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Under the supervision of a healthcare professional, the Silver Hydrofiber® Wound Dressing Reinforced with Nylon may be used for the management of:

• Partial thickness (second degree) burns; .
• Diabetic foot ulcers, leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of . mixed etiology) and pressure ulcers/sores (partial and full thickness);
• Wounds as an effective barrier to bacterial penetration of the dressing as this may help . reduce infection;
• Surgical wounds left to heal by secondary intention such as dehisced surgical incisions; .
• Surgical wounds that heal by primary intention such as dermatological and surgical . incisions (e.g., orthopedic and vascular)
• . Traumatic wounds
• Wounds that are prone to bleeding, such as wounds that have been mechanically or . surgically debrided and donor sites
• Oncology wounds with exudate, such as fungoides-cutaneous tumors, fungating t carcinoma, cutaneous metastasis, Kaposi's sarcoma and angiosarcoma
• Management of painful wounds .
• . Infected wounds

Silver Hydrofiber® Reinforced with Nylon Wound Dressings is a soft, sterile, non-woven flat dressing composed of hydrocolloid fibers (sodium carboxymethylcellulose), that is reinforced with nylon stitching and that contain 1.2% ionic silver which allows for an average of 12mg of silver for a 4 inch x 4 inch dressing. The silver in the dressing kills wound bacteria held in the dressing and provides an antimicrobial barrier to protect the wound bed. This dressing absorbs high amounts of wound fluid and bacteria and creates a soft, cohesive gel that intimately conforms to the wound surface, maintains a moist environment and aids in the removal of nonviable tissue from the wound (autolytic debridement). The moist wound healing environment and control of wound bacteria supports the body's healing process and helps reduce the risk of wound infection.

This document is a Premarket Notification (510(k)) for a medical device – a wound dressing. While it discusses the device's indications, substantial equivalence to a predicate device, and the general safety and effectiveness, it does not contain the specific details of a study that establishes acceptance criteria and then proves the device meets those criteria.

The document states:

"Extensive clinical testing, including controlled GCP studies, has been carried out with AQUACEL® Ag (the predicate). The results of these studies have consistently demonstrated that the products are safe and effective dressings in the treatment of a wide range of wound types. ... See 510(k) #K080383 for details."

And also:

"...extensive clinical investigations with Silver Hydrofiber® Dressings Reinforced with Nylon were not considered necessary to confirm the clinical safety and performance for all indications, however, a single study has been carried out in partial thickness burns, which is anticipated to be the major indication for this product..."

Therefore, I cannot provide the requested information in the format of a table detailing acceptance criteria and reported device performance from this document because it is not present. The document defers to a previous 510(k) (K080383) for the predicate device's studies and mentions a single study for the current device without providing its details.

To answer your request, I would need access to the K080383 submission and/or the details of the "single study...carried out in partial thickness burns" referenced in K090254.

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For Over-the-Counter Use, AQUACEL® Ag with Hydrofiber® Silver Impregnated Antimicrobial Dressing may be used for:

• Abrasions
• Lacerations
• Minor cuts
• Minor scalds and burns

Under the supervision of a healthcare professional, AQUACEL® Ag Hydrofiber Dressing may be used for the management of:

• Wounds as an effective barrier to bacterial penetration of the dressing as this may help reduce infection
• Partial thickness (second degree) burns
• Diabetic foot ulcers, leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) and pressure ulcers/sores (partial & full thickness)
• Surgical wounds left to heal by secondary intention such as dehisced surgical incisions
• Surgical wounds that heal by primary intent such as dermatological and surgical incisions (e.g., orthopedic and vascular)
• Traumatic wounds
• Wounds that are prone to bleeding such as wounds that have been mechanically or surgically debrided and donor sites
• Oncology wounds with exudate such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma and angiosarcoma
• Management of painful wounds
• Infected Wounds

For Over-the-Counter Use, AQUACEL® Hydrofiber® Wound Dressing may be used for:

