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The Haag-Streit Contact Glasses are a family of diagnostic and therapeutic contact lenses used in the examination of the eye fundus, retina and irido-corneal angle, and for the laser therapy of intraocular abnormalities.

The HS Contact Glasses is a family of diagnostic and therapeutic contact lenses used for eye examination and therapy of intraocular abnormalities. The HS Contact Glass family is designed around the classic Goldmann contact lenses. All HS Contact Glass models are of similar design, but provide different optical elements to provide excellent visualization of the ocular anatomical areas for the particular intended use. When used in conjunction with the HS 900 slit-lamp, the HS Contact Glasses provide a binocular and stereoscopic view of the specific optical region of the eye. The HS Contact Glass typically consists of an aluminum housing, one or more mirror elements and a carved of time directly on the globe or cornea of the eye. The HS contact glass family has two principal modes of use. Those used with laser radiation for therapy of ocular abnormalities. HS Contact Glasses used in diagnostic procedures are made of acrylic plastic (PMMA). These are doolgnou with slit-lamps, such as fundus, the vitreous and the may of HS diagnostic Contact Glasses have the Flaag Otreit Bookine by Goldmann: 59/ 66/ 73 degrees.

The provided text describes a 510(k) summary for Haag-Streit Contact Glasses, a family of diagnostic and therapeutic contact lenses. This submission focuses on establishing substantial equivalence to previously cleared predicate devices, rather than presenting a performance study with detailed acceptance criteria and reported device performance metrics in the way one would for a novel AI device or a device requiring clinical trial data.

Therefore, many of the requested sections (e.g., acceptance criteria table with reported performance, sample sizes for test/training sets, number of experts for ground truth, MRMC studies, standalone performance) are not applicable to this type of regulatory submission.

Here's an analysis based on the provided text, indicating which points are not applicable (NA) in this context:

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

Explanation: The 510(k) submission for the Haag-Streit Contact Glasses aims to demonstrate that the device is substantially equivalent to existing, legally marketed predicate devices. This regulatory pathway typically does not involve setting specific quantitative performance acceptance criteria or conducting a clinical study to generate new performance data against those criteria. Instead, it relies on demonstrating that the new device has the same intended use and similar technological characteristics, and does not raise new questions of safety or effectiveness compared to the predicate.

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

• Not Applicable. No test set or clinical data is mentioned as part of this 510(k) submission. The submission focuses on product descriptions and comparison to predicate devices, not on proving performance through a clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not Applicable. Ground truth establishment is not relevant for this 510(k) submission, as it does not involve a clinical study requiring such a process.

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

• Not Applicable. Adjudication methods are not relevant for this 510(k) submission, as it does not involve a clinical study requiring such a process.

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

• Not Applicable. No MRMC study was performed or is mentioned. The device is a diagnostic/therapeutic contact lens, not an AI-powered diagnostic tool.

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

• Not Applicable. The device is a physical contact lens, not an algorithm. Standalone performance as described is not relevant.

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

• Not Applicable. Ground truth is not relevant for this 510(k) submission, as it does not involve a clinical study requiring such a process.

8. The sample size for the training set

• Not Applicable. Training sets are not relevant for this 510(k) submission, as it does not involve machine learning or AI development.

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

• Not Applicable. Ground truth establishment for a training set is not relevant for this 510(k) submission.

Summary of the Study/Submission:

The document is a 510(k) Premarket Notification Summary of Safety and Effectiveness for the Haag-Streit Contact Glasses. The "study" in this context is the process of demonstrating substantial equivalence to legally marketed predicate devices.

• Device: Haag-Streit Contact Glasses (a family of diagnostic and therapeutic contact lenses).
• Intended Use: Diagnostic and therapeutic examination of eye fundus, retina, and irido-corneal angle, and for laser therapy of intraocular abnormalities.
• Mechanism of Equivalence: The submission asserts that the Haag-Streit Contact Glasses are substantially equivalent to other diagnostic and therapeutic contact lenses already cleared by the FDA. Key predicate devices mentioned are:
  • Volk Optical Inc. (Quadraspheric Fundus Lens- K943125 and K023221)
  • Ocular Instruments Inc. (Saurenghi Scan Laser Lens- K014170)
• Basis of Equivalence: The submission highlights that the diagnostic and laser therapy HS Contact Glasses are constructed of PMMA (Polymethylmethacrylate), similar to previously cleared lenses. They are designed around the classic Goldmann contact lenses and provide similar optical elements for visualization and laser therapy when used with a slit-lamp.
• Conclusion: The FDA determined that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market under general controls.

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