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The Ablation Generator System and Ablation Instrument are indicated for palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.

Ablation Generator System is a microprocessor controlled radiofrequency (RF) generator designed for use with the hand held, bipolar, sterile, single use Ablation Instrument for percutaneous delivery of low power bi-polar RF energy by the physician to the tissue site in contact with the Electrode of the Ablation Instrument.

The Ablation Instrument is a hand held, bi-polar, sterile, single use device designed specifically for use with the Ablation Generator System. The user connects the Ablation Instrument to the Ablation Generator System using the AE Cable (for delivery of RF energy). The user positions the distal tip of the device containing the active and return electrodes at the tissue site where the specific treatment is to be performed.

The provided text describes a 510(k) summary for the Ablation Generator System and Ablation Instrument. It focuses on demonstrating substantial equivalence to predicate devices rather than establishing de novo performance criteria against specific numerical acceptance values. Therefore, much of the requested information regarding acceptance criteria and performance metrics (e.g., effect size, specific accuracy metrics, training set details) is not explicitly present in the provided document.

Here's an analysis based on the available information:

Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the given text.
The filing relies on showing substantial equivalence to predicate devices. The "Performance" section within the "Test Results" states: "Results of in-vitro and in-vivo testing (performance, mechanical, electrical, software) demonstrate that the Ablation Generator System and the Ablation Instrument function as intended and the results of tests were as expected." This indicates that the device met internal performance benchmarks, but these specific benchmarks and their numerical acceptance criteria are not detailed.

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

This information is not explicitly provided.
The text mentions "in-vitro and in-vivo testing" but does not specify the sample sizes (e.g., number of patients, animals, or in-vitro samples) used for these tests, nor the provenance of any data (e.g., country of origin, retrospective or prospective nature).

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

This information is not applicable/provided.
The submission does not describe a study involving expert-established ground truth in the way one would for diagnostic or AI-assisted devices. The "testing" appears to be focused on functional performance, mechanical safety, electrical safety, and software functionality.

4. Adjudication Method for the Test Set

This information is not applicable/provided.
As there's no mention of expert consensus-based ground truth establishment, no adjudication method would have been used in this context.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described.
This type of study is typically performed to evaluate the impact of a device on human reader performance, often in AI-assisted diagnostic tools. The provided information relates to an ablation device, where the focus is on its functional safety and efficacy in delivering RF energy for palliative treatment.

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

This information is not applicable/provided.
The device described (Ablation Generator System and Ablation Instrument) is a physical medical device for delivering RF energy. It does not appear to involve an "algorithm" in the sense of a diagnostic or image analysis algorithm that would have standalone performance. Its "performance" refers to its mechanical, electrical, and functional operation.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation appears to be based on engineering specifications, safety standards (e.g., biocompatibility testing against ISO 10993-1), and expected functional outcomes during in-vitro and in-vivo performance tests. It's not about establishing a diagnostic "ground truth" for a condition.

8. The Sample Size for the Training Set

This information is not applicable/provided.
The device is not described as having a "training set" in the context of machine learning or AI. Performance testing was conducted on the physical device.

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

This information is not applicable/provided.
As there is no mention of a training set, the method for establishing its ground truth is not relevant.

Summary of Device Evaluation in the Provided Document:

The 510(k) submission for the Ablation Generator System and Ablation Instrument primarily relies on demonstrating substantial equivalence to existing predicate devices (ArthroCare Cavity SpineWand and ArthroCare Orthopedic Electrosurgery System). The "Test Results" section indicates that:

• Performance: In-vitro and in-vivo tests showed the device "function[s] as intended and the results of tests were as expected." This implies the device met its internal design specifications and safety requirements.
• Biocompatibility: The materials met ISO 10993-1 requirements.

The core argument for clearance is that "The minor technological differences between the subject devices... and their predicate devices... raise no new issues of safety or effectiveness. Performance data demonstrate that Ablation Generator System and the Ablation Instrument are as safe and effective as the predicate devices for their intended use."

