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1. To be used for cooling therapy when applied to the affected body surface during a migraine headache and for the reduction of pain from muscle spasms associated with migraine headaches.

IVC™ device

This is a 510(k) clearance letter for the IVC™ device, a water circulating hot or cold pack. The document states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it does not require a new study to prove its safety and effectiveness.

Therefore, the provided document does not contain the acceptance criteria or a study proving the device meets those criteria because it's a substantial equivalence determination.

Here's why and what information would typically be needed if it were a de novo submission or required clinical data:

Why the requested information isn't in this document:

• Substantial Equivalence (510(k)): The FDA's 510(k) pathway determines if a new device is "substantially equivalent" to a legally marketed predicate device. This means the new device has the same intended use and technological characteristics as the predicate, or if it has different technological characteristics, those differences do not raise different questions of safety and effectiveness.
• No New Clinical Data Required: For most 510(k) clearances, clinical studies demonstrating specific device performance against acceptance criteria are not required. Manufacturers typically provide information comparing their device to a predicate, often using bench testing, non-clinical data, or existing clinical literature on the predicate.

If this were a document for a device requiring clinical performance data, the following would be required:

• Acceptance Criteria Table: This would define specific thresholds (e.g., sensitivity, specificity, accuracy, precision, error rates, pain reduction scores, temperature control ranges) that the new device must meet to be considered safe and effective for its indicated use.
• Study Design and Results: Details of a clinical trial or performance study would be presented.

Let's address the specific points you asked for, even though they are not applicable to the provided document:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample size used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method for the test set: Not provided.
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 not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) clearance letter for an IVC™ device based on substantial equivalence, not a document detailing a performance study with acceptance criteria.

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to cool a small portion of the body to provide temporary relief of minor aches and pains and muscle spasms or bruises.

Cryotron is fabricated by joining two hollow metal or plastic tubes together into a hollow metal tip which is shaped to fit over the maxillary nerve section or other area selected for cold therapy. Ice water driven by a small pump enters the smaller ube and exits the large tube, chilling the metal which is covered by a disposable plastic sheath. The product will be sold non-sterile; prepackaged, presterilized plastic sleeves will be provided with the Cryotron.

This 510(k) summary does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily focuses on establishing substantial equivalence to predicate devices based on intended use, technological characteristics, and materials.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and study details based on the provided text. The document is for a medical device (Cryotron™ Cold Probe) that circulates ice water for cold therapy, and the summary's purpose is to argue for its substantial equivalence to other legally marketed devices, thus avoiding the need for a full premarket approval.

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