(94 days)
The LENSAR Laser System - fs 3D (LLS-fs 3D) is intended for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, laser phacofragmentation, and the creation of full and partial thickness single-plane and multi-plane are cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.
The LENSAR Laser System - fs 3D (LLS-fs 3D) with Streamline™ is a medical device for use in ophthalmic surgery. The device utilizes a pulsed laser that can be used to cut a precision capsulotomy in the anterior lens capsule, to fragment the cataractous lens for removal during cataract surgery, and to create full and partial thickness single-plane and multi-plane arc cuts/ incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure. Use of the laser provides automated precision control of the size of the capsular opening: the type and parameters of laser fragment within the lens; as well as the size, architecture of incisions within the cornea, and depth of arcuate incisions. The LENSAR Laser System - fs 3D (LLS-fs 3D) with Streamline" includes the integration with preop analysis devices, automated Iris Registration with automatic cyclorotation adjustment, IntelliAxis" corneal and capsule marking for simple alignment of Toric IOLs as well as treatment planning tools for precision-guided laser treatments.
Here's an analysis of the provided text regarding the acceptance criteria and study for the LENSAR Laser System - fs 3D (LLS-fs 3D) with the Capsular IntelliAxis feature:
It's important to note that the provided document is a 510(k) summary, which generally focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report with extensive statistical data. As such, some of the requested information (especially quantitative data like effect size in MRMC studies or large sample sizes for training sets) is not explicitly present.
Acceptance Criteria and Reported Device Performance
The document describes the verification and validation (V&V) testing for the Capsular IntelliAxis feature. The acceptance criteria are implicitly tied to the performance specifications and requirements identified for this feature. The reported device performance is that these criteria were met.
| Acceptance Criteria (Implicit from V&V) | Reported Device Performance |
|---|---|
| Compliance with specifications for Capsular IntelliAxis feature | All criteria for unit testing and system testing were met, and results demonstrate the LENSAR Capsular IntelliAxis feature meets all performance specifications and requirements. Objectives defined in the validation plan were achieved. |
| Effectiveness and ease of use in helping surgeons align Toric IOLs | Alignment marks are visible intraoperatively and are therefore effective in helping surgeons align Toric IOL marks along the axis of astigmatism. (Demonstrated against K170576 and K123859) |
| Substantial equivalence of safety profile (biomechanical strength) | The capsular rim for capsulotomy with alignment marks/nubs is substantially equivalent in elongation and tensile strength (ability to elongate and resistance to tearing under a radial force) to the standard capsulotomy with no alignment marks. (Demonstrated against K112098) |
| Accuracy of Capsular IntelliAxis feature requirements | The accuracy of the requirements of the Capsular IntelliAxis feature was validated. |
| No new questions of safety or effectiveness compared to predicate device | Minor differences between the proposed LENSAR device feature and the predicate device do not raise any new questions of safety or effectiveness. (This is a core conclusion for 510(k) clearance, implying the device meets the safety/effectiveness profile of the predicate). |
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document mentions "a study using porcine eyes." It does not specify the exact number of porcine eyes used for this study.
- Data Provenance: Porcine eye study. This indicates the data is from an animal model, not human clinical data, and is prospective experimentation.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number or qualifications of experts involved in the porcine eye study. The evaluation likely involved technical personnel and potentially ophthalmologists, but this is not detailed.
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Adjudication method for the test set:
- The document does not specify an adjudication method like 2+1 or 3+1. Given this was a technical/biomechanical study on porcine eyes, it's less likely to involve a complex expert adjudication process typically seen in image interpretation or clinical outcomes.
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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. The document states: "Clinical performance data to demonstrate substantial equivalence was not required for this product change." The study described is a technical and biomechanical evaluation using porcine eyes for the Capsular IntelliAxis feature, not an evaluation of human reader performance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The "Performance Evaluation of the Capsular IntelliAxis Feature" involved "unit testing and system testing" to verify the software performance against specifications. The biomechanical testing on porcine eyes also evaluated the device's direct output (capsulotomy strength) rather than human interpretation. While a surgeon is "in the loop" for the overall procedure, the evaluation of the feature's effectiveness (mark visibility, capsulotomy strength) is akin to a standalone assessment of the device's functional output.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For effectiveness and ease of use: The ground truth for "effectiveness and ease of use" (i.e., visibility of marks intraoperatively and ability to align Toric IOLs) was likely observational by surgeons during the porcine eye study.
- For biomechanical strength: The ground truth was established through tensile testing (force required to tear and elongation before tearing) to objectively measure biomechanical properties of the capsular rim.
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The sample size for the training set:
- The document does not provide details on a separate "training set" sample size. The description of the device is that it "allows for a modification to the current capsulotomy procedure" and uses "standard pre-operative data" or data "entered by the surgeon." This suggests the algorithm is rules-based or relies on existing pre-operative data sources, rather than being a deep learning model requiring a large training dataset. The verification and validation are described as software testing and a porcine eye study.
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How the ground truth for the training set was established:
- Given the absence of a described "training set" for a machine learning model, this question is not directly applicable. If the system uses established pre-operative data and surgeon input, the "ground truth" for its operation is inherent in those inputs and the validated surgical parameters that the device is programmed to execute.
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.