Therefore, the "acceptance criteria" were implicitly tied to meeting internal design specifications, safety standards, and demonstrating performance comparable to the predicate devices, rather than a specific numerical performance metric in a clinical study against a defined ground truth.

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StabiliT ER Bone Cement:
The StabiliT ER Bone Cement is intended for the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

StabiliT Vertebral Augmentation System (for use with StabiliT ER * Bone Cement):
The StabiliT Vertebral Augmentation System is intended for percutaneous delivery of StabiliT ER Bone Cement in vertebroplasty or kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

StabiliT ER* Bone Cement:
The StabiliT ER Bone Cement is two-component PMMA bone cement with a powder component and a liquid component.

StabiliT Vertebral Augmentation System (for use with StabiliT ER Bone Cement):
StabiliT Vertebral Augmentation System is a motorized, microprocessor controlled bone cement delivery system intended for percutaneous delivery of bone cement in vertebroplasty or kyphoplasty procedures that allows for warming of the cement during cement delivery.

This document describes the 510(k) premarket notification for the StabiliT ER Bone Cement and StabiliT Vertebral Augmentation System. While it confirms the device's substantial equivalence to predicate devices based on in-vitro testing and biocompatibility, it does not contain information typically associated with acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML product or a complex medical device undergoing extensive clinical trials for performance metrics.

Specifically addressing your numbered points based on the provided text:

1. A table of acceptance criteria and the reported device performance:
   The document mentions "Results of in-vitro testing (material, performance, mechanical, electrical) demonstrate that the StabiliT ER* Bone Cement and StabiliT Vertebral Augmentation System (for use with StabiliT ER* Bone Cement) functioned as intended and the results of tests were as expected." However, it does not provide a specific table of acceptance criteria or detailed quantitative performance metrics. It only states that the devices functioned as intended and meet the requirements of ISO 10993-1 for biocompatibility.

2. Sample sizes 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 document. The testing described is "in-vitro testing," which generally refers to laboratory tests, not human or animal clinical trials.

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):
   This information is not applicable/not provided as the testing was in-vitro (material, mechanical, electrical performance, biocompatibility) and did not involve expert-established ground truth for a diagnostic or AI/ML-driven device.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   This information is not applicable/not provided for the same reasons as point 3.

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:
   This information is not applicable/not provided. The device in question is a bone cement and a delivery system for vertebroplasty/kyphoplasty. It is a physical medical device, not an AI/ML diagnostic or assistive technology that would involve human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   This information is not applicable/not provided. The device is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   The "ground truth" for this type of device typically relates to engineering specifications and material science standards (e.g., tensile strength, setting time, biocompatibility standards). The document states the device "meet the requirements of ISO 10993-1" for biocompatibility and "functioned as intended" based on in-vitro material, performance, mechanical, and electrical testing. However, no specific details on the metrics or how "ground truth" was established are provided beyond these general statements.

8. The sample size for the training set:
   This information is not applicable/not provided as the device is not an AI/ML product requiring a training set.

9. How the ground truth for the training set was established:
   This information is not applicable/not provided as the device is not an AI/ML product requiring a training set.

Summary of Acceptance Criteria and Device Performance (as much as can be extracted):

Overall Study Information:

• Study Name/Type: In-vitro testing (material, performance, mechanical, electrical, and biocompatibility).
• Sample Size (Test Set): Not specified. (Applies to in-vitro samples of the cement and device components)
• Data Provenance: Not specified, but generally refers to laboratory testing environment.
• Experts for Ground Truth: Not applicable (in-vitro engineering and material testing).
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Not applicable (device is not an AI/ML diagnostic/assistive technology).
• Standalone Performance: Not applicable (device is not an algorithm).
• Type of Ground Truth: Adherence to established engineering specifications and material science standards (e.g., ISO 10993-1 for biocompatibility).
• Sample Size (Training Set): Not applicable (device is not an AI/ML product).
• Training Set Ground Truth Establishment: Not applicable.