• Abrasions
• Lacerations
• Minor cuts
• Minor scalds and burns

Under the supervision of a healthcare professional, AQUACEL® Hydrofiber® Wound Dressing may be used for the management of:

• Leg ulcers, pressure ulcers (Stage II-IV) and diabetic ulcers
• Surgical wounds (post-operative, donor sites, dermatological)
• Partial thickness (second degree) burns
• Traumatic or surgical wounds left to heal by secondary intention such as dehisced surgical incisions
• Surgical wounds that heal by primary intent, such as dermatological and surgical incisions (e.g., orthopedic and vascular)
• Traumatic wounds
• Local management of wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided and donor sites
• Management of painful wounds

AQUACEL® Ag Hydrofiber® (Silver Impregnated Antimicrobial Dressing) is a soft, sterile, non-woven pad or ribbon dressing composed of sodium carboxymethylcellulose and 1.2% ionic silver which allows for a maximum of 12mg of silver for a 4 inch x 4 inch dressing. The silver in the dressing kills wound bacteria held in the dressing and provides an antimicrobial barrier to protect the wound bed. This dressing absorbs high amounts of wound fluid and bacteria and creates a soft, cohesive gel that intimately conforms to the wound surface, maintains a moist environment and aids in the removal of non-viable tissue from the wound (autolytic debridement). The moist wound healing environment and control of wound bacteria supports the body's healing process and helps reduce the risk of wound infection.

AQUACEL® Hydrofiber® Wound Dressings are soft, sterile, non-woven pad or ribbon dressings composed of hydrocolloid fibers (sodium carboxymethylcelulose) These conformable and highly absorbent dressings absorb wound fluids and create a soft sel which maintains a moist environment which supports the body's healing process.

Based on the provided text, the document is a 510(k) Summary for the AQUACEL® Ag with Hydrofiber® Silver Impregnated Antimicrobial Dressing and AQUACEL® Hydrofiber® Wound Dressing. This type of regulatory submission demonstrates substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a newly conducted study with detailed statistical analysis.

The document discusses clinical studies, but these are literature reviews of existing studies on the predicate device (AQUACEL® Hydrofiber® Wound Dressing) or similar Hydrofiber® technology, used to support the safety and effectiveness for new indications or the new device (AQUACEL® Ag). It does not present a new, dedicated study designed to explicitly meet pre-defined acceptance criteria for the current 510(k) submission in the way one might assess a high-tech diagnostic algorithm.

Therefore, many of the requested categories for a study proving device acceptance criteria cannot be directly answered from this regulatory summary. However, I can extract the relevant information that is present.

Here's a breakdown of what can be inferred or explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present explicit acceptance criteria or target device performance values in a table format for a specific new study to demonstrate device capabilities against defined metrics. Instead, it relies on the established safety and effectiveness of the predicate device and the literature.

The "performance" is reported in terms of clinical outcomes from existing studies, showing the benefits of Hydrofiber® dressings.

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

The "test set" here refers to the patient cohorts involved in the summarized clinical trials, which are part of a literature review rather than a new standalone validation study for this 510(k).

• Study 1 (Ravenscroft et al.): 183 patients (85 patients randomized to AQUACEL® / Tegaderm™, 98 patients to control).
• Study 2 (Abuzakuk et al.): 61 patients (30 patients allocated to AQUACEL® hydrofiber dressing group, 31 patients to control group).
• Study 3 (Harle et al.): 100 hip replacement patients (50 patients randomized to AQUACEL® hydrofiber dressing, 50 patients to control).

Data Provenance: The studies are clinical trials, implying prospective data collection. The countries of origin are not explicitly stated, but the journal publications cited (Ann R Coll Surg Engl; Int Wound J; Journal of Orthopedic Nursing) suggest an international origin, likely including the UK (Ann R Coll Surg Engl), given the author names.

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

This question is not applicable in the context of wound care dressing clinical trials. "Ground truth" in this scenario would typically be established by clinical assessments made by healthcare professionals (e.g., surgeons, nurses) managing the patients in the trials, following established medical protocols for wound assessment and treatment. The document does not specify the number or qualifications of clinicians involved in making these assessments for the referenced studies.

