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510(k) Data Aggregation
(364 days)
Aftamed® Mouthwash provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologics, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, ill-fitting dentures or oral surgery.
Aftamed™ Gel provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologics, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, ill-fitting dentures or oral surgery.
Aftamed® Spray provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations for relief of tallering to the ordination of the many film ulcers caused by braces, ill-litting dentures or oral surgery
Aftamed® Shield provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various etiologies, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, ill-fitting dentures or oral surgery.
Aftamed® Junior Gel provides temporary pain relief by adhering to the oral mucosa and forming a protective film over lesions and irritations due to various ctiologics, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, or oral surgery.
Aftamed® Mouthwash adheres to oral mucosa and forms a protective film over lesions and irritations due to various etiologies, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, illfitting dentures or oral surgery. The viscosity and adherence properties of the constituents of the device allow the device to form the protective film which protects the lesions for external insult.
Aftamed® Gel adheres to oral mucosa and forms a protective film over lesions and irritations due to various etiologies, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, illfitting dentures or oral surgery. The viscosity and adherence properties of the constituents of the device allow the device to form the protective film which protects the lesions for external insult.
Aftamed® Spray adheres to oral mucosa and forms a protective film over lesions and irritations due to various etiologies, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, illfitting dentures or oral surgery. The viscosity and adherence properties of the constituents of the device allow the device to form the protective film which protects the lesions for external insult.
Aftamed® Shield adheres to oral mucosa and forms a protective film over lesions and irritations due to various etiologies, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, illfitting dentures or oral surgery. The viscosity and adherence properties of the constituents of the device allow the device to form the protective film which protects the lesions for external insult.
A flamed® Junior Gel adheres to oral mucosa and forms a protective film over lesions and irritations due to various etiologies, including: aphthous ulcers caused by disease; traumatic ulcers caused by braces, illfitting dentures or oral surgery. The viscosity and adherence properties of the constituents of the device allow the device to form the protective film which protects the lesions for external insult.
The provided document is a 510(k) summary for several Aftamed® products (Mouthwash, Gel, Spray, Shield, and Junior Gel). The purpose of this document is to demonstrate "substantial equivalence" to predicate devices, not to establish performance criteria for a novel device. Therefore, it does not contain the acceptance criteria or a study proving device performance in the manner typically expected for AI/ML devices or diagnostic tools.
Instead, the document focuses on demonstrating that the Aftamed® products are as safe and effective as their respective predicate devices (Gengigel products) by showing identical indications for use, similar ingredients and specifications, and comparable biocompatibility and physical testing results.
Here's an analysis based on the information provided, specifically addressing your points where data is available or noting its absence:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy) like one would see for a diagnostic device. Instead, the acceptance criteria are implicitly that the Aftamed products perform comparably to their predicate devices in terms of safety (biocompatibility) and physical characteristics relevant to their function (adhesion, protective film formation).
The "reported device performance" is presented as the results of non-clinical (biocompatibility) and physical testing.
| Test Category | Acceptance Criteria (Implicit) | Reported Device Performance (Aftamed® Mouthwash, Gel, Spray, Junior Gel) | Reported Device Performance (Aftamed® Shield) |
|---|---|---|---|
| Biocompatibility | Should not be significantly irritating, cytotoxic, or sensitizing. Comparable to predicate device. | - Irritation: Minimal irritant (Mouthwash, Gel); Non-irritant (Spray); Minimal irritant reaction (Junior Gel) | - Irritation (In Vitro EpiGingival™ Tissue Model): Mild/non-irritant |
| - Cytotoxicity: Wholly devoid of cytotoxic/irritant effects on primary human fibroblasts (Mouthwash, Gel); Did not cause cytotoxic effects at all tested concentrations on fibroblasts (Spray); Did not show significant cytotoxic effects on fibroblasts (Junior Gel) | - Cytotoxicity (ISO 10993-5): Did not show significant cytotoxic effects on fibroblasts | ||
| - Sensitization: Does not show significant cytotoxic effects on fibroblasts as a whole (Mouthwash - note: described as cytotoxicity result); Not sensitizing (Gel, Spray, Junior Gel) | - Sensitization (In Vitro THP-1 cell line): Is not considered as a suspect allergen | ||
| - Protective Effect (In vitro, on oral epithelium): Shows epithelium barrier protective and repairing activity following surfactant-induced irritating stress | |||
| Physical Testing | Maintain consistent physical characteristics (organoleptic, viscosity, pH, density, weight, microbe count). Comparable to predicate device. | - Organoleptic characteristics inspected | - Organoleptic characteristics inspected |
| - Viscosity measured | - Viscosity measured | ||
| - pH measured | - pH measured | ||
| - Density measured | - Density measured | ||
| - Mean weight of package contents measured | - Mean weight of package contents measured | ||
| - Microbe count performed | - Microbe count performed |
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: The document does not specify the sample size for the non-clinical or physical tests. For example, it doesn't state how many human subjects were involved in the Human Skin Irritation Test or how many biological samples were used for cytotoxicity evaluations.
