Search Results

PVA particles are indicated for vascular occlusion of blood vessels within the neurovascular and peripheral vascular system. They are intended for arterial embolization of arteriovenous malformations (AVMs) and hypervascular tumors in the peripheral vasculature, and for vascular occlusion of blood vessels within the neurovascular system for the embolization of AVMs and neoplastic lesions.

The subject devices are particles of nonabsorbable synthetic polyvinyl alcohol (PVA) foam. The devices do not contain any colorant or other additive, and are uncoated. Each is offered in a range of particle sizes, from which the clinician may select the particle size most appropriate for the desired effect and targeted vasculature. The devices are intended to be delivered to the selected anatomical site by means of a syringe through an infusion catheter of appropriate diameter. The devices are provided sterile, non-pyrogenic, and are intended for single use.

The provided text is a 510(k) summary for medical devices, specifically PVA Foam Embolization Particles. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical studies or establishing detailed acceptance criteria through novel testing.

Therefore, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as these are typically part of a new device approval process (like a PMA), not a 510(k) for substantial equivalence.

The key takeaway from the document is:

• There are no new performance acceptance criteria or studies described. The basis for clearance is substantial equivalence to existing predicate devices.
• The device is identical to previously cleared devices from Surgica Corporation and Protein Polymer Technologies, Inc. (K001678, K053548, K061790). The only changes are the manufacturer and distributor identification.

Given this, I cannot fill in the requested table and details about acceptance criteria and studies because they are not present in the provided text.

Ask a specific question about this device

PVA particles may be used for vascular occlusion of blood vessels within the neurovascular systems. They are intended for use in the endovascular management of arteriovenous malformations (AVM's) and neoplastic lessions when presurgical devascularization is desirable.

The subject devices are particles of nonabsorbable synthetic polyvinyl alcohol (PVA) foam. The devices do not contain any colorant or other additive, and are uncoated. Each is offered in a range of particle sizes, from which the clinician may select the particle size most appropriate for the desired effect and targeted vasculature. The devices are intended to be delivered to the selected anatomical site by means of a syringe through an infusion catheter of appropriate diameter. The devices are provided sterile, non-pyrogenic, and are intended for single use.

This submission (K073419) is for PVA PLUS™ Vial PVA Foam Embolization Particles and related convenience kits. It is a 510(k) premarket notification for a Class II medical device (neurovascular embolization device, product code HCG).

Here's an analysis of the provided text in relation to your questions:

1. A table of acceptance criteria and the reported device performance

The provided document does not contain any acceptance criteria or reported device performance metrics in the way you would typically see for an AI/algorithm-based device. This submission is for a physical medical device (PVA foam embolization particles), not a diagnostic or prognostic algorithm.

The document states:

• "5.7 Summary of Non-Clinical Tests (Not Applicable)"
• "5.8 Summary of Clinical Tests (Not Applicable)"
• "5.9 Conclusions of Non-Clinical and Clinical Tests (Not Applicable)"

This "Not Applicable" designation is crucial. It means the manufacturer did not conduct new non-clinical or clinical studies for this submission because they are claiming substantial equivalence to existing predicate devices based on the product being identical to previously cleared devices from Surgica Corporation and Protein Polymer Technologies, Inc. The only changes are the manufacturer and distributor.

Therefore, a table of acceptance criteria and device performance cannot be generated from this document because such data was not central to this particular 510(k) clearance process. The acceptance criteria were essentially met by demonstrating the new manufacturer could produce the same device as the predicate.

Regarding your other questions (2-9), these are primarily relevant to studies involving AI/ML algorithms, especially those that involve diagnostic or predictive capabilities and require evaluation against a ground truth established by experts. Since this submission is for a physical medical device and explicitly states "Not Applicable" for clinical and non-clinical tests, the information requested for AI/ML evaluation is not present and not relevant to this specific K073419 submission.

However, to directly address each point based on the absence of such information in the document:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not applicable (no test set discussed).
• Data Provenance: Not applicable (no data discussed).

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)

• Number of Experts: Not applicable (no ground truth established for a test set).
• Qualifications of Experts: Not applicable (no experts used for this purpose in this submission).

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

• Adjudication Method: Not applicable (no test set or adjudication process 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

• MRMC Study: No. This is not an AI/ML device, so such a study would not be relevant.
• Effect Size: Not applicable.

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

• Standalone Performance Study: No. This is not an AI/ML device.

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

• Type of Ground Truth: Not applicable (no ground truth established for an AI/ML evaluation).

8. The sample size for the training set

• Sample Size for Training Set: Not applicable (no training set for an AI/ML model).

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

• Ground Truth Establishment for Training Set: Not applicable (no training set or associated ground truth discussed).

In Summary:

This 510(k) submission (K073419) is a resubmission for a physical PVA foam embolization device under a new manufacturer/distributor. The substantial equivalence was established by demonstrating the device's identity to already-cleared predicate devices, rather than through new performance studies using test sets, expert ground truth, or AI/ML evaluations. Therefore, the information requested regarding acceptance criteria and study details relevant to AI/ML devices is not present in this document.