4. Adjudication Method for the Test Set

The document describes the studies as "randomized controlled trials." This implies a systematic approach to patient assignment, but it does not specify any particular adjudication method (e.g., 2+1, 3+1) for evaluating outcomes. Outcomes were likely assessed by treating clinicians or independent researchers involved in the respective studies based on clinical measures (e.g., wound complications, pain scores, dressing change frequency).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable. The device is a wound dressing, not an AI-powered diagnostic or assistive technology for human readers. Therefore, an MRMC study or AI assistance is irrelevant to this submission.

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

This question is not applicable. The device is a physical wound dressing and does not involve an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth or clinical endpoints for the summarized studies were based on outcomes data directly observed in patients, such as:

• Wound complications (e.g., presence/absence of complications)
• Patient-reported pain scores
• Frequency of dressing changes
• Observations of blister formation, hematoma, and edema

These are clinical outcomes directly measured or observed in patients during the course of their treatment.

8. The Sample Size for the Training Set

This question is not applicable. The device is a wound dressing, not a machine learning algorithm that requires a training set. The clinical data summarized are for demonstrating safety and effectiveness for regulatory clearance, not for training an AI model.

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

This question is not applicable, as there is no training set for a wound dressing.

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For Over - the - Counter use, Aquacel Hydrofiber Wound Dressing may be used for: abrasions, lacerations, minor cuts, and minor scalds and burns. Under the supervision of a health care professional, Aquacel may be used for the management of: leg ulcers, pressure ulcers (Stage II-IV) and diabetic ulcers, surgical wounds (post-operative, donor sites, dermatological), second degree burns. Aquacel may also be used for: management of surgical or traumatic wounds that have been left to heal by secondary intention, local management of wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided, donor sites, and traumatic wounds, the management of painful wounds.

AQUACEL® dressing is a soft, sterile, non-woven pad or ribbon dressing composed of hydrocolloid fibers (sodium carboxymethylcellulose).

Here's an analysis of the acceptance criteria and study information for the AQUACEL® Hydrofiber® Wound Dressing, based on the provided text:

Acceptance Criteria and Device Performance for AQUACEL® Hydrofiber® Wound Dressing

Unfortunately, the provided text does not explicitly state quantitative acceptance criteria for pain reduction. The studies described are comparative, aiming to show that AQUACEL® performs equally well or better than other dressings in terms of pain management. Therefore, the "acceptance criteria" are implied to be demonstrating comparable or superior performance to existing wound dressings.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes Used for the Test Set and Data Provenance:

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

The ground truth for pain assessment in these studies is primarily patient-reported pain scores (e.g., "no pain, mild pain, moderate pain," "analogue scale," "visual analogue scales") and, in one instance, observation of behavior for non-verbal children.

The text does not specify a number of "experts" used to establish ground truth in the traditional sense (e.g., radiologists interpreting images). Instead, the patients themselves provided the primary data for pain perception. Clinicians involved in the studies would have been healthcare professionals managing wounds, but their role was in administering the treatments and collecting patient data, not acting as independent adjudicators of the "truth" of pain.

4. Adjudication Method for the Test Set:

There is no explicit mention of an adjudication method (like 2+1 or 3+1 consensus) for the "test set" in the context of pain assessment. As noted above, the "ground truth" for pain is directly reported by the patient. For observational assessments (e.g., for non-verbal children), the text doesn't specify if multiple observers were used or if a consensus method was employed. The studies are described as "controlled" and "randomized," indicating rigorous design for comparing treatments.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Based on the provided text, there is no MRMC comparative effectiveness study described for human readers improving with AI vs. without AI assistance. The device is a wound dressing, and the studies focus on its clinical performance in pain management, not on AI-assisted diagnostic or interpretative tasks.

6. Standalone (Algorithm Only) Performance:

This question is not applicable as AQUACEL® is a physical wound dressing and not an algorithm or AI-powered device.

