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The VICTUS Femtosecond Laser Platform is indicated for use for:

· the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.

· for anterior capsulotomy during cataract surgery.

· the creation of cuts / incisions in the comea in patients undergoing cataract surgery or other ophflaalmic treatment requiring cuts / incisions in the comea.

· laser-assisted lens fragmentation of nuclear cataracts during cataract surgery, not for fragmentation of posterior subcapsular (PSC) and cortical cataracts

The VICTUS Femtosecond Laser Platform (VICTUS) is a precision ophthalmic surgical laser and is cleared for use in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea and for patients undergoing anterior capsulotomy during cataract surgery (via K120426). The VICTUS has additionally been cleared for patients undergoing cataract surgery or other ophthalmic treatment requiring penetrating arcuate cuts / incisions in the cornea (K122386), primary/secondary corneal incisions (K132534), and laser-assisted lens fragmentation (K140615). This submission does not add to the indications previously cleared for the VICTUS Platform. With the exception of a new patient interface suction clip, the VICTUS Platform hardware and software remain unchanged from that described and cleared via K141379.

A new patient interface suction clip for the VICTUS platform is being introduced within this premarket submission, the new suction clip is smaller in diameter and contains a colorant to aid in positioning on the cornea of the eye. For all indications for use, laser pulses are delivered through a sterile disposable Patient Interface, consisting of a contact lens and suction clip to provide suction. The contact lens and suction clip assembly creates a reference surface for depth control and fix the eye relative to the delivery of the laser beam. The contact lens portion of the patient interface remains unchanged from that previously cleared. Surgical effects are produced by scanning thousands of individual pulses, producing continuous incisions. The location of the tissue photodisruption is controlled by a fixed laser beam focused through a scanning optic system to the desired location.

The fundamental scientific technology and indications for use remains the same as previously cleared for the VICTUS Femtosecond Laser Platform under K141379.

The provided text describes the Victus Femtosecond Laser Platform, which is regulated as an Ophthalmic Laser. The document is a 510(k) premarket notification summary, indicating substantial equivalence to previously cleared devices.

Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The text does not explicitly provide a table of quantitative acceptance criteria for device performance. Instead, it states that the device was found to perform "equivalently to the predicate device" and that "the acquired test data successfully verified that the various parameters meet their pre-defined acceptance criteria." This implies that specific performance metrics and their acceptance thresholds exist but are not detailed in this summary.

However, based on the non-clinical and clinical performance data, we can infer some performance aspects:

2. Sample Size Used for the Test Set and Data Provenance

• Non-Clinical Test Set:

  • Sample Size: Not explicitly stated as a number of distinct "test sets" but mentions "four different materials" (porcine eyes, agarose gel, polyethylene terephthalate (PETG), and polymethyl methacrylate (PMMA)) were used for bench performance testing.
  • Data Provenance: Retrospective (bench testing/lab data). Country of origin is not specified, but the applicant is based in Germany, so it's likely European or global.

• Clinical Test Set:

  • Sample Size:
    • Flap group: 58 eyes
    • Cataract group: 113 eyes
    • Total: 171 eyes
  • Data Provenance: Prospective, single-center clinical study. The country of origin for the study is not specified but the applicant is based in Germany.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications for either the non-clinical or clinical studies.

• Non-Clinical: Ground truth for material testing (e.g., cut quality, precision) would likely be established by engineers or scientists performing the tests, comparing measurements to specifications.
• Clinical: For biometry, the LENSTAR LS900 measurements served as a reference (ground truth proxy). For capsulotomy completion and adverse events, the operating surgeons/investigators would make those assessments, but their specific expert qualifications are not detailed beyond "multi-surgeon" and "investigators."

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set data.

• Biometry: The comparison was statistical ("correlation and agreement") between the VICTUS OCT and LENSTAR LS900.
• Capsulotomy Completion/Adverse Events: These were reported by investigators, implying direct observation and recording without a separate adjudication process mentioned.

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 involving human readers improving with AI assistance was not conducted or described. This device is an ophthalmic laser for surgical procedures, not an AI diagnostic tool primarily interpreted by human readers. The clinical study focused on the device's accuracy for biometry and its effectiveness in performing specific surgical steps like capsulotomy and lens fragmentation. The "OCT subassembly" is part of the device's guidance system, not an AI assistance for human image interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The performance of the VICTUS Femtosecond Laser Platform itself, as a device performing surgical actions (cuts, fragmentation, imaging), is inherently standalone in its operation. However, surgical procedures always involve a human surgeon in the loop for planning, supervision, and execution. The "standalone" aspect, in this context, would relate to the laser's ability to precisely execute its programmed actions and measurements.

