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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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The Pilling Weck Surgical Y Stent Forceps (Bronchoscope (Flexible or Rigid)is to inset tracheobronchial stents during ENT procedures

The Stent Forceps/(Bronchoscope(Flexible or Rigid) consists of a hand controlled forcep with a specially designed grasping tip to restrain the bronchial limbs of the Y Stent and mechanically hold the stent limbs together for insertion into the trachea. Once positioned, the forceps are released and the bronchial limbs of the stent return to their Y position. The Forceps is then withdrawn.

This 510(k) summary describes a traditionally cleared medical device, not an AI/ML-powered device. Therefore, the typical acceptance criteria and study design elements requested in your prompt (such as sample size, ground truth, expert adjudication, MRMC studies, or standalone performance) are not applicable.

The document describes the Pilling Weck Surgical Y Stent Forceps (Bronchoscope (Flexible or Rigid)), which is a mechanical device used in ENT procedures. The clearance is based on a determination of substantial equivalence to an existing legally marketed device, rather than performance against pre-defined acceptance criteria through a clinical study.

Here's an adaptation of your requested table and information based on the provided document:

Acceptance Criteria and Device Performance (for a Traditional Mechanical Device)

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size used for the test set and the data provenance:

• Not Applicable. This is a mechanical device cleared via substantial equivalence, not an AI/ML algorithm that requires a test set of data. The performance is assessed against the predicate device's established safety and effectiveness.

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

• Not Applicable. No ground truth for a test set was established as this is a mechanical device clearance through substantial equivalence. The FDA reviewers assessed the substantial equivalence claim.

4. Adjudication method for the test set:

• Not Applicable. No test set requiring expert adjudication was used.

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. MRMC studies are relevant for AI-assisted diagnostic or interpretative devices, not for mechanical surgical instruments.

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

• Not Applicable. This is a mechanical device; there is no algorithm or standalone performance in the context of AI.

7. The type of ground truth used:

• Not Applicable. For this type of device, the "ground truth" for clearance is the established safety and effectiveness of the legally marketed predicate device. The comparison establishes that the new device shares fundamental characteristics and risks with the predicate.

8. The sample size for the training set:

• Not Applicable. This is a mechanical device; there is no training set as would be found in AI/ML development.

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

• Not Applicable. No training set or ground truth in the AI sense was established for this mechanical device. The substantial equivalence determination relies on comparing the device's design, materials, and intended use to a predicate device already on the market.

Summary Explanation:

The document is a 510(k) premarket notification for a medical device that is not an AI/ML product. The Pilling Weck Surgical Y Stent Forceps is a mechanical surgical instrument. Its clearance is based on demonstrating substantial equivalence to a previously legally marketed device (the Karl Storz Stent Applicator Forceps), as permitted under Section 510(k) of the Federal Food, Drug, and Cosmetic Act.

For such devices, the "acceptance criteria" are effectively the requirements for establishing substantial equivalence: the device must have the same intended use and similar technological characteristics to a predicate device, and any differences in technological characteristics must not raise new questions of safety or effectiveness. There are no performance metrics like sensitivity, specificity, or AUC, nor are there concepts of test sets, training sets, ground truth establishment by experts, or MRMC studies, which are specific to the evaluation of AI/ML software as a medical device (SaMD).

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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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• to coagulate and transect vascular tissue simultaneously; .
• to perform spot coagulation of bleeding vessels; -
• to be used in open. surgical procedures; -

The VersaStat™ MULTIPOLAR Sciators are non-starile, reuseble surgical devices with an insulated coating to schieve the congulation function. This device will be uvaliable in various sizes and shapes similar to conventional surgical sciaeors. One shaft incorporates three pole connectors that create the shillity of current flow for one or both blades willzing a monepolar or a bipolar mode. Located on the cables (monopolar and bipciar) is a switch allowing the use of either one blade or both blades as a cautery surface.
The VersaStat™ MULTIPOLAR Scissors are designed for we only with the VersaStat™ MULTIPOLAR Cables, either monopolar or bipolar, when connected to the uppropriate electrosurgical generator.

I apologize, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria.

The document is a 510(k) summary for the VersaStat™ Multipolar Scissors and Cables, dated February 11, 1998. It details:

• Indications for Use: To coagulate and transect vascular tissue simultaneously, perform spot coagulation, and be used in open surgical procedures.
• Device Description: Reusable surgical devices with an insulated coating for coagulation, available in various sizes/shapes, with three pole connectors for monopolar or bipolar mode via a switch on the cables.
• Directions for Use: Includes compatibility, how to connect and use with an electrosurgical generator, and a pretest for electrical activity.
• Contraindications: Not for contraceptive coagulation of fallopian tubes, but can achieve hemostasis after transection.
• Warnings and Precautions: Emphasizes understanding electrosurgical principles, compatibility, no sharpening/repair, no abrasive cleaning, and caution with high power.
• Cleaning and Sterilization Recommendations: Instructions for enzyme cleaning, brushing, rinsing, and steam/ETO sterilization.
• FDA Clearance Letter: Acknowledging the 510(k) notification and determining substantial equivalence to previously marketed devices.

