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510(k) Data Aggregation
(52 days)
Chemence Medical, Inc.
Exofin® Precision Pen is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. Exofin® Precision Pen may be used in conjunction with, but not in place of, deep dermal sutures.
Exofin® Precision Pen is a sterile liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation for rapid polymerization, and the colorant D&C Violet #2 which aids in visualization during application. The adhesive is provided in a 1.0g size, single-use, aluminum, collapsible tube that is fitted with a polyethylene-based applicator tip. The applicator tip consists of three components, a connector fitted with a self-puncturing cap, porous disc and soft elastomeric brush. The aluminum tube is housed within a silicone bulb that is connected to a polypropylene pen body and held by the end user during application. The adhesive, applicator tip, silicone bulb and pen body are packaged together in a (PETG) plastic blister pack and sealed with a labeled Tyvek® blister backer. A total of 12 units are packaged in a tray which is covered by a sleeve. When applied to the skin, the adhesive is distributed through the applicator tip in a syrup-like viscosity and polymerizes within minutes. The increased viscosity assists in the unintended placement of the adhesive during application due to migration of the liguid adhesive from the wound site. The silicone bulb and pen body of the Exofin® Precision Pen were designed to improve ergonomics during application. In-vitro studies have shown that Exofin® Precision Pen acts as a barrier to microbial penetration when the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties.
The provided document is an FDA 510(k) summary for the Exofin® Precision Pen, a topical skin adhesive. It claims substantial equivalence to a predicate device (Exofin® High Viscosity Topical Skin Adhesive, K200264). This means the submission focuses on demonstrating that the new device is as safe and effective as a legally marketed device, rather than providing extensive de novo clinical studies with detailed acceptance criteria and performance metrics for a novel technology.
Therefore, the information required to fully answer your request regarding acceptance criteria, study details, and specific performance metrics for a new device's clinical efficacy, as one might find for an AI medical device, is not present in this document. This document primarily addresses the substantial equivalence of modifications to a previously cleared device.
However, I can extract the available information related to performance testing that was conducted to support this Special 510(k).
Here's a breakdown of what can be gathered from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not provide a specific table of quantitative acceptance criteria for clinical performance (e.g., wound closure rates, dehiscence rates) or quantitative performance metrics for the Exofin Precision Pen in the context of human studies. The performance testing section discusses "Mechanical Applicator Testing" and states it "met all performance criteria," but these criteria are not detailed.
| Acceptance Criteria Category | Reported Device Performance (Exofin® Precision Pen) | Notes from Document |
|---|---|---|
| Mechanical Applicator Testing | Met all performance criteria. | "In these studies, Exofin® Precision Pen met all performance criteria." The specific quantitative criteria (e.g., force required for dispense, flow rate) are not detailed in this summary. This testing relates to the ergonomic "pen" component, not the adhesive's clinical efficacy itself. |
| Adhesive Performance (Indirect) | No change from predicate device (K200264). | "Because the adhesive, aluminum tube and applicator tip remain unchanged, no additional performance test were done." The performance of the adhesive formulation itself is presumed to be equivalent to the predicate, as it is the same formulation. |
| Biocompatibility | Not required for the pen component; unchanged for adhesive. | "The pen of subject device does not come into direct contact with the patient or adhesive, therefore, biocompatibility is not required. Because the adhesive is unchanged, no additional biocompatibility tests were performed." |
| Sterility Assurance Level (SAL) | 10⁻⁶ | "Exofin® Precision Pen is sterilized in a two-step process by dry heat and ethylene oxide gas at a sterility assurance level (SAL) of 10⁻⁶." |
| Shelf-Life | 12 months | "The data from these studies support a 12-month shelf-life." |
| Microbial Barrier Properties | Acts as a barrier when intact (in-vitro). | "In-vitro studies have shown that Exofin® Precision Pen acts as a barrier to microbial penetration when the adhesive film remains intact." |
2. Sample Size for the Test Set and Data Provenance
- Test Set Sample Size: Not specified for any human clinical trials. The performance testing mentioned ("Mechanical Applicator Testing") would involve device units, not human subjects.
