Search Results
Found 3 results
510(k) Data Aggregation
(30 days)
NORWOOD ABBEY CENTURION SES EPIKERATOME
The Norwood Abbey Centurion SES Epikeratome is intended for use in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea.
The Norwood Abbey Centurion SES Epikeratome is an AC-powered device that is used by incising the epithelium at a predetermined location and diameter using a high-speed oscillating separator made of PMMA. The device consists of the following main components and accessories: console, separator drive assembly, suction ring assembly (with 10.0 and 9.0mm suction franquece, separator anve assombly, oaction ing are may as embly (accessory), forceps and an epithelial separator. The Norwood Abbey Centurion SES Epikeratome contains a Head Unit Assembly (with The Norwood Abbey Container sizes) that allows the cornea to protrude through the ഴിയ വിവിധ വാടിനിന് caction is suspended from the end of the separator drive assembly housing that is moved by a drive mechanism along a forward path inside the suction ring nousing that is moved by a unve mechannel and vacuum for the suction ring are provided by user command via the console and foot pedal.
This submission, K051486, describes the Centurion SES™ Epikeratome, an AC-powered device for separating the corneal epithelium. The submission focuses on a new console for the device and its substantial equivalence to a predicate device.
Here's an analysis of the provided text in relation to the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functionally equivalent to the predicate device (Johnash OEO Epikeratome) | "Bench testing has demonstrated that the new console is functionally equivalent to the Denin testing has dominated inor differences between the modified device and the predicate device do not affect safety or effectiveness." |
| Able to drive the separator assembly to remove epithelium in a consistent and reproducible way. | "Functional test results demonstrate that the Centurion SES system with new console r unfollowar tost Toodko 'device console does to drive the separator assembly to remove epithelium in a consistent and reproducible way." |
| No effect on safety or effectiveness due to modified console. | "Bench testing has demonstrated that the new console is functionally equivalent to the Denin testing has dominated inor differences between the modified device and the predicate device do not affect safety or effectiveness." |
| Equivalent to the predicate device with respect to intended use and technological characteristics. | "Based on the qualification testing, it can be concluded that the new Norwood Abbey Dased on the qualified console is equivalent to the predicate Ochturion SES Epikeratome with respect to intended use and technological characteristics." |
2. Sample size used for the test set and the data provenance
The document explicitly states "Bench testing" and "Functional test results." This implies a series of laboratory-based tests rather than studies involving human subjects or patient data.
- Sample Size: Not specified. Standard engineering and functional testing would likely involve testing multiple units of the device and observing performance over a range of operational parameters, but no specific count is given.
- Data Provenance: The testing appears to be prospective bench testing conducted by Norwood Abbey Limited in Australia. There is no mention of patient data, retrospective analysis, or specific country of origin for any human-derived data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not applicable to this submission. The device is for a surgical procedure (mechanical separation of epithelium), and its performance evaluation focused on its mechanical and functional equivalence to a predicate device, as demonstrated through bench testing. There is no mention of human-interpreted data (like medical images) that would require experts to establish ground truth.
4. Adjudication method for the test set
Not applicable. As the performance evaluation was based on functional and bench testing, there's no "ground truth" to adjudicate in the typical sense of expert review for diagnostic devices.
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. This is a mechanical surgical device, not a diagnostic imaging device with AI assistance. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in spirit. The performance evaluation was entirely "standalone" in the sense that the device's functional characteristics were assessed directly through bench testing without human-in-the-loop performance testing in a clinical diagnostic context. The focus was on the machine's ability to perform its stated mechanical function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance evaluation was defined by:
- Functional equivalence to the predicate device: The new console had to demonstrate it could perform the same functions as the predicate device.
- Consistency and reproducibility: The device had to consistently and reproducibly drive the separator assembly to remove epithelium.
- Lack of impact on safety or effectiveness: The modifications should not negatively affect the device's safety or its ability to perform its intended use.
