(161 days)
The epithelial scrubber is intended for deepithelialization of the cornea in preparation for subsequent surgical procedures on the denuded cornea.
The Amoils Epithelial Scrubber ("epithelial scrubber") is a small, powered handheld device to which is attached a single use brush with Tynex microfilaments. The microfilaments of the brush tip are encased in a retaining ring such that the diameter of the brush is 6.3mm. When being operated, the brush rotates in a circular fashion at approximately 1500 revolutions per minute.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Amoils Epithelial Scrubber:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define formal, quantitative acceptance criteria for the Amoils Epithelial Scrubber. Instead, it relies on comparison to a predicate device and qualitative assessments based on an eye bank study and a human study. Here's a table summarizing the implicit "acceptance criteria" (based on predicate device characteristics and desired outcomes) and the reported device performance:
| Implicit Acceptance Criterion (Derived from text) | Reported Device Performance (Amoils Epithelial Scrubber) |
|---|---|
| Intended Use: deepithelialization of the cornea in preparation for subsequent surgical procedures. | Device is intended for deepithelialization of the cornea in preparation for subsequent surgical procedures. (Met) |
| Tips, Material: Comparable to predicate device's soft plastic "pins". | Tynex microfilament (Determined comparable to predicate's "soft plastic pins") |
| Tips, Size: Comparable to predicate device's 7mm, with ability to adjust treatment zone. | 6.3mm (Determined comparable, as treatment zones can be increased by moving the device sideways) |
| Tips, Usage: Single use. | Single use (Met) |
| Angle of Device Neck: Does not hinder visualization (predicate is 0°). | 90° (Allows easier visualization of epithelial removal by the surgeon) |
| Removal Time: 2-5 seconds (from predicate). | 3-5 seconds (Confirms equivalence to reported speed of predicate) |
| Corneal Damage: No damage to Bowman's Layer. | SEM and TEM photos confirmed no damage to Bowman's layer, even under "worst case" conditions. |
| Corneal Surface: Extremely smooth surface after removal. | SEM and TEM photos confirmed extremely smooth surface. |
| Epithelial "Tags": No remaining tags. | No epithelial "tags" remain after the scrub. |
| Healing: Promotes quick healing. | Promotes quick healing since it leaves intact healthy epithelial rim. |
| Safety: Safe for use. | No MDRs reported for predicate device, and the study results support safety. |
| Effectiveness: Effective for intended use. | Demonstrated ability to remove epithelium rapidly without damage to Bowman's layer, promoting smooth surface and quick healing. |
2. Sample Size Used for the Test Set and Data Provenance
-
Test Set 1 (Eye Bank Study):
- Sample Size: "eyes drawn from an eye bank" - The exact number of eyes is not specified.
- Data Provenance: Not explicitly stated, but likely from a local eye bank given the manufacturer's location in South Africa. This would be retrospective in terms of using donated eyes for laboratory testing.
-
Test Set 2 (Human Study):
- Sample Size: "500 human eyes"
- Data Provenance: Conducted in South Africa. This was a prospective study where the device was used on human patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
-
Eye Bank Study:
- Number of Experts: Not specified.
- Qualifications: Not specified, but the ground truth was established by SEM (Scanning Electron Microscopy) and TEM (Transmission Electron Microscopy) photos. These analyses would typically be performed and interpreted by highly trained specialists (e.g., histologists, pathologists, or researchers with expertise in microscopy), but the document does not name them or their specific qualifications.
-
Human Study:
- Number of Experts: Not specified.
- Qualifications: "surgeon" is mentioned as visualizing the epithelial removal. The assessment of "quick healing" and "equivalence to reported speed" would have been made by the operating surgeons and/or clinical researchers. No specific qualifications beyond "surgeon" are provided.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (e.g., 2+1, 3+1).
- For the eye bank study, the "ground truth" was derived directly from the physical characteristics observed via SEM and TEM.
- For the human study, the observations (removal time, quick healing) were likely made by the operating surgeons and recorded. There's no mention of a separate adjudication process for these clinical observations.
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
No, an MRMC comparative effectiveness study was not done. This device is a mechanical surgical tool, not an AI-assisted diagnostic or therapeutic system. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. This is a mechanical device, not an algorithm. The performance described is of the device as used by a human surgeon.
7. The Type of Ground Truth Used
-
Eye Bank Study:
- Pathology/Histology (Microscopy): The ground truth for surface smoothness and damage to Bowman's layer was established by SEM and TEM photos. This is a direct physical assessment at a microscopic level.
-
Human Study:
- Clinical Observation/Outcomes Data: The ground truth for removal time and healing was based on clinical observation by the surgeons and subsequent patient outcomes (e.g., rapid central epithelium regrowth).
