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510(k) Data Aggregation
(27 days)
CAPERE Thrombectomy System
The CAPERE® Thrombectomy System is indicated for:
- Non-surgical removal of soft emboli and thrombi from blood vessels.
- Injection, infusion and/or aspiration of contrast media and other fluids into blood vessel.
The CAPERE® Thrombectomy System is intended only for use in the peripheral vasculature and is not intended for use in the pulmonary arteries.
The CAPERE® Thrombectomy System primarily consists of a Delivery Catheter and Guide Catheter. The CAPERE® Thrombectomy System is delivered percutaneously via transfemoral or jugular venous access. Once delivered, the System's fine mesh nitinol wire basket is used to capture and mechanically remove emboli and thrombi. The CAPERE® System does not use aspiration to pull out the thrombus but does have a side port in the funnel catheter that allows aspiration or injection of saline or fluids if needed.
The provided text does not contain information about an AI/ML powered device, but rather a medical device for thrombectomy. Therefore, it's not possible to extract the requested information regarding acceptance criteria, study details, and AI/ML specific metrics.
The document describes the CAPERE Thrombectomy System, a device for non-surgical removal of soft emboli and thrombi from blood vessels. It details the device's characteristics, intended use, and provides evidence of substantial equivalence to a predicate device based on nonclinical performance testing.
Here's the information that is available in the provided text regarding the device performance and acceptance criteria for this non-AI/ML device:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (What was measured) | Reported Device Performance (Result) |
|---|---|
| Compression resistance and bond joints | CAPERE® Thrombectomy System maintained the predicate characteristics, demonstrating compliance with relevant standards such as ISO 10555-1 and ISO 594-2. |
| Force to retract the basket into the funnel catheter | The CAPERE® was determined to meet the same retraction force requirements as the predicate, based on evaluation in accordance with the same simulated-use test method. |
| Ability to capture and remove clot | The CAPERE® was determined to completely capture and remove the simulated clot and therefore maintains the characteristics of the predicate, based on evaluation in accordance with the same simulated-use test method. |
| Biocompatibility, sterilization, and packaging characteristics | The materials and packaging are unchanged from the predicate, therefore the biocompatibility, sterilization, and packaging characteristics of the predicate were maintained. |
2. Sample size used for the test set and the data provenance:
- The document states "nonclinical performance testing has been conducted...In all instances, the CAPERE® Thrombectomy System functioned as intended under the previously established test methods." However, specific sample sizes for the nonclinical tests are not provided.
- Data provenance is not explicitly stated, but it can be inferred that the testing was conducted by Vascular Medcure, Inc. or a contracted lab, as it refers to "established test methods used in the cleared predicate device" and "simulated-use test method." No country of origin for the data is mentioned, nor is it specified if the tests were retrospective or prospective, though bench and simulated-use testing are inherently prospective in nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the described tests are nonclinical bench and simulated-use tests, not studies involving expert adjudication of data like images or patient cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable as the described tests are nonclinical bench and simulated-use tests, not studies requiring expert adjudication methods.
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 applicable as the device is not an AI-assisted diagnostic tool but a physical thrombectomy system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable as the device is not an AI algorithm.
7. The type of ground truth used:
- For the nonclinical performance testing, the "ground truth" was established by predetermined technical specifications and performance characteristics of the predicate device, as well as by compliance with relevant international standards (ISO 10555-1 and ISO 594-2). For example, the ability to capture clot was evaluated against the "complete capture and removal of simulated clot."
8. The sample size for the training set:
- This information is not applicable as the device is not an AI algorithm and does not have a "training set."
9. How the ground truth for the training set was established:
- This information is not applicable as the device is not an AI algorithm.
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(64 days)
CAPERE Thrombectomy System
The CAPERE® Thrombectomy System is indicated for:
-Non-surgical removal of soft emboli and thrombi from blood vessels.
-Injection, infusion and/or aspiration of contrast media and other fluids into blood vessel.
The CAPERE® Thrombectomy System is intended only for use in the peripheral vasculature and is not intended for use in the pulmonary arteries.