7. Type of Ground Truth Used:

The primary type of ground truth used is patient-reported outcomes, specifically:

• Subjective pain assessment: Rated by patients as "no pain, mild pain, moderate pain," or using "analogue scales" and "visual analogue scales."
• Behavioral observation: For non-verbal children, pain was assessed by observation of behavior.

8. Sample Size for the Training Set:

The provided text does not describe a "training set" in the context of machine learning or AI. The studies are clinical trials comparing the dressing's performance against other dressings or standard care. Therefore, there's no distinction between a "training set" and "test set" in the AI sense for this product. The sample sizes mentioned above (e.g., 44, 40, 85 patients in ConvaTec studies, 100, 23, 22 in published reports) represent the total patient cohorts for these clinical performance studies.

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

As there is no "training set" in the AI sense, this question is not applicable. The ground truth for pain assessment in the clinical studies was established directly from patient reporting or observation, as described in point 7.

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For over-the-counter use, Absorbent Antimicrobial Wound Dressing may be used for minor abrasions, lacerations, minor cuts, minor scalds and burns.

Under the supervision of a health care professional, Absorbent Antimicrobial Wound Dressing is an effective barrier to bacterial penetration, which may help reduce infection in partial thickness (second degree) burns, diabetic foot ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology) and pressure ulcers/sores (partial & full thickness), surgical wounds left to heal by secondary intent, traumatic wounds, wounds that are prone to bleeding such as wounds that have been mechanically or surgically debrided and oncology wounds with exudate such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma and angiosarcoma.

Absorbent Antimicrobial Wound Dressing may be used on minimally exuding, non-exuding and dry wounds as stated in the DIRECTIONS FOR USE.

Absorbent Antimicrobial Wound Dressing is composed of sodium carboxymethylcellulose and ionic silver. In contact with wound exudate, the highly absorbent dressing creates a soft, cohesive gel that forms an intimate contact with the wound surface and maintains a moist woundhealing environment.

The provided text describes a 510(k) premarket notification for a medical device called "Absorbent Antimicrobial Wound Dressing." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.

Therefore, many of the requested sections regarding acceptance criteria, study design, sample sizes, expert ground truth, and comparative effectiveness studies are not applicable or available in this document. The submission relies on comparative bench testing and biocompatibility testing to establish substantial equivalence.

Here's a breakdown of the available information:

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

This information is not provided in the document. The 510(k) process for this device focuses on demonstrating substantial equivalence to a predicate device rather than meeting specific quantifiable performance criteria against a predefined standard. The document mentions "comparative bench testing" and "biocompatibility testing," but does not detail the acceptance criteria or specific performance results from these tests in a table format.

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

This information is not provided in the document. The document mentions "comparative bench testing" but does not specify the sample sizes or data provenance (country of origin, retrospective/prospective). It also mentions "biocompatibility testing."

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 provided. For bench testing and biocompatibility testing, "ground truth" as it relates to expert consensus for diagnostic or prognostic devices is not relevant. The ground truth for such tests typically relies on established laboratory standards and measurement protocols rather than expert human interpretation.

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

This information is not applicable or provided. Adjudication methods are typically relevant for studies involving human interpretation or clinical endpoints, not for bench testing or biocompatibility testing as 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 information is not applicable or provided. The device in question is a wound dressing, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is not relevant.

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

This information is not applicable or provided. The device is a wound dressing, not an algorithm. Standalone algorithm performance is not relevant.

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

For the biocompatibility testing, the ground truth would be established through laboratory standards and measurements as defined by relevant ISO or ASTM standards for biocompatibility (e.g., cytotoxicity, sensitization, irritation indices).

For the comparative bench testing, the ground truth would be based on physical and chemical measurements comparing the Absorbent Antimicrobial Wound Dressing's properties (e.g., absorbency, silver release) against those of the predicate device (Acticoat™ Silver Coated Wound Dressing) using defined laboratory protocols. The document does not specify what specific parameters were measured or how ground truth for those parameters was established, other than implying standard laboratory methods.

