The OCTAX Laser Shot™ is a laser system for microsurgery on a cellular level, which works on a semiconductor basis. It is intended to be used to ablate a small tangential hole in the zona pellucida (assisted hatching) to be performed immediately prior to transfer on day 2 or day 3 in selected in vitro fertilization (IVF) patients with otherwise poor prognosis for successful pregnancy outcome, such as those with advanced maternal age, prior failed IVF, cyropreserved embryos, or abnormal zona pellucida characteristics. For safety reasons, the system should only be used if more than one embryo is available for transfer.

Device Description

The OCTAX Laser Shot™ laser device is a microscope based micromanipulation tool for use in ART in In Vitro Fertilization laboratories. The device uses a 1.48 um infrared diode laser and has been supplemented with a miniature digital video camera and computer software allowing precise laser control, image storage and database and analysis functions.

AI/ML Overview

The provided text does not contain a specific study with clearly defined acceptance criteria and detailed performance results that would allow for the direct creation of the requested table and comprehensive study description. Instead, it is a 510(k) Pre-Market Notification Summary Report focusing on demonstrating substantial equivalence to a predicate device.

The report references various "preclinical and clinical studies" and "many publications" over a 10-year period to support the device's efficacy, safety, and accuracy. However, it does not present a single, structured study with a clear set of acceptance criteria and the device's reported performance against those criteria.

Therefore, I cannot fulfill all parts of your request directly from the provided text.

Here's an attempt to derive some information based on the text, particularly concerning the substantial equivalence claimed:

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

The document frames "acceptance criteria" as meeting the characteristics of the predicate device (Hamilton Thorne Zona Infrared Laser Optical System (Zilos), K040045) to demonstrate substantial equivalence. Performance is, therefore, largely evaluated by comparison.

Acceptance Criterion (Based on Predicate Device Characteristics)	Reported Device Performance (OCTAX Laser Shot™)
Technological and Scientific History: Implements same technological principle, based on same scientific background.	Similarities: Both devices implement the same technological principle and are based on the same scientific background. Differences: OCTAX Laser Shot™ is more closely aligned with the scientific background as its development was led by Dr. Klaus Rink, a key researcher in the field.
Indications for Use: Identical for zona pellucida drilling.	Similarities: Indications for use regarding zona pellucida drilling are identical. Differences: OCTAX Laser Shot™ does not include the zona thinning indication of the predicate. An additional requirement for more than one embryo to be available for transfer was added.
Target Population: Identical.	Similarities: Identical.
Laser Type: Identical (infrared diode laser).	Similarities: Identical (infrared diode laser).
Wavelength: Identical (1.48 μm).	Similarities: Identical (1.48 μm).
Laser Interaction with Target: Identical interaction process.	Similarities: Identical interaction process.
Objective: High infrared transmission.	Similarities: Objective with high infrared transmission. Differences: OCTAX Laser Shot™ uses a 40x magnification objective, predicate uses 50x.
Laser Path: Functionally identical from laser diode to specimen.	Similarities: Functionally identical. Differences: Predicate integrates objective, mirror, and diode into one enclosure; OCTAX Laser Shot™ has a different design (details of difference in design not fully elaborated here but mentioned as "specific place where the laser is introduced").
Beam Information: Identical (radially symmetric, Gaussian beam profile).	Similarities: Identified (radially symmetric, with Gaussian beam profile).
Power Levels: Same order of magnitude.	Similarities: Same order of magnitude. Differences: Predicate: up to 300 mW. OCTAX Laser Shot™: 90-130 mW (closer to levels in fundamental safety studies).
Laser Pulse Duration: Resulting in same order of magnitude energy per laser pulse.	Similarities: Resulting in same order of magnitude energy per laser pulse. Differences: Predicate: shorter pulses (0.1-2ms) at higher power. OCTAX Laser Shot™: slightly longer pulses (0.1-10ms) with lower total energy per pulse but similar ablation performance.
Laser Pulse Repetition: Identical (single pulses without repetition).	Similarities: Identical (single pulses without repetition).
Laser Targeting: Identical (crosshair overlay on live video).	Similarities: Identical.
Materials: Standard materials, no direct physical contact with target.	Similarities: Standard materials, no direct physical contact (no concern).
Performance: Substantially similar due to similar beam characteristics.	Similarities: Substantially similar performance.
Sterility: No direct physical contact with target.	Similarities: No concern regarding sterility.
Biocompatibility: Not applicable due to no direct contact.	Similarities: Not applicable.
Mechanical Safety: Similar.	Similarities: Similar. Differences: Design difference related to laser introduction addressed for safety.
Chemical Safety: Not applicable.	Similarities: Not applicable.
Anatomical Sites: Not applicable.	Similarities: Not applicable.
Human Factors: Substantially similar design and use.	Similarities: Same human factors apply.
Energy Used and/or Delivered: Amount of laser energy delivered in treatment is similar.	Similarities: Amount of laser energy delivered is similar. Differences: OCTAX Laser Shot™ achieves similar ablation performance with lower beam power and total delivered energy.
Compatibility with Environment & Other Devices: Satisfy similar/identical requirements for electrical standards and listed microscopes.	Similarities: Satisfy similar/identical requirements.
Where Used: IVF routine, mounted on compatible inverted microscopes.	Similarities: Used in IVF routine, mounted on compatible inverted microscopes.
Preclinical studies: Identical (reference to fundamental research journal articles).	Similarities: Identical (reference to fundamental research journal articles).
Clinical studies: Similar (reference to relevant journal articles).	Similarities: Similar (reference to relevant journal articles).
Electrical Safety: Compliance with IEC 60101-1, IEC 61010-1, EMC IEC 61326.	Similarities: Compliance with relevant electrical safety standards.
Radiation Safety: Compliance with IEC EN 60825-1 (eye safety).	Similarities: Compliance with relevant eye safety regulations. Differences: Predicate: Class 1 device. OCTAX Laser Shot™: Class 1M device. Both classes imply sufficient safety.

