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Hem-o-lok ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.

The Weck Hem-O-Lok™ ligation clip is a manually applied hemostatic clip intended to connect internal tissues to aid healing. Hem-o-Lok™ causes hemostasis through vessel ligation. The modified XL size clip is a larger version of the existing Hem-o-lok clip.

This looks like a 510(k) premarket notification for a medical device. This type of document typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo clinical study data to prove acceptance criteria in the way a new AI/software device might.

Based on the provided text, there is no information available regarding "acceptance criteria" for device performance in the context of a study, nor is there a study described that proves the device meets such criteria. This document is a regulatory submission for a physical medical device (a ligating clip), not an AI/software device, and thus the questions about AI-specific metrics and study designs are not applicable.

Here's why each point cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The document focuses on technological characteristics being the same as or equivalent to a predicate device, rather than quantitative performance metrics against specific acceptance thresholds.
2. Sample size used for the test set and the data provenance: Not applicable. No "test set" in the context of performance evaluation as you might find for an AI device.
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 establishment described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): 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.

Summary based on the document:

The document describes the Hem-O-Lok® Ligating Clip (specifically, a modified XL size clip) and asserts its substantial equivalence to previously cleared Weck Hem-o-lok® clip sizes. The primary argument is that the technological characteristics are the same as or equivalent to the predicate device, and a dimensional specification change does not adversely affect safety and effectiveness.

To clarify, this type of regulatory submission (510(k)) for a conventional medical device typically involves:

• Comparison to a predicate device: Demonstrating that the new device is as safe and effective as a legally marketed device.
• Performance Benchmarking (if applicable): For some devices, specific bench testing or engineering evaluations might be conducted to confirm that the changes (e.g., in dimensions) do not compromise key functional aspects like clip strength, locking mechanism, material integrity, etc. However, the provided text does not detail such studies or specific quantitative acceptance criteria for those tests.
• No AI or software component: The questions about AI-specific studies and metrics are entirely irrelevant to this device and its submission.

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Weck Hem-o-lok Automatic Ligating Clip Appliers are indicated for use as delivery devices for Hem-o-lok non-absorbable polymer ligating clips. Hem-o-lok ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structures to be ligated such that the clip completely encompasses the vessel or tissue structure.

The Weck device is a sterile, single use, automatic ligating clip applier consisting of a handle, shaft containing 15 Hem-o-lok® locking polymer clips, and jaw. The major functions of the device are clip feeding, approximation (positioning the clip around the vessel), and closure. The applier is discarded after the surgical procedure whereas the applied non-absorbable polymer clips remain in the patient. Two models are offered: endoscopic and open surgery.

The provided text describes a 510(k) submission for a medical device, the Weck Hem-o-Lok™ Automatic Ligating Clip Applier. The document focuses on demonstrating substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a detailed study proving performance against them.

Therefore, the requested information elements related to specific performance metrics, sample sizes for test and training sets, expert involvement, and ground truth establishment are not available in the provided text, as this type of detail is typically part of specific validation reports or clinical studies, not generally found in a 510(k) summary focused on substantial equivalence.

Based on the provided text, here's what can be extracted:

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

• Acceptance Criteria (Implied): The primary "acceptance criteria" for a 510(k) submission are demonstrating substantial equivalence to existing legally marketed predicate devices in terms of intended use, technological characteristics, and safety and effectiveness.
• Reported Device Performance: The document states:
  • "The results of bench and animal testing demonstrate that any differences between the new device and its predicates do not adversely affect performance or safety."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not available in the provided text. The document refers to "bench and animal testing" but does not specify sample sizes or data provenance.

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/available. This type of detail is typically for AI/imaging device studies. This device is a surgical instrument. The evaluation would likely involve engineering tests and animal models, reviewed by regulatory bodies and internal engineering/medical staff, rather than "experts establishing ground truth" in the diagnostic sense.

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

• Not applicable/available. As above, this is generally for diagnostic and AI studies, not for a surgical instrument's substantial equivalence pathway.

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 pertains to AI-assisted diagnostic devices, not a surgical ligating clip applier.

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

• Not applicable. This pertains to AI algorithms, not a manual surgical instrument.

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

• Implied Ground Truth: For a device like this, "ground truth" would relate to successful ligation, clip integrity, and lack of adverse events in preclinical (bench and animal) testing. The document states "bench and animal testing demonstrate that any differences between the new device and its predicates do not adversely affect performance or safety." This suggests the "ground truth" was established based on the functional performance criteria of the device in these controlled environments, likely involving criteria like clip deployment success rate, clip retention force, and absence of tissue damage or bleeding in animal models. The document doesn't explicitly state the methodology for establishing this.

8. The sample size for the training set

• Not applicable/available. No "training set" in the machine learning sense is mentioned or implied for this mechanical device.

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

• Not applicable/available. As above, no "training set" exists for this type of device submission.

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Weck Cardiac Pacing Wires are intended for use in temporary cardiac pacing following cardiac surgery in adult and pediatric patients.

Weck cardiac pacing wires consist of a small curved stainless steel needle attached to fluoropolymer coated stainless steel braided wire which is attached on the opposite end to a Keith or Milner breakaway needle (see picture below). The wire is bare at the distal end to allow conduction of pacing signals to the heart. This is a standard temporary epicardial pacing wire design.

