(88 days)
The Surgistar 2400-LSK Microkeratome is indicated for use as a replacement blade in the Moria LSK-ONE Keratome. The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea.
The Surgistar 2410-CB Microkeratome blade is indicated for use as a replacement blade in the Moria Carriazo Barraquer Keratome. The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea.
The Surgistar 2420-M2 Microkeratome blade is indicated for use as a replacement blade in the Moria Carriazo Barraquer II Keratome also known as the M2. The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea.
The Surgistar 2400-LSK is a replacement microkeratome blade for the Moria LSK-ONE Keratome. The blade consists of a 420 low carbon stainless steel blade and a plastic holder attached to the blade. The 2400-LSK blades are single-use, disposable blades.
The Surgistar 2410-CB is a replacement microkeratome blade for the Moria Carriazo Barraquer Keratome. The blade consists of a 420 low carbon stainless steel blade and a plastic holder attached to the blade. The 2410-CB blades are single-use, disposable blades.
The Surgistar 2420-M2 is a replacement microkeratome blade for the Moria Carriazo Barraquer II Keratome. The blade consists of a 420 low carbon stainless steel blade and a plastic holder attached to the blade. The 2420-M2 blades are single-use, disposable blades.
The provided text describes three medical devices: Surgistar Microkeratome Blade Models 2400-LSK, 2410-CB, and 2420-M2. All three are replacement blades for specific Moria microkeratomes, intended for use in corneal lamellar resection surgery. The studies presented aim to demonstrate substantial equivalence to their respective predicate devices.
Here's an analysis of the acceptance criteria and the studies that prove the devices meet them, for each model:
Surgistar Microkeratome Blade, Model No. 2400-LSK
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Required Performance for Substantial Equivalence to Predicate) | Reported Device Performance (Surgistar 2400-LSK) | Meets Criteria? |
|---|---|---|
| Dimensional Equivalency: Substantial equivalence to predicate's specifications. | Dimensional Equivalency Measurements of the predicate device are substantially equivalent to the specifications established by Surgistar. | Yes |
| Sharpness: Performs equivalently to the predicate blade. | Sharpness tests indicate the Surgistar 2400-LSK performs equivalently to the Moria LSK-ONE. | Yes |
| Keratome Fit: Acceptable fit with the predicate keratome head. | Fit tests with the Moria LSK-ONE Keratome head demonstrated that the Surgistar 2400-LSK fit was acceptable. | Yes |
| Corneal Lamellar Sections (Functionality): Equivalent to predicate. | Non-clinical porcine eye studies demonstrated equivalent corneal lamellar sections between the Surgistar 2400-LSK and the Moria LSK-ONE. | Yes |
2. Sample Size Used for the Test Set and Data Provenance:
- The document does not specify the exact sample size for each performance test (dimensional, sharpness, fit).
- For the non-clinical porcine eye studies, the sample size is also not specified.
- The data provenance is stated as "non-clinical porcine eye studies," indicating animal studies. The country of origin is not explicitly mentioned but implied to be within the manufacturer's operation given the context of a 510(k) submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable as these are primarily engineering and observational performance tests. The "ground truth" for these tests would be objective measurements and direct observation of functionality, not expert consensus on qualitative data.
4. Adjudication Method for the Test Set:
- Not applicable. The tests described are objective measurements (dimensional, sharpness, fit) and direct observation of results (corneal lamellar sections in porcine eyes).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI systems involving human interpretation.
6. Standalone (Algorithm Only) Performance Study:
- No, a standalone algorithm-only performance study was not done. The device is a physical blade, not an AI algorithm.
7. Type of Ground Truth Used:
- Dimensional Equivalency: Manufacturer's specifications for the predicate device.
- Sharpness: Standardized sharpness testing criteria.
- Keratome Fit: Engineering specifications for the predicate keratome head.
- Corneal Lamellar Sections: Visual and/or histological assessment of the sections produced in porcine eyes, compared to those produced by the predicate, without specific details on the exact metrics or how "equivalence" was defined.
8. Sample Size for the Training Set:
- Not applicable. This is a physical device, not an AI/ML algorithm requiring a training set.
9. How Ground Truth for the Training Set Was Established:
- Not applicable.
