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510(k) Data Aggregation
(132 days)
INRAD, Inc
The ExpressCore Full Core Biopsy Device is intended for use in obtaining biopsies from soft tissues.
The ExpressCore Device is a sterile, single patient use, hand held full core biopsy device comprised of a plastic handle and three stainless steel needle components that work in sequence to capture a full core biopsy sample. The device is capable of infinitely variable throw distance between 10 and 30mm and is equipped with multiple firing modes to accommodate procedural requirements and physician preference. Multiple device gauge size and needle option combinations have been developed from 12ga x 10cm to 18ga x 25cm.
This FDA 510(k) clearance letter pertains to a device, the ExpressCore Biopsy Device, not an AI/ML software. The provided text details the device's characteristics, intended use, and comparison to predicate devices, but it does not include information about a study that proves the device meets specific acceptance criteria in the context of an AI/ML algorithm.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance (for an AI/ML algorithm)
- Sample sized used for the test set and data provenance (for an AI/ML algorithm's test set)
- Number of experts used to establish ground truth and qualifications (for an AI/ML algorithm's ground truth)
- Adjudication method (for an AI/ML algorithm's test set)
- MRMC comparative effectiveness study (as this is a physical device, not an AI system assisting human readers)
- Standalone performance (as this is a physical device, not an AI algorithm)
- Type of ground truth used (for an AI/ML algorithm)
- Sample size for the training set (as this is a physical device, not an AI algorithm)
- How the ground truth for the training set was established (as this is a physical device, not an AI algorithm)
The document focuses on the physical and functional characteristics of the biopsy device and demonstrates substantial equivalence to existing predicate devices through bench performance testing, biocompatibility, sterilization, packaging, and shelf life data.
Key information from the provided text relevant to device testing (not AI/ML):
- Type of Study: Non-Clinical Bench Performance Testing, Biocompatibility, Sterilization, Packaging, Shelf Life.
- Purpose of Study: To confirm the device meets all system requirements and is substantially equivalent to the predicate device.
- Specific Tests Mentioned:
- Usability of the Device
- Biopsy Sample Collection
- Finger Cannula Tensile Test
- Spoon Cannula Tensile Test
- Stylet Tensile Test
- Representative Tissue Sampling
This document is a 510(k) clearance for a physical medical device, not a review of an AI/ML-based medical device.
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(268 days)
INRAD Inc.
The Trilogy Tissue Marker is intended for use to attach to breast tissue at the surgical breast biopsy or percutaneous breast biopsy to radiographically mark the biopsy procedure, and be permanently visible under MRI, x-ray and ultrasound.
The Trilogy Tissue Marker is a sterile, single use device comprised of a disposable delivery device preloaded with a tissue marker. The disposable delivery device includes an introducer needle comprised of a plastic molded deployment handle, a thumb slide, a 14 ga. cannula with 1 cm depth marks and a push rod. The tissue marker is preloaded in the distal end of the cannula. Trilogy tissue markers are made of a non-resorbable polymer embedded with a nitinol shape, allowing for permanent visibility under ultrasound, x-ray, and MRI. This device offers the choice of three unique tissue marker shapes (i) Ring (ii) Cross (iii) Ribbon.
The provided document is a 510(k) summary for the Trilogy Tissue Marker. It details a comparison between the subject device and a predicate device (EasyMark™ Tissue Marker) to demonstrate substantial equivalence, rather than a study about acceptance criteria for an AI device. Therefore, much of the requested information regarding AI device acceptance criteria and study design is not available in this document.
However, I can extract the information related to the device performance and the testing conducted to support its substantial equivalence with the predicate device.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
The document does not detail specific quantitative acceptance criteria or performance metrics in a readily extractable table form. Instead, it lists the types of performance tests conducted and states that the device meets "all system requirements" and is "substantially equivalent" to the predicate device.
| Performance Test Category | Device Performance (as stated in the document) |
|---|---|
| Performance Testing – Bench | Confirmed to meet all system requirements and is substantially equivalent to the predicate device. |
| Accuracy of Marker Deployment | (Implicitly meets requirements for substantial equivalence) |
| Marker Deployment Force | (Implicitly meets requirements for substantial equivalence) |
| Usability of the Device | (Implicitly meets requirements for substantial equivalence) |
| Imaging Assessment | (Implicitly meets requirements for substantial equivalence) |
| Safety and Compatibility in Magnetic Resonance (MR) Environment | (Implicitly meets requirements for substantial equivalence) |
| Tissue Marker Migration Potential | (Implicitly meets requirements for substantial equivalence) |
| Delivery Device Cannula Tensile Test | (Implicitly meets requirements for substantial equivalence) |
| Delivery Device Push Rod Tensile Test | (Implicitly meets requirements for substantial equivalence) |
| Biocompatibility | (Meets requirements for substantial equivalence) |
| Sterilization | (Meets requirements for substantial equivalence) |
| Packaging | (Meets requirements for substantial equivalence) |
| Shelf Life | (Meets requirements for substantial equivalence) |
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 provide details on the sample sizes used for the "Non-Clinical Bench Performance Testing." It also does not specify data provenance (e.g., country of origin or retrospective/prospective nature), as the testing appears to be primarily bench-based (laboratory testing).
