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

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 polyacctal. 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.

I am sorry, but based on the provided text, there is no information about acceptance criteria, a study proving device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established.

The document is a 510(k) summary for a medical device (Hem-O-Lok® Ligation Clips) and primarily focuses on demonstrating substantial equivalence to a predicate device. It describes the device, its intended use, and its technological characteristics. There is no mention of a performance study with specific criteria or results.

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

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 for the Hem-O-Lok® Ligation Clips. It states that the device is substantially equivalent to a previously cleared device (K941972) and details its intended use and technological characteristics. However, it does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information from the provided text. The document is primarily a notification to the FDA for market clearance, focusing on substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria.

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Horizon ligating clips are indicated for procedures involving vessels or anatomic structures where I iorizon ligating this are the best clip size, type and material based upon experience, judgement and needs.

Not Found

The provided document is an FDA 510(k) clearance letter for the Horizon Ligation Clips, dated August 10, 1998. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information about acceptance criteria, device performance, results of a study, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot provide the requested information based on the input document. The document is primarily a regulatory approval letter and does not include the detailed technical study information that would be necessary to answer your questions.

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