- Data Provenance: Not applicable for human clinical data, as no new clinical studies were conducted for this Special 510(k). The "in-vitro studies" for microbial barrier properties suggest lab-based testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable as no human clinical test set requiring expert ground truth establishment for a novel device was conducted for this Special 510(k).
4. Adjudication Method for the Test Set
- Not applicable as no human clinical test set requiring adjudication was conducted for this Special 510(k).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI devices, whereas the Exofin Precision Pen is a therapeutic device (tissue adhesive).
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. The Exofin Precision Pen is a physical medical device (a topical skin adhesive with an applicator), not an algorithm or AI system.
7. Type of Ground Truth Used
- Not applicable in the context of human clinical ground truth (e.g., pathology, outcomes data). The "ground truth" for the mechanical applicator testing would be the engineering specifications and functional requirements for the pen. For the microbial barrier, it would be laboratory culture results.
8. Sample Size for the Training Set
- Not applicable as this is a physical medical device, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable for the same reason as above.
Summary of Device Rationale for this 510(k):
The Exofin® Precision Pen is presented as a modification to an already cleared device (Exofin® High Viscosity Topical Skin Adhesive, K200264). The changes are specifically:
- Addition of a pen (silicone bulb and pen body) for improved ergonomics.
- An increase in blister size to accommodate the pen body.
- An increase in the number of device units per tray from 10 to 12.
The key claim for substantial equivalence is that the adhesive formulation, aluminum tube, and applicator tip remain unchanged from the predicate device. Therefore, clinical performance related to wound closure, strength, etc., is considered unchanged and relies on the predicate's clearance. The new testing conducted was primarily "Mechanical Applicator Testing" to ensure the new pen component functions as intended, and it reportedly "met all performance criteria." Biocompatibility was deemed unnecessary for the non-patient-contacting pen component, and the adhesive's biocompatibility was already established. Sterilization validation and shelf-life studies were also conducted for the new configuration.
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(318 days)
Chemence Medical, Inc.
Exofin® High Viscosity Topical Skin Adhesive is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations.
Exofin® High Viscosity Topical Skin Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.
Exofin® High Viscosity Topical Skin Adhesive is a sterile liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation for rapid polymerization, and the colorant D&C Violet #2 which aids in visualization during application. It is provided in a single-use, aluminum, collapsible tube fitted with a polyethylene-based applicator tip. The applicator tip consists of three components, a connector fitted with a self-puncturing cap, porous disk and soft elastomeric brush, used to apply and spread the adhesive evenly. The adhesive and applicator tip are packaged together in a polyethylene terephthalate glycol plastic blister pack and sealed with a labeled Tyvek® blister backer. When applied to the skin, the adhesive is distributed through the applicator tip in a syrup-like viscosity and polymerizes within minutes. The increased viscosity in Exofin® High Viscosity Topical Skin Adhesive is intended to reduce the risk of unintended placement of the adhesive during application due to migration of the liquid adhesive from the wound site. In-vitro studies have shown that Exofin® High Viscosity Topical Skin Adhesive acts as a barrier to microbial penetration when the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties and a correlation between microbial barrier properties and a reduction in infection have not been established.
The provided text describes a medical device, Exofin® High Viscosity Topical Skin Adhesive, and its review for substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the format requested in the prompt.
Specifically, the document focuses on the regulatory submission (510(k)) and comparison to a predicate device (Exofin® High Viscosity Tissue Adhesive). It lists various performance and biocompatibility tests conducted, and states that the device "met all performance criteria," but it does not specify what those criteria are (e.g., a numerical threshold or range for wound closure strength).
Therefore, for aspects of the prompt related to specific numerical acceptance criteria, reported performance values, sample sizes, expert qualifications, adjudication methods, or MRMC studies, that information is not present in the provided text. The document concerns a Class II medical device, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a new clinical efficacy study with defined acceptance criteria and human expert evaluation in the same manner as, for example, an AI diagnostic algorithm.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be created. The document lists the types of performance tests conducted (e.g., Wound Closure Strength, Adhesive Strength in Tension) and states that the device "met all performance criteria." However, it does not specify the actual numerical acceptance criteria or the measured performance values for these tests. For example, it doesn't say "Wound Closure Strength must be > X N/cm" and "Reported Wound Closure Strength was Y N/cm."
