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The Heart Stabilizer Pad is used on an appropriate heart stabilizer unit for coronary bypass surgery. It provides a mechanical means for immobilization of the anastomotic site on a beating heart and provides coronary artery isolation and occlusion by compression.

Pilling Weck Surgical Stabilizer Removable Pads

I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study proving the device meets those criteria in the format requested.

The document is a 510(k) clearance letter from the FDA for a device called "Pilling Weck Surgical Stabilizer Removable Pads." This letter primarily:

• Confirms that the device is substantially equivalent to legally marketed predicate devices.
• States its regulatory class (Class I) and product code.
• Outlines the general regulatory requirements that apply to the device, such as GMP regulations, registration, and prohibitions against misbranding and adulteration.
• Provides the "Indications for Use" for the device.

It does not include:

• Specific acceptance criteria (e.g., performance metrics, thresholds).
• Details of any specific study (clinical or analytical) conducted to demonstrate device performance against such criteria.
• Information regarding sample sizes, data provenance, ground truth establishment, expert qualifications, or comparative effectiveness studies.

Therefore, I cannot populate the table or answer the specific questions about the study details based on the provided text.

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The Aortic Spoon Jaw Clamp is for use in the coronary bypass operations without application of an aortic clamp. It provides a mechanical means to isolate a 10 x 8mm area of the aortic wall from blood flow.

Aortic Spoon Jaw Clamp

The provided document is a 510(k) premarket notification letter from the FDA for a device called "Aortic Spoon-Jaw Clamp" (K992174). This letter grants clearance based on substantial equivalence to a legally marketed predicate device.

This document does not contain information about acceptance criteria or a study proving the device meets those criteria, as it predates the modern requirements for clinical performance studies in many device clearances.

The 510(k) pathway, especially in the year 2000, primarily focused on demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a device already on the market. This often relied on bench testing, materials characterization, and comparisons of technological characteristics and intended use, rather than extensive clinical studies with specific performance metrics against pre-defined acceptance criteria.

Therefore, I cannot provide the requested information based on the given text.

To answer your specific points, based on the provided document:

1. A table of acceptance criteria and the reported device performance: Not available in this document.
2. Sample size used for the test set and the data provenance: Not available in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available in this document.
4. Adjudication method for the test set: Not available 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 clamp, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a surgical clamp, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not available in this document. Substantial equivalence for this type of device would likely have been based on comparison of design, materials, and functional performance with a predicate device, rather than detailed clinical ground truth.
8. The sample size for the training set: Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

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To be used for exploratory and dilation of strictures of the esophagus. Designed to be used in conjunction with an appropriate size rigid esophagascope.

Device consists of silicone tip, stainless steel rod and nylon sleeve.

The provided text is a 510(k) summary for the Jackson Esophageal Dilator. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested.

Therefore, I cannot fulfill your request with the given input. The document focuses on regulatory classification and substantial equivalence to a predicate device, rather than detailed performance study results.

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To be used for Tracheobronchial or Esophageal foreign body removal or biopsy procedures. To be used through rigid scopes: Bronchoscopes, Esophagoscopic, Laryngoscopes and Mediastinoscopes

The Optical Forcep consists of two components - a. Telescope - b. Biopsy Forcep

The provided text does not contain information about acceptance criteria or a study proving the device meets said criteria. The document is a 510(k) summary for the Pilling Weck Surgical Optical Forcep, focusing on its substantial equivalence to a predicate device, its intended use, and its classification. It explicitly states that the technological characteristics are "the same as, or equivalent to, predicate devices."

Therefore, I cannot provide details for the following requested information as it is not present in the given text:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
• If a standalone performance study was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

The 510(k) summary is primarily concerned with demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting a performance study with specific acceptance criteria.

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To allow airflow over the vocal cords for speaking To be used only as an attachment to CLJackson improved function. trachea tubes, manufactured by Pilling Weck Surgical.

The Shikani-French Speaking Valve consists of a plastic outer body and a captured inner ball that forms the check valve. The assembly attaches to the C.L. Jackson Improved Stainless Steel Trachea Tube. Once in place, the valve allows the patient to inhale through the tracheostomy tube and exhale across the vocal chords which facilitates speak.

Please note: The provided text is a 510(k) summary for a medical device (Shikani-French Speaking Valve) seeking market clearance based on substantial equivalence to predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study would for a novel device or AI algorithm.

The document focuses on establishing equivalence rather than presenting an independent performance study with detailed acceptance criteria and results.

Therefore, many of the requested categories for AI/algorithm-based studies (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, etc.) are not applicable to this type of submission.

Here's the information that can be extracted or deduced from the provided text:

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

The document does not specify quantitative acceptance criteria or report specific performance metrics for the Shikani-French Speaking Valve. Instead, it relies on demonstrating substantial equivalence to legally marketed predicate devices.

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 / Not provided. The document describes a device, not a data-driven model or algorithm that would have a "test set." The basis for equivalence is the design and function of the device compared to predicate devices, not data analysis on a specific patient population.

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 / Not provided. Ground truth for a test set is not relevant for this type of device submission.

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

• Not applicable / Not provided. Adjudication is not relevant in this context.

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

• No. This is a hardware medical device (a speaking valve), not an AI algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.

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

• Not applicable / No. This is a hardware device; there is no "algorithm only" performance to evaluate.

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

• Not applicable / No explicit ground truth. The "truth" in this context is the established safety and effectiveness of the predicate devices and the new device's demonstrable similarity to them in design, materials, and intended use. Performance is implicitly validated by comparison to these established devices.

8. The sample size for the training set

• Not applicable / Not provided. This is not an AI/machine learning device that would have a training set.

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

• Not applicable / Not provided.

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