubled Nd:YAG laser and the Ceralas D1950 laser, as well as the Quanta System Polysurge 808nm, 980nm & 1950nm laser family, Quanta System Model 30 (808nm & 940nm) laser family and the INTERmedic 810nm & 980nm family.

viii. Performance Data

Performance testing of the Ceralas 980nm family demonstrates no significant difference as compared to the cleared Ceralas G15 532nm Frequency-Doubled Nd:YAG and D1950 lasers.

ix. Substantial Equivalence

The Ceralas 980nm family is as safe and effective for this additional Indication for Use as the Ceralas G15 532nm Frequency-Doubled Nd:YAG and D1950 lasers, the Quanta System Polysurge 808nm, 980nm & 1950nm laser family, the Quanta System Model 30 (808nm & 940nm) laser family and the INTERmedic 810nm & 980nm laser family.

The Ceralas 980nm family has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Ceralas 980nm family and its predicate device raises no new issues of safety or effectiveness. Thus, the Ceralas 980nm family is substantially equivalent.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

SEP 1 5 2010

Biolitec, Inc. % Genmarhay BDA Harry Hayes, Ph.D. 1349 Main Road Granville, Massachusetts 01034

Re: K100726

Trade/Device Name: Ceralas Fiber-Coupled Diode Laser 980nm Family 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: GEX Dated: September 07, 2010 Received: September 09, 2010

Dear Dr. Hayes:

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.

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Page 2 - Harry Hayes, Ph.D.

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 CFR Part 807); labeling (21 CFR Part 801); medical device 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkers Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

The Company's Indications for Use Statement for the Device is provided below.

· Indications for Use Statement:

510(k) Number (if known): K100726. Device Name:

Indications for Use:

Ceralas Fiber-Coupled Diode Laser Family 980nm (Covering 980nm Models: D15, D25, D50, E15, & E30; HPD100, HPD120, HPD150 & HPD180)

Added Indication for Use:

Percutaneous Lumbar Disc Decompression/ Diskectomy in soft and cartilaginous tissue.

Prescription Use ----X ---(Part 21 C.F.R. 801 Subpart D)

And/ Or

Over-The-Counter Use ---------(21 C.F.R. 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nil R. Reuber
(Division Plan Offi. for mxm

Division of Surgical, Cithopedic, and Restorative Devices

510(k) Number K100726

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.