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The Nucleotomy Catheter is intended to be used for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs.

The Nucleotomy Catheter is a minimally invasive thermoelectric device. When used in The Nucleolonity Cuthers is a missanerator the Nucleotomy Catheter delivers thermal energy to targeted locations inside the disc. The distal portion of the tip is flexible such that the device can targeted locations instice the answ The flexible tip contains a resistive metal coil, which produces heat when current flows through it. The device contains a thermocouple for monitoring and controlling the temperature of the treated tissue.

This 510(k) summary does not contain any performance data or acceptance criteria. It is a clearance document that states the device, a "Nucleotomy Catheter," is substantially equivalent to a predicate device (SpineCATH Intradiscal Catheter K993967).

Therefore, I cannot provide the requested information, including:

• A table of acceptance criteria and the reported device performance: This document only states that "Safety and biocompatibility testing were conducted to support this claim of substantial equivalence," without providing any specific criteria or results.
• Sample size used for the test set and the data provenance: No test set information is present.
• Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable as no test set data is provided.
• Adjudication method for the test set: Not applicable as no test set data is provided.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No indication of such a study.
• If a standalone performance study was done: No standalone performance data is mentioned.
• The type of ground truth used: Not applicable as no ground truth data is provided.
• The sample size for the training set: No training set information is present.
• How the ground truth for the training set was established: Not applicable as no training set data is provided.

The document focuses on:

• Device Name: Nucleotomy Catheter
• Device Description: Minimally invasive thermoelectric device for delivering thermal energy to disc material. Contains a flexible tip with a resistive metal coil and a thermocouple for temperature control.
• Indications for Use: Coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs.
• Predicate Device: SpineCATH Intradiscal Catheter K993967
• Conclusion: The device is substantially equivalent to the predicate device based on technological characteristics, similar intended use, and safety/biocompatibility testing (details of which are not provided in this summary).

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The ORATEC® Ablator-S Probes are disposable, monopolar electrosurgical devices intended to be used for ablation, and hernostasis of soft tissues in arthroscopic procedures. They are designed to be used with the ORATEC® Vulcan™ EAS™ generator.

The devices described in this 510(k) are sterile, disposable devices designed for use with the ORATEC Vulcan™ EASTM RF generator.

This submission is a 510(k) Pre-market Notification for a medical device called the ORATEC® Ablator™-S Probe (Monopolar Ablation Suction Probe). The purpose of this type of submission is to demonstrate that the new device is substantially equivalent to existing legally marketed predicate devices. It typically does not involve new clinical studies to prove effectiveness or establish acceptance criteria based on performance. Instead, it relies on demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness profiles as legally marketed predicate devices.

Therefore, the provided document does not contain the information requested for acceptance criteria and a study proving the device meets those criteria, as it's a 510(k) summary focused on substantial equivalence.

Based on the content, here's what can be inferred or stated about the requested information:

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

• Not Applicable. The 510(k) summary does not define specific performance-based acceptance criteria for this new device in the way a clinical trial would. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices in areas like intended use, materials, design, and operating principles. Performance is assessed in comparison to these predicates, not against novel, pre-defined quantitative thresholds in this document.

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

• Not Applicable. No test set or associated data provenance is described for proving new performance claims. The 510(k) submission primarily relies on comparisons to known predicate devices and non-clinical testing (which is not detailed here).

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. No expert-established ground truth for a test set is described.

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

• Not Applicable. No test set or adjudication method is described.

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 surgical probe, not an AI software/diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is irrelevant and not mentioned.

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

• Not Applicable. This device is a surgical probe, not an algorithm.

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

• Not Applicable. No new ground truth is established or used for the purpose of this 510(k) submission. The "ground truth" for demonstrating safety and effectiveness relies on the established safety and effectiveness of the predicate devices.

8. The sample size for the training set:

• Not Applicable. This is a hardware medical device, not an AI or machine learning algorithm requiring a training set in the conventional sense.

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

• Not Applicable. As above, no training set for an AI/ML algorithm is relevant to this submission.

Summary of the 510(k) Conclusion:

The 510(k) summary concludes that the ORATEC® Ablator™-S Probe is substantially equivalent to the predicate devices listed:

• ORATEC Electrosurgical Probes (K965007 and K992408)
• ORATEC Bipolar Ablation Suction Probes (K991218)
• ArthroCare Ablation Probes (K943450, K961747, and K962321)

This substantial equivalence determination is the primary "proof" for a 510(k) submission, indicating that the device is as safe and effective as existing devices on the market, rather than meeting specific performance criteria demonstrated through a de novo study.

