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Delivery of restorative and impression material.

The PermaRidge syringe is a device used for the delivery of restorative and impression material. It is composed of a plastic barrel, polypropylene plunger, and rubber plunger tip.

This 510(k) summary for K962838 concerns a medical device (syringe) and not an AI/ML-driven diagnostic or assistive technology. Therefore, the requested information regarding acceptance criteria, study design, expert involvement, ground truth, and AI performance metrics is not applicable to this submission.

The 510(k) summary provided describes a simple physical device called the "PermaRidge syringe" intending to deliver restorative and impression material. The evaluation for such a device typically focuses on:

• Material biocompatibility: Ensuring the materials used are safe for patient contact.
• Sterilization efficacy: Verifying the device can be effectively sterilized without compromising its integrity.
• Functional performance: Confirming the syringe can reliably deliver the intended materials without leakage, premature discharge, or other mechanical failures.
• Comparability to predicate devices: Demonstrating that the new device is substantially equivalent to legally marketed predicate devices, meaning it does not raise new questions of safety or effectiveness.

The document states, "Comparison of Product Characteristics: 6, The PermaRidge syringe consists of a plastic (cellulose acetate propionate) barrel, polypropylene plunger, and rubber plunger tip." This suggests the primary mechanism for demonstrating safety and effectiveness was likely a comparison of materials and design to existing, approved syringes (predicate devices).

Therefore, it is impossible to provide the requested information in the format of an AI/ML study because this document describes a conventional medical device, not an AI/ML system.

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Delivery of restorative and impression material.

The OsteoGraf stainless steel syringe is a device used for the delivery of restorative and impression material. It is composed of a stainless steel barrel, polypropylene plunger, and rubber plunger tip.

The provided text is a 510(k) summary for a medical device: "OsteoGraf stainless steel syringe." This document describes the device, its intended use, and compares it to predicate devices.

However, the text does not contain any information about:

1. Acceptance criteria or reported device performance for clinical or diagnostic efficacy. This device is a syringe for delivering restorative and impression material, implying its performance would be related to material delivery consistency, sterility, biocompatibility, and mechanical integrity, not diagnostic accuracy.
2. Study design, sample sizes (test or training sets), data provenance, expert qualifications, adjudication methods, or ground truth establishment. These elements are typically found in clinical studies or performance validation reports for devices that make diagnostic or prognostic claims. A syringe is a delivery tool, not a diagnostic one.
3. MRMC comparative effectiveness studies or standalone algorithm performance. These are relevant for AI/ML-driven diagnostic devices, which this syringe clearly is not.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and the study proving the device meets them based on the provided text. The K962786 document is a regulatory submission focused on demonstrating substantial equivalence for a non-diagnostic device, not a performance study as you've outlined.

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The intended use of OsteoGraf/N-300 is for the filling of periodontal defects and augmentation of bony defects of the alveolar ridge, including tooth extraction sites.

OsteoGraf/N-300 is a natural, high purity, radiopaque, polycrystalline form of hydroxylapatite, the major mineral phase of bone and dental enamel. It is manufactured as anorganic, rounded, irregular shaped bovine derived hydroxylapatite particles, sized at 250-420 microns.

This document, K960348, is a 510(k) summary for a medical device (OsteoGraf/N-300 Hydroxylapatite) from 1996. It describes the device's characteristics, intended use, and comparison to a predicate device.

Crucially, this document is a pre-market notification (510(k) summary) from 1996 describing the device and its conformity to a standard. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or adjudication methods in the context of an AI/ML device as requested in the prompt.

Therefore, I cannot provide the requested information because the provided text does not contain any information regarding the evaluation of an AI-powered device. The device described, OsteoGraf/N-300 Hydroxylapatite, is a physical implant, not a software or AI-based diagnostic tool.

Therefore, all fields in your requested table will be marked as "Not Applicable" or "Information Not Provided in Document".

Here's a breakdown of why each section cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: The document only states the device conforms to the requirements of ASTM standard #F1581. It does not provide specific acceptance criteria or performance metrics in a table format for diagnostic accuracy, sensitivity, specificity, etc., which would be relevant for an AI device.
2. Sample size used for the test set and the data provenance: Not applicable, as this is not an AI device being tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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for the filling of periodontal defects and augmentation of bony defects of the alveolar ridge, including tooth extraction sites.

OsteoGraf/LD-300 is a high purity, radiopaque, polycrystalline form of hydroxylapatite, the major mineral phase of bone and dental enamel. It is manufactured as rounded, irregular shaped synthetic hydroxylapatite particles, sized at 250-420 microns.

The provided text describes a medical device called OsteoGraf/LD-300, a hydroxylapatite material intended for bone filling and augmentation. However, the document is a 510(k) summary from 1996 for premarket notification, which focuses on device description, intended use, and comparison to predicate devices to establish substantial equivalence.

Crucially, this document does not contain information about acceptance criteria for device performance in a clinical study, nor does it describe a study proving the device meets such criteria in terms of diagnostic or clinical efficacy.

