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The CIMPAX C-CAT Anesthesia Catheter, along with related accessory devices, is intended for the delivery of continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites for preoperative and postoperative pain management. Routes of administration may be intraoperative or percutaneous.

The CIMPAX® C-CAT catheter kit is a sterile, single use, closed tip, multi-perforated catheter with a specified fenestrated length that incoporates micro-holes placed in a spiral pattern to provide 360° drug distribution. Additonally the CIMPAX® C-CAT is radiopaque and has four graduated distance markings along the catheter length for positional reference. The kit is intended for adult patients requiring the delivery of contiguous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites for preoperative and postoperative pain management or as perineural delivery. Routes of administration may be intraoperative or percutaneous. The device is intended to be used in healthcare /hospital facilities.

The CIMPAX® C-CAT catheter is a multi-perforated catheter supplied in a kit which contains components for catheter placement. The drug infusion segment is placed between the blue tip of the catheter and the first blue marking after the tip. The catheter is designed with a specified fenestrated length that incoporates micro-holes placed in a spiral pattern to provide 360° drug distribution. Additonally the CIMPAX® C-CAT is radiopaque and has four graduated distance markings along the catheter length for positional reference. Attached to the catheter is a standard female luer lock that is compatible with and can be used with infusion pumps as well as with syringes for bolus injections with standard make luer connections.

The catheter is placed usually through an incision or wound in order to provide continuous or intermittent administration of local anesthetic to the area affected. This allows only the local nerve endings (pain receptors) to be anesthetized as opposed to giving a systemic pain relief medication to the patient.

The provided text is a 510(k) Premarket Notification from the FDA, specifically concerning the CIMPAX C-CAT Anaesthesia Catheter kit. This document is a regulatory submission for medical devices, demonstrating substantial equivalence to a legally marketed predicate device, rather than a study proving the device meets specific acceptance criteria for an AI/ML product.

Therefore, the document does not contain any information related to:

• Acceptance criteria for an AI/ML device (e.g., performance metrics like accuracy, sensitivity, specificity, AUC).
• A study proving an AI/ML device meets acceptance criteria.
• Sample sizes for test sets or data provenance for AI/ML model evaluation.
• Number of experts, qualifications of experts, or adjudication methods for establishing ground truth in the context of AI/ML.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone AI algorithm performance.
• Type of ground truth used for AI/ML model evaluation (e.g., pathology, outcomes data).
• Sample size for training sets or how ground truth was established for training sets in an AI/ML context.

The document discusses acceptance criteria and studies, but these relate to the physical and biological safety and performance of a medical catheter, not an AI/ML device. For example, it mentions:

• Non-Clinical Testing: Bench testing including mechanical and performance testing (e.g., peak tensile force, burst pressure, kink testing, liquid leakage under pressure, radiopacity, flow testing), biocompatibility, sterilization, packaging, and shelf-life testing.
• Biocompatibility Testing: According to ISO 10993-1 series, covering cytotoxicity, sensitization, irritation, systemic toxicity, Ames Test, in vitro mammalian chromosome aberration, hemolytic properties, and material mediated rabbit pyrogen.
• Flow Test: Performed according to DS/EN 1618, measuring water flow through the catheter.
• Tensile strength: Tested in accordance with ISO 10555-1.
• Packaging: Complies with ISO 11607-1:2014 and EN 865-5:2009.
• Stability: Tested according to ASTM F 1980 Accelerated Aging and ISO 11607-1:2009.
• Sterilization: Method is Ethylene Oxide (EO), complying with EN ISO 11135-1.

In summary, the provided text describes the regulatory process for a physical medical device (an anesthesia catheter) and outlines its non-clinical performance and safety testing to demonstrate substantial equivalence, not information relevant to the performance and acceptance of an AI/ML device.

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Rx:
The KA01 Chitosan Wound Dressing is indicated for the management of moderately to heavily exuding chronic wounds and acute wounds. Under medical supervision the KA01 Chitosan Wound Dressing may be used for management of:

• Pressure sores
• Diabetic ulcers
• Leg ulcers
• Donor sites and graft sites
• Surgical wounds
• Skin abrasions and lacerations
• 1st and 2nd degree burns
• Trauma wounds

OTC:
The KA01 Chitosan Wound Dressing may be used for the management of:

• Minor cuts
• Minor scalds and 1st degree burns
• Abrasions
• Lacerations

The KA01 Chitosan Wound Dressing is a sterile non-woven chitosan dressing comprising 100% chitosan fibers. The KA01 Chitosan Wound Dressing is a highly absorbent, conformable and wet integral. As wound exudate is absorbed the chitosan forms a gel, which assists in maintaining a moist environment for optimal wound healing, aids autolytic debridement, and allows intact removal.

The KA01 Chitosan Wound Dressing is intended for use as a primary dressing on a variety of chronic and acute wounds. It is intended to be secured with a semi permeable adhesive secondary dressing and to remain in place up to 7 days depending on the level of exudate. Dressings are individually packed in paper/poly pouches and terminally sterilized to achieve a SAL 106. A range of dressing sizes between 25cm2 and 220cm2 is available.

I am sorry, but based on the provided document, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, particularly with regards to the specific subsections you outlined (e.g., sample size, experts, adjudication, MRMC, standalone performance, ground truth, training set).

