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The Neodyne Dressing is intended for use in the management of closed hyperproliferative (hypertrophic and keloid) scars.

The Neodyne Dressing is a non-sterile, single use adhesive silicone sheet to be used to protect and manage a newly formed, closed scar. The Dressing is pre-strained prior to application and applied over the new scar. The silicone sheeting protects and stress shields the scar.

The Neodyne Dressing is intended for the management of closed hyperproliferative (hypertrophic and keloid) scars. The device's performance relies on both its silicone sheeting material and the stress shielding provided by the pre-strained dressing.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   Substantial Equivalence to predicate devices (Epi-Derm Silicone Sheeting (K003948) and 3M Steri-Strip (K813265))	The Neodyne Dressing is claimed to be as safe and effective as Steri-Strips and Epi-Derm Silicone Sheeting. It shares the same intended uses, similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences are stated not to raise new issues of safety or effectiveness. Performance data demonstrates that the Neodyne Dressing functions as intended by providing intended strain relief and stress shielding. This conclusion is based on comparing "technological characteristics, and principles of operation" and "performance data" with predicates. The FDA concurred with this assessment, granting 510(k) clearance based on substantial equivalence.
   Provide intended strain relief	Bench testing confirmed that the Neodyne Dressing provided the intended strain relief.
   Function as intended (stress shielding)	Bench testing confirmed that the Neodyne Dressing functioned as intended by providing stress shielding.

2. Sample size used for the test set and the data provenance:
   The document does not specify a test set sample size or data provenance (e.g., country of origin, retrospective/prospective clinical study details) for a clinical trial evaluating the Neodyne Dressing's effectiveness in scar management. The assessment primarily relies on bench testing results regarding strain relief and stress shielding, and a comparison of technological characteristics with predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not provided. The submission hinges on bench testing and comparison to predicate devices, not on a clinical ground truth established by experts.

4. Adjudication method for the test set:
   This information is not provided as no clinical test set for evaluating the device's clinical efficacy in scar management is 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:
   This device is a physical medical dressing, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not conducted.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   This device is a physical medical dressing, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and was not done.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the bench testing, the ground truth was likely established by engineering measurements and specifications for strain relief and stress shielding. For the substantial equivalence argument, the "ground truth" was largely based on a comparison of technological characteristics and intended uses against legally marketed predicate devices, supported by bench test data. There is no mention of clinical outcomes data or pathology as primary ground truth for this 510(k) submission.

8. The sample size for the training set:
   This information is not applicable as the device is not an AI algorithm that requires a training set. The "design" or "development" of the dressing would not typically involve a "training set" in the context of machine learning.

9. How the ground truth for the training set was established:
   This information is not applicable as the device is not an AI algorithm that requires a training set and corresponding ground truth.

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Coreleader Scar-D Silicone Sheeting is intended for use: for the management of closed hypertrophic and keloid scars.

Coreleader Scar-D silicone sheeting is a thin, soft and self-adhesive sheet made from medical grade silicone with a PU Foam/PU non-woven film backing paper and a non-silicone polyester release paper. It is able to hold moisture with adequate pressure on the scar. The sheets are rectangular and come in four sizes, 5 cm x 8 cm, 5 cm x 20 cm, 2.5 cm x 100 cm and 5 cm x 100 cm. They are approximately 0.6 mm thick. The sheet maybe cut or trimmed to the desired shape or size prior to placement on the scar. The sheets are not for use on an open wound, are not sterile but can be washed.

The provided text is a 510(k) summary for the "Coreleader Scar-D Silicone Sheeting." This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a performance study with acceptance criteria.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details cannot be extracted from this document.

The document primarily describes the device's characteristics, intended use, and states that it is substantially equivalent to two predicate devices (BIODERMIS CORP., K003948, EPI-DERM SILICONE GEL SHEETING and SMITH & NEPHEW UNITED, INC., K935803, CICA-CARE SILICONE GEL SHEET). It does not contain information about a specific study designed to prove the device meets pre-defined acceptance criteria for its performance.