- Data Provenance: The document does not explicitly state the country of origin or whether the studies were retrospective or prospective. The applicant, BIOPLAX Limited, is based in London, UK, but the tests themselves could have been conducted elsewhere.
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 type of information is not applicable to this submission. The "ground truth" here is objective scientific measurement for biocompatibility and physical properties, not expert consensus on medical image interpretation or clinical diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This type of information is not applicable to this submission as it pertains to expert review in clinical studies or image interpretation, not laboratory testing for material properties.
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 type of information is not applicable because the device is a medical product for temporary pain relief from oral lesions, not a diagnostic imaging device or an AI/ML-assisted tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This type of information is not applicable for the same reason as point 5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests (biocompatibility) would be defined by the standardized methodologies of the ISO 10993 series, which outline acceptable levels of biological response (e.g., cell viability for cytotoxicity, skin reaction for irritation). For physical testing, the ground truth is based on engineering and chemical standards for measuring properties like viscosity, pH, and density.
8. The sample size for the training set
This type of information is not applicable. This submission is for a traditional medical device (hydrogel products), not an AI/ML device that requires training data.
9. How the ground truth for the training set was established
This type of information is not applicable for the same reason as point 8.
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(94 days)
The AFT™ Greater Tuberosity Cannulated Screws are intended for fracture fixation of long bones and long bone fragments.
The AFT™ Greater Tuberosity Fracture Plate is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
The AFT™ Greater Tuberosity Fracture System (AFT-GTF) consists of anatomically shaped plates which are fixated with 3.5mm or 4.5mm locking screws and 4.5mm diameter non-locking screws. 4.5mm Cannulated screws are provided to be used with or without 10mm washers. The anatomic plate contains multiple holes to allow for suturing. It is available in left and right configurations. The fasteners are available in various lengths. All components are manufactured from Ti-6Al-4V (ASTM F136). The components are provided non-sterile for singleuse.
The provided text is a 510(k) summary for the "AFT™ Greater Tuberosity Fracture System," which is a cannulated bone screw and plate system. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a study on device performance against specific acceptance criteria.
Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), and training set information is not present in the provided 510(k) summary.
Instead, the document states:
- Acceptance Criteria/Performance: Not explicitly defined or measured with a study detailed in the way requested. The core of the submission is demonstrating "geometric equivalence and engineering rationale" and "substantial equivalence" to predicate devices.
- Study Data Summary: "Geometric equivalence and engineering rationale is provided to demonstrate substantial equivalence." This refers to comparative analysis of design, materials, and intended use against existing, approved devices, not a clinical performance study with defined acceptance criteria and statistical outcomes.
In summary, the provided document does not contain the information required to populate the requested table and answer the specific study-related questions. It's a regulatory submission demonstrating equivalence, not a clinical trial report.
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(117 days)
The AFT™ Proximal Humerus Fracture Plate is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
The AFT™ Proximal Humerus Fracture Plate is a low-profile, anatomically shaped plate which matches the natural contour of the proximal humerus. The plate is available in 'long' and 'short' configurations with left and right options. The plate contains holes for 3.5mm locking and nonlocking screws and 4.5mm partially threaded screws. The screws are available in various lengths. Both the plates and the screws are manufactured from Ti-6Al-4V (ASTM F136). The components are provided non-sterile for single-use.
K121672 is a 510(k) premarket notification for a medical device, not an AI/ML device. Therefore, the questions regarding AI/ML device performance, such as sample size for test sets, number of experts, adjudication methods, multi-reader multi-case studies, standalone performance, and training set information, are not applicable.
