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510(k) Data Aggregation
(261 days)
OpenTex is a temporarily implantable material (non-resorbable) for as a space-making barrier in the treatment of periodontal defects.
OpenTex is a non-resorbable PTFE membrane composed of proprietary 100% polytetrafluoroethylene (PTFE) sheet with inert biological features and predictable barrier effect. OpenTex is designed to function as a physical barrier to avoid gingival cell invasion, thus providing a favorable environment for neovascularization and bone derived cells to repopulate and repair the defect. Since space-making is critical to this procedure, the membrane is sufficiently stiff to prevent spontaneous collapse but supple enough to conform easily to tissue contours. OpenTex is supplied sterile and intended for single use only. It is available in various sizes.
This is a 510(k) summary for a medical device called OpenTex, a non-resorbable PTFE membrane for guided tissue regeneration in periodontal defects. The information provided is for regulatory clearance and does not involve AI or algorithms with human-in-the-loop performance. Therefore, many of the requested fields are not applicable.
Here's an analysis of the provided text based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Test Method | Acceptance Criteria | Reported Device Performance (OpenTex) | Predicate Device Performance (Salvin CytoSurg™) | Remarks |
|---|---|---|---|---|---|
| pH | pH measurement test | Difference between blank and extracts < 1.5 | 6.23 (pH) | 6.21 (pH) | Results met criteria and were comparable. |
| Dissolution / Solubility | Evaporation residue test | Evaporation residue of extraction liquid $\leq$ 1.0 mg | 0 mg | 0 mg | Results met criteria and were comparable. |
| Tensile Strength | ASTM D882 | $\geq$ 34 MPa (Internal) | 72.1524 MPa | 33.8444 MPa | Met criteria and was higher than predicate. |
| Tear Resistance | ISO 6383-1 | $\geq$ 1.5 kgf/mm (Internal) | 5.9254 kgf/mm | 1.288 kgf/mm | Met criteria and was higher than predicate. |
| Suture Retention Strength | ANSI/AAMI/ISO 7198 | Equivalent to result of predicate device. (There isn't a numerical criterion, but rather a comparative one.) | 1.083 MPa | 0.842 MPa | Higher than predicate device. |
| Biocompatibility | ISO 10993 series | Compliance with ISO 10993-1, -3, -5, -6, -10, -11 | Evaluated and presumably met | Not explicitly stated; assumed compliant as predicate. | Evaluated for Cytotoxicity, Irritation, Sensitization, Genotoxicity, Acute Toxicity, Subacute Toxicity, Implantation, Material mediated pyrogenicity. |
| Sterilization | ISO 11135 | Sterility Assurance Level (SAL) of 10^-6 | SAL of 10^-6 | SAL of 10^-6 | Demonstrated compliance with standard. |
2. Sample size used for the test set and the data provenance
The document describes non-clinical bench testing comparing the physical and chemical properties of OpenTex to its predicate device. This type of testing typically uses a small number of samples (often 3-5 per test) to evaluate material properties under controlled laboratory conditions, rather than a "test set" in the context of AI or clinical trials. The specific sample sizes for each test are not explicitly provided in the document.
The data provenance is from laboratory testing performed by the manufacturer, Purgo Biologics Inc. The country of origin for the data is implicitly South Korea, where the company is located. The data is non-clinical performance data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the document describes bench testing of physical and chemical properties, not a clinical study involving human reads or expert ground truth establishment for diagnostic purposes. The "ground truth" here is the adherence to established international standards and internal criteria for material performance.
4. Adjudication method for the test set
This question is not applicable as there is no clinical test set requiring adjudication by experts.
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 question is not applicable. The device is a physical bone grafting material (membrane), not an AI-assisted diagnostic or therapeutic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical medical device, not an algorithm.
7. The type of ground truth used
The "ground truth" for the performance tests is based on established international standards (e.g., ASTM D882, ISO 6383-1, ANSI/AAMI/ISO 7198, ISO 10993 series, ISO 11135) and internal criteria set by the manufacturer to demonstrate substantial equivalence to the predicate device.
8. The sample size for the training set
This question is not applicable. There is no "training set" as this is a physical medical device for which performance is evaluated through non-clinical testing, not a machine learning model.
9. How the ground truth for the training set was established
This question is not applicable for the same reasons as #8.
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(49 days)
A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects.
A temporarily implantable material (non-resorbable) for use as a spacemaking barrier in the treatment of periodontal bone defects.
The Cytoplast™ Regentex Titanium 250 Non-Absorbable Barrier Membrane is composed of nanoporous high density polytetrafluoroethylene (n-PTFE) film reinforced with a titanium framework. The membrane has a nominal thickness of 250 microns. Membranes are supplied sterile in sealed pouches in a variety of shapes and sizes.
The biocompatibility of polytetrafluoroethylene (PTFE) and titanium has been established through a long history of use in a variety of implant devices. No additional biocompatibility testing has been conducted with this device.
Here's an analysis of the provided text regarding the Cytoplast Regentex Titanium 250 Non-Absorbable Barrier Membrane, presented in the requested format. It's important to note that the provided 510(k) summary focuses heavily on substantial equivalence to predicate devices rather than detailed performance studies with specific acceptance criteria and outcome data. Therefore, many sections will indicate "Not Applicable" or that the information is "Not provided in the document."
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Biocompatibility | Established through a long history of use of polytetrafluoroethylene (PTFE) and titanium in a variety of implant devices. |
| Effectiveness: Ability to function as a space-making barrier in the treatment of periodontal defects. | Concluded to be "safe and effective for its intended use and performs at least as well as the legally marketed predicate devices" based on substantial equivalence. Specifically, it is "identical in composition, function, and intended use to legally marketed predicate devices such as Gore-Tex™ Regenerative Material." |
| Performance compared to predicate devices. | "Performs at least as well as the legally marketed predicate devices." |
2. Sample size used for the test set and the data provenance
Not provided in the document. The submission relies on substantial equivalence to predicate devices, rather than a new performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no new performance study with a test set requiring expert ground truth establishment is described. The device's safety and effectiveness are established through comparison to predicate devices, whose performance would have been established previously.
4. Adjudication method 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. This device is a barrier membrane, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a barrier membrane, not an algorithm.
7. The type of ground truth used
Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices based on their prior regulatory approvals and clinical use. No new ground truth for a novel device performance study is described.
8. The sample size for the training set
Not applicable. The submission does not describe a training set as it is not an AI/ML device or a device requiring a specific training regimen for its function.
9. How the ground truth for the training set was established
Not applicable.
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