2. Sample size used for the test set and the data provenance
- Cannot be determined. The document mentions performance and biocompatibility testing but does not provide details on sample sizes used for these tests, nor does it specify the provenance (e.g., country of origin, retrospective/prospective) of any data beyond indicating "In-vitro studies" for microbial barrier properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Cannot be determined. This type of information is typically relevant for diagnostic devices, especially those involving image interpretation by human experts. The Exofin® device is a topical skin adhesive. Its evaluation involves laboratory performance tests and biocompatibility, not expert interpretation of diagnostic data to establish a "ground truth" in the requested sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Cannot be determined. Similar to point 3, adjudication methods are relevant for studies comparing expert interpretations, often in diagnostic settings. This device's testing does not involve such a process.
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
- No. An MRMC study is not mentioned. This type of study is typically for evaluating diagnostic accuracy, especially of AI/CAD systems that assist human readers. Exofin® is a therapeutic device (a skin adhesive), not a diagnostic AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This question pertains to AI algorithms, which Exofin® is not.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground truth in the context of device performance testing: For the performance tests listed (e.g., Wound Closure Strength, Adhesive Strength), the "ground truth" would be the objective measurement against established ASTM standards and internal specifications, rather than expert consensus or pathology in a clinical diagnostic sense. For biocompatibility, it's against established biological safety endpoints.
- The document implies that the device "met all performance criteria," meaning its measured performance values conformed to the pre-defined specifications/acceptance criteria for each test (e.g., ISO, ASTM standards).
8. The sample size for the training set
- Not applicable / Cannot be determined. The device is a physical medical product (a skin adhesive), not an AI model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set for an AI model is involved.
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(368 days)
Chemence Medical, Inc.
Exofin Fusion Skin Closure System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. Exofin Fusion Skin Closure System should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.
Exofin® Fusion Skin Closure System is a sterile, liquid topical skin adhesive containing a monomeric (2- octyl cyanoacrylate) formulation and the colorant D & C Violet #2. It is provided in a single-use applicator packaged in a rigid blister. As applied to skin, the liquid is slightly more viscous than water and polymerizes within minutes. In vitro studies have shown that Exofin® Fusion Skin Closure System acts as a barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties and a correlation between microbial barrier properties and a reduction in infection have not been established. Exofin Fusion Skin Closure System also incorporates a self-adhering mesh that is applied to the approximated skin edges to provide temporary skin edge alignment of incisions up to 20 cm each in length until the liquid adhesive is applied to achieve skin closure.
The provided text is a 510(k) Summary for the Exofin® Fusion Skin Closure System. It details the device, its intended use, and comparison to predicate devices, along with non-clinical testing performed to demonstrate substantial equivalence. However, it does not contain the specific information required to address the request regarding acceptance criteria, study details, expert involvement, or AI-related metrics.
Specifically, the document states: "No clinical testing has been submitted, referenced, or relied upon for Clinical Testing: determining substantial equivalence." This means there are no clinical study results to describe in terms of direct clinical performance, acceptance criteria, or human reader improvement with AI.
Therefore, I cannot fulfill the request for information on the study that proves the device meets acceptance criteria, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, or details about the training set, as these aspects are not present in the provided 510(k) summary.