These "ground truths" were assessed via a combination of engineering specifications, comparison to a predicate device's known performance, and functional testing to ensure consistent mechanical operation. It does not involve biological or clinical "ground truth" as you would find in diagnostic device submissions (e.g., pathology for a cancer detection device).
8. The sample size for the training set
Not applicable. This submission is for a mechanical surgical device without any machine learning or AI components that would require a "training set."
9. How the ground truth for the training set was established
Not applicable. See point 8.
Ask a specific question about this device
(16 days)
CENTURION SES EPIKERATOME
The Norwood Abbey Centurion SES Epikeratome is intended for use in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea, and for use in the making of a corneal flap in patients undergoing LASIK or other treatment requiring initial lamellar resection of the cornea.
The Norwood Abbey Centurion SES Epikeratome is an AC-powered device that is used for making a separation or flap by incising the epithelium at a predetermined location and diameter using a high-speed oscillating separator made of PMMA. The device consists of the following main components and accessories: the drive control unit (DCU), handpiece, separator drive assembly, suction positioning ring assembly (now with 10.0 and 9.0mm sizes), a foot pedal, a tubing set with fluid collection assembly (accessory), and an epithelial separator.
The provided document describes the safety and effectiveness summary for the Norwood Abbey Centurion SES™ Epikeratome, specifically the 9.0mm suction ring. This submission is for a Class I device (regulated under 21 CFR 886.4370, Product Code 86 HNO, Keratome, AC - Powered) to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported (Demonstrated) Device Performance |
|---|---|
| Functional Equivalence/Substantial Equivalence: | |
| Same intended use as predicate device. | The new 9.0mm Centurion SES Epikeratome suction ring has the "same intended use" as the predicate device (CIBA Vision/Norwood Abbey Centurion SES Epikeratome 10.0mm suction ring). The indications for use are identical: separation of epithelium from the cornea for subsequent surgical procedures, and making a corneal flap for LASIK or other lamellar resection. |
| Same basic scientific technology as predicate device. | Both devices utilize "suction to the cornea and oscillation principles to separate the epithelium from the cornea." |
| Functionally equivalent to predicate device. | "Bench testing has demonstrated that the new 9.0mm Centurion SES suction ring is functionally equivalent to the predicate Centurion SES 10.0mm suction ring." The device "removes epithelium in a consistent and reproducible way and is equivalent to the predicate device." |
| Minor differences between modified and predicate device do not affect safety or effectiveness. | "any minor differences between the modified device and the predicate device do not affect safety or effectiveness." |
| Biocompatibility: (for patient-contacting components) | All components that come in direct contact with the patient "have a long history of use in ophthalmic medical devices and are biocompatible." |
| Consistency and Reproducibility: (of epithelium removal) | Functional test results demonstrate that the Centurion SES suction ring and separator assembly "removes epithelium in a consistent and reproducible way." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Bench testing" and "Functional test results" but does not specify the sample size for these tests. It also does not directly state the data provenance in terms of country of origin or whether the data was retrospective or prospective. Given that it's a 510(k) summary for a Class I device and the focus is on "bench testing" and "functional equivalence" to a predicate, the testing would typically be conducted in a controlled lab environment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth. The evaluation relied on demonstrable functional equivalence through bench testing.
4. Adjudication Method for the Test Set
Since no experts were used to establish ground truth (as per point 3), there was no adjudication method described or necessary.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not mentioned or performed. The study focused on demonstrating functional equivalence through bench testing, not on human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This device is a mechanical epikeratome, not an AI algorithm. Therefore, the concept of a "standalone (algorithm only)" performance study is not applicable. The "performance data" refers to the mechanical function of the device itself.
7. The Type of Ground Truth Used
The "ground truth" for this submission appears to be derived from the demonstrated functional characteristics and performance of the predicate device. The new device's performance was compared against the known and accepted performance of the predicate in terms of its ability to separate epithelium consistently and reproducibly. It is based on engineering/bench test results showing direct functional equivalence, rather than a clinical ground truth like pathology or outcomes data.