Ask a specific question about this device

PVA particles are indicated for arterial embolization of arteriovenous malformations (AVMs) and hypervascular tumors in the peripheral vasculature, and for vascular occlusion of blood vessels within the neurovascular system for the embolization of AVMs and neoplastic lesions.

The subject devices are particles of nonabsorbable synthetic polyvinyl alcohol (PVA) foam. The devices do not contain any colorant or other additive, and are uncol ted. Each is offered in a range of particle sizes, from which the clinician may saleot the particle size most appropriate for the desired effect and targeted vasculature. The devices are delivered to the selected vascular location by means of a syringe, through an infusion catheter of diameter appropriate for the selected particle size.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the PVA Foam Embolization Particles:

It's important to note that this document is a 510(k) summary for a medical device submitted to the FDA. Unlike a detailed clinical trial report for an AI-powered diagnostic device, this type of submission focuses on demonstrating substantial equivalence to predicate devices based on performance, material, and intended use, rather than setting specific acceptance criteria and proving them through a standalone efficacy study for a new, complex AI algorithm.

Therefore, many of the requested points, especially those related to AI-specific study design (like MRMC studies, training set details, or expert ground truth for AI performance), are not applicable to this type of device and submission. The "study" here refers to non-clinical tests demonstrating equivalence to existing, cleared devices.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Study Information (as derived from the 510(k) summary)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified. The submission states "Nonclinical tests, both in vitro and in vivo, have demonstrated the substantial equivalence." This implies various lab tests and potentially animal studies (in vivo), but specific sample sizes are not provided in this summary.
• Data Provenance: Not explicitly stated. Non-clinical tests are typically performed in a laboratory setting. For "in vivo" tests, this could imply animal studies, but the origin country is not mentioned. The manufacturer is Protein Polymer Technologies, Inc. (PPTI) in San Diego, California, USA, and manufacturing is by Surgica Corporation in El Dorado Hills, CA, USA, suggesting the tests were likely conducted in the US.

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

• Not Applicable. This is a medical device submission, not an AI diagnostic submission. "Ground truth" in the context of AI refers to verified labels used to evaluate algorithm performance. For a physical device, performance is typically assessed against established engineering and biological standards, or compared directly to predicate devices through physical observation and measurement, not against an expert-established "ground truth" in the AI sense.

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

• Not Applicable. Pertains to expert review for AI diagnostic performance, not physical device testing.

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 a medical device submission for physical embolization particles, not an AI device. No human-reader studies for diagnostic improvement are relevant or mentioned.

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

• Not Applicable. This is a medical device, not an AI algorithm.

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

• For the non-clinical tests, the "ground truth" would be the established performance characteristics and safety profiles of the predicate devices, against which the new device was compared using engineering measurements, laboratory assays, and potentially animal study observations. The goal was to prove the new device performed equivalently to these established benchmarks.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI algorithm requiring a "training set."

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

• Not Applicable. As above, no training set for an AI algorithm is involved.

Ask a specific question about this device

PVA particles may be used for vascular occlusion of blood vessels within the neurovascular systems. They are intended for use in the endovascular management of arteriovenous malformations (AVMs) and neoplastic lesions when presurgical devascularization is desirable.

The subject devices are particles of nonabsorbable synthetic polyvinyl alcohol (Pva) foam. The devices do not contain any colorant or other additive, and are uncoated. Each is offered in a range of particle sizes, from which the clinician may select the particle size most appropriate for the desired effect and targeted vasculature. The devices are intended to be delivered to the selected anatomical site by means of a syringe, through an infusion catheter of appropriate diameter. The devices are provided sterile, non-pyrogenic, and are intended for single-use.

This document is a 510(k) summary for Modified PVA Foam Embolization Particles. It outlines the device details, its intended use, and its comparison to predicate devices. Crucially, it states that no clinical tests were performed because the modification is limited to the packaging configuration. The submission relies entirely on non-clinical tests to establish substantial equivalence to existing predicate devices. Therefore, the questions related to clinical study design, acceptance criteria, sample sizes, expert involvement, and ground truth are largely not applicable in the context of this 510(k) submission.

Here's an analysis based on the provided text, indicating where information is present and where it is explicitly stated as "not applicable" or not provided due to the nature of the submission:

1. A table of acceptance criteria and the reported device performance

Study that proves the device meets the acceptance criteria:

The study that proves the device meets the acceptance criteria is a non-clinical testing program focused on the aspects affected by the packaging change, namely sterility and shelf life. For all other aspects (material, configuration, manufacturing, biocompatibility, indications, method of use), the device is deemed substantially equivalent to the predicate devices because these characteristics are unchanged.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified in the provided text for sterility and shelf-life testing.
• Data Provenance: Not specified for the non-clinical 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)

Not applicable, as this was not a clinical study involving ground truth established by medical experts. The non-clinical tests would have involved laboratory personnel and validated testing methods.

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

Not applicable, as this was not a clinical study requiring adjudication of expert opinions.

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 an embolization particle, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

Not applicable. This device is an embolization particle, not an algorithm.