The document focuses on non-clinical testing to demonstrate substantial equivalence to a predicate device, as outlined in the "Non-clinical Testing" section:
- Acceptance Criteria and Reported Performance (based on non-clinical testing available):
| Acceptance Criteria (Test Standard) | Reported Device Performance (Implied Acceptance) |
|---|---|
| Wound closure strength (ASTM F2458-05) | The testing was performed in accordance with the FDA Class II Special Controls Guidance Document, demonstrating substantial equivalence to the predicate. (Specific numerical performance not provided, but implies meeting the standard for substantial equivalence). |
| Adhesive strength in tension (ASTM F2258-05) | The testing was performed in accordance with the FDA Class II Special Controls Guidance Document, demonstrating substantial equivalence to the predicate. (Specific numerical performance not provided, but implies meeting the standard for substantial equivalence). |
| T-peel adhesion strength (ASTM F2256-05) | The testing was performed in accordance with the FDA Class II Special Controls Guidance Document, demonstrating substantial equivalence to the predicate. (Specific numerical performance not provided, but implies meeting the standard for substantial equivalence). |
| Lap-shear strength (ASTM F2255-05) | The testing was performed in accordance with the FDA Class II Special Controls Guidance Document, demonstrating substantial equivalence to the predicate. (Specific numerical performance not provided, but implies meeting the standard for substantial equivalence). |
| Heat of polymerization | The testing was performed in accordance with the FDA Class II Special Controls Guidance Document, demonstrating substantial equivalence to the predicate. (Specific numerical performance not provided, but implies meeting the standard for substantial equivalence). |
| Microbial barrier effectiveness | The testing was performed in accordance with the FDA Class II Special Controls Guidance Document, demonstrating substantial equivalence to the predicate. (Specific numerical performance not provided, but implies meeting the standard for substantial equivalence). |
| Extractables and Leachables | The testing was performed in accordance with the FDA Class II Special Controls Guidance Document, demonstrating substantial equivalence to the predicate. (Specific numerical performance not provided, but implies meeting the standard for substantial equivalence). |
| Biocompatibility Testing (ISO 10993-1) | Conducted according to the requirements for a surface device in prolonged contact with a breached or compromised surface, demonstrating substantial equivalence. (Specific numerical performance not provided, but implies meeting the standard for substantial equivalence). |
Remaining requested information, not found in the provided text:
- Sample size used for the test set and the data provenance: Not provided, as clinical testing was not relied upon. The non-clinical tests would have their own sample sizes, but these are not detailed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical ground truth established or relied upon.
- Adjudication method for the test set: Not applicable.
- 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 not an AI-based diagnostic device where human-in-the-loop performance with AI assistance would be relevant.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: For non-clinical tests, the "ground truth" would be the established testing parameters and results as per ASTM and ISO standards, demonstrating compliance. Clinical or expert consensus ground truth is not reported.
- The sample size for the training set: Not applicable, as there is no mention of an algorithm or AI model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
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(132 days)
Chemence Medical, Inc.
Exofin® Fusion Skin Closure System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. Exofin Fusion Skin Closure System should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.
Exofin® Fusion Skin Closure System is a sterile, liquid topical skin adhesive containing a monomeric (2octyl cyanoacrylate) formulation and the colorant D & C Violet #2. It is provided in a single use aluminum collapsible tube packaged in a RXM 48gaPET-200LDPE Film/1059B uncoated Tyvek pouch containing an applicator. The applicator is comprised of a self-puncturing cap and a soft elastomeric brush, which allows the adhesive to spread uniformly. As applied to skin, the liquid is syrup-like in viscosity and polymerizes within minutes. Exofin® Fusion Skin Closure System has a low viscosity. In vitro studies have shown that Exofin® Fusion Skin Closure System acts as a barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties and a correlation between microbial barrier properties and a reduction in infection have not been established. Exofin Fusion Skin Closure System also incorporates a self-adhering mesh that is applied to the approximated skin edges to provide temporary skin edge alignment of two incisions up to 20 cm each in length until the liquid adhesive is applied to achieve skin closure.
The provided document describes the Exofin® Fusion Skin Closure System and its substantial equivalence to the predicate device, Dermabond™ Prineo™ Skin Closure System. However, it does not contain information on acceptance criteria or a study proving the device meets an algorithm's acceptance criteria.
The document outlines a 510(k) submission for a medical device (a skin closure system), not an AI/ML powered device. The "Performance Data" section details several physical and biological tests conducted on the device components, such as wound closure strength, adhesive strength, biocompatibility, and a porcine wound healing study, to demonstrate its safety and effectiveness. These tests are relevant for a physical medical device.
Therefore, I cannot fulfill the request as it pertains to AI/ML specific acceptance criteria, test set sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as this information is not present in the provided text.
The closest information provided is:
- Type of Ground Truth Used (for the animal study): Histological analysis (for the porcine wound healing study).
- Sample size for the training set: Not applicable/not mentioned, as it's not a machine learning study.