8. The sample size for the training set

This information is not applicable or provided. The development of a wound dressing does not typically involve a "training set" in the context of machine learning. The product development would involve iterative design, formulation, and testing, but not a training set as understood in AI systems.

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

This information is not applicable or provided, as there is no "training set" in the context of this traditional medical device submission.

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For Over-The-Counter use SignaDRESS™ DuoDERM® Dressing may be used on abrasions, minor cuts, minor scalds and burns, and skin tears. Under the supervision of a health care professional, SignaDRESS may be used for wounds such as leg ulcers ( venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology), pressure ulcers (Stage I-IV) and diabetic ulcers, surgical wounds (postoperative wounds, donor sites, dermatological excisions), and burns (first and second degree).

SignaDRESS™ DuoDERM® Dressing is a sterile hydrocolloid dressing that, over-the-counter, may be used on abrasions, lacerations, minor cuts, minor scalds and burns and skin tears. Under the supervision of a healthcare professional, SignaDRESS may be used for wounds such as leg ulcers (venous stasis ulcers, aertial ulcers and leg ulcers of mixed aetiology), pressure ulcers (Stage I-IV) and diabetic ulcers, surgical wounds (post-operative wounds, donor sites, dermatological excisions), and burns (first and second degree).

This document is a 510(k) Premarket Notification for the SignaDRESS™ DuoDERM® Dressing. It establishes the device's substantial equivalence to a predicate device but does not contain a study detailing acceptance criteria and device performance. Instead, it focuses on regulatory approval based on equivalence and safety data from a previous submission.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details for a study, as this document does not describe such a study.

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For over-the-counter use, HA Absorbent Wound Dressing-F may be used for wounds such as: abrasions, lacerations, minor cuts and first degree burns. Under the supervision of a healthcare professional, HA Absorbent Wound Dressing-F may be used for wounds such as: leg ulcers, pressure ulcers (stages I-IV), and diabetic ulcers; surgical wounds (post-operative, donor sites, dermatological), second degree burns; management of wounds that are prone to bleeding such as wounds that have been mechanically or surgically debrided, donor sites, and traumatic wounds.

HA Absorbent Wound Dressing-R is indicated for use in the management of deep exuding wounds, sinuses, and fistulae.

HA Absorbent Wound Dressing is an absorbent fibrous fleece (F) or rope (R), entirely composed of HYAFF 11p757M, a benzyl ester of hyaluronic acid.

Here's a breakdown of the acceptance criteria and study information for the HA Absorbent Wound Dressing, based on the provided text:

HA Absorbent Wound Dressing

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes the HA Absorbent Wound Dressing and its substantial equivalence to predicate devices, but does not explicitly state quantitative acceptance criteria or provide specific device performance metrics in numerical form (e.g., absorption rate in mL/cm², healing time in days, etc.).

Instead, the "performance" is demonstrated through:

• Substantial Equivalence: The device is deemed substantially equivalent to legally marketed predicate devices (FIBRACOL Collagen-Alginate Wound Dressing and Knitted Wound Dressing) based on composition, function, and intended use.
• Biocompatibility Testing: The device passed standard toxicity tests.

Therefore, a direct table of "Acceptance Criteria" and "Reported Device Performance" as typically expected for diagnostic AI/ML devices is not present in this type of submission for a wound dressing. The "acceptance criteria" for clearance in this context are primarily demonstrating substantial equivalence and safety.

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

The provided document does not describe a "test set" in the context of an algorithm or AI system evaluation. This submission is for a physical medical device (wound dressing), and its clearance is based on substantial equivalence to predicate devices and biocompatibility testing, not on clinical performance data in a "test set" as understood for AI/ML devices. Therefore, these categories are not applicable.

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

Not applicable. As above, there is no "test set" or "ground truth" establishment for an algorithm in this submission.

4. Adjudication Method for the Test Set:

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is not an AI/ML device.

6. Standalone (Algorithm Only) Performance:

Not applicable. This is not an AI/ML device.

