(118 days)
The UltraCor™ Twirl™ Breast Tissue Marker is intended for use to attach to soft breast tissue, including axillary lymph nodes, to radiographically mark the location of the biopsy procedure.
The UltraCor™ Twirl™ Breast Tissue Marker (Curls and Clover) consists of a disposable beveled needle applicator containing a Nitinol radiographic marker is intended for long-term radiographic marking of the tissue site. The applicator has a beveled 17g x 10cm needle with 1 cm depth marks and a locking plunger. Each marker shape is deployed from the beveled needle tip into the tissue site.
Here's an analysis of the provided text regarding acceptance criteria and performance studies, based on the requested categories.
Important Note: The provided document is an FDA 510(k) summary for a breast tissue marker. This type of device is a physical implant, not a software-driven AI solution. Therefore, many of the typical questions related to AI/ML device performance (like MRMC studies, training/test set ground truth establishment for an algorithm, expert adjudication for image interpretation, etc.) are not applicable to this document. The "tests" performed here are physical and chemical property tests, not clinical performance studies involving patient images and expert readers.
I will populate the table and address the questions as best as possible given the nature of the device and the provided document.
Acceptance Criteria and Device Performance Study for UltraCor™ Twirl™ Breast Tissue Marker (Curls and Clover)
As per the FDA 510(k) Summary (K243642), the device is a physical breast tissue marker. The "performance testing" summarized here pertains to the physical and chemical properties of the marker and its applicator, assessing its safety and effectiveness for its intended use as an implantable marker. It is designed to be substantially equivalent to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list quantitative "acceptance criteria" with numerical thresholds for these tests, but rather reports "Pass" or lists the type of analysis performed. This is common for biocompatibility and material safety testing where the goal is to demonstrate compliance with standards rather than specific performance metrics against a clinical endpoint.
| Test Category | Specific Test / Parameter | Reported Device Performance (Implied Acceptance) |
|---|---|---|
| Material Properties & Safety | Chemical characterization (Wireform/Marker) | Pass (SVOC by GC/MS, VOC by GC/MS by Headspace, ICP/MS, NVOC by UPLC/MS performed after exhaustive extraction at 50°C for 72 hours) |
| Cytotoxicity (MEM Cell) | Pass | |
| Sensitization (Kligman Maximization) | Pass | |
| Irritation / Intracutaneous Reactivity | Pass | |
| Acute Systemic Toxicity | Pass | |
| Material Mediated Pyrogenicity | Pass | |
| Subchronic Toxicity Study in Rats (13 weeks) | Pass | |
| Genotoxicity (AMES Assay, Mouse Lymphoma Assay) | Pass | |
| Implantation (1, 4, 12 weeks) | Pass | |
| Toxicology (Toxicological Risk Assessment) | Pass | |
| Nickel Ion Release Testing | Performed (Result not explicitly stated as Pass/Fail but implied pass by overall conclusion of substantial equivalence) | |
| Transformation Temperature Testing | Performed (Result not explicitly stated as Pass/Fail but implied pass by overall conclusion of substantial equivalence) | |
| Corrosion Testing of Wireform (Marker) | Performed (Result not explicitly stated as Pass/Fail but implied pass by overall conclusion of substantial equivalence) | |
| Applicator Properties | Aqueous Physicochemical Testing | Pass (Extract - Purified Water) |
| Non-Aqueous Physicochemical Testing | Pass (Extract - Isopropyl Alcohol) | |
| Exaggerated Extraction | Pass (Extract - Purified Water, Isopropyl Alcohol, Cyclohexane) | |
| Cytotoxicity (MEM Elution) | Pass | |
| Sensitization (Kligman Guinea Pig Maximization) | Pass (Extract - 0.9% Sodium Chloride, Cottonseed oil) | |
| Irritation or Intracutaneous Reactivity | Pass (Extract - 0.9% Sodium Chloride, Cottonseed oil) | |
| Acute Systemic Toxicity | Pass (Extract - 0.9% Sodium Chloride, Sesame oil) | |
| Material-Mediated Pyrogenicity | Pass (Extract - 0.9% Sodium Chloride) | |
| Chemical Characterization (Applicator) | SVOC by GC/MS, VOC by GC/MS by Headspace, ICP/MS, NVOC by UPLC/MS performed (Implied pass by overall conclusion of substantial equivalence) | |
| Functional Performance | Marker Differentiation (Stereotactic or X-Ray/Mammography) | Performed (Result not explicitly stated as Pass/Fail but implied pass by overall conclusion of substantial equivalence) |
| Marker Visibility (Ultrasound, Stereotactic, X-Ray/Mammography, MRI) | Performed (Result not explicitly stated as Pass/Fail but implied pass by overall conclusion of substantial equivalence) | |
| Marker Retention Testing | Performed (Result not explicitly stated as Pass/Fail but implied pass by overall conclusion of substantial equivalence) | |
| Marker Deployment Accuracy | Performed (Result not explicitly stated as Pass/Fail but implied pass by overall conclusion of substantial equivalence) | |
| Marker Deployment Force | Performed (Result not explicitly stated as Pass/Fail but implied pass by overall conclusion of substantial equivalence) | |
| Marker Deployment | Performed (Result not explicitly stated as Pass/Fail but implied pass by overall conclusion of substantial equivalence) | |
| MRI Testing | Performed (Result not explicitly stated as Pass/Fail but implied pass by overall conclusion of substantial equivalence) |
2. Sample Size Used for the Test Set and Data Provenance
Due to the nature of the device (implantable clip, not an AI diagnostic algorithm), the concept of a "test set" in the context of clinical data/images doesn't apply directly.
- Sample Size: The document does not specify the sample sizes (number of markers or material samples) for each individual non-clinical test (e.g., how many markers were tested for deployment force, or how many rats were used for the subchronic toxicity study). However, the tests performed (biocompatibility, mechanical, radiographic visibility) inherently involve testing a sufficient sample size of the device or its components to ensure statistical reliability and demonstrate compliance with relevant standards.
- Data Provenance: Not applicable in the sense of patient data. The tests are laboratory-based, performed on the device itself or its materials. The document does not state the country of origin for the testing.
- Retrospective or Prospective: Not applicable; these are laboratory and animal studies, not human clinical studies involving observational data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This is not applicable as the device is a physical marker and its performance evaluation involves laboratory testing and animal studies (e.g., biocompatibility) rather than human expert interpretation of images for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable. There is no human interpretation of data requiring adjudication for this type of device and performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a MRMC study was not done. This type of study is specifically designed for evaluating diagnostic algorithms or imaging techniques where human readers interpret medical images. The UltraCor™ Twirl™ Breast Tissue Marker is a physical implantable device, and its safety and performance are assessed through physical, chemical, and, in some cases, animal biocompatibility testing. It is not an AI-based diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests outlined here is established through:
- Standardized Physical and Chemical Measurements: For tests like marker differentiation, visibility, retention, deployment accuracy, force, and corrosion, the ground truth is determined by objective, measurable physical and chemical properties and engineering specifications.
- Biocompatibility Standards: For the extensive biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation), the "ground truth" is compliance with international standards (e.g., ISO 10993 series) and observed biological responses in in vitro and in vivo models. "Pass" indicates that the material did not induce unacceptable biological reactions.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device that requires a training set.
§ 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.