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The ORA-50 ElectroThermal System and Accessories are intended to be used for general surgical purposes, including orthopedic and arthroscopic applications, in coagulation of soft tissues. The ORA-50 ElectroThermal System and Accessories are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

The ORATEC Interventions ORA-50 ElectroThermal System ("ORA-50") is a single channel, 50-watt, electrothermal generator that offers finely controlled radiofrequency output for use during a variety of arthroscopic procedures. The ORATEC ORA-50 is specifically designed for use with ORATEC cutting and temperature controlled probes.

Temperature and impedance monitoring are provided to assist the physician by automatically adjusting energy delivery to maintain effective tissue heating during temperature-controlled applications. Preset temperature and power settings in the generator software offer the convenience of quickly configuring the generator for use.

The provided text describes a 510(k) submission for the ORATEC Interventions ORA-50 ElectroThermal System and Accessories. The submission focuses on establishing substantial equivalence to a predicate device, rather than presenting a study with specific acceptance criteria, test results, or detailed performance metrics.

Therefore, many of the requested details about acceptance criteria and study methodology are not available in the given document. The document primarily details the device's intended use, description, and comparison to a predicate device to argue for substantial equivalence.

Here's an analysis based on the provided text, highlighting what is and is not available:

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

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

• The document does not describe a test set or clinical study with a sample size. The filing is for substantial equivalence based on hardware and software modifications.

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. No ground truth establishment for a test set is described.

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

• Not applicable. No test set requiring adjudication is described.

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 an electrosurgical system, not an AI diagnostic tool. No MRMC study was conducted or is relevant.

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

• Not applicable. This device is an electrosurgical system, not an algorithm.

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

• Not applicable. The submission is based on engineering principles and comparison to a legally marketed predicate device, not on establishing ground truth for a clinical condition.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device.

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

• Not applicable. This is not an AI/machine learning device.

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The ORATEC® SpineCATH™ Intradiscal Catheter is intended for use for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs. The ORATEC SpineCATH Intradiscal Catheter is intended for use with ORATEC ElectroThermal™ Spine System Generator.

The devices described in this 510(k) are sterile, disposable devices intended for use with the ORATEC ElectroThermal Spine System Generator.

This 510(k) summary provides limited information regarding the specific studies performed. Here's what can be extracted and reported, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document does not provide specific quantitative acceptance criteria (e.g., minimum tensile strength, maximum temperature reached) or the detailed quantitative results of the "performance testing (validation testing)."

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

This information is not provided in the document. The summary only mentions "results of validation testing (performance testing)" without detailing the test set size, type of data (e.g., in-vitro, ex-vivo, animal, human), or its provenance (e.g., country of origin, retrospective or prospective).

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

This information is not provided in the document. This type of device (intradiscal catheter) does not typically involve image interpretation, so "ground truth" as it relates to expert review of images is not applicable here. The "ground truth" for this device would relate to engineering specifications and biological outcomes, which would be established through technical standards and clinical studies, respectively.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of medical device testing (e.g., mechanical, electrical, biocompatibility), adjudication is typically not performed in the same way as in diagnostic AI studies. Test results are usually compared against predefined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable and not provided. The ORATEC SpineCATH™ Intradiscal Catheter is a medical device (catheter) used in a physical intervention, not an AI diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant to its evaluation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This information is not applicable and not provided. This device is a physical catheter, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device would be established through a combination of:

• Engineering Specifications: For mechanical properties, electrical safety, material compatibility, and function.
• Biocompatibility Testing: To ensure the materials are safe for use in the human body.
• Performance Data: Demonstrating the ability of the catheter to achieve its intended function (e.g., coagulation and decompression) in relevant models (e.g., ex-vivo tissue, animal models, and ultimately, human clinical data from the predicate device and potentially limited clinical data for the modified device if applicable, though not detailed here).
• Clinical Outcomes Data: For the predicate device, showing its effectiveness in treating symptomatic patients. For the modified device, the "ground truth" for substantial equivalence relies on demonstrating that the modifications do not negatively impact the clinical outcomes or safety established for the predicate.

The document states that "performance testing (validation testing)" was done, implying that the device was tested against these types of established standards and expected performance characteristics.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This device is not an AI algorithm that requires a training set. The "training" for a physical device is its design and manufacturing process, validated through testing.