The CAPERE® Thrombectomy System primarily consists of an 9Fr Delivery Catheter and 12Fr Guide Catheter. The CAPERE® Thrombectomy System is delivered percutaneously via transfemoral or jugular venous access. Once delivered, the System's fine mesh nitinol wire basket is used to capture and mechanically remove emboli and thrombi. The CAPERE® System does not use aspiration to pull out the thrombus but does have a side port in the funnel catheter that allows aspiration or injection of saline or fluids if needed.
Here's a breakdown of the acceptance criteria and the study information for the CAPERE® Thrombectomy System, based on the provided FDA 510(k) summary:
This device is not an AI/ML device, so some of the requested information (like MRMC studies, training set details, and expert qualifications for ground truth) is not applicable or not provided in this regulatory document. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Study Type |
|---|---|---|
| Functional Bench Testing: | Non-Clinical Performance Testing | |
| - Compliance with ISO 10555-1 (Sterile, single-use intravascular catheters) | Demonstrated compliance | Functional Bench Testing |
| - Compliance with ISO 594-2 (Conical fittings with a 6% (Luer) taper for syringes, needles, and certain other medical equipment) | Demonstrated compliance | Functional Bench Testing |
| - Compression resistance maintained similar to predicate | Maintained predicate characteristics | Functional Bench Testing |
| - Bond joints integrity maintained similar to predicate | Maintained predicate characteristics | Functional Bench Testing |
| - Force to retract basket into funnel catheter meets requirements (same as predicate) | Determined to meet the same retraction force requirements as the predicate | Functional Bench Testing (Simulated-use test method) |
| - Ability to capture and remove clot completely (same as predicate) | Determined to completely capture and remove the simulated clot and therefore maintains the characteristics of the predicate | Functional Bench Testing (Simulated-use test method) |
| Biocompatibility: | Unchanged from the predicate; predicate characteristics maintained | Based on predicate device's characteristics |
| Sterilization: | Unchanged from the predicate; predicate characteristics maintained | Based on predicate device's characteristics |
| Packaging: | Unchanged from the predicate; predicate characteristics maintained | Based on predicate device's characteristics |
| Overall Performance: | Functioned as intended under previously established test methods | Non-Clinical Performance Testing |
Study Details
-
Sample size used for the test set and the data provenance:
- The document does not specify a "sample size" in terms of number of devices or number of tests for each specific functional bench test. It mentions "functional bench testing was conducted" and describes the types of tests.
- Data Provenance: The studies are non-clinical, in-vitro bench tests conducted to evaluate device performance against established standards and predicate device characteristics. No information on geographical origin is typically relevant or provided for this type of testing.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as this is a non-clinical, physical device. "Ground truth" in the context of expert review for diagnostic AI/ML is not relevant here. The acceptance criteria are based on engineering standards (ISO) and performance equivalence to a legally marketed predicate device.
-
Adjudication method for the test set:
- Not applicable. The tests are objective measurements against defined standards and predicate performance, rather than subjective interpretations requiring adjudication.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. This is a physical medical device (thrombectomy system), not a diagnostic AI/ML system that would involve human readers interpreting cases.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is a physical medical device, not a software algorithm.
-
The type of ground truth used:
- The "ground truth" for the performance evaluation is based on engineering standards (ISO 10555-1, ISO 594-2) and the established performance characteristics of the predicate device. For clot capture, the "ground truth" is complete capture and removal of a simulated clot.
-
The sample size for the training set:
- Not applicable. This device does not use machine learning, so there is no training set in the sense of data used to train an algorithm.
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set.
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(27 days)
Capere Thrombectomy System
The CAPERE® Thrombectomy System is indicated for:
- Non-surgical removal of soft emboli and thrombi from blood vessels.
- Injection, infusion and/or aspiration of contrast media and other fluids into blood vessel.
The CAPERE® Thrombectomy System is intended only for use in the peripheral vasculature and is not intended for use in the pulmonary arteries.
The CAPERE® Thrombectomy System primarily consists of an 12Fr Delivery Catheter and 15Fr Guide Catheter. The CAPERE® Thrombectomy System is delivered percutaneously via transfemoral or jugular venous access. Once delivered, the System's fine mesh nitinol wire basket is used to capture and mechanically remove emboli and thrombi. The CAPERE® System does not use aspiration to pull out the thrombus but does have a side port in the funnel catheter that allows aspiration or injection of saline or fluids if needed.
