(128 days)
The KeraVision® Intacs™ Vacuum System ("the Vacuum System") is intended to be used to fixate the eye in patients undergoing ophthalmic surgery requiring a lamellar dissection of the cornea.
The KeraVision Intacs™Vacuum System is indicated to fixate the eye and dissect the lamellae to create tunnels for placement of corneal ring segments to treat myopia.
The Vacuum System primarily consists of the VCG, a vacuum pump, a tubing set with filtration, and dissectors (clockwise and counterclockwise).
The provided text does not contain detailed acceptance criteria, a structured study design, or specific performance metrics that would typically be presented in a table for a medical device. The document is a 510(k) summary for premarket notification, which focuses on demonstrating substantial equivalence to predicate devices rather than providing an exhaustive performance study.
Here's an analysis of the information that is available, and a note on what is missing for each requested point:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated or quantified in the provided text. The document refers to "similar indications" and "similar principles of operation" and "similar technological characteristics" to predicate devices, implying that compliance with these aspects (and safety through biocompatibility and cytotoxicity) are the "criteria."
- Reported Device Performance: The document mentions that the 510(k) notice "summarizes the data regarding the use of the Vacuum System during the clinical trials of the KeraVision Intacs." However, it does not provide any specific performance data (e.g., success rates, complication rates, precision measurements, or quantitative outcomes) for the Vacuum System itself from these clinical trials. It primarily focuses on the Intacs corneal ring segments, which the Vacuum System assists in placing.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Fixate the eye in patients undergoing ophthalmic surgery requiring a lamellar dissection of the cornea. (Intended Use) | The Vacuum System was used during the clinical trials of the KeraVision Intacs (corneal ring segments). (No specific performance metrics for the Vacuum System's fixation or dissection are provided, only its use in the trials.) |
| Operate on the principle of controlled vacuum to a Vacuum Centering Guide (VCG) to hold the eye for lamellar dissection and intrastromal tunnel creation. | Vacuum pump provides controlled vacuum; sterile tubing delivers vacuum; VCG holds the eye; dissectors create an intrastromal tunnel. (This describes the operation, not quantified performance.) |
| Biocompatibility with contact components. | Biocompatibility certification included. |
| Non-cytotoxic parts (VCG and dissectors). | Cytotoxicity test reports included. |
| Similar indications, principles of operation, and technological characteristics to predicate devices (Chiron Vision Corp.'s Hansatome Microkeratome, Laser Light Technology, Inc.'s Automated Disposable Disposable Keratome). | The Vacuum System and predicate devices have the same intended use and similar indications, principles of operation, and technological characteristics. Minor differences (lower max vacuum, no oscillating blade, dissects vs. cuts) do not raise new safety/effectiveness questions. |
2. Sample size 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: This information is not provided. While the clinical trials for KeraVision Intacs are mentioned, no specifics on the number of patients or procedures where the Vacuum System's performance was specifically evaluated are detailed.
- Data Provenance: Not specified. It's only stated that the 510(k) "summarizes the data regarding the use of the Vacuum System during the clinical trials of the KeraVision Intacs." We do not know if these were retrospective or prospective, or the country of origin.
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)
- Ground Truth Experts: Not applicable or not provided. The device (Intacs Vacuum System) is a surgical instrument for fixation and dissection, not an interpretive diagnostic device. Therefore, a "ground truth" derived from expert consensus in the typical sense (e.g., for image interpretation) is not relevant here. The success of the device would be tied to the surgical outcome, which would be evaluated by the attending surgeon.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable or not provided. As explained above, this isn't a diagnostic device requiring adjudicated interpretation. Surgical outcomes would typically be confirmed by the operating surgeon and follow-up examinations by ophthalmologists.
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
- MRMC Study: No. This device is a surgical instrument, not an AI-assisted diagnostic tool. Therefore, an MRMC study and effects on human reader performance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a manual surgical instrument that assists human surgeons, not an automated algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The closest concept to "ground truth" for this device would be the successful completion of the lamellar dissection and creation of the intrastromal tunnel, and ultimately, the clinical outcome of the Intacs procedure (e.g., corneal ring segment placement, refractive correction). This would fall under outcomes data as observed and recorded by the operating surgeon and subsequent ophthalmological examinations during the KeraVision Intacs clinical trials.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is not a machine learning or AI device that requires a training set in the conventional sense. The "training" for such mechanical devices typically involves engineering design, prototyping, and bench testing, followed by clinical trials.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable. As this is not an AI/ML device, a "training set" and associated ground truth for it are not relevant concepts in this context.
§ 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.