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

This information is not applicable and not provided. As explained above, this device is not an AI algorithm.

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The ORA-50 S AutoTemp ElectroThermal Generator ("ORA-50 S") and Accessories are intended to be used for general surgical purposes in coagulation of soft tissues, in combination with ORATEC thermal/coagulating probes. The ORA-50 S ElectroThermal Generator and Accessories are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

The ORATEC Interventions ORA-50 S AutoTemp ElectroThermal Spine System ("ORA-50 S") is a single channel, 50-watt, electrothermal generator that offers finely controlled radiofrequency output for the coagulation of soft tissue during a variety of spine procedures. The ORATEC ORA-50 S is specifically designed for use with ORATEC spine probe devices, although it may be used with any ORATEC electrosurgical or electrothermal probe.

Temperature and impedance monitoring are provided to assist the physician by automatically adjusting energy delivery to maintain effective tissue heating during temperature-controlled applications. Preset temperature and power settings in the generator software offer the convenience of quickly configuring the generator for use. A programmed temperature profile mode specifically designed for use with the ORATEC SpineCATH™ device ("SpineCATH Intradiscal Catheter", K974464) offers the convenience of selecting a treatment profile.

The provided text is a 510(k) summary for the ORA-50 S AutoTemp ElectroThermal Spine System. It focuses on establishing substantial equivalence to a predicate device based on intended use, operating principle, and hardware configuration. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer the specific questions regarding studies, sample sizes, expert involvement, or ground truth. The document describes a regulatory submission for a medical device, which is different from a clinical study report.

The relevant information from the document is:

• Device: ORA-50 S AutoTemp ElectroThermal Spine System and Accessories
• Intended Use: For general surgical purposes in coagulation of soft tissues, in combination with ORATEC thermal/coagulating probes.
• Predicate Device: ORA-50 S Programmable Spine System (K974464)
• Comparison: The ORA-50 S AutoTemp Spine System is a software modification of the predicate, sharing the same intended use, operating principle, and hardware configuration.

Missing Information:
All the specific points requested regarding acceptance criteria, device performance, study types, sample sizes, expert involvement, and ground truth are not present in the provided text. This document is a regulatory submission demonstrating substantial equivalence, not a detailed clinical study report.

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The Vulcan EAS ElectroThermal Arthroscopy System and Accessories are intended to be used for general surgical purposes, including orthopedic and arthroscopic applications, in coagulation, ablation, and hemostasis of soft tissues in combination with ORATEC temperature controlled, cutting, and ablation probes.

The VULCAN EAS ElectroThermal Arthroscopy System and Accessories are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Contraindications for Use:

The use of the VULCAN EAS ElectroThermal Arthroscopy System and Accessories are contraindicated, when in the judgment of the physician, an electrosurgical procedure would be contrary to the best interest of the patient.

The ORATEC Interventions, Inc., VULCAN EAS ElectroThermal Arthroscopy System generator is a single channel, 200-watt, electrothermal generator that offers finely controlled radiofrequency output for the electrocoagulation, cutting, and ablation of soft tissue during a variety of arthroscopic procedures. The unit is specifically designed to be used with ORATEC electrothermal, electrosurgical, and ablation probes. Temperature and impedance monitoring are provided to assist the surgeon by automatically adjusting energy delivery to maintain effective tissue heating during temperature controlled applications.

Accessories provided with the Vulcan EAS include:

• AC power cord .
• Probe extension cable .
• Dual-pedal footswitch control .

Each generator is also accompanied by Instructions for Use and a warranty registration card.

This document is a 510(k) summary for the ORATEC Interventions, Inc., VULCAN EAS ElectroThermal Arthroscopy System and Accessories. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific device performance against acceptance criteria from a study.

Therefore, many of the requested sections about acceptance criteria, study details, and ground truth cannot be fully addressed from the provided text.

Here's what can be extracted and inferred:

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

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics from a specific study. The core of this 510(k) submission is to demonstrate substantial equivalence to a predicate device, the ValleyLab Force FX Electrosurgical Generator. This means the "acceptance criteria" are implicitly met if the device is shown to be as safe and effective as the predicate.

Key points of comparison (which serve as the basis for "performance" as presented here):

The differences highlighted are presented as features that the Vulcan EAS has and the Force FX does not, or vice-versa, but are argued not to raise new questions of safety or effectiveness, thus maintaining substantial equivalence.

