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Jobst Ready-To-Use Arm Sleeve may be used under the direction of a healthcare professional to manage the flowing conditions: Edema Mild to moderate lymphedema Phlebitis Post-thrombotic syndrome Vascular Malformations Hypertrophic scars

This submission covers JOBST Ready-To-Wear Compression Arm Sleeves, which fall under the device classification of medical support stockings (21 CFR §880.5780). They are equivalent to the preamendment Jobst-Custom garments, and the SIGVARIS 902/503 Arm Sleeves, which are used for the same indications. While Jobst-Custom garments are cut and sewn from fabric made of spandex and nylon varns, the SIGVARIS 902 and JOBST Ready-To-Wear Arm Sleeves are circular knit with spandex and nylon yarns. The sizing of the Ready-To-Wear Arm Sleeves is based on circumferential measurements of the wrist, forearm and mid-upper arm and is limited to people whose arm dimensions fall within the specified ranges. The Jobst-Custom garments are sized based on measurements taken every inch and a half. They can be made to fit a wider range of limb dimensions and a wider range of compression as needed by the individual patient. Compression is provided for all of these products by large elastic yarns that act circumferentially on the limb. The gradient compression present in these products helps to force fluid into the deep venous system and helps in the return of lymphatic fluid.

The provided text is a 510(k) summary for a medical device (compression arm sleeves) and an FDA clearance letter. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, or ground truth establishment for an AI/ML device.

This document pertains to a traditional medical device (compression garments) that gained market clearance through the "substantial equivalence" pathway, meaning it was deemed as safe and effective as existing legally marketed predicate devices. This type of submission relies on comparisons to established devices and typically does not involve the rigorous testing and validation studies outlined in your request, which are more applicable to novel diagnostic or AI/ML-driven devices.

Therefore, I cannot extract the requested information from the provided text.

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Cutinova foam is indicated for the management of surface, moderately to highly secreting wounds surrounded by sensitive skin, such as: Stage I-IV pressure ulcers Leg ulcers Diabetic ulcers First and second degree burns

Cutinova foam may be used under the direction of a health care professional for the management of moderately to highly exudating wounds surrounded by sensitive skin, such as: Pressure ulcers Leg ulcers Diabetic ulcers Second degree burns

Cutinova foam is a polyurethane dressing that is indicated for the management of moderately to highly exudating wounds surrounded by sensitive skin. The current modification involves a change in the material used to make the urethane from an aromatic diisocyanate to an aliphatic diisocyanate and does not affect the indications for use.

The provided text describes a 510(k) submission for a modification to an existing wound dressing, Cutinova foam. The submission focuses on demonstrating substantial equivalence to the predicate device, not on proving new efficacy or performance standards through extensive clinical studies. Therefore, many of the requested categories for a typical medical device study are not applicable or explicitly mentioned in this document.

Here's an analysis based on the provided text:

Acceptance Criteria and Study for Cutinova foam - K984599

Study Details:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   The document does not specify a "test set" in the context of human subjects or clinical data for performance comparison. The biological tests were conducted in accordance with ISO 10993, which are standardized laboratory tests. No information is provided regarding the specific number of samples or data provenance for these biological or performance characteristics tests beyond the standard ex vivo or in vitro nature implied by ISO 10993.

2. 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 study described is not a diagnostic or clinical study requiring expert ground truth in the traditional sense. The "ground truth" for the substantial equivalence claim relies on standardized biological testing and comparative performance evaluations against a predicate device.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable. No clinical test set with adjudicated outcomes is described.

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/imaging device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This is not an AI/imaging device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   The ground truth used for demonstrating substantial equivalence was based on:

   • Biological testing results: Conformance to ISO 10993 standards for biocompatibility.
   • Comparative performance characteristics: Evaluation against the predicate device's established performance.
   • Safety information from international databases: Used as supporting evidence.

7. The sample size for the training set:
   Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device. The "training data" for the device's design would effectively be the knowledge and experience used to develop the predicate device and the understanding of material science.

8. How the ground truth for the training set was established:
   Not applicable. As there's no training set mentioned for an AI/machine learning device, this question is not relevant to the provided text.

