(72 days)
The Barron Microkeratome is intended to be used for creating a lamellar section from the cornea to create a flap with predetermined diameter, thickness, and flap hinge width.
The Barron Microkeratome System is indicated for performing lamellar sectioning of the cornea.
The Barron Microkeratome System consists of two components: a single-use Microkeratome and a Control Console that provides 9V DC and vacuum to the Microkeratome. The Barron Microkeratome is designed to perform a lamellar section of the cornea to vield a flap of predetermined diameter, thickness, and flap hinge width. The product will be offered in various sizes to provide flap diameters from 7.5 mm to 10.5 mm, and flap thickness of 130 um, and 180 um. The lamellar section is obtained by an oscillating stainless steel blade that is driven by a small motor in the Microkeratome. The Microkeratome is fixated on the eye by use of vacuum which is applied to a Vacuum Ring that seats on the eye. The vacuum exhaust from the Microkeratome is isolated from the ambient atmosphere by a 0.45-um hydrophobic filter. The Microkeratome is supplied in a sterile package, and includes all components that are necessary to perform the section. The package contains the fully assembled and inspected Microkeratome including Vacuum Ring, Luer Lok connector with filter, Vacuum Tubing, Blade, Electrical wire, and Electrical connector. There are no reusable components to be sterilized, and there are no reusable motor and drive mechanisms that are subject to long term wear. The entire Microkeratome, including the motor and the blade drive mechanism, are disposable. The only reusable portion of the Barron Microkeratome is the electronic Control Console, which is outside the operative sterile field.
The provided text describes a 510(k) summary for the Barron Microkeratome System and does not contain detailed information about specific acceptance criteria or a study designed to prove the device meets these criteria in the way a modern AI/ML device submission would. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and non-clinical testing.
Here's a breakdown of the information that can be extracted, and where the provided text falls short of the requested details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Create a lamellar section from the cornea (Intended Use) | The non-clinical testing on porcine eyes and cadaver eyes was found to result in corneal lamellar sections equivalent to predicate devices. |
| Achieve predetermined flap diameter (7.5 mm to 10.5 mm) | Flap Diameter: Fixed at 8 or 9.5mm (for the Barron Microkeratome System) - This implies it meets its own specified range, but no specific performance data on achieved diameter vs. target is presented. The device offers flap diameters from 7.5mm to 10.5mm, but the specific models tested were 8 or 9.5mm. |
| Achieve predetermined flap thickness (130 um, 160 um, 180 um) | Thickness Control: Fixed Depth Keratome Head (130u, 160u, or 180u) - Similar to flap diameter, this indicates the capability, but no performance data on achieved thickness vs. target is presented. |
| Achieve predetermined flap hinge width | No specific performance data on flap hinge width is presented. |
| Safety equivalent to predicate devices | Non-clinical testing found equivalence. Device designed and tested to IEC60601-1 (safety standard). |
| Effectiveness equivalent to predicate devices | Non-clinical testing found equivalence. |
| Performance equivalent to predicate devices | Non-clinical testing found equivalence. |
Missing Information/Not Applicable:
The submission in this 1998 510(k) is based on substantial equivalence to existing predicate devices, rather than establishing de novo acceptance criteria and then proving the device meets them with a standalone performance study. The "study" here refers to non-clinical testing to confirm equivalence.
2. Sample size used for the test set and the data provenance
- Sample size: Not explicitly stated. The document mentions "non-clinical testing on porcine eyes and cadaver eyes," but the number of eyes or cases tested is not provided.
- Data provenance: "porcine eyes and cadaver eyes." This indicates ex vivo animal and human cadaveric tissue, not data from living patients or a specific country of origin in the conventional sense.
- Retrospective or prospective: Not applicable as it's non-clinical ex vivo testing rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. Given the nature of the non-clinical testing (creating lamellar sections), the "ground truth" would likely be the physical measurement and observation of the resulting corneal flaps for their dimensions and quality, rather than expert interpretation of medical images. However, who performed these measurements and their qualifications are not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided. It's unlikely such a formal adjudication method (common in AI/ML studies involving human readers) would apply to this type of non-clinical device testing from 1998.
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 type of study is relevant for AI/ML devices that assist human readers in diagnostic tasks. The Barron Microkeratome System is a surgical instrument, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This question is not applicable to the Barron Microkeratome System, as it is a physical surgical device, not an algorithm. The device's "performance" is its mechanical ability to create corneal sections. The device only performance was assessed in the non-clinical tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth was likely physical measurements and visual inspection of the lamellar sections created on porcine and cadaver eyes. The goal was to confirm that the device could consistently produce sections with characteristics "equivalent to predicate devices." This is a form of direct measurement and observation of the device's physical output.
8. The sample size for the training set
- This question is not applicable. The Barron Microkeratome System is a mechanical device, not a machine learning algorithm, so there is no "training set."
9. How the ground truth for the training set was established
- This question is not applicable as there is no training set for a mechanical device.
In summary, the provided 510(k) submission for the Barron Microkeratome System details a traditional approach to device clearance through substantial equivalence to existing predicate devices, supported by non-clinical ex vivo testing for basic performance and safety. It does not contain the kind of detailed clinical study design, acceptance criteria, or statistical analysis that would be expected for a modern AI/ML medical device submission.
§ 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.