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

The document does not specify a distinct "test set" sample size for a focused study to prove acceptance criteria. Instead, it states: "The OCTAX Laser Shot™ system, and its predecessor, the Fertilase system have been used throughout the world for over 10 years. Its efficacy, safety and accuracy has been tested and retested over the years and noted in many publications."

This suggests the "test set" and provenance are based on a broad history of use and published literature rather than a single, controlled study described within this document. No specific countries of origin or retrospective/prospective nature are detailed for these aggregated "many publications."

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)

This information is not provided. The document relies on the existing body of scientific literature and the long-term use of the device and its predecessor, implicitly assuming expert consensus within the field over time.

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

This information is not provided.

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

This document describes a laser microsurgery device, not an AI or imaging diagnostic device that would typically involve human "readers" or MRMC studies in the context of improving interpretation. Therefore, an MRMC comparative effectiveness study involving AI assistance would not be applicable here, and no such study is mentioned.

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

This is not an AI algorithm but a physical laser device controlled by software. The performance is inherently linked to human operation and control via the microscope and targeting system. There is no concept of "standalone" algorithm performance without human interaction for this device.

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

The ground truth for the device's efficacy, safety, and accuracy is indicated to be established over years of use and "many publications," implying a combination of:

Scientific literature/published research: On the fundamental mechanics and effects of the laser.
Clinical outcomes data: From reported IVF pregnancy successes and safety profiles over time.
Expert experience/consensus: Widespread use and acceptance in ART laboratories.

8. The sample size for the training set

This is not an AI algorithm requiring a training set in the conventional sense. The "training" for the device's development and validation comes from the extensive historical use of the device itself and its predecessor, along with "fundamental safety studies published in the literature." Therefore, there isn't a defined "training set" sample size.

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

As above, there isn't a "training set" for an AI model. The device's "ground truth" (its demonstrated safety and effectiveness) was established through years of clinical use, "many publications," and fundamental scientific research, with Dr. Klaus Rink, a physicist, leading its development based on this experience.

