(567 days)
The VisiJet Hydrokeratome is intended for use in performing anterior lamellar circular corneal resections.
The VisiJet Hydrokeratome is indicated for use in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea.
The VisiJet Hydrokeratome - Model 50 is a non-oscillating, non-mechanical microkeratome which utilizes a continuous high-velocity beam of sterile water for injection to effect a lamellar resection of the cornea. The major elements of this microkeratome are a system console, a footswitch and a handpiece with interchangeable suction rings. The operating principle of the water beam microkeratome is based on the ability to create high levels of static hydraulic pressure that is directed across the cornea, effecting a lamellar resection.
The provided text describes the VisiJet™ Hydrokeratome™ and its premarket notification (K991124). However, it does not contain acceptance criteria or a study proving the device meets specific performance criteria in the way a clinical trial or detailed performance report would.
The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific performance metrics against pre-defined acceptance criteria. The "Brief summary of nonclinical tests and results" section ({2}) broadly states that the device was "found to perform equivalently to the predicate devices" and "as intended in all cases," but this is a high-level summary without specific data.
Therefore, I cannot populate the requested table or detail studies as requested, because the provided text does not contain this information.
Here's an explanation of what information is available and what is missing for each point you requested:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the provided text.
- Reported Device Performance: Only general statements are made, such as "found to perform equivalently to the predicate devices" and "as intended in all cases" ({2}). No specific numerical performance metrics (e.g., flap thickness accuracy, resection diameter consistency, complication rates) are provided.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not mentioned.
- Data Provenance: Not mentioned. The "nonclinical tests and results" ({2}) imply in-house testing or bench testing, but provide no details on where or how these tests were conducted, or on what kind of "test set" (e.g., ex vivo animal eyes, artificial cornea models) they were performed.
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 applicable and not present. The submission focuses on device comparison and basic functionality, not expert-adjudicated ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable and not present.
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 information is not applicable. The device (a keratome) is surgical equipment, not an AI diagnostic tool intended to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable. The device is a surgical instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly defined. The "nonclinical tests and results" likely refer to engineering validation against design specifications and comparison to the performance of predicate devices, rather than a "ground truth" in a clinical data sense.
8. The sample size for the training set
- Not applicable as this is not an AI/machine learning device. The "training set" concept is not relevant to this type of device submission.
9. How the ground truth for the training set was established
- Not applicable as this is not an AI/machine learning device.
Summary of available information related to performance/equivalence:
- Predicate Devices: Barron Microkeratome System Model B2000 (K973317), Medjet HydroBrush (K971078), Hansa Automatic Corneal Shaper (ACS) (913697).
- Basis of Equivalence: "The VisiJet Hydrokeratome was found to perform equivalently to the predicate devices, the Baron Microkeratome System, Automatic Corneal Shaper (ACS) and the Medjet Hydrobrush, and as intended in all cases." ({2})
- Technological Comparison: A table ({3}) comparing characteristics like intended use, operating principle, thickness control, flap diameter, etc., is provided to highlight similarities and differences with predicate devices. For example, the VisiJet Hydrokeratome, like the Medjet HydroBrush, uses a "High-velocity water beam" as its operating principle, differentiating it from the blade-based predicate devices. It offers thickness control via "Clear applanation plate that is part of the suction-applanation rings (140u, 160u, 180u, 200u)" which is conceptually similar to the "Fixed Depth Keratome Head" or "Thickness Plates" of predicate devices.
In conclusion, the document emphasizes substantial equivalence through comparison of technological characteristics and general statements of equivalent performance rather than presenting a detailed study with specific acceptance criteria and performance data.
§ 886.4370 Keratome.
(a)
Identification. A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.(b)
Classification. Class I.