(88 days)
To perform microlamellar keratoo asty for the correction of myopia or hyperopia
Power urit Turbine motor Adjustable keratome head Keratome blade Pneumatic fixation rings Applanation lenses Plate check ng gauge
I understand you're looking for a detailed breakdown of acceptance criteria and study information for a medical device. However, the provided text snippets (K960395) are primarily descriptive comparisons of device features (intended use, system composition, turbine motor, keratome, etc.) between a submitted device and two predicated devices.
This information does not contain any details about:
- Acceptance Criteria: There are no stated performance metrics, thresholds, or targets.
- Study Design or Results: There's no mention of any clinical trials, pre-clinical studies, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.
It seems this document is a summary for demonstrating substantial equivalence based on device features and intended use, rather than a performance study report.
Therefore, I cannot fulfill your request for the tables and study details based on the provided text.
To answer your request, I would need a document that describes:
- Specific numerical or qualitative performance targets the device must meet.
- Details of a study conducted to evaluate the device's performance against those targets. This would include information on the study's methodology, data collection, analysis, and results.
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K960395
PR 26 1996
SAFETY AND EFFECTIVENESS SUMMARY
| Designation / | Submitted device | Predicated device ① | Predicated device ② |
|---|---|---|---|
| Feature | PLANCON INSTRUMENTS | ||
| Intended use | To perform microlamellarkeratoo asty for the correction ofmyopia or hyperopia | To perform micro lamellarkeratop asty for the correction ofmyopia or hyperopia | To perform micro lamellar keratoplasty forthe correctior of myopia or hyperopia |
| System composition | Power uritTurbine motorAdjustable keratome headKeratome bladePneumatic fixation ringsApplanation lensesPlate check ng gauge | Power uritTurbine motorAdjustable keratome headKeratome bladePneumat c fixation ringsApplanat on lensesPlate checking gauge | Power unitTurbine motorAdjustable keratome headKeratome bladePneumatic fixation ringsApplanation lensesPlate checking gauge |
| Power unit | Vacuum pumpBatteryVacuum release valveKnob to regulate gas pressureGas & vacuum pressure gaugesVacuum & turbine quick connectorsBattery charger un.t | Vacuum pumpBatteryVacuum release valveKnob to regulate gas pressureGas & vacuum pressure gaugesVacuum & turbine quick connectorsBattery charger un t | Vacuum pumpBatteryVacuum release valveKnob to regulate gas pressureGas & vacuum pressure gaugesVacuum & turbine quick connectorsBattery charger unit |
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K960395
SAFETY AND EFFECTIVENESS SUMMARY
| PLANCON INSTRUMENTS | PREDICATED DEVICE 1 | PREDICATED DEVICE 2 | |
|---|---|---|---|
| Turbine motor | Gas poweredAdjustable speed 0 to 20 000 RPM(recommended 14 000 RPM)Material : stainless steel, t tanium,and aluminium.No gear system | Gas poweredAdjustable speedMaterial : stainless steelNo gear system | Gas poweredAdjustable speed from 10 to 24 000 RPMPre-set speed 14 000 RPMMaterial : stainless steel and brassNo gear system |
| Keratome | Material : stainless steelAdjustableSafety : maximum cut depth, andchecking gauge | Material : stainless steelAdjustablePermanent adjustable head withadjustment knobSafety :- maximum cut depth and checkinggauge | Material : stainless steelAdjustableSafety :- maximum cut depth and checking gauge |
| Pneumatic fixationrings | Material : stainless steelDouble dovetails | Material : stainless steelDouble dovetails | Material : stainless steelDouble covetails |
| Applanation lenses | Material : clear plastic + stainlesshandleEngraved inner reticle diameter | Material : clear plastic + stainlesshandleEngraved inner reticle diameter | Material : clear plastic + stainless handleEngraved inner reticle diameter |
§ 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.