Here's a breakdown of the available information relevant to this device's acceptance criteria and studies:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance (demonstrate substantial equivalence to predicate devices in terms of mechanical strength and durability applicable for its intended use) | Static and Dynamic Bending Testing per ASTM F382-99: The device underwent static and dynamic bending testing according to ASTM F382-99. This standard typically defines the methods for mechanical testing of metallic bone plates. The purpose of this testing is to ensure the device can withstand the forces it will encounter in the body without failure, thereby demonstrating that its mechanical properties are comparable to or better than predicate devices. The submission states that this testing was performed "to demonstrate substantial equivalence," implying the results met the performance characteristics of the predicate devices. |
| Material Biocompatibility (use of biocompatible materials suitable for implantation) | Manufactured from Ti-6Al-4V (ASTM F136): The plates and screws are manufactured from Ti-6Al-4V, which is a widely accepted and biocompatible medical-grade titanium alloy with established use in orthopedic implants. ASTM F136 is the standard specification for wrought titanium-6aluminum-4vanadium alloy for surgical implant applications. |
| Design and Indications for Use (similar design and intended use as predicate devices) | Low-profile, anatomically shaped plate: The device is designed to match the natural contour of the proximal humerus, available in 'long' and 'short' configurations with left and right options. It accepts 3.5mm locking and non-locking screws and 4.5mm partially threaded screws. This design is consistent with similar humeral fracture plates on the market. Indications for Use: "The AFT™ Proximal Humerus Fracture Plate is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone." This indication is explicitly stated to be the "same as" the predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable. This is a hardware device (bone plate), and the "test set" refers to mechanical testing of the device itself, not patient data in the context of an AI/ML study. The 510(k) summary does not specify the number of devices tested, but the standard ASTM F382-99 would dictate the number of samples required for static and dynamic testing. Data provenance for such mechanical testing typically pertains to the testing laboratory and its adherence to standards, not patient data.
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. Ground truth in the context of expert review for medical imaging or clinical outcome is not relevant for this type of mechanical device submission. The "ground truth" for mechanical testing is established by the ASTM F382-99 standard and the physical properties observed in controlled laboratory conditions.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are used to resolve discrepancies in expert opinions on ground truth, which is not relevant for mechanical testing of a hardware device.
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 bone plate, so it does not involve human readers, AI, or MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a bone plate and does not involve any algorithms or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Mechanical Performance Standards. For this device, the "ground truth" is defined by the established industry standards for mechanical testing of bone plates (ASTM F382-99). The device's performance is compared against the known safe and effective performance of the predicate devices according to these standards.
8. The sample size for the training set
- Not Applicable. This device is a bone plate and does not involve AI or training sets.
9. How the ground truth for the training set was established
- Not Applicable. This device is a bone plate and does not involve AI or training sets.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" conducted for the AFT™ Proximal Humerus Fracture Plate to demonstrate it meets acceptance criteria and is substantially equivalent was primarily a mechanical performance study coupled with a comparison to predicate devices for materials and design.
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Study Type: Mechanical Testing and Substantial Equivalence Comparison.
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Methodology:
- Mechanical Testing: The device underwent static and dynamic bending testing according to the ASTM F382-99 standard. This standard prescribes methods for quantitatively determining the bending stiffness and strength of metallic bone plates. The 510(k) summary explicitly states this testing was performed "to demonstrate substantial equivalence." This implies that the device's performance in these tests was found to be comparable to or better than the predicate devices, thereby meeting the necessary mechanical acceptance criteria for safety and effectiveness.
- Predicate Device Comparison: The submission also relies heavily on direct comparison to legally marketed predicate devices (Synthes LCP Proximal Humerus Plate, Synthes 4.5mm Non-Locking Cannulated Screw, Zimmer NCB Proximal Humerus Non-Locking Screw). The manufacturer asserts that the AFT™ Proximal Humerus Fracture Plate has the "same 'Indications for Use'," uses similar materials (Ti-6Al-4V, a common and accepted material for such implants), and has a comparable design (low-profile, anatomically shaped, accepts standard screws).
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Conclusion: Based on the mechanical testing (meeting ASTM F382-99 standards) and the comparison of indications, materials, and design to the predicate devices, the FDA concluded that the AFT™ Proximal Humerus Fracture Plate is "substantially equivalent" to the predicate devices. This determination signifies that the device meets the necessary safety and effectiveness criteria for market clearance.
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(60 days)
AFT is intended for use as a bone void filler in the extremities, spine and pelvis for voids or gaps that are not intrinsic to the stability of the bony structure. AFT is indicated for use in the treatment of osseous defects caused by surgery or traumatic injury.
AFT is intended for single patient use only.
AFT is composed of human demineralized bone matrix, human non-demineralized bone and sodium hyaluronate. All components of AFT are resorbable. AFT is aseptically processed and provided pre-loaded into a disposable delivery tube.
This 510(k) premarket notification for the AFT Allograft Filler Tube does not include detailed acceptance criteria or a dedicated study section with the type of quantitative performance data you're requesting. Instead, it relies on demonstrating substantial equivalence to predicate devices and general safety/effectiveness information.
