Search Results

The Ball Fiducial Markers are intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization. Specifically, they can be used in intracranial diseases such as gliomas, neuromas, meningiomas, astrocytomas, arteriovenous malformations, and metastatic carcinomas. Additionally, they can be used in the body for treating hepatic, pancreatic, retroperitoneal, paraspinal, skeletal, prostatic and breast tumors.

The Cosman Ball Fiducial Markers have similar physical and technical characteristics to the predicate devices.

The provided document is a 510(k) summary for the Cosman Ball Fiducial Markers. It states that the device is "substantially equivalent" to a predicate device (CIVCO MEDICAL SOLUTIONS, Fiducial Markers) and is "safe and effective for indicated intended use." However, it does not contain the specific information requested regarding acceptance criteria and a study proving those criteria are met.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, training sets, or data provenance.
• Information on the number or qualifications of experts used for ground truth.
• Adjudication methods.
• Details of any Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or their effect sizes.
• Information on standalone algorithm performance.
• The type of ground truth used (e.g., pathology, outcomes data).
• How ground truth for any training set was established.

The document is a regulatory submission focused on demonstrating substantial equivalence to a previously cleared device, not a detailed performance study report. The core of its argument for safety and effectiveness is simply that it has similar physical and technical characteristics to the predicate device.

Ask a specific question about this device

The Cosman G4 Radiofrequency Generator is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures. The Cosman G4 Radiofrequency Generator is used with separately approved Cosman Radiofrequency Probes.

Not Found

This document is a 510(k) summary for the Cosman G4 Radiofrequency Generator, which is a medical device. This type of document focuses on establishing substantial equivalence to existing devices rather than presenting a detailed clinical study demonstrating acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and performance studies is not available in this filing.

Here's a breakdown of what can be extracted and what is not applicable:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as pass/fail criteria in the provided text. The document states that "Performance testing was done to validate the intended use of the Cosman device." However, specific quantitative acceptance criteria (e.g., "output power must be within X% of target") are not detailed.
• Reported Device Performance: Not detailed in this summary. The 510(k) summary asserts "The comparison and performance test results in this 510(k) notification show that the Cosman G4 Radiofrequency Generator is substantially equivalent to the predicated devices and is safe and effective for the intended use." This indicates that performance data was collected and reviewed by the FDA, but the actual data and specific performance metrics are not included in this high-level summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• This information is not provided in the 510(k) summary. Performance testing is mentioned, but details about the test set, its size, or provenance are absent. For a radiofrequency generator, performance testing typically involves bench testing or animal studies, not human data sets in the way AI/ML devices do.

3. 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/Not provided. For a device like a radiofrequency generator, "ground truth" would relate to its physical output and operational parameters rather than clinical diagnoses established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided. This concept is typically relevant for studies involving human interpretation (e.g., image analysis for AI devices).

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 a radiofrequency generator, not an AI-assisted diagnostic tool or an imaging device that requires human interpretation.

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

• Not applicable. This is not an algorithm-based device. Its performance is directly tied to its physical operation.

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

• Not explicitly stated. For a physical device like this, "ground truth" for performance testing would likely involve objective measurements of electrical output (e.g., power, impedance, temperature at the probe tip) against specifications, using calibrated equipment.

8. The sample size for the training set

• Not applicable. This is a hardware device, not a machine learning model, so there is no "training set."

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

• Not applicable. As above, this is not a machine learning device.

Ask a specific question about this device

The Cosman RF Injection Electrodes are used for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. The nerve is localized either by electrical stimulation or by injecting contrast medium through the device and using radiography concomitantly. The nerve may then be blocked by injection of local anesthetic solution or a radiofrequency lesion is made.

The Cosman RF Injection Electrodes are used in conjunction with the commercially available Cosman RF Generator (K050084) to create radiofrequency (RF) lesions of nerve tissue or for use in percutaneous nerve blocks.. The COSMAN CU, CUR, TCD and CCD are temperature sensing RF injection electrodes. The COSMAN CP, CR and CN are non-temperature sensing RF injection electrodes. The Cosman RF Injection Electrodes are available in a variety of lefegths and gauges. The Cosman RF Injection Electrodes are provided sterile packed and are labeled for Single Use Only.

The provided text is a 510(k) Summary for the Cosman RF Injection Electrodes. It describes the device, its intended use, and a comparison to predicate devices to establish substantial equivalence.

Based on the document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or report specific performance metrics from a clinical study for the Cosman RF Injection Electrodes. Instead, the basis for clearance is substantial equivalence to predicate devices.

