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The SureClip Clip Applier is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated.

The SureClip Clip Applier ("SureClip") is comprised of a cartridge ("SureClip Clip Applier Cartridge" or "SureClip Cartridge") (5mm or 10mm) (Class II) and a handle (Class I). Each cartridge is pre-loaded with 17 implantable titanium clips. The SureClip Clip Applier is intended to apply implantable, medium/large, titanium clips. The clips are manufactured from unalloyed implant grade titanium (ASTM F67 Grade 1 Titanium, UNS R50250). The cartridge must be assembled and locked into the handle. The handle includes a pistol grip trigger and a rotation knob for 360° rotation in either direction. The jaws, which are located at the distal end of the SureClip Cartridge, form each clip as the trigger is actuated.

The provided text does not contain information about acceptance criteria for a device's performance that can be presented in a table with reported device performance. It also does not describe a study that proves a device meets such acceptance criteria in the way requested (e.g., sample sizes for test/training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC comparative effectiveness study results).

The document is a 510(k) summary for the ConMed SureClip Clip Applier, primarily focused on establishing substantial equivalence to a predicate device. It mentions "Non-clinical Performance Testing" and "Performance testing" but does not provide specific metrics or acceptance criteria for those tests in a format suitable for the requested table.

Here's an analysis of what is available in the document regarding testing:

Key Information from the Document:

• Device Name: ConMed SureClip Clip Applier
• Intended Use / Indications for Use: The SureClip Clip Applier is intended for use on tubular structures or vessels wherever a metal ligating clip is indicated.
• Predicate Device: LIGAMAX™ 5 Clip Applier (K110699) by Ethicon Endo-Surgery. Reference devices: LIGAMAX™ 10-M/L (K864102, K830503, and K812291)
• Testing Conducted:
  • Non-clinical bench and simulated use testing
  • Clip burst testing
  • Clip retention testing
  • Animal testing (implantation) per Good Laboratory Practice 21 CFR Part 58.
  • Material analysis and biocompatibility testing (complying with ANSI/AAMI/ISO 10993-1:2009(R)/2013)
• Outcomes of Testing:
  • "demonstrate the SureClip Clip Applier is substantially equivalent to the predicate with regard to intended use, materials, technology, and performance."
  • "Results of product performance testing confirm that devices comply with design specifications and applicable sections of ISO 11135:2014, AAMI/ANSI ST67:2011, ISO 10993-7:2008, ISO 14971:2007, ASTM F67-13:2013, and ASTM F2503-13:2013."
  • "Product performance and animal testing demonstrate the safe and effective application of the new design features for the same intended use as the predicate device."
  • "Comparison of device features and side-by-side comparison testing conducted for clip applier performance demonstrate that SureClip Clip Applier is substantially equivalent to Ethicon's Clip Applier for both the 5mm and 10mm regarding intended use/indications for use, technology, and performance specifications."

Missing Information (required by your request):

1. Table of Acceptance Criteria and Reported Device Performance: Not provided explicitly. The document states compliance with design specifications and standards but doesn't list specific performance metrics (e.g., minimum burst strength, maximum clip retention force) or the exact values achieved by the device.
2. Sample sizes used for the test set and data provenance: No specific sample sizes for bench, simulated, or animal testing are mentioned, nor is the data provenance (country, retrospective/prospective) described.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable/not mentioned, as these are primarily engineering performance tests, not clinical evaluations requiring human expert interpretation in the way AI/diagnostic devices do.
4. Adjudication method: Not applicable/not mentioned.
5. MRMC comparative effectiveness study: Not conducted. This is an engineering/performance substantial equivalence claim, not an AI or diagnostic effectiveness study.
6. Standalone (algorithm only) performance: Not applicable. This is a mechanical device, not an algorithm.
7. Type of ground truth used: For the physical performance tests (burst, retention), the "ground truth" would be the measured physical properties themselves, established through standardized testing methodologies. For biocompatibility, it's compliance with established ISO standards. For animal testing, it's observation of biological response in live subjects.
8. Sample size for the training set: Not applicable. This is not a machine learning/AI device.
9. How the ground truth for the training set was established: Not applicable.