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

The document does not describe a clinical study with a "test set" in the context of validating algorithm performance. This is a 510(k) for an electrosurgical generator, and the information provided focuses on the device's design, intended use, and comparison to a predicate, not performance derived from a diagnostic algorithm or image analysis. Therefore, there is no mention of sample size or data provenance for such a test set.

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. This is not a study involving expert-established ground truth for a test set.

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

Not applicable.

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 is not a diagnostic AI device.

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. The "ground truth" for a 510(k) substantial equivalence submission for an electrosurgical generator is based on the functional and technical characteristics of the device being compared to a known safe and effective predicate, and potentially bench testing demonstrating its functionality as described. Specific clinical "ground truth" in the diagnostic sense is not typically used here.

8. The sample size for the training set:

Not applicable. This document does not describe an AI/ML device that requires a training set.

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

Not applicable.

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The Bipolar Ablation Probes are disposable, bipolar electrosurgical devices intended to be used for ablation and hemostasis of soft tissues in arthroscopic procedures. They are designed to be used with the ORATEC® Vulcan™ EAS™ generator.

The ORATEC Bipolar Ablation Probes are disposable, bipolar electrosurgical devices designed to cut or ablate soft tissues. They provide minimally invasive access to the targeted tissues. The Bipolar Ablation Probes are used in conjunction with the ORATEC Vulcan™ EAS™ RF generator to deliver bipolar radiofrequency (RF) energy for ablation of soft tissues. The probes consist of an insulated shaft, an insulated power electrode, a return electrode, and a handle. Probes may incorporate suction capability for the removal of ablated tissue from the surgical site.

The provided text is a 510(k) summary for a medical device called ORATEC Bipolar Ablation Probes. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a clinical trial for a novel therapy would.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC study, training set details) are not applicable or not explicitly detailed in this type of regulatory submission.

However, I can extract the information that is present and indicate where information is not provided.

Here's the analysis based on the provided text:

Acceptance Criteria and Study for ORATEC Bipolar Ablation Probes

The provided 510(k) summary describes ORATEC Bipolar Ablation Probes and aims to demonstrate their substantial equivalence to a predicate device, the ArthroCare Ablation Probes. As such, the "acceptance criteria" are primarily related to showing that the ORATEC probes are as safe and effective as the predicate device, and the "study" mentioned refers to comparative testing against that predicate.

1. Table of Acceptance Criteria and Reported Device Performance

No explicit quantitative acceptance criteria or detailed performance metrics are given in the 510(k) summary. Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to the predicate device. The performance is assessed comparatively.

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

• Sample Size: Not specified in the provided 510(k) summary. The summary mentions "bench and in clinical testing" but does not detail the number of participants, cases, or tests.
• Data Provenance: Not specified. It's likely from the US, given the FDA submission, but no country of origin is explicitly stated. The summary does not indicate if the data was retrospective or prospective.

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

• Not Applicable / Not Specified. This type of information is typically related to diagnostic image interpretation or complex clinical outcome assessments, which are not the primary focus of this 510(k) for an electrosurgical device assessing substantial equivalence. The "clinical testing" would likely have involved surgeons or other medical professionals, but their role in "ground truth establishment" in the context of diagnostic accuracy is not relevant here.

4. Adjudication method for the test set:

• Not Applicable / Not Specified. Adjudication methods (e.g., 2+1, 3+1 consensus) are typically used for establishing ground truth in diagnostic accuracy studies. For an electrosurgical device demonstrating functional equivalence, such a method would not typically be used. Performance assessment would involve direct observation of function, tissue effects, and patient outcomes (if a clinical study was performed).

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. This is an electrosurgical tool, not an AI-assisted diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not conducted.

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

• Not Applicable. This is an electrosurgical device, not a standalone AI algorithm. Its function inherently involves a human operator (surgeon).

7. The type of ground truth used:

• Direct functional assessment and clinical observation. For this device, "ground truth" would likely refer to the direct observation of the device successfully ablating and achieving hemostasis in soft tissues during "bench and in clinical testing," as well as surgical outcomes in a clinical setting. It's not a diagnostic "ground truth" established by expert consensus or pathology in the sense of an image interpretation task. The primary "ground truth" in this 510(k) is the established safety and effectiveness of the predicate device.

8. The sample size for the training set:

• Not Applicable / Not Specified. As this is not an AI/machine learning device, there is no "training set" in that context. If "training set" refers to pre-clinical or in-vitro testing for design optimization, details are not provided.

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

• Not Applicable. See point 8.

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