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

The document does not report on a test set sample size or data provenance from a study demonstrating the device's performance through direct human or animal trials. The clearance is based on comparison to predicate devices, which implies that the prior performance of those devices, not a new study, forms the basis of the safety and efficacy argument.

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

Not applicable. The document does not describe a study involving expert-established ground truth for a test set.

4. Adjudication method for the test set

Not applicable. The document does not describe a study involving adjudication of a test set.

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. The Cosman RF Injection Electrodes are a medical device (electrode/probe), not an AI-powered diagnostic tool, so an MRMC comparative effectiveness study involving AI assistance is irrelevant to this submission.

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

Not applicable. As stated above, this is a medical device, not an algorithm.

7. The type of ground truth used

Not applicable. The safety and effectiveness are established through substantial equivalence to predicate devices, not through a study involving a defined ground truth like pathology or outcome data for this specific device.

8. The sample size for the training set

Not applicable. The document does not describe a study involving a training set for an algorithm.

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

Not applicable. The document does not describe a study involving a training set for an algorithm.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The document describes a comparison study rather than an independent performance study with new human or animal subjects. The "study" referenced is the process of comparing the Cosman RF Injection Electrodes to legally marketed predicate devices.

• Methodology: The sponsor performed a detailed comparison of the Cosman RF Injection Electrodes' "physical and technical characteristics" and "intended use" to those of predicate devices (Technomed Europe RF Injection Needles (K04237), Cosman Medical TC Electrodes (K050084), and Cosman Medical RF Cannula (K060799)).
• Proof of Acceptance Criteria: The submission asserts that this comparison, along with "testing results" (though specific tests or data are not detailed in the summary), demonstrates that the Cosman RF Injection Electrodes are "substantially equivalent" to the predicates and are "safe and effective for its intended use."

The entire submission is focused on establishing substantial equivalence under the 510(k) pathway, which does not typically require new clinical performance data if substantial equivalence can be demonstrated through technological characteristics and intended use alongside existing predicate devices.

Ask a specific question about this device

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.

Ask a specific question about this device

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

The LesionPoint RF Cannula is used in conjunction with the commercially available Cosman RFG-1A Lesion Generator (K050084) to create radiofrequency (RF) heat lesions for the treatment of pain. The LesionPoint 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 LesionPoint RF Cannula is provided as a sterile, single use, disposable device. The LesionPoint RF Cannula will be available in a variety of lengths and gauges. The LesionPoint RF Cannula is provided sterile packed, and is labeled for Single Use Only.

The provided 510(k) summary for the LesionPoint RF Cannula does not contain acceptance criteria or detailed study information.

The summary states:

1. Non-Clinical Data: "Cosman Medical has done bench testing on the LesionPoint RF Cannula to confirm performance characteristics of this device."
2. Conclusion: "The comparison to the predicate device demonstrates that the LesionPoint RF Cannula is safe and effective and is substantially equivalent to the predicate devices."

This document is a marketing application for a medical device seeking substantial equivalence to existing predicate devices. For such applications, detailed performance metrics, acceptance criteria, and comprehensive study results like those requested are typically not included in this summary document. The FDA determines substantial equivalence based on the device's intended use, technological characteristics, and safety and effectiveness information compared to predicates, often relying on a combination of bench testing, comparisons to predicate devices, and sometimes (but not always for 510(k)s) clinical data.

Therefore, for the specific questions:

1. A table of acceptance criteria and the reported device performance: Not provided in the document. The document only mentions "bench testing...to confirm performance characteristics." No specific metrics or acceptance criteria are reported.
2. Sample size used for the test set and the data provenance: Not provided. The document only mentions "bench testing." No details on sample size or data provenance (e.g., country, retrospective/prospective) are given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. The document doesn't describe a test set requiring expert ground truth for performance evaluation of classification or diagnostic accuracy.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/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 a radiofrequency cannula, not an AI diagnostic or assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/not provided. The device undergoes "bench testing," which typically involves engineering and physical property measurements rather than ground truth based on clinical or expert consensus.
8. The sample size for the training set: Not applicable/not provided. The document doesn't mention a training set, as it's not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable/not provided.

In summary, the provided 510(k) documentation focuses on demonstrating substantial equivalence to predicate devices through physical and technical characteristic comparisons and general bench testing, rather than detailed performance studies with specific acceptance criteria as might be seen for novel diagnostic or AI-powered devices.

