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The Maxiocel Chitosan Wound Dressing is indicated for the management of moderately to heavily exuding chronic and acute wounds and to provide a barrier against bacterial penetration. Under medical supervision, the Maxiocel Chitosan Wound Dressing may be used for the management of the following wounds: Pressure sores, Diabetic ulcers, Leg ulcers, Donor sites and graft sites, Surgical wounds, Skin abrasions and lacerations, 1st and 2nd degree burns, Trauma wounds. Over-the-counter use: The Maxiocel Chitosan Wound Dressing is indicated for the management of Minor cuts, Minor scalds and 1st-degree burns, Abrasions, Lacerations and to provide a barrier against bacterial penetration.

The Maxiocel Chitosan Wound Dressing is a soft, sterile, single-use absorbent gelling wound dressing used for absorption of wound exudate. The Maxiocel Chitosan Wound Dressing helps in maintaining a moist, optimal wound healing environment, helps in autolytic debridement, and is easy to remove. The Maxiocel Chitosan Wound Dressing is provided both in prescription (Rx) and over-the-counter (OTC) forms. The Maxiocel Chitosan Wound Dressing can be kept on the wound site for up to 7 days. Dressings are individually packed in moisture-proof pouches and terminally sterilized using gamma radiation to achieve a SAL 10t. The Maxiocel Chitosan Wound Dressing can be manufactured in different sizes and are currently available in the following sizes. 18" x 18" (45 cm x 45 cm), 8"x 12" (20 cm x 30cm), 6" x 6" (15 cm x 15 cm), 4" x 4" (10 cm x 10 cm), 2" x 4" (5 cm x 10 cm), 2"x 2" (5 cm x 5cm), 1"x2" (2.5 cm x 5cm), 1"x1" (2.5 cm x 2.5 cm), 1" x 12" (2.5 cm x 30 cm).

The provided text describes information about the Maxiocel Chitosan Wound Dressing, but does not contain information related to acceptance criteria, device performance in terms of specific metrics like sensitivity or specificity, or the methodology of a study proving such performance against acceptance criteria.

The document is a 510(k) summary for an FDA submission, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific clinical performance acceptance criteria using metrics typically associated with AI/algorithm performance (like sensitivity, specificity, or AUC).

Therefore, I cannot fulfill the request as it asks for information not present in the provided text, specifically:

• A table of acceptance criteria and the reported device performance: No such table or metrics are provided. The "performance data" section details bench tests, biocompatibility tests, and bacterial barrier tests, but these are not presented as acceptance criteria with numerical performance results against them.
• Sample sized used for the test set and the data provenance: Not mentioned, as it's not an AI/algorithm performance study.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not mentioned for this type of device submission.
• Adjudication method: Not applicable/not mentioned.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is a physical wound dressing, not an algorithm.
• The type of ground truth used: Not applicable/not mentioned in the context of AI/algorithm performance. The ground truth for the non-clinical tests is the established scientific methods and standards used for those specific tests.
• The sample size for the training set: Not applicable, as this is not an AI/algorithm.
• How the ground truth for the training set was established: Not applicable, as this is not an AI/algorithm.

The document primarily focuses on:

• Biocompatibility testing: Passed, indicating non-cytotoxic, non-sensitizer, non-irritant, non-toxic, and compliant with bacterial endotoxin limits.
• Heavy metal testing: Met USP-232 limits.
• Bench performance testing: Mentioned tests like Appearance, Moisture Content, Absorbency, pH, Dispersion Test, Fluid Retention Test, and Tensile Strength. No specific numerical results or acceptance criteria are given for these, only that the "Subject Device performs as intended."
• Bacterial Barrier Testing: Demonstrated capacity to act as a barrier to bacterial penetration by showing "No bacterial growth was observed in the plates containing the Maxiocel Chitosan Wound Dressing" compared to control plates with cotton gauze that showed bacterial growth. The sample size was n=3 for test samples and n=3 for control samples.
• Sterilization and Packaging validation: Gamma radiation per ISO 11137-2, sterility assurance level (SAL) of 10^-6, and validated 3-year shelf life through real-time stability studies including seal strength, dye penetration, sterility, bacterial endotoxin, and bench performance tests.

In summary, the provided document does not contain the specific information requested about acceptance criteria and study details for an AI/algorithm-based device. It details non-clinical safety and performance testing for a wound dressing.

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MAXIO™ is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments during Computed Tomography (CT) guided percutaneous procedures.

