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The Wexler Endoscope Accessories are indicated for use in endoscopic surgical procedures to provide minimally invasive handling during the instrument's intended function. Clamps and forceps are used to grasp tissue or other items in the surgical field, while scissors are used to cut tissue or other items and needle holders are employed during the suturing process.

The Wexler Endoscope Accessories is a group of instruments used during endoscopic procedures such as thoracoscopy and laparoscopy. The instruments include clamps, forceps, needle holders, and scissors. The devices are made of stainless steel, and are supplied non-sterile.

The provided text describes a 510(k) submission for Wexler Endoscope Accessories. It does not contain information about acceptance criteria, device performance testing, study design (sample size, data provenance, expert ground truthing, adjudication), or comparative effectiveness studies.

The submission focuses entirely on demonstrating substantial equivalence to a predicate device (Scanlan® thoracoscopic instruments, K945474) based on similar technological characteristics, intended use, and materials (stainless steel). The language used ("virtually identical," "no significant differences") suggests that formal performance studies with specific acceptance criteria were not required by the FDA for this particular submission, as the device is deemed sufficiently similar to an already cleared product.

Therefore, I cannot populate the requested tables and information. The document explicitly states:

• "There are no significant differences in either technology or performance specifications." This implies that performance testing beyond demonstrating substantial equivalence to the predicate was not performed or deemed necessary for this 510(k) clearance.

If this were a different type of submission (e.g., for a novel device or one with significant technological differences from predicates), such performance data would typically be included.

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The Wexler Vascular Clamp Series is indicated for use for temporary or partial occlusion of blood vessels during surgical procedures.

The Wexler Vascular Clamp Series is a family of vascular clamps, both stainless steel and titanium alloy, used during surgical procedures. The clips are supplied nonsterile and are chosen based on the dimensions, features and technological characteristics desired.

The provided document is a 510(k) summary for the Wexler Vascular Clamp Series, which is a medical device. This type of regulatory submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance criteria through a detailed study in the way a novel AI or diagnostic device would.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study demonstrating the device meets those criteria. Specifically:

• No acceptance criteria table or reported device performance: The submission focuses on comparing the new device's characteristics (materials, design, intended use, principle of operation) to an existing predicate device, not on quantitative performance metrics.
• No sample size for test set or data provenance: There is no mention of a test set, as no study was conducted to establish performance metrics in the way a diagnostic algorithm would require.
• No number of experts or qualifications: No expert review for ground truth establishment is described.
• No adjudication method: Not applicable as there's no ground truth establishment process.
• No Multi Reader Multi Case (MRMC) comparative effectiveness study: This type of study is not relevant for a vascular clamp.
• No standalone (algorithm only) performance study: This device is a surgical instrument, not an algorithm.
• No type of ground truth used: Not applicable.
• No sample size for the training set: Not applicable as there is no machine learning component.
• No description of how ground truth for the training set was established: Not applicable.

The submission claims substantial equivalence based on:

• Identical indications for use: "The Wexler Vascular Clamp Series is indicated for use for temporary or partial occlusion of blood vessels during surgical procedures," which is stated to be virtually identical to the predicate.
• Identical principles of operation: "The indications for use, principles of operation, and device design of the Wexler Vascular Clamp Series are virtually identical to those of the predicate device."
• Similar device design: "Both series of devices are made of stainless steel or titanium, and share technological characteristics common to all vascular clamps of their types."
• Similar technological characteristics and performance specifications: "There are no significant differences in either technology or performance specifications."

In essence, the "study" demonstrating the device meets acceptance criteria is the comparison to the predicate device K072834 (manufactured by Surgical Instruments Belgium (SIBEL) SA), and the acceptance criterion is substantial equivalence to that predicate. This is a regulatory pathway, not a clinical or performance study in the context of diagnostic accuracy or AI performance.

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The Nexus Ligating Clip is indicated for use in surgical procedures on vessels or other tubular structures where a metal ligating clip is required.

The Nexus Ligating Clip is a titanium clip used during surgical procedures. The clips are supplied sterile in four sizes: small, medium-large, and large; six clips per cartridge. The size of clip should be chosen based on experience, judgment, and needs, ensuring that the tissue to be occluded fits completely within the clip. The devices are heart-shaped to provide a firm grip on the structure to be ligated, and there are transverse grooves on the inner surface of each clip to resist slippage.

This 510(k) summary (K053255) describes the Nexus Ligating Clip, a titanium clip used in surgical procedures. The submission focuses on demonstrating substantial equivalence to a predicate device, the Horizon Ligation Clips (K982313) from Weck Closure Systems, rather than establishing de novo acceptance criteria through clinical studies.

As such, the document does not contain information on dedicated clinical studies to proactively establish and meet acceptance criteria for a novel device. Instead, it relies on demonstrating similar characteristics and performance to an already legally marketed device. Therefore, many of the requested sections (sample size, expert qualifications, ground truth, MRMC study, training set details) are not applicable in the context of this 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided because the submission relies on demonstrating substantial equivalence through comparison of technical characteristics and existing validated processes (sterilization, shelf life) rather than a clinical test set. No specific patient data or test set data provenance is mentioned.

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

This information is not applicable. No "ground truth" for a clinical test set was established in this 510(k) submission.

4. Adjudication Method for the Test Set

This information is not applicable. No clinical test set requiring adjudication was conducted or described.

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

No MRMC comparative effectiveness study was mentioned or performed as part of this 510(k) submission. The focus is on device characteristics, not human reader performance with or without AI.

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

This is not applicable, as the device is a titanium ligating clip, not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth concept, as typically applied in AI/clinical studies (e.g., pathology, outcomes data), is not relevant here. The "ground truth" for this submission revolves around:

• Adherence to international sterilization standards.
• Successful completion of shelf-life testing.
• Demonstrated similarity in design, materials (titanium), indications for use, and principle of operation to the predicate device.

8. The Sample Size for the Training Set

This information is not applicable, as this device does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable.

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