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Cutinova thin is a dressing indicated for the management of surface wounds with low to moderate exudate, such as: Minor burns Abrasions Cutinova thin may also be used under the direction of a health care professional for partial thickness wounds such as: Second degree burns Leg ulcers Pressure ulcers Post-op wounds Donor sites

Cutinova thin is a polyurethane dressing that is indicated for the management of wounds with low to moderate exudate. The current modification involves a change in the material used to make the urethane from an aromatic diisocyanate to an aliphatic diisocyanate and does not affect the indications for use.

The provided text is a 510(k) summary for a medical device modification, specifically for the Cutinova® thin wound dressing. It details regulatory information and a brief summary of testing, but it does not contain the specific information requested in the prompt regarding acceptance criteria and a detailed study's results.

Here's an analysis based on the provided text, Highlighting the information that is not present:

1. Table of acceptance criteria and the reported device performance:

• Not present in the document. The document states "Performance characteristics were also comparable to the currently marketed product," but it does not define these characteristics, their acceptance criteria, or the specific quantitative results achieved.

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

• Not present in the document. The document mentions "Biological tests were done in accordance with ISO 10993" and "Performance characteristics were comparable," but it does not specify the sample sizes used for these tests, the type of study (retrospective or prospective), or the data's origin.

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 / Not present. This type of information is typically relevant for studies involving human interpretation (e.g., image analysis, diagnoses). The described tests are biological and performance characteristic tests for a wound dressing, which do not involve human expert consensus for ground truth as would be seen in diagnostic device studies.

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

• Not applicable / Not present. Similar to point 3, adjudication methods are for expert consensus on subjective assessments. The tests described are laboratory-based biological and performance tests.

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 wound dressing, not an AI-powered diagnostic tool, so an MRMC study is not relevant.

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

• Not applicable. This device is a wound dressing, not an algorithm, so standalone performance is not relevant.

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

• Implied by the tests, but not explicitly stated as 'ground truth'. For biological tests (ISO 10993), the ground truth generally refers to established biological safety standards or predetermined acceptable ranges for various biological responses (e.g., cytotoxicity, sensitization, irritation). For performance characteristics, the "ground truth" would be the established performance metrics of the predicate device. However, the document doesn't detail how these were specifically established.

8. The sample size for the training set:

• Not applicable / Not present. Training sets are relevant for machine learning/AI models. This document describes a physical medical device.

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

• Not applicable. As above, training sets and ground truth establishment for them are not relevant to this type of device.

In summary, the provided K984593 510(k) summary focuses on demonstrating substantial equivalence through:

• Biological testing: "Biological tests were done in accordance with ISO 10993 and showed no negative effects for the modified Cutinova thin." (This implies a comparison against safety standards).
• Performance characteristics comparison: "Performance characteristics were also comparable to the currently marketed product." (This implies a comparison against the predicate device's performance).
• Material change justification: The primary change is a material alteration (aromatic to aliphatic diisocyanate) and the addition of a small amount of Vitamin E for thermal stability, which the submission argues does not affect the indications for use or safety/effectiveness.

The document does not provide the detailed study results, specific acceptance criteria values, or sample sizes common in a detailed study report for a diagnostic or AI-powered device. Its purpose is to demonstrate substantial equivalence to a predicate device for regulatory clearance, not to publish a comprehensive scientific study.

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Cutinova cavity is indicated for the management of deep secondary healing wounds such as: Cavity wounds Stage III and IV pressure ulcers Deep leg ulcers Excisions Post-op wound dehiscence

Cutinova cavity is a polyurethane dressing that is indicated for the management of deep secondary healing wounds. The current modification involves a change in the material used to make the urethane from an aromatic disocyanate to an aliphatic diisocyanate and does not affect the indications for use.

The provided text describes a 510(k) submission for a modification to a wound dressing, Cutinova cavity, and the FDA's response. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML medical device.

The document is a regulatory filing for a medical device (wound dressing), not an AI/ML algorithm. Therefore, the questions related to AI/ML device performance, such as sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance, are not applicable to this submission.