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The Beau RX™ Scar Care Gel is intended for the management of old and new hypertrophic and keloid scarring on scars resulting for burns, general surgical procedures and trauma wounds

Beau RxTM Scar Care Gel is a non sterile viscous emulsion/gel formulation, which is presented for over-the-counter use It is applied topically to aid in the management of both old and new Hypertrophic and Keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds

The manufacturer, Beau Rx Solutions, LLC, did not conduct a study to prove that the device meets specific acceptance criteria based on performance metrics. Instead, they performed biocompatibility testing and sought to demonstrate substantial equivalence to legally marketed predicate devices (Kelo-cote® Scar Gel and Silicone Scar Gel) under a 510(k) premarket notification.

The "acceptance criteria" in this context are not quantitative performance metrics for the device's efficacy in scar management, but rather the criteria for demonstrating substantial equivalence to a predicate device, primarily focusing on design, composition, function, intended use, and safety (biocompatibility).

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for substantial equivalence rather than a de novo marketing application requiring novel efficacy data, the "acceptance criteria" are tied to alignment with the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

No specific clinical test set for performance efficacy in scar reduction is described. The "testing" mentioned refers to biocompatibility screenings of individual materials used in the gel, not a clinical study on patient scars. The data provenance is from the specific materials used in the device. The document does not specify country of origin or whether chemical testing data was retrospective or prospective, but it implies standard lab testing results.

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. The ground truth for biocompatibility is established by standardized material testing according to recognized protocols (e.g., ISO standards, though not explicitly cited, it's implied for medical device materials). There's no mention of experts establishing ground truth for clinical outcomes as no clinical efficacy study was performed for this 510(k).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set requiring adjudication was performed.

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 topical scar gel, not an AI-powered diagnostic or treatment assistance tool. Therefore, an MRMC study is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the submission is primarily based on the established safety and performance characteristics of the predicate devices and the results of biocompatibility testing for the component materials of Beau Rx™ Scar Care Gel. This is a regulatory "ground truth" (i.e., substantial equivalence has been met), not a clinical efficacy ground truth from patient outcome data.

8. The sample size for the training set

Not applicable. No algorithm or AI system was developed that would require a training set. The "training set" in a broader sense would be the cumulative knowledge and regulatory history surrounding silicone scar gels that underpin the substantial equivalence argument, but this isn't a quantifiable "sample size."

9. How the ground truth for the training set was established

Not applicable. As above, no training set in the AI sense was used. The "ground truth" for the regulatory submission (substantial equivalence) was established through comparison to predicate devices, supported by material biocompatibility testing.

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Kelo-Cote Spray is a topical silicone spray intended for the management of old and new hypertrophic and keloid scarring on scars resulting from burns, general surgical procedures and trauma wounds.

Kelo-Cote Spray is a lightweight, self-drying silicone gel spray for the treatment of scars. Upon drying, the silicone gel layer forms a film for the management of scars. The components of Kelo-Cote Spray include fumed silica and silicone elastomer, liquid, and gum. It is provided in a can with a spray nozzle for application purposes.

The provided text is a 510(k) premarket notification for a medical device called Kelo-Cote Spray. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria, study details, sample sizes, expert ground truth, or comparative effectiveness studies.

Specifically, the following points cannot be addressed from the given text:

1. A table of acceptance criteria and the reported device performance: Not present. The submission focuses on substantial equivalence.
2. Sample sizes used for the test set and the data provenance: Not present. No test set described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No ground truth establishment described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, no test set 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: Not applicable. This is not an AI device, and no MRMC study is described.
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.): Not present.
8. The sample size for the training set: Not applicable, no training set for an algorithm described.
9. How the ground truth for the training set was established: Not applicable.

The submission states: "ABT believes Kelo-Cote Spray is substantially equivalent to legally marketed products: ABT's Kelo-Cote Topical Gel (K002488) and the Curad Spray Bandage (K022645)." and further clarifies that "The ABT Kelo-Coat Topical Gel provides a substantial equivalence basis for the intended use and components of Kelo-Coat Spray. The Curad Spray Bandage provides a substantial equivalence basis for the method of application of Kelo-Cote Spray." This indicates that rather than new studies, the equivalence is based on existing, predicate devices.