Summary

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510(k) Pre-Market Notification Summary Report

Submitted By:	Minitube of America, Inc.411 B Venture Ct. PO Box 930187Verona WI. 53593	DEC 15 2006
Contact Person:	Frederick RikkersRikkers Law419 Venture Court, P.O. Box 930555Verona, WI 53593
Date Prepared:	July 18, 2006
Trade Name:	OCTAX Laser Shot™ System
Common Name:	OCTAX Laser
Device Classification Name:	Assisted Reproduction Laser SystemsMRX - CFR # 884.6200
Special Controls Document:	"Class II Special Controls Guidance Document: AssistedReproduction Laser System" issued on December 28th, 2004
Predicate Device:	Hamilton Thorne Zona Infrared Laser Optical System (Zilos),510(k) number: K040045.

Description of Device:

The OCTAX Laser Shot™, introduced to the market in October 2000, is the 2nd generation infrared diode laser developed at OCTAX Microscience GmbH by a team lead by Dr. Klaus Rink, based on extensive experience with the first commercial 1.48 um infrared diode laser (Fertilase), introduced to the market 1996, director research and development at that time: Dr. Klaus Rink (Physicist).

Statement of Indicated Use

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Technological Characteristics

The OCTAX Laser Shot™ system is to be compared with the following predicate device: Hamilton Thorne Zona Infrared Laser Optical System (Zilos), 510(k) number: K040045, based upon the criteria provided by the FDA. The technological and performance characteristics of the OCTAX Laser Shot™ system are substantially equivalent to this predicate device and are detailed in the Substantial Equivalence Performance section of the 510(k) submission document. The substantial equivalence applies both on a technological level, as well as preclinical/clinical data and operating characteristics.

Testing Performed for Safety, Accuracy and Software Validation

The OCTAX Laser Shot™ system, and its predecessor, the Fertilase system have been used throughout the world for over 10 years. Its efficacy, safety and accuracy has been tested and retested over the years and noted in many publications. Also, the software used in the OCTAX Laser Shot™ system has been validated on numerous occasions.

	Similarities	Differences
Technological andscientific history	Both devices implement the sametechnological principle and are based on thesame scientific background as published inthe literature.	In addition to sharing the common history, theOCTAX Laser Shot™ system is more close tothe scientific background of the technology dueto the fact that its development was lead by Dr.Klaus Rink, who was also a member of the teamof researchers who established this scientificbackground.
Indications for use	The indications for use regarding zonapellucida drilling are identical for bothdevices.	The indication for zona thinning of the predicatedevice has not been included in the indicationsfor use of the OCTAX Laser Shot™ system tolower the requirements for documentation of thedevice and of relevant clinical studies in thisextent. Additionally, as a result of a moreconservative approach to potential hazards oflaser assisted hatching, an additional requirementof the availability of more than one embryo fortransfer was added.
Target Population	Identical
Laser type	Identical (infrared diode laser)
Wavelength	Identical (1.48 μm)
Laser interactionwith target	Identical interaction process
Objective	Objective with high infrared transmission	The OCTAX Laser Shot™ system includes anobjective with a 40x magnification, while theobjective of the predicate device has a 50xmagnification.
Laser path	Functionally identical - from the laser diodepassing by a semi-transparent mirror into(and focused by) the objective onto the	While the predicate device integrates objective,semitransparent mirror and laser diode into asingle enclosure, the OCTAX Laser Shot™
	specimen
Beam information	Identical (radially symmetric, with Gaussian beam profile)
Power levels	Same order of magnitude	While predicate device operates with a power in focus in air of up to 300 mW, the OCTAX Laser Shot™ has a power in focus in air of 90-130 mW (which is more close to the power levels used in the fundamental safety studies published in the literature).
Laser pulse duration	Resulting in same order of magnitude energy per laser pulse	While the predicate device relies on shorter pulses (0.1-2ms) at higher power levels, the OCTAX Laser Shot™ uses slightly longer pulses (0.1-10ms) while the total energy per laser pulse remains lower compared to the predicate device, while achieving similar ablation performance (size of ablations)
Laser pulse repetition	Identical (single pulses without repetition)
Laser targeting	Identical (through crosshair overlay superimposed to a live video display of the microscope image implemented by software on a PC).
Materials	Both use standard materials common to microscopy equipment. The materials in use are of no concern as the devices do not come into direct (physical) contact with the target.
Performance	Both devices have substantially similar performance due to the substantial similarity of the laser beam characteristics.
Sterility	Both devices present no concern regarding sterility as they do not come into direct (physical) contact with the target
Biocompatibility	Not applicable, see Sterility.
Mechanical Safety	The mechanical safety aspects are similar for both devices.	The difference in design relating to the specific place where the laser is introduced into the microscope beam path is addressed with respect to its safety implications in Exhibit A.
Chemical Safety	Not applicable
Anatomical Sites	Not applicable
Human Factors	As the design and the use of the device is substantially similar, the same human factors apply.
Energy Used and/or Delivered	The amount of laser energy delivered in a treatment procedure is similar.	The OCTAX Laser Shot™ system can achieve similar ablation performance (size of ablations) with a lower laser beam power in focus and a lower total delivered energy.
Compatibility with Environment and Other Devices	Relevant compatibility aspects consist of compatibility with electrical standards and compatibility with listed microscopes. Both devices satisfy the similar/identical requirements.
Where Used	Both devices are used in IVF routine and are mounted on compatible inverted
	microscopes.
Preclinical studies	Identical (reference of fundamental researchjournal articles published in the literature)
Clinical studies	Similar (reference of relevant journal articlespublished in the literature)
Electrical Safety	Compliance with relevant electrical safetystandards, IEC 60101-1, IEC 61010-1 andEMC compliance according to IEC 61326
Radiation Safety	Compliance with relevant eye safetyregulations according to IEC EN 60825-1	According to IEC EN 60825-1, the OCTAXLaser Shot™ system is a class 1M device. TheHamilton Thorne Zilos system is a class 1 device.As stated in Exhibit A, both class I and class 1Mimply sufficient safety for the use of the device.