The provided text describes the 510(k) premarket notification for the CAPERE® Thrombectomy System, focusing on its substantial equivalence to a predicate device (K180722). However, it does not contain a specific acceptance criteria table with reported device performance metrics in the format requested.
The document primarily discusses the nonclinical performance testing conducted to support substantial equivalence. It does not detail a clinical study with human patients for AI/device performance evaluation as implied by some of the questions (e.g., MRMC studies, standalone algorithm performance, AI improvement for human readers). The device described is a medical device for thrombectomy, not an AI/ML algorithm requiring ground truth from experts or large datasets for training and testing in the typical sense of AI product evaluation.
Based on the provided information, I can answer the following:
1. A table of acceptance criteria and the reported device performance
The document states that "the CAPERE® Thrombectomy System functioned as intended under the previously established test methods" and "demonstrated that the CAPERE® Thrombectomy System maintained the predicate characteristics." It also mentions "preestablished acceptance criteria" but without listing them explicitly or providing specific numerical results.
However, based on the descriptions of the tests, we can infer some of the implicit acceptance criteria:
| Acceptance Criteria Category | Reported Device Performance (Implicitly Met) |
|---|---|
| Biocompatibility | No differences in materials between subject and predicate device; confirmed biocompatibility. |
| Packaging | Packaging capable of maintaining a sterile barrier and protecting the device after sterilization, simulated handling/shipping, environmental conditioning, and accelerated aging for a 6-month shelf-life. |
| Functional Bench Testing | Compliance with relevant standards (ISO 10555-1 and ISO 594-2) for bond joints; maintained predicate characteristics despite reduced diameter. |
| Simulated Use Testing | Simulated clot retrieved under simulated conditions without capture basket rupture, catheter damage, or other adverse device effect; maintained predicate characteristics. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes nonclinical performance testing (bench and simulated use testing) rather than a clinical study with human patient data. Therefore, the concept of a "test set" and "data provenance" in the context of human data is not directly applicable here. The testing involved device components and simulated clots. No information is provided regarding the specific number of devices or simulated clots used for each test.
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 question is not applicable. The study described is nonclinical performance testing of a physical medical device, not an AI algorithm evaluated against expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. There was no clinical study with expert readers requiring 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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document does not describe a study involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The CAPERE® Thrombectomy System is a physical medical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the nonclinical performance tests would be defined by the engineering and quality standards for device functionality. For example:
- Biocompatibility: Confirmation against established biological safety standards.
- Packaging: Ability to maintain sterility and physical integrity as per accelerated aging and handling protocols.
- Functional Bench Testing: Compliance with ISO standards (e.g., ISO 10555-1 for sterile single-use catheters, ISO 594-2 for conical fittings) and maintenance of mechanical characteristics (e.g., bond strength, dimension).
- Simulated Use Testing: Successful retrieval of simulated clots without device failure (rupture, damage) as per predefined criteria.
8. The sample size for the training set
This question is not applicable. There is no mention of a "training set" for an AI algorithm. The studies are nonclinical performance tests of a physical device.
9. How the ground truth for the training set was established
This question is not applicable.
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(29 days)
CAPERE Thrombectomy System
The CAPERE® Thrombectomy System is indicated for:
- Non-surgical removal of soft emboli and thrombi from blood vessels.
- Injection, infusion and/or aspiration of contrast media and other fluids into blood vessel.
The CAPERE® Thrombectomy System is intended only for use in the peripheral vasculature and is not intended for use in the pulmonary arteries.
The CAPERE® Thrombectomy System primarily consists of an 8Fr Delivery Catheter and Funnel Catheter. The CAPERE® Thrombectomy System is delivered percutaneously via transfemoral or jugular venous access. Once delivered, the System's fine mesh nitinol wire basket is used to capture and mechanically remove emboli and thrombi. The CAPERE® System does not use aspiration to pull out the thrombus but does have a side port in the funnel catheter that allows aspiration or injection of saline or fluids if needed.
The provided text describes the 510(k) clearance for the CAPERE Thrombectomy System. This regulatory submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving a specific performance acceptance criteria against a medical outcome (like 'improving diagnostic accuracy'). Therefore, many of the requested categories for AI/diagnostic devices (e.g., multireader-multicase studies, expert consensus for ground truth on a training set) are not applicable to this type of device clearance.
