(84 days)
The DANNIK Titanium Ligation Clips is designed for the intended use of ligating blood vessels .The Clip has been specially designed to insure occlusion of vessels and prevent any slippage once applied. The clip has applications in many types of surgical procedures where hemostasis is required or radiographic marking is necessary.
Choose the size of clip to fit the procedure making certain the tissue to be occluded fits completely within the clip. The DANNIK Titanium Ligation, clip can be left in vivo without sequela as it is biologically inert.
The DANNIK Titanium Ligation Clips are exclusively made of titanium and supplied in four different sizes: small, medium-large, and large. Packaged in cartridge of six clip units.
The titanium 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".
This device is packaged and sterilized for single use only. Do NOT re-use, reprocess or resterilize. Discard after use with care.
The provided text describes a 510(k) premarket notification for a medical device: the DANNIK Titanium Ligation Clip. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through new clinical trials.
Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/machine learning performance metrics (e.g., sensitivity, specificity, reader improvement with AI assistance). The "acceptance criteria" and "study" described in the prompt are typical for AI/ML device submissions, but not for a physical device like a ligation clip, where the focus is on material properties, mechanical performance (e.g., clamping force, corrosion resistance), and biocompatibility.
Based on the provided text, here's what can be extracted about the device and its testing:
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A table of acceptance criteria and the reported device performance:
The document does not present a formal table of explicit acceptance criteria with quantitative performance metrics for AI/ML. Instead, it states:Acceptance Criteria (Implied) Reported Device Performance Appearance "PASS" Dimension "PASS" Surface Roughness "PASS" Hardness "PASS" Toughness "PASS" Clamping (Retention) Performance "PASS" Corrosion Resistance "PASS" Other technical standard requirements of Dannik compared to predicate "meets" -
Sample sizes used for the test set and the data provenance:
The document mentions "performance studies and bench testing" and "non-clinical tests." It does not specify the sample size for these tests or the data provenance (e.g., country of origin, retrospective/prospective). These are typically physical tests on a sample of manufactured clips. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable in the context of AI/ML ground truth. The tests were evaluated by the "Design Engineer." Qualifications of the Design Engineer are not specified beyond their title. -
Adjudication method for the test set:
Not applicable in the context of AI/ML ground truth. The results were simply reported as "PASS." -
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC study was not done. This type of study is relevant for AI/ML diagnostic devices, not for a titanium ligation clip. -
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. -
The type of ground truth used:
The "ground truth" for the performance of the ligation clips appears to be based on physical measurements and material science standards (e.g., ASTM F-67 95, ISO 5832-2-93, ISO 10993) and comparison to the predicate device's known performance characteristics. For biocompatibility, it "Conforms to ISO 10993." -
The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set. -
How the ground truth for the training set was established:
Not applicable.
Summary of Device Performance and Equivalence:
The DANNIK Titanium Ligation Clip's safety and effectiveness were demonstrated through:
- Substantial Equivalence: Comparison to legally marketed predicate devices (Vitalitec International Inc Implantable Titanium Hemostatic Clip K981645 and Weck Metal Ligating Clips K132658) in terms of:
- Intended Use: Ligation of blood vessels for hemostasis or radiographic marking.
- Device Description: Titanium ligation clips.
- Clip Material: Titanium meeting ASTM F-67 95 Grade I and ISO 5832-2-93 and 10993 standards.
- Sterilization: Ethylene Oxide (ETO) conforming to ISO 11135-1.
- Prescription Only Use: Yes.
- Biocompatibility: Conforms to ISO 10993.
- Non-Clinical Bench Testing: Evaluation of physical and mechanical properties including appearance, dimension, surface roughness, hardness, toughness, clamping (retention) performance, and corrosion resistance. All tests resulted in "PASS."
- No new technologies: The document states that "There are no new technologies being added to this device from the predicate, in terms of finished device functions."
- No Clinical Trials: "No Clinical trials performed on the DANNIK Titanium Ligation Clips." This is common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical data.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.