MAXIO™ permits physician verification of patient position prior to needle advancement and monitoring of respiratory levels during the procedure. Image registration and overlay tools available in MAXIO™ are intended to provide guidance to the user during planning and instrument placement.

MAXIO™ is indicated for use with rigid straight instruments such as needles and probes used in Computed Tomography (CT) guided percutaneous interventional procedures performed by physicians trained for CT procedures on organs and anatomical structures in the thorax, abdomen and pelvis.

MAXIO™ is an image-guided, physician controlled stereotactic accessory to a Computed Tomography (CT) system, intended for the stereotactic spatial positioning and orientation of an end effector and instrument guide to assist in manual advancement of one or more instruments such as rigid straight needles and probes during CT guided percutaneous procedures on organs and anatomical structures in the thorax, abdomen and pelvis.

MAXIOTM System provides pre-operative planning assistance to the physician by creating a reconstructed 3D image model of received CT data and by visually representing the planned instrument path and position(s) of one or more instruments on the model, along with performance data provided by the instrument manufacturer or as specified by the user.

MAXIO™ permits physician verification of patient position prior to needle advancement and monitoring of respiratory for levels during the procedure. Image registration and overlay tools available in MAXIO™ are intended to provide guidance to the user during planning and instrument placement. MAXIOTM is intended to be used by physicians trained for CT procedures.

MAXIO" consists of a stereotactic device and its accessories, software loaded on a computer, and a respiratory gating system. The accessories include a patient immobilizer and skin-markers. MAXIO™ System uses single use sterile disposables viz, end effector, instrument guide and drapes.

Here's a breakdown of the acceptance criteria and the studies that prove MAXIO™ meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• 170 CT Guided Interventions:
  • Sample Size: 170 needle placements
  • Provenance: Outside of the USA (retrospective analysis of interventions performed by users of MAXIO™)
• 20-Patient Liver Ablation Study:
  • Sample Size: 20 patients, 40 tumors
  • Provenance: University of Malaya Medical Center, Kuala Lumpur (likely prospective)
• CRO-supervised study on skin marker/laser alignment:
  • Sample Size: 14 patients
  • Provenance: Global Hospitals, Chennai, India (likely prospective)
• Animal Study (needle placement accuracy):
  • Sample Size: 6 animal liver targets, 35 needle placements
  • Provenance: Memorial Sloan Kettering Cancer Center (likely prospective)
• Bench Tests: Used static phantom, not human or animal data.

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

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications for any of the studies mentioned. It generally refers to "qualified users" or "physicians trained for CT procedures." For the animal study, it mentions comparison to "freehand placement by experts," implying expert involvement but not quantifying or qualifying them.

4. Adjudication Method for the Test Set

The document does not specify any formal adjudication method (e.g., 2+1, 3+1) for establishing ground truth in any of the studies.

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

• Was it done? The document mentions an animal study where "the accuracy of needle placement with MAXIO assistance is comparable to freehand placement by experts however fewer needle manipulations, check-scans." This implies a comparison between human performance (experts doing freehand) and human performance with AI assistance (MAXIO™ assistance).
• Effect size of how much human readers improve with AI vs. without AI assistance: The document states "fewer needle manipulations, check-scans" with MAXIO™ assistance compared to expert freehand. It doesn't provide a quantitative "effect size" or specific percentage of improvement, but rather a qualitative benefit in procedural efficiency.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The accuracy targets, segmentation accuracy, and registration accuracy were demonstrated through "bench tests" using a "static phantom." This portion of the evaluation appears to be a standalone assessment of the device's capabilities without human intervention, focusing on its technical precision.

7. Type of Ground Truth Used

• Bench Tests (Accuracy, Segmentation, Registration): Likely based on precisely known measurements from a static phantom and potentially expert-defined benchmarks or measurements for segmentation/registration.
• Clinical/Animal Studies:
  • Needle Placement Accuracy: Most likely determined by subsequent imaging (e.g., CT scans) to verify the actual needle tip position relative to the planned target, along with clinical outcomes or observations during the procedure. The "accurate needle placement using MAXIO for CT guided Tumor ablations" in the 20-patient study points to this.
  • Patient Movement Detection/Correlation: Verified through direct observation, measuring shifts, and comparing skin marker data to anatomical movement in CT scans.
  • Needle Manipulations/Check-scans: Direct observation and recording during the procedures.

8. Sample Size for the Training Set

The document does not provide any information about a training set or its sample size. The studies described are primarily for validation of the device's performance.

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

Since no training set is described, there's no information on how its ground truth was established.

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