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The Cosman RF Cannula is indicated for use in RF heat lesion procedures for the relief of pain.

The Cosman RF Cannula is used in conjunction with the commercially available Cosman RF Generator (K050084) to create radiofrequency (RF) lesions for the treatment of pain. The Cosman RF Cannula is a stainless steel cannula with an insulated shaft having an exposed (uninsulated) tip to deliver the RF energy to the tissue. The Cosman RF Cannula is provided as a sterile, single use, disposable device. The Cosman RF Cannula will be available in a variety of lengths and gauges. The Cosman RF Cannula is provided sterile packed, and is labeled for Single Use Only.

Here's an analysis of the provided text regarding the Cosman RF Cannula, focusing on acceptance criteria and supporting studies:

Based on the provided 510(k) summary, the device is not an AI/ML powered device. This document describes a medical device, a radiofrequency cannula, and its substantial equivalence to predicate devices, focusing on physical and technical characteristics and bench testing. Therefore, many of the typical acceptance criteria and study components relevant to AI/ML devices, such as performance metrics like accuracy, sensitivity, specificity, and detailed study designs with ground truth establishment, are not applicable or not present in this type of submission.

The document focuses on demonstrating substantial equivalence to existing, legally marketed predicate devices rather than proving novel performance against predefined acceptance criteria for an AI algorithm.

Here's a breakdown based on your requested information, highlighting what is (and isn't) present in this particular 510(k) summary for a non-AI device:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: The primary "acceptance criteria" here is substantial equivalence to predicate devices. This isn't quantified with specific performance metrics in the same way an AI/ML device would be, but rather through comparison of characteristics and functional testing.
  • Functional Equivalence: The device must perform the same intended use as the predicate (RF heat lesion procedures for pain relief).
  • Technical Equivalence: The device must have similar physical and technical characteristics (e.g., stainless steel cannula, insulated shaft, exposed tip, sterile, single-use, disposable, available in various lengths and gauges).
• Reported Device Performance:

  Performance Characteristic	Acceptance Criteria / Predicate Equivalence	Reported Device Performance (Cosman RF Cannula)
  Intended Use	RF heat lesion procedures for pain relief	Indicated for use in RF heat lesion procedures for the relief of pain.
  Physical Characteristics	Similar to predicate devices: Material (stainless steel), construction (insulated shaft, exposed tip), sterility (sterile, single-use, disposable), dimensions (various lengths and gauges).	"The Cosman RF Cannula is a stainless steel cannula with an insulated shaft having an exposed (uninsulated) tip... provided as a sterile, single use, disposable device. will be available in a variety of lengths and gauges."
  Technical Characteristics	Similar to predicate devices (e.g., ability to deliver RF energy for lesion creation).	Used in conjunction with the Cosman RF Generator (K050084) to create RF lesions.
  Safety & Effectiveness	Demonstrated by substantial equivalence to predicate devices and confirmed by non-clinical (bench) testing.	"Cosman Medical has done bench testing on the Cosman RF Cannula to confirm performance characteristics of this device." "The comparison to the predicate device demonstrates that the Cosman RF Cannula is safe and effective and is substantially equivalent to the predicate device."

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

• Not Applicable / Not Provided: For this type of device (RF cannula), there isn't a "test set" of patient data in the way there would be for an AI/ML diagnostic or prognostic device. The testing mentioned is "bench testing" to confirm performance characteristics, which would involve physical samples of the device undergoing various engineering tests. The sample size for this bench testing is not specified. Data provenance (country of origin, retrospective/prospective) is also not applicable here.

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

• Not Applicable: Given this is a physical medical device and not an AI/ML algorithm, there is no "ground truth" to be established by experts in the context of diagnostic performance. "Ground truth" for this device would relate to its physical properties and functional capability, confirmed through engineering tests.

4. Adjudication method for the test set

• Not Applicable: No adjudication method is described because there is no "test set" of clinical cases requiring expert review or consensus for this device type. Adjudication methods like 2+1 or 3+1 are specific to AI diagnostic performance 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

• No, Not Applicable: An MRMC study is designed to evaluate AI assistance for human readers in diagnostic tasks. This device is an instrument used in a surgical/procedural context, not a diagnostic aid with an AI component.

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

• Not Applicable: This device is a physical instrument, not an algorithm. Therefore, "standalone algorithm" performance is not relevant.

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

• Not Applicable / Engineering Specifications: For this device, the "ground truth" is its adherence to engineering specifications and its ability to function as intended (e.g., generate a specific RF lesion profile) as demonstrated through bench testing. It's not a clinical "ground truth" derived from patient data.

8. The sample size for the training set

• Not Applicable: This device is not an AI/ML algorithm that requires a "training set."

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

• Not Applicable: As there is no training set for an AI/ML algorithm, this question is not relevant.

In summary: The provided 510(k) pertains to a traditional, non-AI medical device (an RF cannula). The "study" referenced is "bench testing" to confirm performance characteristics and establish substantial equivalence to predicate devices, rather than a clinical trial or AI/ML performance study with specific acceptance criteria related to accuracy, sensitivity, etc. Therefore, most of your detailed questions regarding AI/ML study design are not applicable to this document.

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