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 study described is not a clinical study involving expert interpretation of medical images or data from human subjects. It focuses on the physical and functional aspects of a medical device (a tissue marker).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided, as the study is not an AI performance evaluation involving multiple readers or complex ground truth adjudication.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study relates to the performance of AI systems in assisting human readers, which is not the subject of this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
A standalone performance study of an algorithm was not done. This submission is for a physical medical device (tissue marker), not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The concept of "ground truth" as typically used in AI studies (e.g., expert consensus, pathology, outcomes data) is not directly applicable here. The "ground truth" for the bench performance testing of this physical device would stem from objective measurement standards and engineering specifications. For instance, "Accuracy of Marker Deployment" would be evaluated against designed specifications for marker placement, and "Tissue Marker Migration Potential" would be assessed against defined metrics for stability.
8. The sample size for the training set
This information is not applicable and not provided, as this is not an AI device that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided, as this is not an AI device.
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(304 days)
INRAD Inc.
The EasyMark Tissue Marker is intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the biopsy procedure.
The EasyMark Tissue Marker is a sterile, single use device comprised of a disposable delivery device preloaded with a tissue marker. The disposable delivery device includes an introducer needle comprised of a plastic molded deployment handle, a thumb slide, a 17 ga. cannula with 1 cm depth marks and a push rod. The tissue marker is preloaded in the distal end of the cannula. This device offers the user the choice of two unique tissue markers (i) 316 LVM Stainless Steel Anchor shaped Marker (ii) Titanium 6AI-4V ELI Ribbon shaped Marker.
The provided text describes the 510(k) premarket notification for the EasyMark Tissue Marker. It details the device, its indications for use, and a comparison to predicate and reference devices. However, it does not contain specific acceptance criteria or the study results proving the device meets those criteria, nor does it include information about a standalone study, MRMC study, sample sizes, ground truth establishment, or expert details for such studies.
Based on the information provided, here's what can be inferred and what is missing:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The document lists the types of non-clinical tests performed but does not state the specific acceptance criteria for each test or the quantitative results from those tests.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided as the document only states "non-clinical testing and evaluation was conducted." It doesn't detail specific sample sizes for any of the performance tests.
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 provided as the document does not describe any studies involving human experts or ground truth establishment in this manner.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no studies involving human interpretation or adjudication are described.
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
This information is not provided. The EasyMark Tissue Marker is a physical implantable device, not an AI software. Therefore, an MRMC study with human readers improving with AI assistance would not be relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. The device is a physical tissue marker, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided. The document describes performance testing, but not the specific methods used to establish ground truth for metrics like "Accuracy of Marker Deployment." It likely refers to objective measurements against predefined specifications.
8. The sample size for the training set
Not applicable. The EasyMark Tissue Marker is a physical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. The EasyMark Tissue Marker is a physical device, not an AI model that requires a training set.
Summary of Provided Information (within the scope of the document):
Device Name: EasyMark Tissue Marker
Intended Use: To attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the biopsy procedure.
Non-clinical Testing and Evaluation Performed to demonstrate substantial equivalence to the predicate device:
- Performance Testing Bench:
- Accuracy of Marker Deployment
- Marker Deployment Force
- Usability of the Device
- Imaging Assessment (X-ray and MRI)
- Safety and Compatibility in Magnetic Resonance (MR) Environment
- Tissue Marker Migration Potential
- Delivery Device Cannula Tensile Test
- Delivery Device Push Rod Tensile Test
- Biocompatibility
- Sterilization
- Packaging
- Shelf Life
Predicate Device: UltraClip® Tissue Marker, K993785
Reference Device (for biocompatibility of delivery device): SelectCore, K093256
Conclusion: The non-clinical testing and evaluation demonstrated that the EasyMark Tissue Marker "does not raise new concerns of safety or effectiveness and is substantially equivalent to the predicate device."
Disclaimer: The provided document is a 510(k) summary for a medical device. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not typically include detailed acceptance criteria or study results in the format requested, especially since the device is a physical marker and not an AI or diagnostic software tool.
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(30 days)
INRAD INC.
The device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors.
