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The Slit Lamps HS-5500, HS-7000, HS-7500 are intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment.

A slit lamp biomicroscope is intended for use in eye examination of the anterior eye segment, form the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segment. These devices are designed for use by ophthalmologists and optometrists (within the realms of their respective professions) for specific diagnostic procedures (bio-microscopic examination of the eye). The instrument is consist of a microscope, a swiveling illumination system providing a slit image and a power supply.

The provided document is a 510(k) summary for a Slit Lamp device (HS-5500, HS-7000, HS-7500). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical performance studies to meet specific acceptance criteria.

Therefore, the document does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for an AI/ML or novel diagnostic device.

Here's why and what information is available:

• Acceptance Criteria & Reported Device Performance: This section is not applicable as the submission leverages substantial equivalence. There are no specific performance metrics like sensitivity, specificity, or accuracy that are typically associated with acceptance criteria for new diagnostic devices.
• Study Details (Sample size, data provenance, expert ground truth, adjudication, MRMC, standalone, ground truth type, training set size/ground truth): These details are also not present because the submission for the Slit Lamp is based on demonstrating that its technological characteristics and intended use are similar to a previously cleared device (the predicate device HS-5000). The safety and effectiveness are established through compliance with electrical, mechanical, and environmental safety standards (IEC 60601-1 and IEC 60601-1-2), rather than through performance studies against a clinical ground truth.

What the document does state about "performance":

The "Performance Data" section (Section 8) focuses on safety and electrical compliance, not clinical performance or diagnostic accuracy.

• Acceptance Criteria (Implied for Safety & Electrical Performance):
  • Compliance with IEC 60601-1 (Electrical, mechanical, and environmental safety).
  • Compliance with IEC 60601-1-2(2001) (EMC testing).
• Reported Device Performance (for Safety & Electrical Compliance):
  • "The devices meet all requirements and passed all tests." (Page 2)

In summary, for the given Slit Lamp device 510(k) submission:

• A table of acceptance criteria and the reported device performance: Not applicable in the context of clinical performance. The "acceptance criteria" are compliance with specified electrical and safety standards, which the device reportedly met.
• Sample sized used for the test set and the data provenance: Not applicable. Performance was assessed via engineering and safety tests, not clinical data sets.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No, not mentioned.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, this is a physical medical device, not an algorithm.
• The type of ground truth used: For safety testing, the "ground truth" is compliance with engineering standards.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

This 510(k) submission is indicative of a Class II medical device where the primary pathway to market is through demonstrating substantial equivalence to a predicate, often relying on engineering standards and shared technological characteristics rather than extensive new clinical performance studies.

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