(35 days)
This device is intended for use in refractive surgery, to perform , microlamellar keratoplasty or keratomileusis in-situ for the correction of myopia and hyperopia.
The submitted device system composition includes: Power unit, Turbine motor, Fixed keratome head, Keratome blade, Pneumatic fixation rings, Applanation lenses. The power unit includes: Vacuum pump, Battery, Vacuum release valve, Knob to regulate gas pressure, Gas & vacuum pressure gauges, Vacuum & turbine quick connectors, Battery charger unit. The turbine motor is gas powered with adjustable speed 0 to 20 000 RPM (recommended 14 000 RPM), made of stainless steel, titanium and aluminium, with no gear system. The keratome is made of stainless steel with a fixed single piece head and safety allowing only one cut depth. Pneumatic fixation rings are made of stainless steel with double dovetails. Applanation lenses are made of clear plastic + stainless handle with engraved inner reticle diameter.
The provided text describes a 510(k) submission for a medical device, the Plancon Microlamellar Keratome - EVOLUTION power unit. This submission is focused on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific performance acceptance criteria. Therefore, much of the requested information regarding a formal study with acceptance criteria, sample sizes, expert involvement, and ground truth establishment is not present in the provided document.
However, based on the "Safety and effectiveness analysis" (Excerpt 1) and the comparison table of features (Excerpt 2 & 4), we can infer the manufacturer's approach to demonstrating safety and effectiveness.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for device performance in the typical sense (e.g., accuracy, sensitivity, specificity values). Instead, the acceptance criterion for a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device. The "performance" is therefore described in terms of design improvements and safety features that either address known problems or enhance the existing functionality of predicate devices.
| Problem Reported (or Feature Improved) | Causes (or Previous State) | Submitted Device Solution/Performance (Improvement stated) |
|---|---|---|
| Machine performance, Poor cut quality, Poor suction | Quality of maintenance and cleaning procedure, Insufficient I.O.P., Poor suction | - Vacuum level gage: Liquid crystal display (vs. needle indicator) |
- Turbine pressure gage: Liquid crystal display (vs. needle indicator)
- Insufficient vacuum indicator: Red LED and audible tone (new feature)
- Wrong turbine pressure indicator: Red LED and audible tone (new feature)
- Dual level vacuum function: Vacuum can be decreased from 600 mmHg to 150 mmHg with a switch and LED indicator, allowing a softer hold after surgery (new feature)
- Two vacuum pumps: Second pump acts as backup for vacuum loss (new feature)
- Dry chamber: Double cavity dry chamber for increased prevention of fluid aspiration (vs. single cavity)
- Test function: Self-checking function for pumps, nitrogen, and turbine pressure (new feature) |
| Wrong assembly, Microkeratome incision too deep/shallow | Forgetting pieces or not following check-list, Incorrect setting/checking, Incorrectly assembled Keratome | - Keratome head assembly: Stated as "problem cancelled with submitted device" for blade and blade holder assembly (vs. predicate devices) - Fixed Keratome head: Single piece head, only one cut depth allowed by head principle (vs. adjustable heads in predicate devices, potentially simplifying setup) |
| Sterility / cleaning more stringent | Poor maintenance, cleaning, and sterilization | - Cleaning & Sterilization: Stated as "problem cancelled with new device" for disassembling, cleaning, sterilizing (implies improved design for easier/more effective processes, though details aren't provided beyond the statement). |
| Battery autonomy | 1 battery of 12 Volts, Capacity: 6 Ah (predicate device) | - Battery: 1 battery of 12 Volts, Capacity: 12 Ah for higher autonomy (improvement) |
| Undesired unplugging of vacuum connector | LUER lock type (predicate device) | - Vacuum connector: LUER lock plus a safety lock plate to prevent undesired unplugging (new safety feature) |
| Insufficient nitrogen pressure supply | None (predicate device) | - Tank input pressure indicator: Visible indicator in case of insufficient nitrogen pressure supply (new feature) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical study with a "test set" in the sense of patient data. The basis for equivalence relies on comparing the new device's design and features to existing legally marketed devices (K960395 and K970377).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No clinical test set or ground truth establishment by experts is described for this 510(k) submission.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set or adjudication process is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. No MRMC study is mentioned. The submission is focused on device design comparison for substantial equivalence.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study
Not applicable. This is a medical instrument (Keratome power unit), not an algorithm or AI system.
7. Type of Ground Truth Used
Not applicable in the typical sense of a diagnostic or AI device. The "ground truth" implicitly refers to the known problems and safety/effectiveness performance of existing predicate devices and the general understanding of microlamellar keratoplasty. The manufacturer asserts that the new features address these known problems effectively.
8. Sample Size for the Training Set
Not applicable. This is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.