7. Type of Ground Truth Used:

Not applicable in the context of an algorithm. For the physical device, the "ground truth" or basis for acceptance relies on:

• Predicate Device Equivalence: The established safety and effectiveness of the legally marketed predicate devices.
• Biocompatibility Standards: Pre-defined standards for biological safety testing of medical devices.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary for the HA Absorbent Wound Dressing (K984388):

This submission is for a physical medical device (a wound dressing), not an AI/ML-driven device. As such, the concept of "acceptance criteria" and "study" as typically applied to AI performance (e.g., sensitivity, specificity, F1-score on a test set) is not directly applicable.

The "study" in this context refers to biocompatibility testing and the comparison to predicate devices to demonstrate substantial equivalence and safety. The acceptance criteria for clearance were primarily based on:

• Demonstrating the HA Absorbent Wound Dressing is substantially equivalent to legally marketed predicate devices (FIBRACOL Collagen-Alginate Wound Dressing and Knitted Wound Dressing) in terms of materials, intended use, and fundamental function.
• Passing a series of biocompatibility tests to ensure the material is safe for its intended use (non-toxic, non-hemolytic, negligible irritant, non-cytotoxic, 0% sensitization potential).

The FDA's decision letter (K984388) confirms the device's substantial equivalence and outlines specific labeling limitations, which effectively become part of the modified acceptance criteria for its marketing.

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The ConvaTec Nonwoven Pad is intended for use in the management of moderately to heavily exudating acute and chronic wounds. The dressing is indicated for minor lacerations and minor burns. Under the guidance of a healthcare professional, the dressing is also indicated for biopsies, open and closed surgical incisions and excisions, pressure ulcers, diabetic ulcers and leg ulcers such as venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology.

Nonwoven Pad is a sterile, absorbent pad dressing intended for use in the management of moderately to heavily exudating acute and chronic wounds. The dressing is indicated for minor abrasions, minor lacerations and minor burns. Under the guidance of a healthcare professional, the dressing is also indicated for biopsies, open and closed surgical incisions, pressure ulcers, diabetic ulcers and leg ulcers such as venous stasis ulcers, arterial ulcers of mixed aetiology. Nonwoven Pad absorbs wound exudate. The hydrophobic layer minimizes strike through of exudate and ensures distribution of the fluid throughout the dressing.

The provided text describes basic conformity testing for a medical device (Nonwoven Pad) for a 510(k) submission, not a study involving AI or complex statistical analysis for performance metrics as you've outlined in your request. Therefore, most of the information required for your output (like acceptance criteria for AI, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, etc.) is not present in the given document.

However, I can extract the relevant information that is available regarding acceptance criteria and the "study" that proves the device meets them, keeping in mind the limitations of the input text.

Here's a summary of what's available and an explanation of why other requested fields cannot be filled:

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: Not specified.
   • Data Provenance: Not specified, but implied to be from laboratory bench testing.

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. This device does not involve expert interpretation or AI. The tests are physical/chemical.

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

   • Not applicable. This device does not involve expert interpretation.

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. This is not an AI device.

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

   • No. This is not an AI device.

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

   • The "ground truth" for the comparative bench testing was likely the performance of the predicate device (TENDERSORB® WET PRUF® Abd Pad) for characteristics like absorbency and preventing strike-through.
   • The "ground truth" for biocompatibility was established through ISO 10993 Part I "Biological Evaluation of Medical Devices" standards.

8. The sample size for the training set

   • Not applicable. This device does not involve a "training set" in the context of machine learning.

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

   • Not applicable. This device does not involve a "training set."

Summary of the Study (as described in the text):

The "study" refers to a series of tests conducted to demonstrate the safety and effectiveness of the Nonwoven Pad, primarily through substantial equivalence to a predicate device.

