(277 days)
The LaFaci Surgical System is intended for use during LASIK procedures. The LaFaci Surgical System consists of a reusable Handpiece, Surgical Cart, and disposable Tubing Accessories. The LaFaci System provides ocular fixation and containment of surgical field, corneal flap placement and flap re-positioning, and is used for ophthalmic plume aspiration, fluid aspiration, and the delivery of micro filtered air to the surgical field.
LaFaci™ Surgical System combines multiple functions commonly utilized during LASIK into a single hand piece allowing for the delivery of sterile balanced saline irrigation solution to the surgical field, fluid aspiration from the surgical field, delivery of micro-filtered air to the surgical field, and plume evacuation from the surgical field. All of these functions are generated and delivered from the LaFaci™ Surgical Cart to the LaFaci™ Handpiece through fourlumen surgical tubing.
LaFaci™ Handpiece also provides manual ocular fixation, and provides a platform for the temporary placement of the corneal flap during ablation. In addition the platform can be manually pivoted over the corneal bed thereby providing a spatula means to reposition the flap onto the stromal bed.
The LaFaci™ Surgical Cart accessories include an adjustable instrument tray, and handpiece tubing swing arm that provides sterile setup and operational efficiency during surgery. The LaFaci™ Surgical Cart disposable accessories include the LaFaci Handpiece Tubing Set (sterile) and the LaFaci Smoke/Fluid Evacuation Accessories (non-sterile).
Here's an analysis of the provided text regarding the acceptance criteria and study for the LaFaci™ Surgical System:
This device (LaFaci™ Surgical System) is a surgical apparatus, not an AI/ML device, and therefore the concepts of "acceptance criteria," "device performance," "sample size for test set," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for training set," and "ground truth for training set" in the context of diagnostic accuracy with AI are not applicable.
The submission is a 510(k) for a medical device that performs mechanical functions during LASIK procedures. The "acceptance criteria" for this type of device are primarily compliance with recognized safety standards (like electrical safety and biocompatibility) and functional bench testing to confirm its mechanical operation (e.g., plume evacuation, irrigation, aspiration, air delivery). The "study that proves the device meets the acceptance criteria" refers to these non-clinical bench tests and compliance with standards.
Here's a breakdown of the requested information based on the provided document, highlighting where the AI/ML-specific questions are not applicable:
Acceptance Criteria and Study for LaFaci™ Surgical System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Performance |
|---|---|
| Biocompatibility | Materials with patient contact are biocompatible. |
| Functional Performance | Bench testing of the Handpiece functions (plume evacuation, irrigation, aspiration, and air delivery) determined to be acceptable. (Specific quantitative metrics for "acceptable" are not detailed in this summary, but would be expected in the full submission). |
| Electrical Safety/EMC | Compliance with UL 60601-1 and EN 60601-1-1-2 electrical testing. |
| Clinical Performance | No clinical performance data was required or performed for approval based on substantial equivalence to predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for a non-AI/ML mechanical device. The "test set" in this context refers to the units of the device that underwent bench testing. The document does not specify the number of units tested, but it would be a small number of manufactured devices for engineering verification. Data provenance (country, retrospective/prospective) is not relevant here as no patient data was used.
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)
- Not applicable for a non-AI/ML mechanical device. "Ground truth" in the context of diagnostic performance (which AI/ML often addresses) is not relevant here. The "truth" for this device's performance is objective measurements during bench testing (e.g., flow rates, pressure, filter efficiency, electrical safety parameters) and material testing for biocompatibility, assessed by engineers, technicians, and potentially lab specialists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for a non-AI/ML mechanical device. Adjudication methods are used to establish ground truth from expert opinions, which is not relevant for the functional and safety testing of this mechanical device.
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
- Not applicable for a non-AI/ML mechanical device. This type of study relates to the diagnostic performance of AI-assisted human interpretation, which is not what this device does.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable for a non-AI/ML mechanical device. There is no algorithm or 'standalone' performance in the AI/ML sense for this mechanical surgical system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable for a non-AI/ML mechanical device in the diagnostic sense. The "ground truth" for this device's performance is based on:
- Objective Measurement Data: Electrical safety measurements, flow rate measurements, pressure measurements, filtration efficiency, and other engineering specifications verified during bench testing.
- Material Science Analysis: For biocompatibility.
- Regulatory Standards: Compliance with recognized consensus standards (e.g., UL, EN standards).
8. The sample size for the training set
- Not applicable for a non-AI/ML mechanical device. This concept applies to AI/ML models that are trained on data. This device is a mechanical system, not a learning algorithm.
9. How the ground truth for the training set was established
- Not applicable for a non-AI/ML mechanical device. There is no "training set" or corresponding "ground truth" in the AI/ML sense for this device.
§ 878.5070 Air-handling apparatus for a surgical operating room.
(a)
Identification. Air-handling apparatus for a surgical operating room is a device intended to produce a directed, nonturbulent flow of air that has been filtered to remove particulate matter and microorganisms to provide an area free of contaminants to reduce the possibility of infection in the patient.(b)
Classification. Class II (special controls). The device, when it is an air handling bench apparatus, an air handling room apparatus, or an air handling enclosure apparatus, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.