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The Spinery™ RF Ablation System is intended for:
Palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.
Coagulation and ablation of tissue in bone during surgical procedures including palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy.

Spinery™ RF Ablation System is an active medical device, intended for radiofrequency thermal ablation of spine metastation tumors.
It is a surgically invasive device intended for transient use, as the catheter percutaneously the human body in the target bone through a surgical incision, aided by other access kit), and remains in the body for the treatment time, estimated in about 20 minutes as a maximum time length.
It is an active therapeutic device because it is intended to provide treatment and pain alleviation of the human bone.
It is not intended to be used on the central nervous system.
The Spinery™ RF Ablation System includes the following components:

1. SpineryTM Radiofrequency Generator (REF: SPINERY)
   a. Peristaltic Pump
2. Spinery™ Needles:
   a. Bipolar cooled needle with electrodes length of 7 mm and intra-electrodes length of 4 mm (REF: SP-B10704)
   b. Bipolar cooled needle with electrodes length of 10 mm and intra-electrodes length of 5 mm (REF: SP-B11005)
3. Spinery™ Connections
   a. Cooling system connection pipe for double needle approach (REF: SP-CD)
   b. Cooling system connection pipe for single needle approach (REF: SP-CS)
4. Manual Infusion System
5. Bone Access Kit
   a. The SP-BI0704 needle has the access kit with code AXONKIT-22
   b. The SP-BI1005 needle has the access kit with code AXONKIT-29

The provided text does not contain information about the acceptance criteria or a study proving the device meets specific performance criteria. The document is a 510(k) summary for the Spinery™ RF Ablation System, primarily focusing on its substantial equivalence to predicate devices and a summary of non-clinical testing performed.

Therefore, many of the requested fields cannot be filled from the provided text.

Here's a breakdown of what information is not available in the provided text, and what minimal information can be inferred:

Information NOT available in the provided text:

• A table of acceptance criteria and the reported device performance: This detailed information is typically found in specific study reports, not in a 510(k) summary. The summary only broadly states that "performance data supports the safety of the device and demonstrates that the subject device complies with the recognized standards as specified."
• Sample size used for the test set and the data provenance: No details on sample sizes or data origin (country, retrospective/prospective) for any specific performance study are given.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no human-expert-based ground truth is discussed for device performance.
• Adjudication method: Not applicable.
• 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 device is an RF ablation system, not an AI diagnostic or assistance tool for human readers. Therefore, an MRMC study in this context is irrelevant and not mentioned.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): No specific ground truth for performance metrics is detailed. The non-clinical testing mentioned involves mechanical, electrical, EMC, sterilization, biocompatibility, pyrogen, thermocouple accuracy, impedance, usability, and software verification.
• The sample size for the training set: Not applicable, as this is not a machine learning/AI device that requires a training set in that context.
• How the ground truth for the training set was established: Not applicable.

Minimal Information that can be inferred from the provided text regarding "acceptance criteria" and "study":

The "studies" mentioned are non-clinical verification and validation tests, not a single overarching performance study with specific acceptance criteria that would fall into a simple table format. The acceptance criteria for these tests are generally compliance with recognized standards or meeting specified test requirements.

Summary of Non-Clinical Testing (implies meeting "acceptance criteria" of relevant standards):

Overall Conclusion from the text:

The "Conclusions" section in the document states: "The performance data supports the safety of the device and demonstrates that the subject device complies with the recognized standards as specified. In summary, we believe the Spinery is substantially equivalent to the predicate devices with respect to the general design approach, function, and the intended use. Differences between subject device and predicated affect the safety and effectiveness of the subject device and raise no new questions of safety or effectiveness." This statement implies that all the non-clinical tests successfully met their respective acceptance criteria based on established standards and requirements.

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