• Bench Testing: Comparative bench testing was performed between the Nonwoven Pad and the predicate device, TENDERSORB® WET PRUF® Abd Pad. The purpose was to show equivalence in intended use, design, and function. The results indicated that "the two products to be equivalent." Specific metrics like absorbency or strike-through minimization are mentioned as functions of the device, implying these were likely part of the bench tests, though no specific numerical results or methodologies beyond a general statement of equivalence are provided.
• Biocompatibility Testing: The device underwent biocompatibility testing according to ISO 10993 Part I "Biological Evaluation of Medical Devices" with an FDA modified matrix. The results "demonstrate that Nonwoven Pad is considered to be non-toxic," and these tests were conducted under Good Laboratory Practices (GLP).

Conclusion on Meeting Acceptance Criteria:

Based on the provided text, the device met its acceptance criteria by demonstrating:

1. Substantial Equivalence to a legally marketed predicate device (Kendall's TENDERSORB® WET PRUF® Abd Pad) through comparative bench testing for intended use, design, and function.
2. Biocompatibility by passing tests conducted under ISO 10993 Part I and being deemed non-toxic.

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Non-woven Compress is indicated for use in the management of light to moderately exuding acute wounds such as minor burns, superficial cuts, skin tears, lacerations and abrasions and minor irritations of the skin; and light to moderately exuding chronic wounds such as diabetic ulcers, leg ulcers and pressure ulcers.

Non-woven Compress is a sterile wound dressing indicated for use in the management of light to moderately exuding acute wounds such as minor burns, superficial cuts, skin tears, lacerations and abrasions and minor irritations of the skin; and light to moderately exuding chronic wounds such as diabetic ulcers, leg ulcers and pressure ulcers. Non-woven Compress absorbs wound exudate. The absorbent material, on hydration, forms a gel which immobilizes absorbed fluid exudate and helps prevent migration. The wound contact layer is designed to facilitate easy removal from both wet and dry wounds.

The provided document is a 510(k) Premarket Notification for a Non-woven Compress wound dressing. It focuses on demonstrating substantial equivalence to a predicate device, not on clinical performance acceptance criteria based on specific metrics like sensitivity or specificity. Therefore, many of the requested items (e.g., expert ground truth, MRMC study, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified in the provided document. The comparative bench testing and biocompatibility testing were performed, but details on the number of samples or specimens are not disclosed in this summary.
• Data Provenance: Not specified for the bench testing. Biocompatibility testing was conducted in accordance with ISO 10993 Part I and GLP, implying controlled laboratory settings. The document is a submission to the US FDA.

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

• Not Applicable. This type of medical device (wound dressing) submission relies on bench testing and biocompatibility rather than expert clinical assessment of diagnostic accuracy. There is no "ground truth" in the sense of expert consensus on images or clinical outcomes for performance evaluation in this context.

4. Adjudication Method for the Test Set

• Not Applicable. As there are no expert assessments for ground truth, no adjudication method is relevant.

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

• No. An MRMC study is not relevant for this type of device. The comparison is between the new device and a predicate device through bench tests and biocompatibility, not on human reader performance.

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

• Not Applicable. This is a physical wound dressing, not a software algorithm or AI device.

7. The Type of Ground Truth Used

• For Bench Testing: The "ground truth" for bench testing would be the performance characteristics of the predicate device (Mirasorb Sponges) and predefined engineering specifications or performance standards for wound dressings. The document states "Test results show the two products to be equivalent," implying that the Non-woven Compress's performance characteristics matched those of the predicate device.
• For Biocompatibility: The "ground truth" is established by the pass/fail criteria defined in the ISO 10993 Part I standard and FDA guidance for biological evaluation.

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of a physical wound dressing and its regulatory submission. This concept applies to machine learning algorithms.

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

• Not Applicable. There is no training set for this device.

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Nonwoven Dressing is indicated for use in the management of light to moderately exuding acute wounds such as minor burns, superficial cuts, skin tears, lacerations and abrasions and minor irritations of the skin; and light to moderately exuding chronic wounds such as diabetic ulcers, leg ulcers and pressure ulcers.