- How the ground truth for the training set was established: Not applicable/not mentioned.
Essentially, the device in question is a physical tissue adhesive system, not an AI software.
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(121 days)
CHEMENCE MEDICAL INC
derma+flex® QS ™ High Viscosity Tissue Adhesive is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations.
derma+flex® QS ™ High Viscosity Tissue Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.
derma+flex® QS™ High Viscosity Tissue Adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D&C Violet #2. It is provided in a single use aluminum collapsible tube packaged in a RXM 48gaPET-200LDPE Film/1095B uncoated Tyvek pouch also containing 2 Indothene HD Grade HD50MA 180 applicator tips. The dauber applicator is comprised of a self-puncturing cap and a foam surface, which allows spreading of the adhesive with uniformity.
The nozzle applicator is also a self-puncturing cap with an elongation that enables detailed application of the adhesive. As applied to the skin, the liquid is syrup-like in viscosity and polymerizes within minutes. The increased viscosity of derma+flex® QS™ is intended to reduce the risk of unintended placement of the adhesive during application due to migration of the liquid adhesive from the wound site.
The provided text describes a 510(k) premarket notification for a medical device called derma+flex® QS™ High Viscosity Tissue Adhesive. This type of filing aims to demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a traditional clinical study. Therefore, the information you're looking for, such as a table of acceptance criteria and device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, is not directly applicable or available in this document.
However, I can extract information about the shelf-life study which included performance testing to demonstrate that changes in the sterilization process did not alter the device's performance over time. This is the closest equivalent to a performance study mentioned in the document.
Here's a breakdown of the relevant information from the document regarding the shelf-life study:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table with specific quantified acceptance criteria and reported performance values. It only lists the types of tests performed to demonstrate that the minor differences in sterilization did not change the performance of the device over time. The implied acceptance criterion would be that the device's performance on these tests remains within pre-defined acceptable ranges or comparable to the predicate for its stated shelf-life.
| Performance Metric Tested (as per ASTM standards) | Implicit Acceptance Criteria (not explicitly quantified in document) | Reported Device Performance (not explicitly quantified in document) |
|---|---|---|
| Wound Closure Strength (ASTM F2458-05) | Maintain performance over time, comparable to predicate. | Performance not altered by sterilization changes. |
| Tensile Strength (ASTM F2258-05) | Maintain performance over time, comparable to predicate. | Performance not altered by sterilization changes. |
| T-Peel Strength (ASTM F2256-05) | Maintain performance over time, comparable to predicate. | Performance not altered by sterilization changes. |
| Lap Shear Strength (ASTM F2255-05) | Maintain performance over time, comparable to predicate. | Performance not altered by sterilization changes. |
| Viscosity | Maintain specified viscosity range over time. | Performance not altered by sterilization changes. |
| Polymerization Time | Maintain specified polymerization time over time. | Performance not altered by sterilization changes. |
| Purity | Maintain specified purity over time. | Performance not altered by sterilization changes. |
| Water Content | Maintain specified water content over time. | Performance not altered by sterilization changes. |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the document.
- Data Provenance: Not specified in the document. This was a lab-based, pre-clinical study focusing on material and performance characteristics under different sterilization conditions for shelf-life testing. It is not a clinical study involving human patients or data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Experts: Not applicable. These were laboratory tests against ASTM standards, not expert-adjudicated clinical outcomes.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. Lab tests are typically performed according to established protocols and measured objectively, not through human adjudication in this context.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No. This document describes a 510(k) submission for a tissue adhesive, not an AI or imaging device that would typically undergo an MRMC study.
6. Standalone (Algorithm Only) Performance Study:
- Standalone Study: No. This is a physical medical device (tissue adhesive), not an algorithm or software.
7. Type of Ground Truth Used:
- Ground Truth: For the shelf-life studies, the "ground truth" would be the established performance characteristics of the predicate device and the specified limits/ranges for each material property and mechanical strength test as defined by industry standards (ASTM), against which the performance of the new device was compared.