• Non-Clinical Tests: These were standalone tests of the device's physical performance characteristics.
• Clinical Studies: The study confirmed the "intraoperative accuracy of biometry visualization performed by VICTUS optical coherence tomography (OCT)" and the laser's ability to complete capsulotomy. This can be considered evaluating the standalone performance of the device's functions, although within the context of a surgical procedure where a surgeon operates the device.

7. The Type of Ground Truth Used

• Non-Clinical: The ground truth for bench testing would typically be established through precise metrological measurements and adherence to predefined engineering specifications. For material like porcine eyes, histopathology might be used to confirm laser effects, though not explicitly stated.
• Clinical:
  • Biometry: The LENSTAR LS900 was used as the reference standard for axial optical resolution accuracy (lens thickness, anterior chamber depth, and central cornea thickness). This acts as a proxy for ground truth, assuming the LENSTAR LS900 is accepted as an accurate measurement device.
  • Capsulotomy Completion: The ground truth was observed clinical outcome, specifically whether the capsulotomy was completed fully by the laser without manual intervention.
  • Adverse Events: The absence of reported adverse events constitutes the ground truth for safety in the study.
  • Cataract Grades: Clinical assessment (implicitly by ophthalmologists) was the ground truth for cataract grading.

8. The Sample Size for the Training Set

The document does not mention any "training set." This summary pertains to the evaluation of a physical medical device (femtosecond laser) whose functionality is based on established physics and pre-programmed parameters, not a machine learning or AI algorithm that requires a training dataset in the conventional sense. The "software version 3.2" is updated device control software, not a trainable AI model in the common "training set" connotation.

9. How the Ground Truth for the Training Set Was Established

Since no training set for an AI/ML algorithm is mentioned, this question is not applicable based on the provided text. The device's "training" in a broad sense would be its design, calibration, and validation against engineering specifications during its development.

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The VICTUS Femtosecond Laser Platform is indicated for use in:

· The creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea

· For anterior capsulotomy during cataract surgery

• The creation of cuts / incisions in the cornea in patients undergoing cataract surgery or other ophthalmic treatment requiring cuts / incisions in the cornea.

The VICTUS Femtosecond Laser Platform (VICTUS) is a precision ophthalmic surgical laser. For all indications for use, laser pulses are delivered through a sterile disposable Patient Interface, consisting of a contact lens and suction clip to provide suction. The contact lens and suction clip assembly creates a reference surface for depth control and fix the eye relative to the delivery of the laser beam. Surgical effects are produced by scanning thousands of individual pulses, producing continuous incisions. The location of the tissue photodisruption is controlled by a fixed laser beam focused through a scanning optic system to the desired location. The VICTUS Platform mode of operation delivers femtosecond pulses to produce a pattern of photodisruption to create cuts / separation in ophthalmic tissue. The VICTUS Platform uses vacuum to affix a suction ring to the corneal surface prior to use.

The device referenced in the document is the VICTUS Femtosecond Laser Platform. The document describes a 510(k) submission, which means the device is being compared to a legally marketed predicate device to establish substantial equivalence. Therefore, the "acceptance criteria" discussed here are primarily about demonstrating that the modified device performs similarly to or no worse than the predicate device.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance in a table, but it does describe the outcomes of the non-clinical and clinical studies designed to show equivalence.

2. Sample Sizes and Data Provenance

• Test Set (Clinical Study):
  • Sample Sizes:
    • Femtosecond-laser flap creation (flap group): 58 eyes
    • Femtosecond laser assisted cataract surgery (cataract group): 113 eyes
  • Data Provenance: Single-center clinical study (location not specified, but likely where Technolas Perfect Vision GmbH is active). Retrospective analysis of correlation and agreement of biometric data.

3. Number of Experts and Qualifications (for Ground Truth)

• The document does not specify the number of experts used to establish ground truth or their qualifications.
• For the clinical study, the "consistency" of VICTUS OCT measurements with LENSTAR LS900 implies that the LENSTAR LS900 measurements served as a reference or a highly accepted method. LENSTAR LS900 is a well-established biometer, and its measurements are generally accepted as a clinical standard for these parameters.

4. Adjudication Method (for Test Set)

• The document does not describe any adjudication method for the clinical study data or for establishing a ground truth based on multiple expert opinions.
• The comparison was made against LENSTAR LS900, suggesting it served as the reference standard.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done comparing human readers with and without AI assistance. The device is a laser platform for surgical procedures, not an AI-assisted diagnostic tool for human readers.

6. Standalone (Algorithm Only) Performance Study

• A form of standalone performance was done for the device. The non-clinical performance data involved testing the device against engineering specifications and predicate equivalence using various materials (porcine eyes, agarose gel, PETG, PMMA).
• The clinical study also evaluated the device's performance in creating capsulotomies and biometry measurements directly.

