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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.

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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.

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The MDSA is an intraoral device (mandibular repositioning) for the treatment of snoring and sleep apnea. The device is worn during sleep with the intention to reduce the incidence of snoring and obstructive sleep apnea.

Prescription Device
Custom-Made
Mandibular Repositioning Device
Reduce Snoring
Treat Mild to Moderate Obstructive Sleep Apnea
Single Patient / Multi-Use
Not for Use in Persons Younger than 18 Years of Age
Home or Sleep Laboratory Environment

The MDSA is an intraoral dental device for the treatment of snoring and sleep apnea. The MDSA is worn during sleep with the intention to reduce the incidence of snoring and obstructive sleep apnea.

The MDSA is a prescription Custom Made titratable mandibular repositioning device for the dental treatment of patients suffering snoring and obstructive sleep apnea.

Patient's dental impressions must be used to construct the device. The MDSA is a 2-part device. With an upper containing the hook component in the front that when in the patient's mouth engages a shelf in the lower.

The MDSA is supplied with an Adjuster Key, which is used to move the hook in the upper to advance the lower jaw forward and accordingly advance the mandible and tongue thereby improving patency of the airway, decrease air turbulence and aid improvement of obstructive sleep apnea.

The MDSA can be molded with commonly available materials used by Dental Laboratories either Hard Acrylic and ball clasps or Double Laminate (Hard /Soft) Functional mouthguard materials for the construction of the device.

A Bite Registration taken at the same time as the impressions facilitates the Laboratory technician correctly locating the components during construction.

Because of its unique design when incitu the patient has full lateral movement and the device can be titrated to the individual patients needs.

The advantage of the MDSA is that its construction can be easily performed by a normally qualified Laboratory Technician using standard Laboratory Equipment. This affords a saving in costs to the end user.

The MDSA components are made from Medical Grade 316 Stainless Steel. The Hook/Screw component is welded into its outer housing to ensure security during use.

The provided text is a 510(k) summary for the MDSA (Anti-Snoring / Sleep Apnea Device). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical study results with specific acceptance criteria and performance metrics typically found in a clinical trial report or a more extensive PMA submission.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the way a clinical study report would.

Specifically, the document lacks:

1. A table of acceptance criteria and reported device performance: There are no quantitative performance metrics (e.g., reduction in AHI, snore reduction percentages, or specific comfort scores) and no pre-defined acceptance criteria for these metrics.
2. Sample size used for the test set and data provenance: No test set is mentioned, nor any details about its size, country of origin, or retrospective/prospective nature.
3. Number of experts and their qualifications for ground truth: No experts are mentioned in the context of establishing ground truth for a test set.
4. Adjudication method: Not applicable as no ground truth is being established by experts.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned. The device is a physical intraoral device, not an AI-assisted diagnostic tool for human readers.
6. Standalone (algorithm only) performance: Not applicable as this is a physical medical device.
7. Type of ground truth used: Not discussed, as no specific performance outcomes are being evaluated against a ground truth in this document.
8. Sample size for the training set: Not applicable as this is a physical medical device, not a machine learning model.
9. How ground truth for the training set was established: Not applicable.

What the document does provide is:

• Device Description: An intraoral dental device for the treatment of snoring and sleep apnea, worn during sleep, custom-made, titratable mandibular repositioning device.
• Intended Use: To reduce the incidence of snoring and obstructive sleep apnea.
• Technological Characteristics Summary: Compares the MDSA to a predicate device (TAP, K962516), highlighting similarities (indications for use, single patient, multi-use, prescription, non-sterile, custom fabricated, adjustable, environment, components, materials, removable) and minor differences (adjuster key vs. winder, hook/shelf mechanism vs. lingual bar).
• Substantial Equivalence: The FDA determined the device is substantially equivalent to legally marketed predicate devices, which means it is as safe and effective as a legally marketed device. This determination is based on the comparison of technological characteristics as outlined.

In conclusion, this 510(k) summary is a regulatory document to establish "substantial equivalence" of a new device to an existing one, not a clinical study report detailing performance against specific acceptance criteria.

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