8. Sample Size for the Training Set:
- Sample Size: Not applicable. There is no training set mentioned, as this is not an AI/machine learning device. The studies described are for shelf-life validation, where samples of the device are tested over time.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth Establishment: Not applicable, as there is no training set. The "ground truth" for showing substantial equivalence relies on comparing the device's characteristics and performance to existing, legally marketed predicate devices and established standards.
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(337 days)
CHEMENCE MEDICAL INC.
DERMA+FLEX™ Gel Adhesive is indicated for OTC use to cover minor cuts, scrapes and minor irritations of the skin and help protect them from infection.
DERMA+FLEX™ Gel Adhesive is a sterile, clear, high viscosity, flexible, liquid topical bandage composed of a blend of 2-Octyl and N-Butyl cyanoacrylate monomers with an octyl cyanoacrylate polymer, tributyl citrate (a plasticizer) and containing D&C violet #2 pigment. DERMA+FLEX™ is supplied in 0.5g single patient use aluminum tubes with (2) self-piercing applicator caps (a dauber cap and a nozzle cap). Each sterile single use aluminum tube is packaged with applicators in individual Tyvek pouches and sterilized by EtO sterilization rendering the exterior of the tube and applicators suitable for dispensing on sterile fields.
The provided text describes the 510(k) summary for the DERMA+FLEX™ Gel Adhesive and the FDA's clearance letter. It focuses on establishing substantial equivalence to predicate devices and provides details on the device description, indications for use, and a summary of biocompatibility testing. It does not contain information about acceptance criteria for performance, a study to demonstrate device performance in terms of efficacy or effectiveness, or details about sample sizes, expert involvement, or adjudication methods for performance studies.
Therefore, I cannot fulfill the request for a table of acceptance criteria, reported device performance, or details about performance studies, multi-reader multi-case studies, or standalone algorithm performance.
However, I can extract the information related to the biocompatibility testing that was performed:
1. Table of acceptance criteria and the reported device performance (for biocompatibility testing):
| Acceptance Criteria (Biocompatibility) | Reported Device Performance (DERMA+FLEX™ Gel Adhesive) |
|---|---|
| ISO 10993-5 and USP 24, Biological Reactive Tests In-Vitro (87) requirements met for cytotoxicity. | Met the requirements of the cytotoxicity test. Result: Grade 1 (non-cytotoxic). |
| Not considered to be sensitizing (Murine Local Lymph Node Assay). | Not considered to be sensitizing. |
| Potential irritation effects for intracutaneous injection (screen extracts for potential irritation effects). | Saline extract yielded a mean score of 0.0 (out of 4). Cottonseed oil extract yielded a mean score of 1.4 (out of 4). Considered a mild irritant. (Warning label for cyanoacrylate allergy provided). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- The document describes in vitro and in vivo biocompatibility tests using cell lines (L929 agar overlay test) and animal models (Murine Local Lymph Node Assay and Intracutaneous Inject). Specific sample sizes for these tests are not provided in the document.
- Data provenance is not specified. These are standard laboratory tests typically conducted under controlled conditions and would likely be prospective for the purpose of the 510(k) submission.
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 information is not applicable or not provided for biocompatibility testing. Biocompatibility tests rely on established scientific protocols and quantitative measurements, not expert consensus on qualitative data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable or not provided for biocompatibility 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:
- No MRMC comparative effectiveness study was mentioned or performed. The device is a "Liquid Bandage" and does not involve AI or human image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. The device is a physical product (liquid bandage), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For biocompatibility testing, the "ground truth" is established through:
- Validated biological assays: such as cell viability assays (L929), immune response assays (LLNA), and irritation potential assays (intracutaneous injection).
- Interpretation against international standards: (e.g., ISO 10993-5, USP 24) and regulatory guidelines.
8. The sample size for the training set:
- Not applicable. This pertains to algorithm development. For a physical medical device, there isn't a "training set" in the computational sense. The "development" would involve formulation and bench testing.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
In summary, the provided document details biocompatibility testing results to demonstrate the safety of the DERMA+FLEX™ Gel Adhesive, not its performance in terms of efficacy, which is typically established through clinical studies not present in this 510(k) summary. The focus of the 510(k) was on demonstrating substantial equivalence to predicate devices based on technological characteristics and safety (biocompatibility).
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