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For the management of hypertrophic and keloid scars

The NewGel Plus introduced by NewMedical Technology, Inc., is a device which substantially equivalent to other marketed silicone gel sheets. Indications for use are substantially the same, that is, topical treatment of scars. The advantages over other marketed devices from other vendors include the size of the strips in the package to enhance ease of use. In summary, the features incorporated into the NewMedical NewGel Plus have specific advantages over other substantially equivalent products to enhance ease of placement/ application along with the care and comfort of the patient. Neither one of the above features will raise any safety concern because they don't change any of the basic design concepts compared to other similar approved devices.

The provided text describes a 510(k) summary for the NewGel Plus device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove performance against specific acceptance criteria.

Therefore, many of the requested categories for a study proving device performance against acceptance criteria cannot be extracted from this document, as such a study was not conducted or reported in this format.

Here's an breakdown of what can be determined:

1. A table of acceptance criteria and the reported device performance

No explicit acceptance criteria or performance metrics are reported in this 510(k) summary. The document solely focuses on establishing substantial equivalence based on:

• Intended Use: Topical treatment of scars (hypertrophic and/or keloid). (Met by claiming similarity to predicate)
• Materials: Medical grade silicone gel and natural alpha-tocopherol (Vitamin E). (Met by claiming similarity to predicate and listing materials)
• Design: Adhesive methods of scar management, similar reinforcement materials, similar non-stick backings, similar transparent trays. (Met by claiming similarity to predicate)
• Operational Principles: Similar site preparation, method of application, ease of use and replacement, precautions, indications, and components. (Met by claiming similarity to predicate)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No formal "test set" or clinical study with data provenance is described as the basis for this 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)

Not applicable. No ground truth establishment by experts for a test set is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method is mentioned.

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 not an AI-assisted diagnostic tool, and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical product (silicone gel sheet), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The basis of this submission is substantial equivalence to legally marketed predicate devices, not direct performance against a "ground truth" derived from patient outcomes or pathology for this specific device. The implicit "ground truth" is that the predicate devices are considered safe and effective for their intended use.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of device and submission.

9. How the ground truth for the training set was established

Not applicable.

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HANSON SCAR ADE is indicated for the topical management of keloid and hypertrophic scars

HANSON SCAR ADE is a topical gel made from silicones. HANSON SCAR ADE is intended for use in managing would and keloid scarring resulting from surgery, laser abrasion, chemical peels and other trauma. This product is offered non-sterile. For convenience it is packaged in half ounce and one ounce plastic tubes. Each tube will have Directions for Use, and Cautions. HANSON SCAR ADE is indicated for use to aid associated erythema or discoloration of scars. HANSON SCAR ADE is applied to the scar in a thin coat and excess is wiped away with a tissue. HANSON SCAR ADE is to be used on healed scars, in the case of surgery typically after 10 days from surgery. The product is not to be used on open wounds. Discontinue use if any infection is suspected, and obtain professional health care assistance.

I am sorry, but the provided text does not contain information on acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for a device. The document is a 510(k) summary statement and a clearance letter for a medical device called "HANSON SCAR ADE," which is a silicone gel for scar management. It primarily focuses on the device's classification, intended use, and substantial equivalence to a predicate device (Kelo-Cote topical gel).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given information.

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Intended for the management of hypertrophic and keloid scars. May be used as prophylactic therapy on closed wounds which may prevent hypertrophic and keloid scarring.

Curad® Scar Therapy is a semi-occlusive, flexible pad for the management of hypertrophic scars resulting from burns, surgery, or injuries, after complete healing. The device is also intended for management of keloid scars. It may be used as a prophylactic therapy on closed wounds which may prevent hypertrophic and keloid scarring. It is intended for over-the-counter use.

Curad® Scar Therapy consists of an adhesive aliphatic polyurethane matrix. Embedded in this matrix are absorbent sodium polyacrylate particles. The product has a waterproof polyurethane film that is permeable to oxygen and water vapor.

The Curad® Scar Therapy pads are individually sealed in envelopes and packaged in cartons of 21 pads. The size of the pads is 7x4 cm. The pad is intended to be exchanged daily for a new pad, and may remain in place 24 hours a day. Treatment should consist of at least 12 hours a day for at least eight weeks.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Curad® Scar Therapy device, structured according to your request:

Device: Curad® Scar Therapy

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not explicitly state the sample size used for the efficacy clinical studies or the data provenance (country of origin, retrospective/prospective). It only makes a general statement about "Clinical studies".