Ask a specific question about this device

The Cosman Radiofrequency Lesion Generator, Model RFG-1A, and associated Radiofrequency Lesion Probes, is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures.

Cosman RF Lesion Generator, Model RFG-1A, and associated Radiofrequency Lesion Probes

Here's an analysis of the provided text regarding the Cosman RF Lesion Generator, Model RFG-1A, and associated Radiofrequency Lesion Probes:

Important Note: The provided text is a 510(k) summary for a medical device. 510(k) submissions typically demonstrate substantial equivalence to a predicate device, rather than providing extensive de novo clinical trials to prove efficacy. Therefore, much of the requested information regarding detailed study design (like sample sizes for test and training sets, expert qualifications, MRMC studies, standalone performance, and specific ground truth establishment methods) is often not explicitly present in these types of documents. The focus is on showing similarity in intended use, technological characteristics, and performance data sufficient to establish equivalence.

Description of Acceptance Criteria and Study to Prove Device Meets Criteria

The Cosman RF Lesion Generator, Model RFG-1A, and associated Radiofrequency Lesion Probes' acceptance criteria and the study proving it meets these criteria are framed within the context of a 510(k) premarket notification. This means the primary "acceptance criterion" is substantial equivalence to existing predicate devices.

The text states: "Performance testing was done to results in this 510(k) notification show that the Cosman RF Lesion Generator, Model RFG-1A, and associated Radiofrequency Lesion Probes are substantially equivalent to predicate devices and are safe and effective for their intended use."

This implies that the "study" conducted was a comparison of the device's performance against the predicate devices to demonstrate that it operates safely and effectively in a similar manner. The document does not outline specific, quantitative acceptance criteria in the typical sense (e.g., "sensitivity must be >90%"). Instead, the acceptance is based on the demonstration of equivalent performance characteristics to the identified predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) submission, specific quantitative acceptance criteria in the format of a clinical trial endpoint are not explicitly listed. The "acceptance criterion" is proving substantial equivalence to predicate devices. The "reported device performance" would encompass various engineering and functional tests designed to demonstrate this equivalence and ensure the device functions as intended.

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

• Sample Size for Test Set: Not specified in the provided text. 510(k) submissions often rely on engineering and laboratory testing rather than large-scale human subject clinical trials for non-novel devices. If human data were used, the specifics are not detailed here.
• Data Provenance: Not explicitly stated. Given it's a device manufactured in the USA, it's likely testing was conducted domestically, but the text doesn't confirm this or specify whether data was retrospective or prospective.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. Again, for a 510(k) of this type, the "ground truth" often relates to engineering specifications and performance benchmarks, not subjective expert assessment of medical images or diagnostic outputs.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. It is unlikely that a formal adjudication process (like 2+1 or 3+1) was used, as this is typically applied in studies involving expert interpretation of data (e.g., radiology reads), which isn't the primary focus of this type of 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not conducted (or at least, not reported in this summary). This type of study is more common for diagnostic imaging devices where human interpretation is a key component and the goal is to show improved reader performance with AI assistance. The Cosman device is a therapeutic lesion generator, not a diagnostic tool with AI.
• Effect Size of Human Readers Improve with AI vs. Without AI Assistance: Not applicable, as no MRMC study was performed and the device does not involve AI assistance for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: Not applicable. This device is a physical instrument for generating lesions, not an algorithm. Its performance is inherent in its operation and interaction with human users, not in a "standalone algorithm" sense.

7. The Type of Ground Truth Used

Given the nature of the device (a lesion generator), the "ground truth" would likely involve:

• Engineering specifications and performance metrics (e.g., output power accuracy, temperature control, impedance measurement).
• Bench testing to verify the ability to create lesions of appropriate size and characteristics in controlled environments or simulated tissue.
• Potentially, non-clinical (e.g., animal) studies to demonstrate lesion creation and safety without specific clinical outcome data being the "ground truth" for this 510(k).
• Comparison to the established performance characteristics of the predicate devices.
  The provided text does not specify the exact nature of this "ground truth."

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The Cosman RF Lesion Generator is not an AI/machine learning device that requires a training set in the conventional sense. Its design and validation rely on established engineering principles and performance testing.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this type of device.

In summary, the provided document is a 510(k) summary focused on demonstrating substantial equivalence to predicate devices, and as such, it does not contain the detailed clinical study information often associated with novel AI/software as a medical device (SaMD) clearances or PMAs. The "study" refers to the entire body of testing and comparison data submitted to the FDA to support the claim of substantial equivalence.

Ask a specific question about this device