8. The Sample Size for the Training Set
The document describes pre-market studies for a medical device and does not mention any "training set." This type of device does not involve machine learning or AI that would require a training set in the conventional sense. The studies described are validation studies.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
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BURDITT & RADZIUS, CHARTERED
JAN - 9 1997
333 WEST WACKER DRIVE, SUITE 2600 CHICAGO, ILLINOIS 60606-1218 FAX: (312) 781-6630 TELEPHONE: (312) 781-
510(K) SUMMARY
1. Name and Address
Dr. S. Percy Amoils, 134 Grayston Drive, Suite 1K, Sandown, Sandton 2010, South Africa.
The U.S. Contact is
Mr. Richard O. Wood Burditt & Radzius, Chtd. 333 W. Wacker Dr. Suite 2600 Chicago, IL 60606-1218 (312) 781-6611 (312) 781-6630 fax
(27) 11 884 5624/5.
Date Summary Prepared: December 23, 1996
2. Name of the Device
| Tradename: | Amoils Epithelial Scrubber |
|---|---|
| Common name: | Corneal Epithelial Removal Device |
| Classification: | Powered corneal burr, Class I, 21 CFR §886.4070 |
| Panel: | 86 Ophthalmic |
| Procode: | HOG (Burr, Corneal) |
3. Identification of Predicate Device(s)
The Pallikaris Automated Epithelial Removal Brush, K960261
4. Description of the Device
The Amoils Epithelial Scrubber ("epithelial scrubber") is a small, powered handheld device to which is attached a single use brush with Tynex microfilaments. The microfilaments of the brush tip are encased in a retaining ring such that the diameter of the brush is 6.3mm. When being operated, the brush rotates in a circular fashion at approximately 1500 revolutions per minute.
5. Intended Use of the Device
The epithelial scrubber is intended for deepithelialization of the cornea in preparation for subsequent surgical procedures on the denuded cornea.
1 The FDA Checklist for summaries is attached.
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| Item to be Compared | Amoils Epithelial Scrubber | Pallikaris Epithelial RemovalBrush, K960261 |
|---|---|---|
| Intended Use | deepithelialization of thecornea in preparation forsubsequent surgicalprocedures on the denudedcornea. | removal of the cornealepithelium prior to T-PRK®or PRK surgery |
| Tips, material | Tynex microfilament | soft plastic "pins" derivedfrom a surgical hand brush |
| Tips, size | 6.3mm | 7mm |
| Tips, usage | single use | single use |
| Angle of Device Neck | 90° | 0° |
| Removal Time | 3-5 seconds | 2-5 seconds |
6. Comparison of Technological Characteristics
The differences between the epithelial scrubber and the predicate device are minor and do not impact the safety and effectiveness of the device in any significant way. The difference in tip size does not affect safety and effectiveness, because the treatment zones can be increased with both devices by moving the device sideways to create a larger diameter. The 90° angle in the neck of the Amoils scrubber permits easier visualization of the epithelial removal by the surgeon, and the Tynex microfilaments of the Amoils device and the soft plastic "pins" of the Pallikaris brush are comparable.
7. Performance Data
The Amoils epithelial scrubber was used according to the instructions for use on eyes drawn from an eye bank. The eyes were then subjected to SEM and TEM photos, which confirmed that the epithelium was removed and the surface of the cornea was extremely smooth, with no damage to Bowman's layer. In addition, certain of the eye bank eyes were exposed to "worst case" treatments with the device, i.e., at twice the time and with excessive pressure. The photos from that part of the study again confirmed that the epithelium was removed and the surface of the cornea was extremely smooth, with no damage to Bowman's layer
The device was evaluated on 500 human eves in a study conducted in South Africa. The procedure took from 3 to 5 seconds, confirming its equivalence to the reported speed of the Pallikaris brush (2 to 5 seconds). It was also found to promote quick healing, because the procedure does not remove the healthy epithelial rim from the 7 mm. zone to the limbus. This facilitates rapid central epithelium regrowth.
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8. Safety and Effectiveness
Based on the data presented in this PMN, the Amoils epithelial scrubber is safe and effective:
- · It permits rapid removal of the central 7 mm. corneal epithelium without damage to the harder Bowman's layer lying underneath.
- · The Bowman's layer is not dried out by alcohol used in certain procedures and uneven dehydration of the stroma after mechanical scraping is eliminated.
- · It is easy to visualize and manipulate through the microscope in the laser apparatus.
- · No epithelial "tags" remain after the scrub.
- It promotes quick healing since it leaves intact healthy epithelial rim from the 7 mm. zone to the limbus, which facilitates rapid central epithelium regrowth.
In addition, a manual search in the Product SOS™2 book found that no MDRs were reported.
9. Conclusions
The similarity in technological characteristics, coupled with the results of the work on both eve bank and human eves, demonstrate the safety and efficacy of the Amoils Epithelial Scrubber and support the finding of substantial equivalence to the Pallikaris Epithelial Removal Brush, K960261.
2 Product SOS™, Medical Economics Data Production Company, Montvale, NJ 07645-1742.
§ 886.4070 Powered corneal burr.
(a)
Identification. A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.