(138 days)
This system is intended to be used to drill a small tangential hole in or to thin the zona pellucida of the embryo in selected in vitro fertilization (IVF) patients with otherwise poor prognosis for successful pregnancy outcome, such as advanced maternal age, prior failed IVF procedures, cryopreserved embryos, or abnormal zona pellucida morphology, and in IVF patients undergoing PGD to avoid genetic disease or aneuploidy.
The ZILOS-tk uses an infra-red [IR] laser beam [of wavelength in the range 1450
Here's an analysis of the provided text regarding the ZILOS-tk device's acceptance criteria and studies:
Acceptance Criteria and Device Performance
The submission for the ZILOS-tk device is primarily focused on extending its Indications for Use to include Laser-Assisted Blastomere or Trophectoderm Biopsy (LAB), in addition to its existing approval for Laser Assisted Hatching (LAH). The core argument for meeting acceptance criteria is that the device itself, its operation, and its effects on the zona pellucida are identical across both applications. Therefore, the safety and effectiveness demonstrated for LAH are directly transferable to LAB.
| Acceptance Criteria (Implicit) | Reported Device Performance (for LAB) |
|---|---|
| Safety: No increase in embryo damage compared to predicate/LAH use. | 3-day embryos: More than six hundred 3-day embryos treated with lasers for biopsy assistance, with "no reports of embryo damage." |
| 5-day embryos (Trophectoderm biopsy): More than 1000 embryos treated, "all of which survived the procedure." | |
| Effectiveness: Device performs as well as predicate/LAH for drilling the zona pellucida. | Device performs "exactly as well as the predicate device" in drilling application. The range of hole diameters used for LAH is "closely similar to that used for LAB." |
| Technological Equivalence: Device remains identical to the predicate device. | "The ZILOS-tk in this Submission is identical to the ZILOS-tk already approved for marketing in its physical properties and in its computer control software." All components (laser, objective, computer, software, microscope type, laser controller, pulse power, pulse duration, firing switch) are identical. |
Study Information
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Sample size used for the test set and the data provenance:
- 3-day embryos (blastomere biopsy): More than six hundred embryos.
- 5-day embryos (trophectoderm biopsy): More than 1000 embryos.
- Data Provenance: "numerous laboratories throughout the world." The data appears to be retrospective as it's referred to as "evidence from the field use" and "ZILOS-tk has been applied to laser biopsy and PGD in numerous laboratories throughout the world." Specific countries are not listed, but "France" and "Singapore" are mentioned for other contexts.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The "ground truth" here is implied by the reported outcomes (no embryo damage, survival of procedures, successful PGD). However, there's no mention of a formal expert panel establishing a gold standard for these outcomes in the context of the study.
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Adjudication method for the test set:
- None explicitly mentioned. The document states "no reports of embryo damage have been found" and "all of which survived the procedure," suggesting aggregated reporting of outcomes rather than an adjudication process by multiple experts for each case.
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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:
- No, an MRMC study was not done. This device is a laser system for physical intervention on embryos, not an AI-based diagnostic or imaging device for "human readers." Therefore, this type of study is not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone (algorithm only) study was not done. The ZILOS-tk is a physical device operated by a human. Its performance is always human-in-the-loop. The "performance data" provided refers to the outcomes of embryos after being treated with the device, which is an integrated human-device process.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth relied on is outcomes data (survival of embryos, absence of reported damage) and clinical success (successful PGD to prevent hereditary disease). This is implicitly validated by the medical community's continued use of the device and the successful delivery of healthy infants when PGD is employed.
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The sample size for the training set:
- Not applicable/Not specified. This device is a physical instrument, not an AI model that requires a "training set" in the conventional sense. The "training" here refers to the development and refinement of the device based on engineering principles and prior clinical experience with its predicate function (LAH).
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How the ground truth for the training set was established:
- Not applicable/Not specified. As it's not an AI model, the concept of a "ground truth for a training set" does not directly apply. The device's efficacy and safety for its initial indication (LAH) would have been established through prior clinical use, pre-market approvals (K040045), and scientific understanding of laser-zona interaction. This historical performance serves as the basis for arguing equivalence for the new indication.
§ 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.