The "acceptance criteria" in this context refer to the device meeting engineering and functional performance specifications, and demonstrating that changes from the predicate device do not introduce new safety or effectiveness concerns.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from text) | Reported Device Performance |
|---|---|
| Compliance with relevant standards (e.g., ISO 10555-1, ISO 594-2) for bond joints affected by increased length. | Demonstrated compliance; maintained predicate characteristics. |
| Simulated clot retrieval without capture basket rupture. | Functioned as intended; simulated clot retrieved without rupture. |
| Simulated clot retrieval without catheter damage. | Functioned as intended; no catheter damage. |
| Simulated clot retrieval without other adverse device effect. | Functioned as intended; no other adverse device effects. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified in terms of numerical units (e.g., N devices tested). The document states "functional bench testing was conducted" and "Simulated Use Testing was completed." It refers to "the CAPERE® Thrombectomy System" in the singular, but implies testing was performed sufficiently to make general claims. It does not provide the number of devices or iterations tested.
- Data Provenance: The tests are described as "nonclinical performance testing" and "functional bench testing" / "Simulated Use Testing." This indicates laboratory-based, simulated data, not data from human patients or a specific country of origin. The data is implicitly prospective in the sense that the tests were designed and conducted to evaluate the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not Applicable. This is not a study involving human interpretation of data where expert ground truth is established (e.g., radiology image interpretation). The "ground truth" for these tests is defined by the engineering specifications and the ability of the device to perform its mechanical functions in a simulated environment.
4. Adjudication Method for the Test Set
- Not Applicable. No human adjudication method (like 2+1, 3+1) is relevant for this type of mechanical and functional performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This is a mechanical device, not an AI/diagnostic software. MRMC studies are not relevant for its clearance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is a hardware medical device, not an algorithm. Its performance is inherent to its design and function. However, the "Simulated Use Testing" could be considered analogous to "standalone performance" in the sense that it evaluates the device's function without a human patient or a full clinical scenario, but within a simulated environment.
7. The Type of Ground Truth Used
- Engineering Specifications and Functional Performance Benchmarks: The ground truth for this device's testing is primarily based on predefined engineering and functional performance criteria. For example, "without capture basket rupture," "without catheter damage," and "maintained predicate characteristics" are the benchmarks.
8. The Sample Size for the Training Set
- Not Applicable. This device is a mechanical thrombectomy system, not an AI/machine learning algorithm that requires a "training set" in the computational sense. The device's design and manufacturing process are informed by engineering principles, not data-driven training.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI algorithm, this question is not relevant. The "ground truth" for the device's design (if you were to interpret it broadly as the basis for its creation) would be established through established medical device design principles, biomechanical understanding of fluid dynamics and clot removal, and experience with predicate devices.
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(101 days)
CAPERE Thrombectomy System
The CAPERE™ Thrombectomy System is indicated for:
· Non-surgical removal of soft emboli and thrombi from blood vessels.
- · Injection, infusion and/or aspiration of contrast media and other fluids into blood vessel.
The CAPERE™ Thrombectomy System is intended only for use in the peripheral vasculature and is not intended for use in the pulmonary arteries.
The CAPERE™ Thrombectomy System primarily consists of an 8Fr Delivery Catheter and Funnel Catheter. The CAPERE™ Thrombectomy System is delivered percutaneously via transfemoral or jugular venous access. Once delivered, the System's fine mesh nitinol wire basket is used to capture and mechanically remove emboli and thrombi. The CAPERE™ System does not use aspiration to pull out the thrombus but does have a side port in the funnel catheter that allows aspiration or injection of saline or fluids if needed.
The document provided pertains to a 510(k) premarket notification for the CAPERE Thrombectomy System, a physical medical device (embolectomy catheter), not an AI/ML medical device. Therefore, the information typically required for describing the acceptance criteria and the study proving an AI/ML device meets those criteria (such as ground truth, expert consensus, MRMC studies, training/test set details, etc.) is not present in this document.
The document describes performance data for a physical device, which includes:
- Biocompatibility testing: To ensure the materials are safe for patient contact.
