(84 days)
Hypergel provides a moist wound environment. Moist wound environment is known to support autolytic debridement. Hypergel is recommended for the softening and removal of dry necrosis in wounds such as pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, and open surgical wounds.
Hypergel® 20% Hypertonic Saline Gel is a sterile solution in amorphus gel form. Hypergel is composed of water, sodium chloride, sodium hydroxide, xanthan gum, and potassium phosphate. Hypergel provides a moist wound environment. Moist wound environment is known to support autolytic debridement. Hypergel is recommended for the softening and removal of dry necrosis in wounds such as pressure ulcers, venous and arterial leg ulcers, diabetic ulcers, and open surgical wounds. Hypergel® 20% Hypertonic Saline Gel represents a new formulation of Mölnlycke Health Care currently marketed Hypergel Protective Wound Gel product. This new formulation provides a higher viscosity. Hypergel® 20% Hypertonic Saline Gel is provided in 5 gm volumes in aluminum tubes. The tube nozzle is sealed with an aluminum foil which can be opened by employing a puncturing device integral to the inner surface of the cap. The nozzles are fitted with a poly retaining ring/collar which prevents the aluminum foil from being inadvertently punctured during manufacturing and handling.
I apologize, but the provided text from K984370 for Hypergel® - 20% Hypertonic Saline Gel does not contain the information necessary to describe acceptance criteria and a study proving device performance as requested.
The document is a 510(k) summary for a medical device. It focuses on:
- Device Description: What the device is composed of and its intended function (providing a moist wound environment for autolytic debridement).
- Substantial Equivalence: Comparing the device to a previously marketed predicate device (an earlier formulation of Hypergel). The core of a 510(k) is to demonstrate that a new device is "substantially equivalent" to an existing one, meaning it's as safe and effective.
- Biocompatibility: Stating that biocompatibility was determined according to ISO 10993.
- Indications for Use: Listing the specific types of wounds for which the gel is recommended.
- FDA Communication: The FDA's letter granting clearance, including specific limitations on labeling claims (e.g., not for third-degree burns, no claims of accelerating healing).
Missing Information:
The document does not include:
- Acceptance Criteria or Reported Device Performance: There are no specific quantitative or qualitative criteria for how well the gel should perform (e.g., rate of debridement, reduction in wound size, time to healing) or any study data reporting such performance.
- Study Details: Crucially, there is no mention of a clinical or analytical study, its design, sample size, data provenance, ground truth establishment, or expert involvement to prove the device meets any performance criteria.
- MRMC, Standalone, Training Set Details: Since no performance study is described, these elements (MRMC, standalone, training set, etc.) are entirely absent.
Conclusion:
Based only on the provided text, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study details.
- Standalone performance details.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This is typical for a 510(k) summary, as it generally relies on demonstrating equivalence to an already approved device rather than presenting extensive new clinical efficacy data unless specifically required by the FDA. The biocompatibility testing mentioned is for safety, not for the clinical performance criteria you're asking about.
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