(161 days)
The VisuMax Laser Keratome is indicated for the following:
- In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea;
- In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea;
- In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty;
- In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting.
The VisuMax Laser Keratome is an ophthalmic surgical femtosecond laser intended for use in patients requiring corneal incisions. The cutting action of the VisuMax Laser Keratome is achieved through precise individual micro-photodisruptions of tissue, created by tightly focused ultrashort pulses which are delivered through a disposable applanation lens while fixating the eye under very low vacuum.
The provided text describes a 510(k) premarket notification for the Carl Zeiss Meditec VisuMax Laser Keratome. It focuses on demonstrating substantial equivalence to predicate devices and expanding indications for use.
However, the document does not contain specific acceptance criteria, a detailed study proving the device meets those criteria, sample sizes for test or training sets, information about ground truth establishment, expert qualifications, or MRMC study results. The information provided is primarily focused on the device's technical characteristics, intended use, and a summary of pre-clinical testing, which is often used to demonstrate substantial equivalence rather than explicitly proving performance against predefined acceptance criteria for a new device.
Therefore, I cannot populate the requested table and answer many of the questions directly from the provided text. I will indicate where information is missing or not applicable based on the document.
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it aims to demonstrate substantial equivalence in performance to predicate devices for expanded indications. The "reported device performance" in this context refers to the findings from the ex-vivo studies.
| Acceptance Criteria (Not explicitly stated as numeric thresholds) | Reported Device Performance (from ex-vivo studies) |
|---|---|
| For Lamellar Keratoplasty Incisions: | |
| Accuracy and Reproducibility | "Ex-vivo porcine eye studies demonstrate the accuracy and reproducibility of the VisuMax Laser Keratome for lamellar keratoplasty incisions and that the level of precision is maintained over a wide range of incision diameters and depths. The results further demonstrate that the proposed device performed equivalently to the predicate device." |
| For Full Penetrating Keratoplasty Performance: | |
| Quality of Performance | "Ex-vivo study in human globes shows that the quality of the full penetrating keratoplasty performance of the VisuMax Laser Keratome and the predicate device are comparable." |
| General Equivalence to Predicate Devices | "The VisuMax Laser Keratome has the same operating characteristics as the predicate devices... Therefore, the VisuMax Laser Keratome is substantially equivalent to these legally marketed predicate devices." and "The VisuMax Laser Keratome is substantially equivalent to the predicate devices." (Conclusion section) |
Study Details:
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text for either the porcine eye studies or the human globes study.
- Data Provenance:
- "Ex-vivo porcine eye studies"
- "Ex-vivo study in human globes"
- The location of these studies (country of origin) is not specified.
- Both are "pre-clinical" studies, implying they are not retrospective or prospective clinical studies on live patients.
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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):
- Not specified. The studies are ex-vivo (on animal and human globes), and the evaluation of "accuracy," "reproducibility," and "quality" would likely involve objective measurements or expert assessment, but the number and qualifications of evaluators are not detailed.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not specified.
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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. This is a medical device (laser keratome), not an AI diagnostic tool. Therefore, an MRMC comparative effectiveness study with human readers assisting/being assisted by AI is not relevant to this device's evaluation as described. The comparison is between the new device and predicate devices in performing surgical cuts.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The performance data presented refers to the device's ability to make incisions ("accuracy and reproducibility," "quality of performance") when compared to predicate devices, during ex-vivo studies. This evaluates the device's intrinsic function. The device's operation still requires a human operator, but the performance "testing" as described focuses on the machine's output in isolation (the cut it makes).
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated. For "accuracy," "reproducibility," and "quality" of surgical incisions, the ground truth would likely be based on objective measurements (e.g., microscopy, optical coherence tomography to measure incision depth, diameter, smoothness, and morphology against predefined surgical targets) possibly interpreted or confirmed by expert ophthalmologists/pathologists, but this is not detailed in the summary.
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The sample size for the training set:
- Not applicable. This device is a surgical laser, not a machine learning model, so there is no "training set" in the sense of data used to train an algorithm. The device's design and engineering would have involved extensive testing and calibration during development, but this is distinct from "training data" for an AI.
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How the ground truth for the training set was established:
- Not applicable (as it's not an AI/ML device with a training set).
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.