There are three design variations included in this submission that are offered as a convenience to the user:

1. Color coding White and orange color coding of the insulation allows the user to differentiate between atrial and ventricular wires after chest closure.
2. Heart needle Three heart needle sizes are intended to allow for variations in physiology between patients. Another variation has no curved heart needle for surgeons who prefer to suture the wire to the epicardium rather than implanting it.
3. Retention feature A "wing" version wire is formed by peeling back the insulation in three places, 120° apart, for a distance of 1/2" near the curved heart needle. The "wing" is intended as a convenience feature to provide a suture-free method of securing the electrode to the heart.

The provided text describes a 510(k) summary for Weck Cardiac Pacing Wires, which aims to demonstrate substantial equivalence to predicate devices rather than conducting a full de novo study with strict acceptance criteria and performance evaluations as might be found for a novel device. Therefore, much of the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical trial or algorithm performance study is not explicitly detailed.

However, based on the document, we can infer the "acceptance criteria" as ensuring the device performs equivalently to predicate devices on key functional attributes. The "study" refers to the engineering and bench testing performed to confirm these characteristics.

Here's a breakdown of the requested information based on the provided text, with explanations where information is not explicitly stated or is inferred from the regulatory context:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for "test sets" in terms of patient data or clinical trials. The "testing" refers to bench and engineering evaluations. The provenance of this engineering testing data (e.g., country of origin, retrospective/prospective) is not provided.

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)

This information is not applicable and not provided. The "ground truth" for this type of device (a medical wire) would be based on established engineering standards and material science, not expert consensus on interpretations of images or patient data.

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

Not applicable and not provided. Adjudication methods are typically used in clinical trials or studies where there is subjective assessment by multiple reviewers. This submission focuses on objective engineering and performance characteristics.

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 is not an AI-assisted diagnostic device, nor is it a device where "human readers" would be involved in interpreting its output. No MRMC study was conducted or mentioned.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for the performance evaluations (electrical continuity, strength, corrosion resistance, etc.) would be established against engineering specifications, material standards, and industry-accepted benchmarks for temporary cardiac pacing wires, based on the performance of the predicate devices. This is implied by the statement "Weck evaluated each characteristic of the wires important to proper functioning and confirmed that each of the wires is equivalent and performs acceptably."

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a "training set."

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

Not applicable. No training set was used.

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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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Hem-O-Lok® ligating clips are intended for use in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size clip for the size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.

Weck Closure System's Hem-O-Lok® ligation clip is a manually applied hemostatic clip intended to connect internal tissues to aid healing. Hem-O-Lok® causes hemostasis through vessel ligation. The clip is nonabsorbable and is manufactured from polyacetal.

The clips are housed in a cartridge and packaged in a rigid plastic blister with Tyvek coated lidding which is sold sterile. The method of sterilization will be EtO with a SAL of 10°. The blister packs are fitted into an overpack carton which serves as the sales unit.

This document is a 510(k) Premarket Notification summary for the Hem-O-Lok® Ligation Clips. It describes the device, its intended use, and claims substantial equivalence to a previously cleared device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way typically found for AI/ML-based medical devices.

The information provided describes a traditional
medical device (ligation clips), not an AI/ML-based device. Therefore, many of the typical acceptance criteria and study components for AI/ML devices (like sample size for test/training sets, ground truth methodology, expert qualifications, MRMC studies, standalone performance) are not applicable or not reported in this type of submission for a physical device.

Here's an analysis based on the provided document, addressing the relevant points and noting where information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify formal "acceptance criteria" and "reported device performance" in the context of a statistical study for efficacy or performance as would be expected for a diagnostic or AI/ML device. For a physical device like a ligation clip, acceptance is typically based on:

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

Not applicable. This is a physical, manually applied surgical device. Its performance is demonstrated through material properties, manufacturing controls, and equivalence to a predicate device, not through a "test set" of data in the AI/ML sense. Data provenance regarding country of origin or retrospective/prospective does not apply here.

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

Not applicable. Ground truth, in the context of an AI/ML device for disease detection or measurement, is not relevant for this physical surgical clip.

4. Adjudication method for the test set

Not applicable. An adjudication method for a test set is not relevant for this physical surgical clip.

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 is a physical surgical device, 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 is a physical surgical device, not an algorithm.

7. The type of ground truth used

Not applicable. Ground truth is not a concept applied to the evaluation of a physical surgical clip in this context. The "truth" is its physical and material properties, and its ability to achieve ligation, which is established through manufacturing, standards, and clinical use history of similar devices.

8. The sample size for the training set

Not applicable. There is no AI/ML algorithm requiring a training set.

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

Not applicable. There is no AI/ML algorithm requiring a training set and associated ground truth.

Summary of Study (Substantial Equivalence Determination)

The "study" or justification proving the device meets acceptance criteria (primarily substantial equivalence) is based on the following:

• Comparison to a Predicate Device: The Hem-O-Lok® clip is deemed substantially equivalent to Weck's previous Hem-O-Lok® clips cleared under 510(k) filing number 982941. This means the new device shares similar technological characteristics, intended use, and performance claims as a device already on the market.
• Technological Characteristics: The document states that the technological characteristics are the "same as or equivalent to the predicate device." This includes the polyacetal material used, which is confirmed to be biocompatible.
• Intended Use: The intended use "for procedures involving ligation of vessels or tissue structures" is identical to the predicate.
• Manufacturing and Sterilization: The device is manufactured from polyacetal, is nonabsorbable, housed in a cartridge, sterile-packaged, and sterilized by EtO with a SAL of 10⁻⁶. These are standard practices and properties for such devices, implying compliance with established safety and performance benchmarks.

In essence, the "study" for this device is a demonstration of equivalence to an already legally marketed device, supported by known material properties and manufacturing processes, rather than a prospective clinical trial or performance evaluation against a diagnostic ground truth.

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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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