The "Summary of Safety and Effectiveness" (K984597) states:

• Modification: Change in the material used to make the urethane from an aromatic diisocyanate to an aliphatic diisocyanate, and the addition of a very small amount of α Tocopherol to improve thermal stability. The indications for use remain unchanged.
• Study/Testing: "Biological tests were done in accordance with ISO 10993 and showed no negative effects for the modified Cutinova cavity. Performance characteristics were also comparable to the currently marketed product."

Based on this, the "acceptance criteria" appear to be:

1. Biocompatibility: No negative effects as per ISO 10993.
2. Performance: Comparable to the previously cleared Cutinova cavity.

However, specific quantitative acceptance criteria (e.g., "tensile strength must be >X MPa") and detailed results of "comparable performance characteristics" are not provided in this summary. The document focuses on establishing substantial equivalence to a predicate device for regulatory approval, rather than a detailed performance study with explicit acceptance criteria for an AI/ML algorithm.

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Cutinova hydro is indicated for the management of surface, moderately to highly secreting wounds such as: Leg ulcers Stage I-IV pressure ulcers First and second degree burns

Cutinova hydro is a polyurethane dressing that is indicated for the management of moderately to highly exudating wounds. The current modification involves a change in the material used to make the urethane from an aromatic diisocyanate to an aliphatic disocyanate and does not affect the indications for use.

The provided text is a 510(k) premarket notification for a medical device called Cutinova Hydro. It describes a modification to an already cleared wound dressing and aims to demonstrate substantial equivalence to the predicate device.

Regarding acceptance criteria and study information, the document unfortunately does not contain the detailed information you've requested for typical AI/ML device studies. This is because:

• It's a modification of a physical wound dressing, not an AI/ML device. The "device" in this context is a physical product (a polyurethane dressing), not a software algorithm. Therefore, the types of studies and acceptance criteria (e.g., sensitivity, specificity, F1 score) associated with AI/ML performance metrics are not applicable here.
• The regulatory submission is for substantial equivalence (510(k)). This type of submission focuses on demonstrating that the modified device is as safe and effective as a legally marketed predicate device, rather than proving novel performance against specific clinical acceptance criteria in the way an innovative AI device would.

However, I can extract the relevant information presented in the provided text as it pertains to the safety and performance of this physical device:

Summary of Safety and Effectiveness for Cutinova® hydro - K984595

This submission is for a modification to an existing wound dressing, Cutinova hydro. The modification involves changing the material used for the urethane from an aromatic diisocyanate to an aliphatic diisocyanate and adding a small amount of an antioxidant (alpha-tocopherol) to improve thermal stability.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not specified. The document only states "Biological tests were done" and "Performance characteristics were also comparable."
• Data Provenance: Not specified. The study types (biological tests, performance characteristic comparisons) suggest laboratory-based testing rather than clinical data from patients.

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

• Not applicable. This is not an AI/ML device, and the evaluation relies on standardized biological and performance testing, not expert interpretation of outputs.

4. Adjudication Method for the Test Set

• Not applicable. (See #3)

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/ML device.

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

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

7. The type of ground truth used

• Ground Truth for Biocompatibility: Compliance with ISO 10993 standards and established toxicology/biocompatibility protocols.
• Ground Truth for Performance Characteristics: Comparative measurements against the established performance of the predicate device (the original Cutinova hydro) using standardized material testing methods.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device. There is no concept of a "training set" for the modification of a physical wound dressing; rather, it would be R&D and manufacturing process optimization.

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

• Not applicable. (See #8)

Conclusion from the document:

"Based on safety information in international data bases, biological testing and performance characteristics, it can be concluded that the modified Cutinova hydro is substantially equivalent to the current legally marketed Cutinova hydro."

Important Note on Indications for Use based on FDA Letter (March 19, 2007 - Correction Letter):

While the submission states the modification does not affect the indications for use, the FDA's corrected letter imposes specific labeling limitations:

• May not be labeled for use on third-degree burns.
• May not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
• May not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
• May not be labeled as a treatment or a cure for any type of wound.

The 510(k) submission document itself (Page 4 & 5) lists the intended indications:

• Management of surface, moderately to highly exudating wounds such as:
  • Leg ulcers
  • Pressure ulcers (Stage I-IV, though the FDA approval slip on page 4 just says 'Pressure ulcers')
  • Second-degree burns.

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