(109 days)
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.
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.
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.
§ 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.