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The CAP-35BIII and the CINE 275 are intended to view 35 mm cineangiogram film.

The CAP-35BII cineangiogram projector is a continuous film transport 16-facet rotating prism projectors. The CINE 275 is a simpler version of the CAP-35BIII, with fewer options. The CAP-35BIII consists of a 35 mm film projector with built-in viewing hood, a movable cart, a sheet film duplicator, a 35 mm slide camera, a remote control, and an optional TV camera assembly. The CINE 275 consists of a 35 mm film projector with built-in viewing hood and a movable cart.

This document describes a 510(k) submission for two cineangiogram projectors, the CAP-35BIII and CINE 275. It focuses on demonstrating substantial equivalence to a predicate device, the Vanguard XR-350, rather than proving performance against specific acceptance criteria through a clinical study in the way modern AI/ML devices might.

Therefore, many of the requested categories are not applicable to this type of submission. However, I can extract the relevant information and indicate where information is not available or not required for this specific device type and regulatory pathway.

Here's a breakdown based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (cineangiogram projector), the "acceptance criteria" are primarily based on demonstrating substantial equivalence to a predicate device. This involves comparing technical characteristics and intended use. Performance is typically assessed by ensuring the device can perform its intended function (viewing 35mm cineangiogram film) safely and effectively, demonstrating equivalence in key operational and design parameters.

Note: For a 510(k) for a device like this, "acceptance criteria" are not usually defined as quantitative performance metrics with specific targets (e.g., AUC > 0.9). Instead, the primary criterion is demonstrating that the new device is as safe and effective as a legally marketed predicate device, typically through a comparison of technological characteristics and intended use. Differences are acceptable if they do not raise new questions of safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable. This submission is for a medical device (cineangiogram projector), not an AI/ML diagnostic algorithm. There is no "test set" of patient data in the context of evaluating a diagnostic algorithm's performance. The "test" is primarily the comparison of technical specifications and features to the predicate device.
• Data Provenance: Not applicable. The "data" here refers to the device's design specifications and performance under engineering tests/benchmarking, not patient-derived data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not applicable. This is not a study requiring expert-established ground truth for a diagnostic outcome.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No "test set" in this context.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No. This type of study is relevant for evaluating the impact of an AI/ML diagnostic tool on human reader performance, which is not applicable to a cineangiogram projector.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

• Standalone Study: Not applicable. This device is an instrument for viewing film, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for this submission is based on the technical specifications and functional performance of the predicate device (Vanguard XR-350), and engineering verification of the new devices (CAP-35BIII and CINE 275) against their own design specifications and relevant safety standards. It does not involve patient outcomes, pathology, or expert consensus on a diagnostic finding.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable.

Summary of Key Takeaways for this Specific Document:

The provided document is a 510(k) Summary for medical device clearance. The primary focus is on demonstrating substantial equivalence to a predicate device. This is achieved by comparing the new devices' (CAP-35BIII and CINE 275) technical characteristics and intended use with those of the predicate device (Vanguard XR-350). The "acceptance criteria" are implicitly met if the sponsor can convince the FDA that the new devices are as safe and effective as the predicate, despite some technological differences, and do not raise new questions of safety or effectiveness. Clinical trials or extensive performance studies with patient data, as required for AI/ML algorithms, are not typically part of this specific type of 510(k) submission for a non-AI hardware device like a projector.

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The Model 2100 is a leader card black-and-white 35 mm cine film processor, most commonly used for developing cineangiogram films. The Model 2100 has four (4) tanks, the developer, fixer, wash, and dryer tanks. The Model 2100 is 58.5 inches long, 17 inches wide, and 43 inches high.

This document is a 510(k) Summary for a film processor (Jamieson Model 2100 Cine Processor and Kodak Cineflure Processor Model 2100). It describes the device, its intended use (developing cine angiogram films), and states that it has been altered to meet electrical and safety requirements and customer preferences.

However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies pertaining to AI or algorithmic performance.

The document is a safety and efficacy summary for a physical medical device (film processor), not a software or AI-driven diagnostic device. Therefore, the questions posed in the prompt (which are typically relevant for AI/ML-based medical devices) are not applicable to the information provided in this 510(k) summary.

In summary:

1. A table of acceptance criteria and the reported device performance: Not found.
2. Sample sized used for the test set and the data provenance: Not found.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not found.
4. Adjudication method for the test set: Not found.
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 AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, no algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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I am sorry, but the provided text is a 510(k) clearance letter for the Kodak Cardiology Digital Archive and Review System. It does not contain any information about acceptance criteria, study design, or performance metrics. Therefore, I cannot fulfill your request based on the given input.

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