This information describes the device, its intended use, how to operate it, and its regulatory clearance based on substantial equivalence. However, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Details on experts used for ground truth or their qualifications.
4. Adjudication methods.
5. Information about multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
6. Results of standalone algorithm performance.
7. The type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document is from 1998 and pertains to a physical surgical device, not an AI/software device that would typically involve the detailed performance study information you are requesting. The 510(k) process for such devices at that time primarily relied on demonstrating substantial equivalence to a predicate device, often through bench testing, design specifications, and compatibility, rather than the extensive clinical performance studies typical for modern AI/ML medical devices.

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The Pilling Weck Secondary Flexible Sleeve with Cap and Trocar are manual surgical instruments used to support a cut down ( has approach) on secondary puncture placement.

The Trocar is used in Endoscopic Surgery (Gmecologic, general and other laparoscopic procedures and thoracic) for incision and peritoneal access for positioning of the hollow flexible sleeve.

Once the Trocar is removed, the port of entry provided by the sleeve through the cap, is used with manual instruments, laproscopes, and probes.

The device consists of Trocar and Sleeves, with integral and separately available Single Use Disposable Caps. The Sterile Disposable Cap Assembly consists of a universal adapter seal, which is used as a port of entry for the instrument/probe and used to minimize leakage and loss of pneumoperitoneum.

The Optional Disposable Cap Assembly is packed sterile in individual pouches or two to a pouch.

The Trocar, sizes 3mm .- 15mm .. is constructed with a polymer hub and shaft with stainless steel tip and is available in pyramidal style.

The Sleeve, proportionally sized, is made of polymer and comes with or accepts the Disposable Cap Assembly to seal the port of entry for the surgical instrument.

This 510(k) summary (K971334) for the Pilling Weck Secondary Flexible Sleeve and Trocar does not contain the detailed information necessary to describe acceptance criteria and a study proving the device meets those criteria.

510(k) summaries for Class II devices primarily focus on establishing substantial equivalence to legally marketed predicate devices, rather than presenting de novo clinical study results against specific performance acceptance criteria.

The provided document describes:

• The device and its intended use.
• The predicate devices to which it claims substantial equivalence.
• General technological characteristics of the device and how they compare to predicates.
• The FDA's determination of substantial equivalence.

Therefore, I cannot extract the following requested information from the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria or provide performance data.
2. Sample size used for the test set and the data provenance: No test set or study data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
4. Adjudication method for the test set: No test set or adjudication is mentioned.
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: This is a physical medical device (trocar and sleeve), not an AI/software device, so an MRMC study is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is a physical device, so "standalone algorithm performance" is not applicable.
7. The type of ground truth used: No ground truth is mentioned.
8. The sample size for the training set: No training set is mentioned as this is a physical device.
9. How the ground truth for the training set was established: No training set or ground truth is mentioned.

In summary, the provided 510(k) document is a regulatory submission focused on substantial equivalence, not a clinical study report detailing performance against pre-defined acceptance criteria.

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The Pilling Weck 2-Piece Take-Apart Instrumentation is designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions.

The Pilling Weck 2-Piece Take-Apart Instrumentation are endoscopic instruments, which have jaws designed to cut, grasp, dissect, retract, and manipulate. The reusable handles are offered in both insulated and noninsulated actuating rings that adapt to various interchangeable jaw configurations with integral shafts. The shaft of the jaws fits into the handle and can be taken apart for cleaning. The jaws are rotated by turning the knob on the handle. The devices have reusable handles that accommodate inserts, that can be rotated 360 Degrees during use. Both devices include insulated and noninsulated handles, and accommodating shafts. In the Pilling Weck device there is included a flushing port to facilitate cleaning. All Pilling Weck device handles adapt the interchangeable working ends by inserting them through the inner diameter of the shaft that is an integral part of the handle. The fit is secured by a detented proximal end that locks securely in place by encapsulation with the actuation of a push button.

I am sorry, but based on the provided text, there is no information available regarding the acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance studies or acceptance criteria for the new device.

The document mainly describes:

• The submitter's information.
• The device's name and classification.
• The predicate device.
• A description of the Pilling Weck 2-Piece Take-Apart Instruments.
• The intended use of the device.
• A comparison of the technological characteristics of the new device to the predicate device to establish substantial equivalence.

Therefore, I cannot fill out the requested table or answer the questions related to studies, sample sizes, expert qualifications, or ground truth.

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