Substantial Equivalence Performance

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Conclusion

The non-clinical and clinical data for the OCTAX Laser Shot™ system, as reported in the Substantial Equivalence Performance section above, shows that the device is as safe, as effective, and performs as well or better than the predicate device.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Minitube of America, Inc. % Mr. Frederick T. Rikkers Attorney at Law 419 Venture Court P.O. Box 930555 VERONA WI 53593

DEC 1 5 2006

Re: K062524

Trade/Device Name: OCTAX Laser Shot System Regulation Number: 21 CFR 884.6200 Regulation Name: Assisted reproduction laser system Regulatory Class: II Product Code: MRX Dated: November 2, 2006 Received: November 3, 2006

Dear Mr. Rikkers:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/4/Picture/10 description: The image shows the FDA Centennial logo, which includes the years 1906-2006. Below the logo is the text "Protecting and Promoting Public Health" in a decorative font. The logo is circular and contains the letters FDA in a stylized design. The text is centered below the logo.

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Page 2 -

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150

or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

K062524 510(k) Number (if known):

Device Name: OCTAX Laser Shot™

Indications For Use:

Indications For Use: The OCTAX Laser Shot™ is a laser system for microsurgery on a cellular level, which works on a semiconductor basis. It is intended to be used to ablate a small tangential hole in the zona pellucida (assisted hatching) to be performed immediately prior to transfer on day 2 or day 3 in selected in vitro fertilization (IVF) patients with otherwise poor prognosis for successful pregnancy outcome, such as those with advanced maternal age, prior failed IVF, cryopreserved embryos, or abnormal zona pellucida characteristics. For safety reasons, the system should only be used if more than one embryo is available for transfer.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David B. Lyman

(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devices 510(k) Number

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 884.6200 Assisted reproduction laser system.

(a)
Identification. The assisted reproduction laser system is a device that images, targets, and controls the power and pulse duration of a laser beam used to ablate a small tangential hole in, or to thin, the zona pellucida of an embryo for assisted hatching or other assisted reproduction procedures.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Assisted Reproduction Laser Systems.” See § 884.1(e) for the availability of this guidance document.