7. Type of Ground Truth Used

• Non-Clinical Performance: Engineering specifications, measurements against a predicate device, and physical properties of test materials (e.g., cut quality in various materials).
• Clinical Performance:
  • For biometry accuracy: Comparison with measurements from a commercially available and clinically accepted biometer (LENSTAR LS900). This acts as a proxy for "gold standard" or highly reliable measurement.
  • For capsulotomy completeness: Observation of the actual surgical outcome (full completion without manual intervention).
  • For adverse events: Reported clinical observations by investigators.

8. Sample Size for the Training Set

• The document does not mention a training set in the context of an algorithm or AI. This submission is for a medical device (laser platform) that performs physical procedures, not a software algorithm that learns from data in the traditional AI sense. Its "training" would be more akin to design verification and validation, and calibration.

9. How Ground Truth for Training Set was Established

• As there's no explicitly defined "training set" for an AI algorithm as per the question's premise, this question is not directly applicable. If interpreting "training set" as the data used during the device's development and design verification, the ground truth would have been established through engineering design specifications, bench testing protocols, and comparison with predicate device characteristics and safety standards.

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The VICTUS Femtosecond Laser Platform is indicated for use for:

• The creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea
• For anterior capsulotomy during cataract surgery
• The creation of cuts / incisions in the cornea in patients undergoing cataract surgery or other ophthalmic treatment requiring cuts / incisions in the cornea.

The VICTUS Femtosecond Laser Platform (VICTUS) is a precision ophthalmic surgical laser and is cleared for use in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea and for patients undergoing anterior capsulotomy during cataract surgery (via K120426). In addition, the VICTUS has been cleared for patients undergoing cataract surgery or other ophthalmic treatment requiring penetrating arcuate cuts / incisions in the cornea (via K122386). This 510(k) expands the arcuate corneal incision by allowing the ability for primary and secondary corneal incisions. These cuts/incisions are performed for patients undergoing cataract surgery to allow direct access into the eye. The correct position and shape of the cuts is verified by the video image. The expansion of the corneal incision indication is supported by software version 2.7 SP2. In addition, an increased diameter patient interface is being introduced (referred to as PI125). The PI125 is a universal PI that allows the use for either corneal or cataract procedures. User request for a smaller diameter patient interface that can be used for both cataract and corneal procedures resulted in the qualification of the existing cataract patient interface as a universal smaller diameter patient interface. Lastly, the bottom end of the pulse duration range has been modified to be lower than that previously cleared in K120426 and K122386. For all indications for use, laser pulses are delivered through a sterile disposable Patient Interface, consisting of a contact lens and suction clip to provide suction. The contact lens and suction clip assembly creates a reference surface for depth control and fix the eve relative to the delivery of the laser beam. Surgical effects are produced by scanning thousands of individual pulses, producing continuous incisions. The location of the tissue photodisruption is controlled by a fixed laser beam focused through a scanning optic system to the desired location. The fundamental scientific technology remains the same as previously cleared for the VICTUS Femtosecond Laser Platform under K120426 and K122386.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, where available:

1. A table of acceptance criteria and the reported device performance

The provided text does not explicitly state quantitative acceptance criteria for device performance (e.g., a specific tolerance for depth, diameter, or angle of incisions). Instead, it describes general claims of performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not explicitly stated. The text mentions "A variety of test procedures were conducted" and "Four different materials were used for the bench performance testing: porcine eyes, agarose gel, polyethylene terephthalate (PETG), and polymethyl methacrylate (PMMA)." It does not quantify the number of tests performed on these materials.
• Data Provenance: The study was a "Non-Clinical Performance Data" study, implying it was conducted in a laboratory setting (bench testing) using specified materials. The location of the testing is not mentioned, nor is it explicitly stated as retrospective or prospective, but given it's bench testing, it would inherently be "prospective" in the sense that the tests were designed and executed for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The study was non-clinical bench testing, not involving human subjects or expert assessment of clinical outcomes. Ground truth would be based on physical measurements of the incisions in the tested materials.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The study was non-clinical bench testing. Performance was evaluated by "comparing the mean values to the specified acceptance criteria and their 95% confidence intervals." This suggests quantitative measurement and statistical analysis rather than expert adjudication.

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 was a non-clinical bench study of a laser surgical device, not an AI-assisted diagnostic or imaging system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to a standalone performance of a device itself, which is what the bench testing aimed to assess. The device performance was evaluated independently without human intervention during the "cutting" process, as it is an automated laser system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for the non-clinical testing appears to be based on direct physical measurements of attributes like depth, diameter, and angle of incisions in the various test materials (porcine eyes, agarose gel, PETG, PMMA). This would be established using appropriate metrology tools for precision measurement.

8. The sample size for the training set

Not applicable. This is not an AI-based system that requires a "training set" in the context of machine learning. The device is a laser platform; its "training" per se would relate to its engineering and calibration.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" in the machine learning sense for this device.

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