Here's a breakdown of what is available based on your request, and where the document falls short:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Osteoconductivity | AFT is osteoconductive. |
| Osteoinductivity Potential | Demonstrated in an athymic mouse model. Every lot of final product will be tested for this potential. |
| Biocompatibility | Established through long history of safe and effective clinical use of materials, and laboratory testing per ISO 10993. |
| Sterility | Single-donor processed using aseptic techniques and tested per current USP <71>. |
| Viral Inactivation (DBM component) | DBM processing methods provide significant viral inactivation potential for a wide range of model viruses. |
| Viral Inactivation (CBM component) | CBM processing methods provide some viral inactivation potential for a wide range of model viruses (less than DBM, but risk of disease transmission remains low due to multiple safeguards). |
| Function and Intended Use | Same as predicate devices (OSTEOSET® and Exactech Resorbable Bone Paste). |
| New Bone Growth Support | In vivo testing in the athymic mouse model demonstrated that AFT materials can effectively support new bone growth in osseous defects. |
Important Note: The document explicitly states: "Osteoinduction assay results in the athymic mouse model should not be interpreted to predict clinical performance in human subjects." This highlights that while animal data is presented, it's not considered directly predictive of human clinical outcomes for this specific aspect. There are no quantitative metrics (e.g., specific percentages, measurements of new bone formation) presented as acceptance criteria or performance results within this document.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Description: The document refers to "in vivo testing in the athymic mouse model" for osteoinductivity potential and new bone growth support.
- Sample Size: The exact sample size ("n") for the athymic mouse model study is not provided in this document.
- Data Provenance: The athymic mouse model is an animal model. The country of origin for the data is not specified, though the sponsor is in Edison, NJ, USA. The data is presented as a result of experimentation, making it prospective data within the context of the animal study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not provided. Given that the listed "performance" data comes from an animal model, the concept of "ground truth" derived from human clinical experts is not directly applicable in the same way as it would be for a diagnostic device. Any assessment of the animal study results would presumably be done by researchers/pathologists specializing in histology and bone biology, but their number and qualifications are not disclosed.
4. Adjudication Method for the Test Set:
- This information is not provided. Again, for an animal study focused on biological endpoints, a formal clinical adjudication method (like 2+1) is typically not used in the same context as for human diagnostic device performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for diagnostic imaging AI devices where human readers interpret medical images. The AFT Allograft Filler Tube is a bone void filler product, not a diagnostic device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- No, a standalone (algorithm only) study was not done. This concept is also not applicable to a bone void filler. The device itself is the "algorithm" in a sense, and its performance is assessed via biological outcomes (like bone growth), not through an AI algorithm's independent interpretations.
7. Type of Ground Truth Used:
- For the athymic mouse model: The ground truth would likely be based on histopathological examination (e.g., histology slides showing new bone formation, cell differentiation) and potentially radiographic analysis (e.g., assessment of bone density or defect filling in animal models). The document mentions "in vivo testing" and "osteoconductive," implying biological assays.
8. Sample Size for the Training Set:
- This information is not applicable/not provided. The AFT device is a biological product, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The components (DBM, CBM, sodium hyaluronate) have an "established history of safe and effective clinical use," which could be considered analogous to a large historical dataset informing their safety, but not a "training set" for an algorithm.
9. How Ground Truth for the Training Set Was Established:
- This information is not applicable/not provided for the same reasons as #8. The "ground truth" for the raw materials is their known biological and chemical properties, and their established clinical safety and effectiveness through prior research and clinical use.
In summary, this 510(k) notification focuses on demonstrating substantial equivalence, biocompatibility, sterility, and potential for osteoinductivity/new bone growth based on animal models and an established history of safe use for its components, rather than providing quantitative performance metrics typical of a diagnostic AI device or a direct clinical trial with a defined acceptance criteria table.
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(356 days)
AFT is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. It can be used in the extremities and pelvis. It is indicated for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. AFT is for single patient use only.
AFT is composed of human demineralized bone matrix, human nondemineralized bone and sodium hyaluronate. All components of AFT are resorbable. AFT is aseptically processed and provided pre-loaded into a disposable delivery tube.
The provided text describes the regulatory clearance of a bone void filler and does not contain information about acceptance criteria, device performance, or human-AI comparative effectiveness studies. It focuses on demonstrating substantial equivalence to predicate devices based on safety, biocompatibility, osteoinductivity potential in an animal model, and viral inactivation processes.
Therefore, I cannot populate the table or answer most of the questions as the required information is not present in the provided document.
Here's what can be inferred:
1. A table of acceptance criteria and the reported device performance
Not available in the provided text. The text highlights "osteoconductive" and "osteoinductivity potential in an athymic mouse" as performance characteristics, but no specific quantitative acceptance criteria or detailed performance metrics are given.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable for this type of submission. The "test set" mentioned refers to in vivo testing in an athymic mouse model, but sample size, country of origin, or whether it was retrospective/prospective are not specified.
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. No human experts were used to establish ground truth for the device's performance in the context of this regulatory submission. Animal model results were presented.
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. This is not a description of an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "osteoinuductivity potential" was established through "in vivo testing in the athymic mouse model." This animal model serves as the "ground truth" for demonstrating the material's ability to support new bone growth.
8. The sample size for the training set
Not applicable. This is a medical device (bone void filler), not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
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