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide information on the number or qualifications of experts used to establish ground truth for the clinical studies. Given the nature of scar assessment, it is likely that clinicians (e.g., dermatologists, plastic surgeons) would have been involved, but this is not specified.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the clinical studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

The document does not mention an MRMC comparative effectiveness study or any effect size related to human reader improvement with or without AI assistance. This device is a topical medical device, not an AI-powered diagnostic tool, so an MRMC study would generally not be applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the device is a physical scar therapy pad and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

Based on "Clinical studies have demonstrated that Curad® Scar Therapy is as effective as the Mepiform in the management and reduction of hypertrophic and keloid scars," the ground truth for efficacy would likely be based on clinical assessment of scar appearance and characteristics by medical professionals. This could involve subjective ratings (e.g., Vancouver Scar Scale, patient satisfaction) or objective measurements (though not specified). It is not pathology or direct outcomes data in the sense of mortality or disease progression, but rather clinical improvement in a visible condition.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical scar therapy pad and does not involve AI or machine learning models that require a "training set."

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reason as point 8.

Summary of Study Information Provided in the 510(k):

The 510(k) summary for Curad® Scar Therapy relies on demonstrating substantial equivalence to predicate devices (Cutinova®thin Wound Dressing and Mepiform Adherent Silicone Dressing).

• Safety: Demonstrated through "biocompatibility studies and long-term use" of the device's polyurethane pad, claiming it "does not raise new issues of safety" since it's applied only to intact skin.
• Efficacy: Stated that "Clinical studies have demonstrated that Curad® Scar Therapy is as effective as the Mepiform in the management and reduction of hypertrophic and keloid scars," implying a comparative clinical study against the Mepiform predicate. However, specific details about these clinical studies (e.g., sample size, methodology, endpoints, blinding) are not provided in this summary document. The submission is primarily focused on asserting equivalence rather than detailing the full clinical study report.

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[Trade Name] silicone sheeting is indicated for management of hypertrophic scars and keloids. Consistent use of [Trade Name] can reduce hypertrophic scarring and keloid formation, resulting from surgical or traumatic injury of the skin. [Trade Name] may be useful as a prophylaxis after surgical or traumatic dermal injury to aid in the prevention of hypertrophic scars and keloids.

[Trade Name] is a self-adhesive, fabric-backed, semi-disposable silicone sheet. The main component of the product is a proprietary material called Silon®. The basic Silon material is made from a blend of medical grade silicone and polytetrafluoroethylene ("PTFE") in the form of an interpenetrating polymer network. [Trade Name] is not sterile and does not contain antibiotics. [Trade Name] is not intended for use on open wounds. Each package of [Trade Name] contains 30 individual sheets (1.5" x 3"). Each sheet can be cut to fit the size of the scar or applied side-by-side, depending on the size of the scar.

This 510(k) submission does not contain information about acceptance criteria or a study demonstrating that the device meets such criteria. The document states "Performance Data: Not applicable" and primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and biocompatibility testing.

Therefore, I cannot provide the requested information.

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The intended use for the DIMISIL Scar Gel is topical management of keloid or hypertrophic scars secondary to trauma of the skin by surgery, burns, abrasions or lacerations. Not for use on open wounds.

The DIMISIL Scar Gel is manufactured from a medical grade silicone gel and is an amorphous paste that has minimal to no elasticity or strength. The scar gel is supplied in 0.34 fl. oz. (10ml) tubes. The DIMISIL Scar Gel is intended to be used for topical management of keloid or hypertrophic scars secondary to trauma of the skin by surgery, burns, abrasions or lacerations.

This document is a 510(k) premarket notification for a medical device called DIMISIL Scar Gel. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for an AI/ML device.

Here's why and what information can be extracted:

This document describes a traditional medical device (a scar gel), not an AI/ML device. Therefore, the concepts of "acceptance criteria" and "study proving device meets acceptance criteria" for AI/ML performance metrics (like sensitivity, specificity, F1 score, etc.) are not applicable here.

Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices based on design, materials, function, and intended use.

However, I can extract information relevant to the device and its regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance

As explained above, traditional performance metrics and acceptance criteria for an AI/ML device are not present. The "performance" for this device relates to its equivalence to predicate devices for scar management.

The following numbered points are specific to AI/ML device studies and are therefore not applicable to this document:

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML device.
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. The "ground truth" here is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of what this document does provide:

• Device Name: DIMISIL Scar Gel
• Intended Use: Topical management of keloid or hypertrophic scars secondary to trauma of the skin by surgery, burns, abrasions or lacerations. Not for use on open wounds.
• Predicate Devices: Kelocote (marketed by Allied Biomedical Corporation) and Kelocote Scar Gel (marketed by Hanson Medical, Inc.).
• Basis for Equivalence: Substantial equivalence in function, design, performance, and materials to the predicate devices.
• K Number: K023678
• Date of Submission: Received November 1, 2003 (Dated October 28, 2002)
• Date of FDA Decision: January 23, 2003 (as per the stamp)

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Oleeva Fabric is indicated for the management of hypertrophic scars and keloids. Consistent use of Oleeva Fabric can reduce hypertrophic scaring and keloid formation resulting from surgical or traumatic injury of the skin.

Oleeva Fabric may be useful as a prophylaxis after surgical or traumatic dermal injury to aid in the prevention of hypertrophic scars and keloids.

Oleeva Fabric is used topically to reduce hypertrophic scars and keloids. Consistent use of Oleeva may minimize scars resulting from traumatic or surgical injuries. Oleeva can reduce existing scars, and may be used after traumatic or surgical injury to aid in the prevention of new scars.

The provided document is a 510(k) summary for the Oleeva® Fabric, a silicone elastomer for scar management. It discusses the device identification, classification, product description, and indications for use. Crucially, it asserts substantial equivalence to existing predicate devices rather than presenting a study demonstrating new acceptance criteria or device performance against specific targets.

Therefore, many of the requested categories in your prompt are not applicable (N/A) based on the content of this document, as a clinical study with detailed performance metrics and ground truth establishment was not part of this 510(k) submission.

Here's a breakdown of the information that can be extracted or determined to be N/A:

1. A table of acceptance criteria and the reported device performance

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 for Test Set: N/A. No clinical test set data is presented for this 510(k) submission. The submission relies on substantial equivalence.
• Data Provenance: N/A.

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: N/A. No clinical test set data where ground truth would need to be established is presented.
• Qualifications of Experts: N/A.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: N/A. No clinical test set.

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: N/A. This is a medical device (silicone fabric), not an AI-powered diagnostic or assistive technology for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Standalone Performance: N/A. This is a medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Type of Ground Truth: N/A. No clinical study requiring ground truth generation is described. The basis for approval is substantial equivalence to legally marketed predicate devices, supported by biocompatibility testing.

8. The sample size for the training set

• Sample Size for Training Set: N/A. This is a medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

• Ground Truth for Training Set: N/A.

Summary based on the provided text:

This 510(k) submission for Oleeva® Fabric is based on demonstrating substantial equivalence to existing legally marketed predicate devices (Oleeva Fabric K982036, Oleeva Foam K002109, and other silicone sheeting products from Bio Med Sciences, Inc.). The document explicitly states: "The new device is substantially equivalent to the existing Oleeva Fabric product (K982036), Oleeva Foam (K002109), as well as the other silicone sheeting products manufactured by Bio Med Sciences, Inc."

The primary "evidence" in this submission, beyond the claim of equivalence, is a biocompatibility summary, indicating the product's safety for human contact. It passes the following tests in conformity with EN/ISO 10993 guidelines:

• Kligman Maximization
• Primary Dermal Irritation
• Agarose Diffusion Cytotoxicity

The FDA's response letter confirms that the device is deemed "substantially equivalent" to predicate devices for its stated indications for use, thereby permitting its marketing. This regulatory pathway does not typically involve new clinical studies to prove performance against novel acceptance criteria but rather a demonstration that the new device is as safe and effective as a device already on the market.

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