The document primarily focuses on establishing "substantial equivalence" to predicate devices based on shared intended use, indications, technological characteristics, and principles of operation, supported by in-vitro tests that showed the device "functioned as intended" and met biocompatibility standards. It does not provide detailed performance metrics or clinical study results that typically accompany acceptance criteria for more complex medical devices or AI/ML products.

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The SPACE CpsXL bone cement is indicated for the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

The SPACE CpsXL bone cement is a self-curing polymethyl-methacrylate (PMMA) bone cement intended for use in the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. SPACE CpsXL bone cement is provided as a two-component system. The powder component of both devices consists of a PMMA polymer with a barium sulphate as a radiopacifier and benzoyl peroxide as an initiator. The liquid component consists of methylmethacrylate monomer with the addition of hydroquinone as a stabilizer and N.N-dimethyl-p-toluidine as a promoter.

The provided text is a 510(k) Premarket Notification Summary for the SPACE CpsXL bone cement. This document describes a medical device and its substantial equivalence to a predicate device, rather than a study evaluating an AI-powered diagnostic or assistive tool against specific acceptance criteria.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not present in this document.

Here's what can be extracted and a clear statement about what is not available based on the request:

Acceptance Criteria and Device Performance:

The document implicitly defines "acceptance" as demonstrating substantial equivalence to a predicate device. This is a regulatory standard for medical devices. The performance criteria are therefore primarily related to the physical, chemical, and mechanical properties of the bone cement, ensuring they are comparable to the predicate.

Information NOT available in the provided text, as it pertains to AI/diagnostic studies:

1. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of device submission.
2. 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. "Ground truth" in this context would likely refer to material science standards, not clinical interpretations.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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, as this is not an AI-assisted diagnostic device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device would be established through established engineering and biomaterial standards and testing, not clinical consensus or pathology.
7. The sample size for the training set: Not applicable for this type of device submission.
8. How the ground truth for the training set was established: Not applicable.

Study Details (as per the provided document):

The "study" or evaluation described is a series of physical, chemical, and mechanical tests conducted on the SPACE CpsXL bone cement. The purpose of these tests was to demonstrate its performance and substantial equivalence to a legally marketed predicate device (SPACE CpsXL bone cement, cleared under 510(k) K061531).

The document states:

• "Physical, chemical and mechanical testing of the SPACE CpsXL bone cement has been conducted."
• This testing, along with comparison to the predicate device and commercially available bone cements, formed the basis for the conclusion that the device "performs as intended and is substantially equivalent to the predicate device."

Without the actual detailed testing reports, the specific parameters, methodologies, or quantitative results of these "physical, chemical, and mechanical tests" are not available in this summary.

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The SPACE 360 Delivery System is intended for percutaneous delivery of SPACE CpsXL Bone Cement in vertebroplasty or kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

The SPACE 360 Delivery System consists of a reusable controller and disposable, single-use components, including a delivery cannula and stylet, a hydraulic assembly and bone cement syringe, and control cables.

This document is a 510(k) Premarket Notification summary for the SPACE 360 Delivery System, a device for delivering bone cement in vertebroplasty and kyphoplasty procedures.

Based on the provided text, a detailed breakdown of acceptance criteria and a study proving the device meets them cannot be fully generated as the information is not present in this document. This document pertains to regulatory approval and focuses on substantial equivalence to predicate devices rather than a detailed performance study with specific acceptance criteria.

Here's what can be extracted and what is missing:

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

Explanation: The document states that the device "meets its performance requirements," but it does not list those performance requirements as specific acceptance criteria (e.g., flow rate must be X, burst pressure must be Y) nor does it provide the numerical results from the tests against such criteria.

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

• Sample Size: Not specified. The document mentions "Mechanical performance and safety testing" but does not detail the number of units tested.
• Data Provenance: Not specified.
• Retrospective or Prospective: Not specified.