In conclusion, the document focuses on demonstrating substantial equivalence through compliance with recognized standards and comparison to a predicate device, rather than presenting a detailed "acceptance criteria vs. performance" table with specifics on sample sizes, expert ground truth, or MRMC studies as typically requested for diagnostic or AI-based devices.

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The GENICON implantable clips are intended for use during procedures for the purpose of approximating soft tissue, closing off vessels and other structures in order to stop bleeding or to connect internal tissues to aid in healing.

The ligation clips are composed exclusively of titanium, and are supplied as sterile products in various sizes (mini-micro, micro, smallmedium, medium, medium-large, large and extra large) with six clips per disposable holder. The titiaum used meets all requirements for A.S.T.M. specifications F-67 95 "Unalloyed Titanium for Surgical Implant Applications", Grade I and ISO 5832-2-93 and 10993 "Implants for Surgery - Metallic Materials - Part 2: Unalloyed Titanium".

The provided text is a 510(k) summary for the GENICON Titanium Ligation Clip. It describes the device, its intended use, and substantial equivalence to a predicate device, but it does not contain information about a study that proves the device meets specific acceptance criteria in the way a diagnostic AI/ML device would.

Instead, the summary focuses on:

• Material Composition: Stating the device is made of titanium meeting specific ASTM and ISO standards.
• Substantial Equivalence: Claiming the device is substantially equivalent in material and function to a predicate device (Ethicon K830503).
• Safety and Efficacy: Asserting that titanium is "well recognized as being safe and effective for long term implantation" and that millions of titanium clips applied yearly "attest to the wide acceptance of this method of hemostatic and ligation control."
• Compliance with Standards: Stating that devices are manufactured according to GMP, AAMI, ASTM, and ISO 13485 requirements.

Therefore, many of the requested items related to an AI/ML device performance study cannot be answered from this document.

Here's an analysis based on the information available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This document describes a medical device (titanium ligation clip), not an AI/ML diagnostic or predictive model that would use a "test set" in this context. The "safety and efficacy information" refers to general acceptance of titanium clips over time, not a specific clinical study with a test set.

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

Not applicable. This is not an AI/ML device's performance study.

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

Not applicable. This is not an AI/ML device's performance study.

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/ML device, nor is an MRMC study described.

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

Not applicable. This is a physical medical device.

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

The document implicitly relies on:

• Material Standards: ASTM and ISO specifications for titanium.
• Historical Clinical Use/Outcomes: "Millions of titanium clips are applied yearly...attest to the wide acceptance of this method of hemostatic and ligation control."
• Substantial Equivalence: Ground truth for equivalence is based on comparison to a legally marketed predicate device, likely involving material properties, design, and intended use.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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Cutters, Staplers and Appliers are indicated for resection, transection or ligation of tissue in abdominal, gynecological, pediatric and thoracic applications.

Vanguard intends to market Reprocessed Disposable Cutters and Staplers, that have removable reloads. Vanguard reprocesses only the hand held instrument. All reloads are removed and discarded before being reprocessed. Reprocessing Cutters, Staplers and Appliers is performed according to Vanguard protocol Number 40018. "Reprocessed," means all operations performed to render a contaminated single-use device patient ready. (See FDA Guidance Document: Enforcement Priorities for Single-Use Devices Reprocessed by Third Party Reprocessors and Hospitals). Vanguard is a "third party reprocessor" and reprocesses used single-used medical devices. Vanguard does NOT reprocess the re-loads. Reloads must be supplied by the hospital. Vanguard believes that single-use Cutters, Staplers and Appliers can be considered "reusable" - by Vanguard " as defined in the Food and Drug Administration Compliance Policy Guide #7124.16; they are able to withstand the necessary cleaning and sterilization process, the physical characteristics or quality of the device will not be adversely effected, and the device remains safe and effective for its intended use. Linear staplers deliver staggered rows of staples in order to approximate internal tissues. Linear Cutters are hand held surgical devices used to deliver staggered rows of staples while simultaneously dividing the tissue. Appliers are hand held surgical instruments that litigate tubular structures and vessels.

This document is a 510(k) summary for Vanguard Medical's reprocessed disposable cutters, staplers, and appliers. It does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria. The document focuses on establishing substantial equivalence to legally marketed predicate devices rather than providing performance study details.

Therefore, I cannot provide the requested information from the given text.

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