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Oculostat is intended to reduce eye movement and stabilize the eye in any procedure in which the globe needs to be immobilized.

The Oculostat by Laser Center Development Corporation consists of a scleral vacuum suction ring attached to a medical quality plastic ophihalmic speculum. After retracting the eyelids and inserting the lid margins into the speculum portion of the Oculostat, the suction-vacuum ring is attached to the sclera by sequentially contering, depressing, and enguing low vacuum (30mm Hg or less) by pump or spring-loaded syringe. The frictional forces between the eyelids and speculum, together with the vacuum ring, hold the eye steady despite extraocular muscle activity.

The provided text is a 510(k) summary for the Oculostat, an ophthalmic speculum. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for assessing device performance.

This type of submission (510(k)) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive clinical study data with performance metrics against acceptance criteria. For devices like the Oculostat (Class I ophthalmic speculum), a detailed clinical study with performance endpoints and defined acceptance criteria is typically not required for 510(k) clearance.

Therefore, I cannot populate the requested table or provide information on the study details because the provided document does not contain this information.

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The Automated Corneal Trephine is intended for preparation of recipient and donor comeas for lamellar and penetrating keratoplasty.

The Automated Corneal Trephine consists of a sterile, single use, disposable corneal trephine made of medical grade injection-molded plastic and stainless steel. The trephine is used to create a partial or full-thickness circular cut for lamellar or penetrating keratoplasty. This trephine features a DC motor which automatically rotates the trephine, eliminating cumbersome manual rotation. The blade depth is preset at the factory so that the extent of penetration is very precise.

The provided text is a 510(k) summary for the Automated Corneal Trephine (K981063) and an FDA clearance letter. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, this document does not contain information about acceptance criteria, detailed study designs, or performance results in the way typically expected for answering your request.

The 510(k) process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials or performance studies with specific acceptance criteria and detailed statistical analysis, especially for Class I devices like this one.

Therefore, I cannot fully answer your request with the information provided. I can only report what is directly stated or inferred from the document.

Here's a breakdown of what can be extracted or inferred, and what is missing:

The core of the submission for K981063 is based on substantial equivalence to the Barron-Hessburg manual corneal trephine (K864520). The performance criteria are implicitly met by demonstrating that the new device operates similarly and achieves the same intended purpose as the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific quantitative acceptance criteria (e.g., "blade depth variability must be less than X microns") or quantitative performance data from a specific study. The "reported device performance" is descriptive and aims to show functional equivalence to the predicate.

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified. It is highly unlikely a "test set" in the context of clinical data was used for this type of submission. Performance was likely demonstrated through pre-clinical testing, engineering specifications, and comparison to the predicate.
• Data Provenance: Not specified. Given the nature of the device and the submission type, any data would likely be from engineering tests or simulated use, not human clinical data.

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

• Not Applicable. The document does not describe a study involving expert assessment of device outputs or "ground truth" derived from experts in the context of a diagnostic or subjective assessment device. The "ground truth" for a surgical instrument would be its ability to perform its mechanical function consistently and accurately, which is typically assessed through engineering measurements and bench testing.

4. Adjudication method for the test set

• Not Applicable. No human adjudication method is described as there's no mention of subjective assessment or an expert panel reviewing test results in this document.

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. This device is a surgical instrument (corneal trephine), not an AI-powered diagnostic or image analysis tool. Therefore, an MRMC study or assessment of human reader improvement with AI assistance is not relevant to this device.

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

• Not Applicable. This is a mechanical surgical instrument, not an algorithm or AI system. There is no "standalone algorithm only" performance to evaluate.

7. The type of ground truth used

• Implied Mechanical/Engineering Specifications and Performance: For a surgical instrument like a trephine, the "ground truth" would relate to its ability to create a precise, circular cut of a specified depth and diameter, its sharpness, sterility, material integrity, and safety during use. This would be established through engineering measurements, material testing, and simulated use models, not expert consensus, pathology, or outcomes data in the clinical sense mentioned.

8. The sample size for the training set

• Not Applicable. This is a mechanical device, not a machine learning model. There is no "training set."

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

• Not Applicable. As there is no training set, there is no ground truth established for it.

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