Instead, the document focuses on:

• Material composition: "100% anorganic hydroxylapatite, Ca1o(PO4),OH2."
• Material properties: "X-ray diffraction and infrared analysis (FTIR) show OsteoGraf/LD-300 to be 100% hydroxylapatite."
• Compliance with standards: "OsteoGraf/LD-300 conforms to the requirements of ASTM standard #F1185, 'Composition of Ceramic Hydroxylapatite for Surgical Implants.'"
• Physical form: "manufactured as rounded, irregular shaped synthetic hydroxylapatite particles, sized at 250-420 microns."

These are specifications and characterizations of the material itself, not performance metrics derived from a clinical efficacy study with acceptance criteria.

Therefore, I cannot provide the requested information for acceptance criteria and study details because the provided text does not contain them. The 510(k) summary is for a material device, not a diagnostic or AI device that would typically have acceptance criteria related to accuracy, sensitivity, or specificity in a performance study with a test set, ground truth, and expert adjudication.

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Bone filling and/or augmentation of the alveolar ridge.

PermaMesh-D is a synthetic form of hydroxylapatite, the major mineral component of tooth enamel and bone, produced in the form of a woven sheet. It is manufactured as high purity, radiopaque, rounded particles sized at 1000 microns diameter and organized into a flat, flexible clothlike form by means of absorbable suture.

I am sorry, but the provided text is a 510(k) summary for a medical device (PermaMesh-D Hydroxylapatite Matrix) and does not contain any information about acceptance criteria, device performance studies, or efficacy data as it relates to software or AI algorithms.

The document describes the device's characteristics, intended use, and comparison to predicate devices, focusing on its material composition and physical form. It does not touch upon any computational, diagnostic, or interpretive performance.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the necessary information is not present in the provided input.

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Facial (malar) restoration and augmentation

PermaMesh-D is a synthetic form of hydroxylapatite, the major mineral component of tooth enamel and bone, produced in the form of a woven sheet. It is manufactured as high purity, radiopaque, rounded particles sized at 1000 microns diameter and organized into a flat, flexible clothlike form by means of absorbable suture.

The provided text describes a medical device (PermaMesh-D Hydroxylapatite Matrix) and its intended use, but it does not contain information about acceptance criteria, device performance studies, or AI/software components.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, as the necessary information is absent from the input.

The document is a 510(k) summary from 1996 for a physical implant, not a software or AI-powered diagnostic/analysis device. The questions in your prompt are geared towards evaluating AI/machine learning medical devices.

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Facial restoration and augmentation.

PermaMesh is a synthetic form of hydroxylapatite, the major mineral component of tooth enamel and bone, produced in the form of a woven sheet. It is manufactured as high purity, radiopaque, rounded particles sized at 1000 microns diameter and organized into a flat, flexible clothlike form by means of absorbable suture.

This document is a 510(k) summary for a medical device called "PermaMesh Hydroxylapatite Matrix," submitted in 1996. It describes the device, its intended use, and compares it to predicate devices.

However, the provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria. The document focuses on the physical characteristics and composition of the device, its classification, and comparison to existing products. It does not mention any performance metrics, clinical trials, or validation studies in the context of effectiveness or safety in a patient population.

Therefore, I cannot fulfill your request for the tables and details regarding acceptance criteria and study design based on the input text. The information required for those points (performance data, sample sizes, expert involvement, ground truth methods, MRMC studies, standalone performance, training set details) is entirely absent from this 510(k) summary excerpt.

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Facial restoration and augmentation.

PermaRidge is a synthetic form of hydroxylapatite, the major mineral component of tooth enamel and bone, produced in the form of a woven sheet. It is manufactured as high purity, radiopaque, rounded particles sized at 1000 microns diameter and organized into a flat, flexible clothlike form by means of absorbable suture.

This document is a 510(k) summary for a medical device called "PermaRidge Hydroxylapatite Matrix". It is a pre-market notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) summary focuses on:

• Device Identification: Submitter, device name (PermaRidge Hydroxylapatite Matrix, 1000 microns), classification name (Chin implant).
• Predicate Device: MEDPOR® Surgical Implant OsteoGraf/D-700.
• Device Description: Synthetic hydroxylapatite in the form of a woven sheet with rounded particles (1000 microns diameter) organized by absorbable suture. It's radiopaque.
• Intended Use: Facial restoration and augmentation.
• Comparison of Product Characteristics: States PermaRidge is 100% synthetic hydroxylapatite beads on absorbable suture, shows 100% HA by X-ray diffraction, and conforms to ASTM Standard # F1185 for trace elements and Ca:P ratio.

Therefore, I cannot provide the requested table or answer the questions related to studies, sample sizes, ground truth, or expert involvement because this information is not present in the provided 510(k) summary.

In regulatory submissions like 510(k)s, "acceptance criteria" and "device performance" usually refer to the results of non-clinical (e.g., sterilization validation, biocompatibility, mechanical testing) or clinical (if applicable and necessary for substantial equivalence) studies that demonstrate safety and effectiveness. The provided text only describes the composition of the device and its compliance with an ASTM standard for material composition, not performance data from a specific study.

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