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

For the non-clinical tests (sterility, shelf life), the "ground truth" would be established by validated laboratory testing methods and standards (e.g., ISO, ASTM). For the unchanged aspects of the device, the "ground truth" is that they are identical to the predicate devices, which were previously cleared by the FDA based on their own testing or substantial equivalence.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm requiring a training set.

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

Not applicable. This device is not an AI algorithm.

Ask a specific question about this device

The Surgica Corporation MicroStat™ PVA Foam Embolization Particles are intended for the following indication: PVA particles may be used for vascular occlusion of blood vessels within the neurovascular systems. They are intended for use in the endovascular management of arteriovenous malformations (AVMs) and neoplastic lesions when presurgical devascularization is desirable.

Surgica Corporation MicroStat™ Polyvinyl Alcohol (PVA) foam cmbolization particles are artificial embolization devices used to obstruct or reduce the blood flow to hypervascular or neoplastic lesions via superselective catheter delivery. The embolization particles are supplied in various size ranges to enable appropriate size selection for the lesion to be treated. Polyviny) Alcohol (PVA) foam embolization particles are designed to be delivered under fluoroscopic guidance through compatible infusion catheters. The product is delivered sterilized with radiation, is nonpyrogenic, and is for single use only.

The provided document is a 510(k) summary for the Surgica Corporation MicroStat™ Polyvinyl Alcohol (PVA) Foam Embolization Particles. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical studies with specific acceptance criteria or performance metrics in the way AI/ML devices might.

Therefore, the document explicitly states: "Clinical Tests: None". This means there was no study conducted in the typical sense for this submission to "prove the device meets acceptance criteria." Instead, the acceptance is based on demonstrating similarity to an already approved device.

Given this, a direct answer to your request regarding acceptance criteria and a study to prove they are met cannot be fully provided from the given document as it would for a performance-based medical device claim. However, I can infer and frame the information within the constructs you've provided, addressing the aspects that are relevant and noting where information is not available due to the nature of the submission.

Here's a breakdown based on your requested information, making clear what is present and what is absent:

Acceptance Criteria and Device Performance (Derived from Equivalence):

As no clinical tests were performed, there are no specific quantitative "acceptance criteria" and "reported device performance" in terms of clinical outcomes or diagnostic accuracy from a study described in this document. The "acceptance" for this 510(k) relies on demonstrating substantial equivalence to the predicate device.

Study Information (Based on the provided document):

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not Applicable. No clinical test set or study was conducted for this 510(k) submission. Therefore, there's no data provenance information.

2. 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):

   • Not Applicable. No ground truth establishment was described as no clinical study was performed. The ground truth for the predicate device's approval would have been established at that time, but not for this specific 510(k).

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

   • Not Applicable. No test set or study, hence no adjudication method.

4. 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 physical medical implant (PVA foam embolization particles), not an AI/ML diagnostic or assistive device. Therefore, no MRMC study or AI assistance is relevant.

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

   • Not Applicable. This is not an algorithm or software device.

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

   • Not Applicable (for this submission). For the approval of this device, the "ground truth" was essentially the established safety and effectiveness of the predicate device (EMB™ PVA Foam Embolization Particle devices, K001678) demonstrated through its previous approval.

7. The sample size for the training set:

   • Not Applicable. No AI/ML model or training set is involved.

8. How the ground truth for the training set was established:

   • Not Applicable. No AI/ML model or training set is involved.

Summary of the K032619 Submission:

The approval of the Surgica Corporation MicroStat™ Polyvinyl Alcohol Fourn Embolizaion Particles (K032619) was based on demonstrating substantial equivalence to an existing predicate device (EMB™ PVA Foam Embolization Particle devices, K001678). This means the new device shares similar basic design, construction, intended use, and performance characteristics with the predicate. Because of this, no new clinical studies or tests were required or performed to establish "acceptance criteria" or "device performance" for this specific submission. The safety and effectiveness are inferred from the predicate's prior approval.

Ask a specific question about this device

The Surgica Corporation MaxiStat™ PVA Foam Embolization Particles are intended for the following indication: PVA particles may be used for vascular occlusion of blood vessels within the neurovascular systems. They are intended for use in the endovascular management of arteriovenous malformations (AVMs) and neoplastic lesions when presurgical devascularization is desirable.

Surgica Corporation MaxiStat™ Polyvinyl Alcohol (PVA) foam embolization particles are artificial embolization devices used to obstruct or reduce the blood flow to hypervascular or neoplastic lesions via superselective catheter delivery. The embolization particles are supplied in various size ranges to enable appropriate size selection for the lesion to be treated. Polyvinyl Alcohol (PVA) foam embolization particles are designed to be delivered under fluoroscopic guidance through compatible infusion catheters. The product is delivered sterilized with radiation, is nonpyrogenic, and is for single use only.

The provided text is a 510(k) summary for the Surgica Corporation MaxiStat™ Polyvinyl Alcohol Foam Embolization Particles. It explicitly states:

"Clinical Tests: None"

This means that no clinical studies were performed to establish acceptance criteria or to demonstrate that the device meets those criteria. The submission relies on substantial equivalence to a predicate device. Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets them because such a study was not conducted as part of this 510(k) submission.

Ask a specific question about this device

Ask a specific question about this device