Nonwoven Dressing is a sterile wound dressing indicated for use in the management of light to moderately exuding acute wounds such as minor burns, superficial cuts, skin tears, lacerations and abrasions and minor irritations of the skin; and light to moderately exuding chronic wounds such as diabetic ulcers, leg ulcers and pressure ulcers. Nonwoven Dressing absorbs wound exudate. The absorbent material, on hydration, forms a gel which immobilizes absorbed fluid exudate and helps prevent migration. The wound contact layer is designed to facilitate easy removal from both wet and dry wounds.

The provided text describes a 510(k) premarket notification for a "Nonwoven Dressing." This document is a regulatory submission for a medical device and, as such, outlines its intended use and demonstrates its substantial equivalence to a predicate device.

However, the provided text does not contain any information regarding specific acceptance criteria, a study proving the device meets those criteria, or any of the detailed aspects of a study typically associated with AI/ML device evaluations. This is because the device in question (a nonwoven dressing) is a physical medical device, not an AI/ML-based diagnostic or analysis tool. The "studies" mentioned are limited to comparative bench testing and biocompatibility testing against established standards for physical materials.

Therefore, it is not possible to complete the requested table and answer the study-related questions (2-9) in the context of an AI/ML device, as the provided document pertains to a traditional medical dressing.

Here's what can be extracted from the document regarding the device's performance based on the general information provided:

Table of Acceptance Criteria and Reported Device Performance (as far as discernible for a non-AI/ML device)

Regarding the specific questions about AI/ML device studies:

1. Sample size used for the test set and the data provenance: Not applicable. The document describes bench testing and biocompatibility testing, not a test set of data for an AI/ML model.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth in the context of AI/ML is established.
3. Adjudication method for the test set: Not applicable.
4. 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/ML device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
7. The sample size for the training set: Not applicable.
8. How the ground truth for the training set was established: Not applicable.

In summary, the provided K974823 document details a traditional wound dressing device. The "acceptance criteria" are based on its intended use, performance in comparative bench testing against a predicate, and biocompatibility, as required for a Class I/unclassified medical device. It does not involve any AI/ML components or associated studies.

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Knitted Wound Dressing Standard, WCL and Ribbon can be used in the management of acute and chronic wounds, including diabetic ulcers. The design of Standard makes it suitable for shallow or cavity wounds and Ribbon as a packing strip for cavity wounds, fistulae and sinuses.

Knitted Wound Dressing is a sterile gelling gauze. The warp (fibers running top to bottom) consist of viscose yarn, while the wefts (fibers running left right) are a co-spun alginate and viscose.

The provided text describes a 510(k) Premarket Notification for a "Knitted Wound Dressing." This document focuses on demonstrating substantial equivalence to predicate devices based on intended use, design, and performance through comparative bench testing and biocompatibility testing. It is not a study proving device performance against specific clinical acceptance criteria, especially not for an AI/ML device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth, and training data is not applicable to this document.

Here's why and what information can be extracted:

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

• Acceptance Criteria (Implied): The acceptance criteria for this type of medical device submission (510(k)) are primarily focused on demonstrating "substantial equivalence" to a legally marketed predicate device. This means the new device must be as safe and effective as the predicate.
• Reported Device Performance: The document states:
  • "Comparative bench testing was conducted on the Knitted Wound Dressing versus its substantially equivalent products. Test results show the products to be equivalent."
  • "Knitted Wound Dressing has been subjected to biocompatibility testing utilizing the ISO 10993 Part I 'Biological Evaluation of Medical Devices' with FDA modified matrix (Guidance effective July 1, 1995). The results of this testing demonstrate that Knitted Wound Dressing is considered to be non-sensitizing, non-toxic, non-hemolytic and a negligible irritant."

The following numbered items (2-9) are not applicable to this document because it describes the regulatory clearance of a physical medical device (knitted wound dressing), not an AI/ML-based diagnostic or prognostic tool that would typically involve such studies.

The document details a regulatory submission for a physical medical device. The "study" mentioned is "comparative bench testing" and "biocompatibility testing," which are laboratory-based tests comparing the physical properties and safety of the new wound dressing to existing ones. It does not involve patient data, expert interpretations, or AI/ML algorithms.

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