- Package integrity and accelerated aging studies: To demonstrate the sterility barrier and shelf-life.
- Functional bench testing: To ensure the device performs as intended, adhering to standards like ISO 10555-1 and ISO 594-1.
- Simulated Use Testing: To show the device can retrieve simulated clots without damage or adverse effects.
- Confirmatory In vivo testing in an animal model: To confirm usability, ease of use, and interaction within the vascular system.
The acceptance criteria for these tests would be related to specific measurements (e.g., tensile strength, burst pressure, clot retrieval efficiency, absence of damage) that are typically defined in engineering specifications and test protocols for physical medical devices.
Based on the provided text, I cannot extract the specific details requested for an AI/ML device's acceptance criteria and study, as the device in question is a physical thrombectomy system.
Therefore, I cannot fill out the requested table or answer the specific questions about AI/ML device validation.
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(84 days)
CAPERE Thrombectomy System
The CAPERE™ Thrombectomy System is indicated for:
- Non-surgical removal of soft emboli and thrombi from blood vessels.
- Injection, infusion and/or aspiration of contrast media and other fluids into blood vessel.
The CAPERE™ Thrombectomy System is intended only for use in the peripheral vasculature and is not intended for use in the pulmonary arteries.
The CAPERE™ Thrombectomy System consists of a 12Fr Delivery Catheter and a 20Fr Guide Catheter. The 12Fr Delivery Catheter consists of a nitinol basket that comes in two different sizes (10 mm and 18 mm). The 20Fr Guide Catheter consists of an inner and outer guide and an inner and outer introducer. The CAPERE™ Thrombectomy System is delivered percutaneously via transfernoral or jugular venous access. Once delivered, the System's fine mesh nitinol wire basket is used to capture and mechanically remove emboli and thrombi. The CAPERE™ System does not use aspiration to extract thrombus but does have a side port in the guide catheter that allows aspiration or injection of saline or fluids if needed.
The provided text describes a medical device, the CAPERE™ Thrombectomy System, and its regulatory clearance by the FDA based on a 510(k) submission. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a full premarket approval (PMA) process that would typically involve extensive clinical trials with human subjects.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in human subjects, specifically for an AI/ML medical device. The data provided focuses on:
- Nonclinical performance testing: Biocompatibility, package integrity, accelerated aging, functional bench testing (visual inspection, dimensional testing, guidewire compatibility, catheter trackability, etc.).
- Simulated Use Testing: Demonstrating clot retrieval without device damage under simulated conditions.
- In vivo testing in an animal model: Evaluating acute and chronic performance, handling, vascular safety, and clinical outcomes compared to a predicate device.
Key reasons why the provided document cannot fulfill the request:
- No AI/ML Component: The CAPERE™ Thrombectomy System is a mechanical device (embolectomy catheter system with a nitinol basket), not an AI/ML driven device. The request specifically asks about "device meets the acceptance criteria" in the context of an AI/ML study, which is not applicable here.
- No Human Clinical Performance Study: The 510(k) submission for this device does not describe a human clinical trial to establish performance metrics like sensitivity, specificity, accuracy, or reader improvement with AI assistance. The "performance data" section refers to non-clinical and animal studies.
- No Ground Truth Generation: Since there's no human clinical performance study, there's no mention of expert consensus, pathology, or outcomes data used to establish ground truth for a test set.
- No Multi-Reader Multi-Case (MRMC) Study: This type of study is relevant for evaluating the impact of AI on human readers, which is not discussed for this mechanical device.
To directly answer your prompt based only on the provided text, I must state that the information is not present for an AI/ML device.
However, if we interpret "acceptance criteria" and "study" in the context of this 510(k) submission for a mechanical device, we can infer what constitutes "meeting the criteria" for regulatory clearance.
Here's an attempt to structure an answer, while clearly highlighting what information is not available due to the nature of the provided document:
Acceptance Criteria and Device Performance (Based on 510(k) for a Mechanical Device)
The provided document (K180722 510(k) for CAPERE™ Thrombectomy System) describes the non-clinical and animal testing conducted to demonstrate substantial equivalence to predicate devices, which served as the "acceptance criteria" for its regulatory clearance. It does not describe an AI/ML-driven device or human clinical performance studies with metrics like sensitivity, specificity, or reader improvement. Therefore, the information requested regarding AI/ML device performance (like accuracy, F1 score, MRMC study results, etc.) is not present in this document.