8. The Sample Size for the Training Set
This device is a hardware product, not an AI model. Therefore, the concept of a "training set" is not applicable.
9. How the Ground Truth for the Training Set Was Established
As this is not an AI model, the concept of a "training set" and establishing its ground truth is not applicable.
Ask a specific question about this device
(78 days)
CENTURION SES EPIKERATOME
The CIBA Centurion SES Epikeratome is intended for use in the separation of the epithelium from the cornea in preparation for subsequent surgical procedures on the denuded cornea, and for use in the making of a corneal flap in patients undergoing LASIK or other treatment requiring initial lamellar resection of the cornea.
The Centurion SES Epikeratome is an AC-powered device that is used for making a separation or flap by incising the epithelium at a predetermined location and diameter using a high-speed oscillating separator made of PMMA. The device consists of the following main components and accessories: the control unit. handpiece with drive assembly, suction positioning ring assembly, a foot pedal, a tubinq set with fluid collection assembly (accessory), and a epithelial separator.
The provided 510(k) summary for the CIBA Centurion SES Epikeratome describes a medical device, but it does not contain specific acceptance criteria or a detailed clinical study demonstrating the device's performance against such criteria. Instead, it relies on substantial equivalence to predicate devices, supported by bench testing.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from the given text, nor can I answer questions about sample sizes for test sets, ground truth establishment, expert adjudication, or MRMC studies. This information is typically found in more comprehensive clinical study reports, which are not part of this 510(k) summary.
However, based on the provided text, I can infer and state what was used to establish equivalence:
Acceptance Criteria and Study Summary (Based on Substantial Equivalence and Bench Testing):
| Acceptance Criteria (Inferred from Substantial Equivalence Basis) | Reported Device Performance |
|---|---|
| Functional equivalence to predicate devices (Biovision Visitome 20-10, Alcon Pallikaris Brush, Amoils Epithelial Scrubber) | Bench testing demonstrates functional equivalence, showing the Centurion SES device is functionally equivalent to the Visitome 20-10. Minor differences between Centurion SES and predicate devices do not affect safety and effectiveness. |
| Consistent and reproducible epithelium removal | Bench testing demonstrates that the Centurion SES separator removes epithelium in a consistent and reproducible way. |
| Biocompatibility of patient-contacting components | All components that come in direct contact with the patient have a long history of use in ophthalmic medical devices and are biocompatible. |
| Equivalence in intended use (separation of epithelium, making corneal flap) | Centurion SES is substantially equivalent to predicate devices with respect to intended use. |
| Equivalent technological characteristics | Centurion SES has equivalent technological characteristics to predicate devices. |
Detailed Study Information (Based on provided 510(k) Summary):
-
A table of acceptance criteria and the reported device performance: See table above. These are inferred from the 510(k)'s focus on substantial equivalence and bench testing, rather than explicit numerical acceptance criteria.
-
Sample sized used for the test set and the data provenance: Not specified. The document refers to "bench testing" but does not provide details on sample sizes, specific test protocols, or data provenance (e.g., country of origin, retrospective/prospective nature).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for showing equivalence was based on functional performance in bench testing relative to predicate devices, not on expert consensus from human data.
-
Adjudication method for the test set: Not applicable. No human adjudication process is described for performance evaluation; the assessment was based on bench testing.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done: No. The document does not mention an MRMC study or any study involving human readers or AI assistance.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is an AC-powered surgical tool, not an algorithm. Its standalone performance was assessed through "functional and electrical" bench testing to demonstrate consistent and reproducible epithelium removal, and equivalence to predicate devices.
-
The type of ground truth used: The "ground truth" for demonstrating the device's performance was the established functionality and performance of the predicate devices, against which the Centurion SES Epikeratome was quantitatively and qualitatively compared via bench testing. The biocompatibility of materials was also a "ground truth" based on historical use.
-
The sample size for the training set: Not applicable. This device is a mechanical surgical tool, not an AI or algorithm that requires a training set.
-
How the ground truth for the training set was established: Not applicable.
Ask a specific question about this device
Page 1 of 1