Surgistar Microkeratome Blade, Model No. 2410-CB
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Required Performance for Substantial Equivalence to Predicate) | Reported Device Performance (Surgistar 2410-CB) | Meets Criteria? |
|---|---|---|
| Dimensional Equivalency: Substantial equivalence to predicate's specifications. | Dimensional Equivalency Measurements of the predicate device are substantially equivalent to the specifications established by Surgistar. | Yes |
| Sharpness: Performs equivalently to the predicate blade. | Sharpness tests indicate the Surgistar 2410-CB performs equivalently to the Moria C-B Microkeratome blade. | Yes |
| Keratome Fit: Acceptable fit with the predicate keratome head. | Fit tests with the Moria Carriazo Barraquer Keratome head demonstrated that the Surgistar 2410-CB fit was acceptable. | Yes |
| Corneal Lamellar Sections (Functionality): Equivalent to predicate. | Non-clinical porcine eye studies demonstrated equivalent corneal lamellar sections between the Surgistar 2410-CB and the Moria C-B Microkeratome blade. | Yes |
2. Sample Size Used for the Test Set and Data Provenance:
- The document does not specify the exact sample size for each performance test.
- For the non-clinical porcine eye studies, the sample size is also not specified.
- The data provenance is stated as "non-clinical porcine eye studies," indicating animal studies.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable.
4. Adjudication Method for the Test Set:
- Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No.
6. Standalone (Algorithm Only) Performance Study:
- No.
7. Type of Ground Truth Used:
- Dimensional Equivalency: Manufacturer's specifications for the predicate device.
- Sharpness: Standardized sharpness testing criteria.
- Keratome Fit: Engineering specifications for the predicate keratome head.
- Corneal Lamellar Sections: Visual and/or histological assessment of the sections produced in porcine eyes, compared to those produced by the predicate, without specific details.
8. Sample Size for the Training Set:
- Not applicable.
9. How Ground Truth for the Training Set Was Established:
- Not applicable.
Surgistar Microkeratome Blade, Model No. 2420-M2
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Required Performance for Substantial Equivalency to Predicate) | Reported Device Performance (Surgistar 2420-M2) | Meets Criteria? |
|---|---|---|
| Dimensional Equivalency: Substantial equivalence to predicate's specifications. | Dimensional Equivalency Measurements of the predicate device are substantially equivalent to the specifications established by Surgistar. | Yes |
| Sharpness: Performs equivalently to the predicate blade. | Sharpness tests indicate the Surgistar 2420-M2 performs equivalently to the Moria M2 Microkeratome blade. | Yes |
| Keratome Fit: Acceptable fit with the predicate keratome head. | Fit tests with the Moria Carriazo Barraquer II Keratome head demonstrated that the Surgistar 2420-M2 fit was acceptable. | Yes |
| Corneal Lamellar Sections (Functionality): Equivalent to predicate. | Non-clinical porcine eye studies demonstrated equivalent corneal lamellar sections between the Surgistar 2420-M2 and the Moria M2 Microkeratome blade. | Yes |
2. Sample Size Used for the Test Set and Data Provenance:
- The document does not specify the exact sample size for each performance test.
- For the non-clinical porcine eye studies, the sample size is also not specified.
- The data provenance is stated as "non-clinical porcine eye studies," indicating animal studies.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable.
4. Adjudication Method for the Test Set:
- Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No.
6. Standalone (Algorithm Only) Performance Study:
- No.
7. Type of Ground Truth Used:
- Dimensional Equivalency: Manufacturer's specifications for the predicate device.
- Sharpness: Standardized sharpness testing criteria.
- Keratome Fit: Engineering specifications for the predicate keratome head.
- Corneal Lamellar Sections: Visual and/or histological assessment of the sections produced in porcine eyes, compared to those produced by the predicate, without specific details.
8. Sample Size for the Training Set:
- Not applicable.
9. How Ground Truth for the Training Set Was Established:
- Not applicable.
Summary of Device Substantial Equivalence Claims:
For all three blades, Surgistar conducted a series of performance tests to demonstrate substantial equivalence to their respective predicate devices. These tests focused on:
- Dimensional Equivalency: Comparing the new blade's dimensions to the specifications of the predicate.
- Sharpness: Ensuring the new blade performs equivalently in sharpness tests.
- Keratome Fit: Confirming the new blade properly fits the specified microkeratome head.
- Non-clinical Porcine Eye Studies: Verifying that the new blade produces equivalent corneal lamellar sections in an animal model, indicating comparable functional performance during the intended surgical procedure.
The conclusions for all three devices stated "substantially equivalent" based on these performance tests. The studies are not designed for AI/ML algorithms or human reader performance, but rather for physical device characteristics and functionality in a laboratory/animal setting.
§ 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.