(223 days)
The device is for the treatment of external hemorrhoids by applying cold therapy (cryotherapy) directly to swollen hemorrhoidal veins. By applying the device to the tissue, the inflammation is reduced. The direct application of cold provides prompt relief of/extinguishes itching, burning, pain, and swelling. In addition, the device is beneficial for the treatment of perianal fissures due to the vasoconstriction and analgesia properties of the device.
The Cryostat Cold Therapy Pack device consists of a combination of water and chemicals in an anatomically designed sealed plastic bag, enclosed in a cloth outer wrapper for comfort. Six Cold Therapy Packs are packaged in one carton. An individual cold pack is 95mm long and 25mm wide and 26mm in depth. A cold pack consists of a series of inner plastic containers, one of which contains water and FDA food grade dye (to distinguish it from the other fluid), inside a second container which contains a secondary fluid, consisting of water, USP Food grade Kosher propylene glycol as well as a different color FDA food grade dye. The freezing temperature of the first fluid is higher than that of the second fluid. This allows a time released cooling process which delivers high performance cold therapy because of conduction and convection following the phase change of the primary fluid from solid to liquid. The containers are made of formable film common in the food and medical packaging industry. The film is a multi-layer extrusion with one layer being Nylon to add strength and act as a vapor barrier. Visual inspection is performed to verify seal integrity and the dye in the fluids facilitates quality control. Since the intended use of the device is to treat a specific ailment which requires comfort, the miniature cold pack is then wrapped in a heat sealable fabric for comfort to the affected area. The material chosen is white, so that the device, once used can be seen as soiled and therefore is disposed of.
The provided text is a 510(k) Premarket Notification Submission for the Lil' Drug Store Products, Inc. Cryostat™, a device for treating external hemorrhoids with cold therapy. This document focuses on demonstrating substantial equivalence to a predicate device, not on conducting a study with specific acceptance criteria related to a new device performance metric for diagnosis or treatment effectiveness that would involve clinical trials, expert adjudication, or AI.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable in this context. The "study" here refers to a battery of technical tests, not a clinical study involving human participants in the way the questions imply.
Here's an analysis based on the provided text, addressing the applicable points and explaining why others are not present:
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A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the format of specific thresholds for clinical performance metrics (like sensitivity, specificity, accuracy). Instead, it lists technical tests performed to demonstrate safety and effectiveness, and implicitly, the device "met" these tests for the FDA to issue a substantial equivalence determination.
Test Performed Reported Device Performance (Implicitly Met for Substantial Equivalence) Temperature longevity Demonstrated adequate duration of cold therapy. Flammability Met safety standards for flammability. Burst strength Met safety standards for burst strength. Tensile strength Met safety standards for tensile strength. Tear strength Met safety standards for tear strength. Safety/toxicological Demonstrated safety regarding materials and potential toxicity. Irritation Demonstrated no or acceptable irritation. Sensitization Demonstrated no or acceptable sensitization. Cytotoxicity Demonstrated no cytotoxicity. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document describes engineering and materials testing, not a clinical test set with human subjects. The "tests performed" (temperature longevity, flammability, etc.) would be conducted on samples of the device itself. Specific sample sizes for these engineering tests are not mentioned in this summary. Data provenance is not relevant in this context.
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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 is not a study requiring expert ground truth for diagnostic or clinical evaluation. The "ground truth" for the engineering tests would be established by standard engineering and safety protocols and measurements.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring expert adjudication of clinical outcomes or interpretations.
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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 document pertains to a physical medical device (cold therapy pack), not an AI algorithm or a diagnostic tool that involves human readers/interpreters.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the technical tests (flammability, burst strength, etc.), the "ground truth" is defined by established engineering standards, material science properties, and safety thresholds. For example, flammability testing would have a pass/fail criterion based on material burning characteristics. For the toxicological assessment, it would be based on established toxicology protocols.
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The sample size for the training set
Not applicable. There is no "training set" in the context of this device and its regulatory submission. This is not an AI/machine learning device.
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How the ground truth for the training set was established
Not applicable. There is no "training set."
Summary of the Device's "Study" and Basis for Acceptance:
The "study" described in this 510(k) submission is a "rigorous risk assessment and performance test regimen" designed to demonstrate the safety and effectiveness of the Cryostat device. The submission’s primary goal is to prove substantial equivalence to a previously legally marketed predicate device (Hemor-Rite Cryotherapy, K042564).
The tests performed were:
- Temperature longevity
- Flammability
- Burst strength
- Tensile strength
- Tear strength
- Safety/toxicological assessment
- Irritation
- Sensitization
- Cytotoxicity
The device "met" these performance criteria implicitly, as "The FDA finding of substantial equivalence of your device... permits your device to proceed to the market." The detailed results or specific thresholds for these tests are not provided in this summary but would have been part of the full 510(k) submission reviewed by the FDA. The "acceptance criteria" here are inherent to meeting relevant safety and performance standards for a medical device of this type, allowing the FDA to determine it is "safe and effective for its proposed indications" and "substantially equivalent" to predicate devices.
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