(77 days)
The WaveLight® FS200 Patient Interface 1505 is indicated to be used with the WaveLight® FS200 Laser System, consistent with the cleared Indications for Use for this ophthalmic surgical laser.
The WaveLight® FS200 Patient Interface 1505 is a patient contact consumable (disposable) consisting of a Tubing System with integrated Suction Ring and an Applanation Cone. The flat bottom of the cone is used as an applanation plate for the patient's cornea.
The provided 510(k) summary for the WaveLight® FS200 Patient Interface 1505 describes a device that is essentially a consumable component (patient interface) for an existing laser surgical system (WaveLight® FS200 Laser System). The focus of the submission is to demonstrate substantial equivalence to a predicate device (WaveLight® FS200 Patient Interface 1504), rather than proving the performance of a novel diagnostic or therapeutic algorithm.
Therefore, the typical acceptance criteria and study designs associated with AI/ML-driven medical devices (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by experts) are not applicable to this submission. This device does not involve an AI algorithm, a diagnostic output, or a performance metric like accuracy that would require human expert adjudication of ground truth or a comparative effectiveness study with human readers.
Instead, the acceptance criteria and supporting studies for this device relate to its safety and functional equivalence as a consumable physical component.
Here's a breakdown based on the provided text, addressing the points where applicable and explaining why others are not relevant:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests Performed | Reported Device Performance/Conclusion |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993 standards. | Passed: "Biocompatibility evaluations... have been performed against the applicable ISO 10993 standards." Laser exposure test (ISO 11979-5:2006) also performed. |
| Sterility | Achievement of 10⁻⁶ SAL (sterility assurance level). | Passed: "The EtO sterilization cycle has been validated per the FDA Recognized Consensus Standard - 'AAMJISO 11135: 2007'... validated to achieve a 10⁻⁶ SAL." (Provided sterile; single use only). |
| Packaging & Shelf-life | Compliance with ISO 11607-1:2006. | Passed: "Packaging and shelf-life have been validated according to the FDA Recognized Consensus Standard 'ISO 11607-1: 2006'." |
| Function & Performance | Equivalence to predicate device in flap cutting results. | Passed: "Flap cutting tests demonstrate that the performance of the WaveLight® FS200 Patient Interface 1505 is equivalent to the one of the predicate device." (Performed after sterilization, transportation, and aging). Compliance with FDA Guidance for Keratomes. |
| System Validation | Compliance with 21 CFR 820 and ISO 14971:2007 (risk management). | Passed: "The use of the WaveLight® FS200 Patient Interface 1505 with the WaveLight® FS200 Laser system has been validated at the system level." Developed/manufactured per 21 CFR 820 and ISO 14971:2007. |
| Technological Equivalence | Identical tubing system, one-piece molded plastic applanation cone (vs. aluminum/glass of predicate). | Concluded: "The technological characteristics... are equivalent to those of the predicate device." (Main difference is the applanation cone material, which was supported by the functional and performance tests). |
2. Sample size used for the test set and the data provenance
- Biocompatibility: No specific sample size provided, but tests were "evaluations of materials coming into contact with the patient or fluid path."
- Sterility: Validated for the "product." No specific sample size mentioned, but validation typically involves multiple batches/units for statistical confidence.
- Packaging & Shelf-life: Validated for the "product." No specific sample size mentioned.
- Function and Performance (Flap cutting tests): No specific sample size (number of cuts or units tested) is provided in the summary. Data provenance is implied to be laboratory testing conducted by the manufacturer, not patient data from a specific country or retrospective/prospective collection.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This device is a physical consumable component for a surgical laser, not a diagnostic or AI-powered device requiring expert-established ground truth. The "ground truth" here is objective physical and chemical properties and functional equivalence to the predicate device.
4. Adjudication method for the test set
- Not Applicable. As this is not a diagnostic device requiring interpretation, no adjudication method (e.g., 2+1, 3+1) was used. Testing relies on objective measurements and established standards.
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 study is not relevant as this device is a physical consumable for a surgical laser, not an AI-assisted diagnostic or therapeutic tool that involves human readers interpreting output.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device does not contain an algorithm or AI component; it is a passive, sterile, disposable physical interface.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Objective Measurements and Predicate Equivalence: The "ground truth" for this device's performance relies on:
- Compliance with recognized international standards (ISO 10993 for biocompatibility, AAMJ/ISO 11135 for sterility, ISO 11607-1 for packaging) which define acceptable limits for parameters.
- Functional comparison to the legally marketed predicate device (WaveLight® FS200 Patient Interface 1504) for "flap cutting results," demonstrating equivalence rather than an absolute ideal "ground truth."
- System validation against internal development and risk management procedures (21 CFR 820, ISO 14971).
8. The sample size for the training set
- Not Applicable. This product does not involve an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. This product does not involve an AI/ML algorithm that requires a training set or its associated ground truth establishment.
In summary, this 510(k) submission successfully demonstrated substantial equivalence of a consumable device based on rigorous non-clinical testing (biocompatibility, sterility, packaging, functional performance, and system validation) against established standards and direct comparison to a predicate device, rather than patient-level clinical performance data or AI algorithm validation.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.