The "acceptance criteria" for this device were met by successfully completing a battery of non-clinical and animal tests, demonstrating that the device functions as intended and is safe and effective when compared to its predicates.
1. Table of Acceptance Criteria and Reported Device Performance (Inferred from the document for a mechanical device):
| Acceptance Criteria Category (Inferred) | Specific Tests / Performance Metrics (Reported) | Description of "Meeting Criteria" |
|---|---|---|
| Biocompatibility | ISO 10993 Compliance | Patient-contacting components established as biocompatible. |
| Packaging & Sterilization | ISO 11607-1, ASTM D4332-14, ASTM D4169-16, ASTM F88/F88M-15, ASTM F2096-11, ASTM 1980-16 | Package integrity and accelerated aging studies completed, ensuring sterility and shelf-life. |
| Functional Bench Testing | ISO 10555-1, ISO 80369 (formerly ISO 594-1) compliance, including: visual inspection, dimensional testing, guidewire compatibility, catheter trackability, radio-detectability, kink resistance, luer compatibility, force to deploy/recapture basket, leak test, tensile, corrosion resistance, flexibility, funnel deployment/recapture force, torsion, basket resistance to rupture. | "In all instances, the CAPERE™ Thrombectomy System functioned as intended." All tests passed. |
| Simulated Use Testing | Retrieval of simulated clot in simulated conditions. | Demonstrated clot retrieval without "filter rupture, catheter damage, or other adverse device effect." |
| In Vivo Performance | Animal Model Study: Evaluation of acute and chronic overall performance and handling, regional and downstream vascular safety, clinical pathologic, and overall in-life clinical outcomes compared to predicate device. | "Evaluate and establish the substantial equivalence... to the predicate device." Results supported substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set (for a mechanical device, relevant to animals/bench): The document does not specify exact "sample sizes" (e.g., number of animals, number of bench test iterations) for each test. For instance, it mentions "in vivo testing in an animal model" without detailing the number of animals.
- Data Provenance: Not explicitly stated for each test beyond "nonclinical performance testing" and "in vivo testing in an animal model." Specific country of origin or whether data was retrospective/prospective is not mentioned. Given the nature of a 510(k), these studies are typically conducted by the manufacturer as prospective engineering/animal tests.
3. Number of Experts and Qualifications for Ground Truth:
- Not applicable for a mechanical device 510(k) submission. The concept of "ground truth" established by experts (e.g., radiologists for image interpretation tasks) is primarily relevant for AI/ML devices or diagnostic accuracy studies on human data. The assessment of this mechanical device relied on engineering specifications and animal model observations.
4. Adjudication Method for the Test Set:
- Not applicable for a mechanical device 510(k) submission. Adjudication methods like 2+1 or 3+1 are used in clinical trials or reader studies where human interpretation of data is involved.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No MRMC study was done. This type of study is relevant for evaluating the impact of AI assistance on human readers, which is not applicable to this mechanical medical device.
6. Standalone (Algorithm Only) Performance:
- Not applicable. The CAPERE™ Thrombectomy System is a physical, mechanical medical device. There is no algorithm to assess independently.
7. Type of Ground Truth Used:
- For a mechanical device: The "ground truth" was established by comparing the device's performance against pre-defined engineering specifications, in vitro test protocols, and observations in an animal model, all benchmarked against the performance of predicate devices. There was no "expert consensus," "pathology," or "outcomes data" in the sense of clinical diagnoses from human subjects.
8. Sample Size for the Training Set:
- Not applicable. This is a mechanical device, not an AI/ML device that requires a training set.
9. How Ground Truth for the Training Set Was Established:
- Not applicable. This is a mechanical device, not an AI/ML device that requires a training set with established ground truth.
In summary, the provided FDA 510(k) summary (K180722) details the engineering, in vitro, and animal studies used to demonstrate substantial equivalence for a mechanical thrombectomy system. It does not contain information relevant to AI/ML device performance evaluation, human clinical studies, or associated methodologies like MRMC studies or expert-driven ground truth.
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