The EliteCore™ Full Core Biopsy Device is a sterile, disposable device which features a stainless steel cutting cannula with spoon, rotating coring cannula and stylet. The device is comprised of a plastic housing that contains the mechanically actuated components. The key performance attribute of the EliteCore™ Full Core Biopsy Device is the capability of obtaining a full core specimen. A variable throw feature allows the user to choose a throw setting ranging from 13 to 25 mm.
The EliteCore™ Full Core Biopsy Device is a sterile, disposable device for obtaining biopsies from soft tissues. The performance of this device was assessed by comparing it to a predicate device, the Revolution® Full Core Biopsy Device (K090611). The tests conducted aimed to confirm that the quality of samples obtained with the EliteCore™ device is equivalent to that of the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (How Equivalent) | Reported Device Performance |
|---|---|---|
| Package Inspection | Identical testing performed on predicate device with equivalent results. | Visually inspected packaging for damage, loose components, secure tip protector, and variable throw set at 22mm. Results were equivalent to predicate device. |
| Burst Test | Identical testing performed on predicate device with equivalent results. | Measured pressure at which sealed tray fails. Results were equivalent to predicate device. |
| Device Inspection | Identical testing performed on predicate device with equivalent results. | Visually inspected device for damage. Results were equivalent to predicate device. |
| Dimensional (Variable Throw) | Identical testing performed on predicate device with equivalent results. | Measured variable throw desired vs. actual. Results were equivalent to predicate device. |
| Dimensional (Variable Throw after Dry Fires) | Identical testing performed on predicate device with equivalent results. | Measured variable throw after dry fires, desired vs. actual. Results were equivalent to predicate device. |
| Force to Fire Front Triggers (RH / LH) | Identical testing performed on predicate device with equivalent results. | Measured force to fire front triggers. Results were equivalent to predicate device. |
| Force to Fire Rear Trigger | Identical testing performed on predicate device with equivalent results. | Measured force to fire rear trigger. Results were equivalent to predicate device. |
| Tissue Test (Chicken and Liver) | Identical testing performed on predicate device with equivalent results. | Able to take tissue samples in chicken and liver. Results were equivalent to predicate device. |
| Tissue Test (Various Throw Distances) | Additional testing that was not performed on predicate. | Able to take tissue samples at various throw distances. (No direct comparison to predicate stated for this specific aspect, but overall tissue test performance confirmed equivalence). The document states identical testing performed on predicate device with equivalent results. |
| Tissue Test (1st vs. Last Sample Weight) | Identical testing performed on predicate device with equivalent results. | Measured 1st sample as compared to last sample for sample weight and verified no loss of effectiveness. Results were equivalent to predicate device. |
| Mates with Adjustable Coaxial and Able to Take Sample | Identical testing performed on predicate device with equivalent results. | The device successfully mated with an adjustable coaxial and was able to take a sample. The results were equivalent to the predicate device. |
| Verify Weld Integrity (Visual Inspection after Functional Testing) | Identical testing performed on predicate device with equivalent results. | Visually inspected device for damage along weld joints after functional testing. Results were equivalent to predicate device. |
| Dimensional (Cannula, Spoon, and Stylet Migration) | Identical testing performed on predicate device with equivalent results. | Measured cannula, spoon, and stylet for migration. Results were equivalent to predicate device. |
| Dimensional (Joint Strength for Cannula, Spoon, and Stylet) | Identical testing performed on predicate device with equivalent results. | Measured the joint strength for the cannula, spoon, and stylet. Results were equivalent to predicate device. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific number of devices or biopsy attempts used for each test. Instead, it broadly states that "Identical testing performed on predicate device w/ equivalent results" for most tests. The tissue tests mention "chicken and liver" and "various throw distances," indicating a lab-based, prospective evaluation with animal tissue. No country of origin for the data is specified, but given the submission to the FDA, it is presumed to be conducted by the manufacturer, Inrad, Inc., located in Kentwood, MI, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The performance testing appears to be based on objective physical measurements and visual inspections rather than expert interpretation of biopsy samples.
4. Adjudication Method for the Test Set:
Not applicable. The tests are focused on device performance metrics (e.g., dimensions, forces, ability to take tissue samples) rather than diagnostic accuracy that would require an adjudication process.
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 device is a biopsy instrument, not an AI-powered diagnostic tool. The performance evaluation is based on engineering and basic tissue procurement capabilities.
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:
The ground truth for most tests was based on objective physical measurements (e.g., pressure, force, dimensions, weight) and visual inspections for damage or proper function. For tissue tests, the ground truth was the ability to successfully obtain a tissue sample and verify its properties (e.g., weight, no loss of effectiveness). The comparison was made against the performance of a legally marketed predicate device.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML device requiring a training set. The performance testing is for a physical medical instrument.
9. How the Ground Truth for the Training Set was Established:
Not applicable. (See #8)
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