This document is a 510(k) premarket notification letter from the FDA to Foshan United Medical Technologies LTD regarding their KA01 Chitosan Wound Dressing. It primarily focuses on the FDA's determination of substantial equivalence to predicate devices. While it mentions "Functional and Safety Testing" including "bench testing (absorbency, gel absorbency retention, moisture content, pH), viral inactivation testing, biocompatibility testing (cytotoxicity, irritation, sensitization, systemic toxicity), packaging testing (pouch seal and transportation), sterilization validation testing, and shelf life stability testing (accelerated aged and real time)," it does not provide any specific acceptance criteria, performance metrics, or details of the studies conducted to demonstrate these, nor does it refer to any clinical studies involving human readers or AI.

The document states that the manufacturer "considers the KA01 Chitosan Wound Dressing to be equivalent to the predicate devices listed above. This conclusion is based upon the devices' similarities in intended use, design, mechanisms of action, technology and materials." This suggests the approval is based on substantial equivalence to existing devices rather than a direct demonstration of meeting new, quantifiable acceptance criteria through detailed clinical performance studies that you are asking for.

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The Iodofoam® Iodophor Foam Dressing is indicated for use in cleaning wet ulcers and wounds, including diabetic ulcers, pressure ulcers, arterial ulcers, venous stasis ulcers, and infected traumatic or surgical wounds and burns.

Iodofoam ® is a sterile, single use absorptive foam dressing consisting of polyvinyl alcohol (PVA) foam complexed with iodine to create a controlled release iodophor comprising 8% iodine (w/w). When applied to the wound, Iodofoam absorbs fluids, removing exudate, debris, and loose slough while providing a and protective covering over the wound surface. Iodofoam® releases iodine to kill bacteria in the wound dressing upon absorbing wound fluid and changes color to indicate when the iodine is depleted

The medical device in question is the Iodofoam® Iodophor Foam Dressing. The study provided focuses on demonstrating substantial equivalence to predicate devices rather than setting and meeting specific performance acceptance criteria for a novel device.

The 510(k) summary provided indicates that the primary approach to establishing substantial equivalence for the Iodofoam® Iodophor Foam Dressing was through comparison to legally marketed predicate devices: Iodoflex® Pads (K940414) and Iodosorb® Gel (K905069).

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state "acceptance criteria" in the traditional sense of a new device having to meet specific performance thresholds. Instead, it demonstrates that the Iodofoam® device's characteristics are "substantially equivalent" to two predicate devices. The study aimed to show that the new device's performance falls within the range or is comparable to existing, legally marketed devices for key characteristics.

The table below presents the comparative data points used to demonstrate substantial equivalence, which effectively serve as the "acceptance criteria" through a bracketing or comparability approach.

2. Sample size used for the test set and the data provenance

Cumulative Iodine Release:

• Sample Size: "three independent lots of each device" (Iodofoam®, Iodosorb®, and Iodoflex®). The exact number of samples per lot is not specified but implies multiple measurements per lot to establish average and lot-specific profiles.
• Data Provenance: In vitro study, conducted in distilled water under agitation at 37°C. The country of origin of the data is not specified but is implied to be from an independent lab commissioned by Progressive WoundCare Technologies. The study is prospective in nature since it was conducted specifically for this 510(k) submission.

Biocompatibility Testing & In Vivo Histology/Wound Healing Model:

• Sample Size:
  • Cytotoxicity (ISO): Not specified, typically uses cell cultures.
  • Intracutaneous Reactivity (ISO): Not specified, typically involves animal subjects.
  • Guinea Pig Maximization Testing (ISO): Not specified, typically involves animal subjects.
  • In Vivo Porcine Wound Healing Model: Not specified, but involved comparing Iodofoam®, Iodoflex®, and "PVA controls."
• Data Provenance: The document states "an independent in vitro study" for iodine release and "Biocompatibility testing (per ISO 10993)" and "in vivo porcine wound healing model" for other aspects. The country of origin is not mentioned. These studies were prospective, conducted for the purpose of the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This inquiry is not directly applicable to the type of device and studies presented. The studies involve laboratory measurements (iodine release, cytotoxicity, histology) and animal models, not human interpretation requiring expert consensus on a test set. Therefore, there are no "experts used to establish ground truth" in the context of clinical interpretation, nor are qualifications mentioned. The ground truth is established through standardized laboratory procedures and measurement protocols.

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

Not applicable. This concept is typically relevant for studies where subjective human interpretation (e.g., radiology reads) requires reconciliation or consensus, which is not the case for these laboratory and animal model studies.

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. An MRMC study is relevant for evaluating diagnostic systems involving human readers and typically artificial intelligence. The Iodofoam® Iodophor Foam Dressing is a physical wound dressing, and its evaluation does not involve human readers or AI in a diagnostic context.

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

Not applicable. This concept applies to AI algorithms and is irrelevant for a physical wound dressing device.

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

For the studies presented:

• Cumulative Iodine Release: The ground truth is objective quantitative measurement of iodine concentration (in ppm) over time through chemical analysis.
• Biocompatibility (Cytotoxicity, Intracutaneous Reactivity, Guinea Pig Maximization): The ground truth is derived from standardized in vitro and in vivo biological assays according to ISO 10993, which produce measurable endpoints (e.g., cell viability, erythema, edema).
• In Vivo Histology and Wound Healing Model: The ground truth is derived from histological examination of tissue samples and macroscopic observation/measurement of wound healing parameters in an animal model, often assessed by trained histopathologists or researchers.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set. The studies described are for direct characterization and comparison to predicate devices.

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

Not applicable, as there is no training set for this type of device evaluation.

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