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The Insight Technologies Instruments, Model K3000 Keratome System is designed to produce a corneal flap.

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This document is a 510(k) clearance letter from the FDA for a medical device (Keratome System, Model K3000). It acknowledges that the device is substantially equivalent to a predicate device and can be marketed.

However, the provided text DOES NOT contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the given input. The letter is purely an FDA clearance notice, not a study summary.

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The Insight Technologies Instruments, Model K-1000 Keratome System is designed to produce a corneal flap.

The model K-1000 keratome features a high speed, low torque nitrogen driven motor, which drives a reciprocating surgical blade will be a single-use, disposable device that will be filed under a separate 510k. The keratome head is preset to produce a corneal resection approximately 160 microns in depth with the corresponding blade insertion and flap diameter of approximately 10.0mm. The model K-1000 keratome system is battery operated and may also operate from its charger. The power unit provides on/off footswitch controls for the keratome head and drive assembly, and suction to the suction ring. Analog gauges located on the front panel of the unit indicate nitrogen pressure and suction level supplying the appropriate connectors.

The K-1000 Keratome System does not contain information to completely answer the request; however, I can provide the following:

The provided document describes the Insight Technologies Instruments, LLC, Model K-1000 Keratome System, which is a medical device. The document is a 510(k) summary for premarket notification to the FDA. It compares the K-1000 Keratome System to previously marketed predicate devices (Plancon Instruments Lamellar Keratoplasty System Model L.K.S. and S.C.M.D. Keratomes of Arizona TurboKeratome System by SCMD Model MLK) to demonstrate substantial equivalence.

This document focuses on regulatory compliance, design characteristics, safety certifications (electrical safety, sterilization), and comparison with predicate devices, rather than a clinical study demonstrating performance against specific acceptance criteria. The device being described is a surgical instrument (keratome) used to create a corneal flap, not an AI or diagnostic device that would typically have the performance metrics requested in the prompt.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics (e.g., sample size for test/training sets, expert qualifications, adjudication methods, MRMC study, standalone performance) are not applicable or available in this document.

However, I can extract information related to what constitutes "acceptance criteria" in the context of this device's regulatory submission, which primarily revolves around safety, design, and equivalence to predicate devices, rather than a clinical accuracy study.

Acceptance Criteria and Device Performance (Based on provided document)

Since this is a mechanical surgical instrument and not an AI or diagnostic device, the "acceptance criteria" are related to design specifications, safety standards, and demonstrated substantial equivalence to predicate devices. There isn't a "reported device performance" in terms of clinical accuracy or diagnostic metrics as typically seen for AI. Instead, the performance is implicitly accepted by meeting design specifications and safety standards.

Information Not Applicable or Not Available from the Document:

Due to the nature of the device (mechanical surgical instrument) and the type of document (510(k) summary for substantial equivalence), the following information is not applicable or not provided:

1. Sample size used for the test set and the data provenance: Not applicable. Performance data in a clinical trial sense is not presented for this type of device in a 510(k) summary, which relies on demonstrating equivalence to known safe and effective devices.
2. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. No clinical test set or ground truth establishment process is described.
3. Adjudication method for the test set: Not applicable. No clinical test set is described.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for diagnostic or AI-assisted devices, not a mechanical keratome.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve an algorithm.
6. The type of ground truth used: Not applicable. No "ground truth" as typically defined for AI/diagnostic devices is mentioned. The "ground truth" for a mechanical device is its adherence to design specifications and safety standards, and its functional performance as intended.
7. The sample size for the training set: Not applicable. No AI model or training set is involved.
8. How the ground truth for the training set was established: Not applicable. No AI model or training set is involved.

The "study" that proves the device meets the acceptance criteria is primarily the design and testing adhering to specified electrical safety standards (ANSI/AAMI ES1-1993, IEC 601-1) and comparison to predicate devices to establish substantial equivalence. The FDA's review and concurrence of the 510(k) submission served as the ultimate "proof" in the regulatory context, allowing the device to be marketed.

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