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 Specified. This device is a bone cement delivery system, not an AI diagnostic or clinical decision support tool that would require expert-established ground truth for performance evaluation in the way a diagnostic algorithm does. The testing likely focused on mechanical and safety aspects.

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

• Not Applicable / Not Specified. As above, this is not relevant for a mechanical device's performance testing described here.

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 a mechanical bone cement delivery system, not an AI or computational imaging device that would typically undergo an MRMC study.

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

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

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

• Not Applicable / Not Specified. For mechanical testing, the "ground truth" would be engineering specifications and standards, not clinical ground truth in the diagnostic sense.

8. The sample size for the training set:

• Not Applicable. This is a physical device, not an AI model. Therefore, there is no "training set."

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

• Not Applicable. No training set exists for this type of device.

Study Summarized in the Document:

The document refers to a study as:

• "Mechanical performance and safety testing demonstrates that the SPACE 360 Delivery System meets its performance requirements to support its use as a bone cement delivery system."

This statement confirms that testing was performed to substantiate the device's claims for its intended use, focusing on its mechanical function and safety. However, the details of these tests (e.g., specific parameters measured, test methods, sample sizes, numerical results, and the acceptance thresholds) are not detailed in this 510(k) summary. The purpose of this summary is to demonstrate "substantial equivalence" to predicate devices, not to provide a full scientific report of all validation testing.

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The DFine SPACE CpsXL Bone Cement is indicated for the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

The DFine SPACE CpsXL Bone Cement is a self-curing polymethylmethacrylate (PMMA) bone cement intended for use in the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. DFine SPACE CpsXL Bone Cement is provided as a two-component system. The powder component of both devices consists of a PMMA polymer with a barium sulphate as a radiopacifier and benzoyl peroxide as an initiator. The liguid component consists of methylmethacrylate monomer with the addition of hydroquinone as a stabilizer and N,Ndimethyl-p-toluidine as a promoter.

The provided text describes a 510(k) premarket notification for the "DFine SPACE CpsXL Bone Cement." This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting an effectiveness study with specific performance metrics against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, human reader performance, and ground truth establishment is not present in this document.

Here's an breakdown of the available information based on your request:

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

This information is not provided in the document. The submission is a 510(k) for substantial equivalence, which primarily relies on demonstrating that the new device has the same intended use, technological characteristics, and safety/effectiveness as a legally marketed predicate device. It does not typically involve setting specific performance acceptance criteria for a new clinical study.

The document states: "Based upon the testing and comparison to the predicate device and commercially available bone cements, the DFine SPACE CpsXL Bone Cement, performs as intended and is substantially equivalent to the predicate device." This is a general conclusion of substantial equivalence, not a report against specific performance criteria.

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

This information is not provided in the document. The testing mentioned ("Physical, chemical and mechanical testing") is likely bench testing or non-clinical, not a clinical study with a "test set" in the context of human data.

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

This information is not provided in the document, as there is no mention of a clinical study or human expert review to establish ground truth for a test set.

4. Adjudication method for the test set

This information is not provided in the document, as there is no mention of a clinical study or adjudication process.

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

There is no mention of an MRMC study or AI assistance in this document. The device is a bone cement, not an AI diagnostic tool.

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

This is not applicable as the device is a bone cement, not an algorithm.

7. The type of ground truth used

This information is not directly provided for a "test set" because no clinical effectiveness study is described. The "ground truth" for demonstrating substantial equivalence for this type of device typically revolves around established performance characteristics of the predicate device and relevant industry standards for material properties and biomechanical performance. The document only mentions "Physical, chemical and mechanical testing."

8. The sample size for the training set

This information is not applicable as the device is a bone cement and would not typically have a "training set" in the context of machine learning or AI.

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

This information is not applicable as the device is a bone cement and would not typically have a "training set" in the context of machine learning or AI.

In summary: The provided document is a 510(k) summary for a medical device (bone cement) that focuses on demonstrating substantial equivalence to a predicate device through physical, chemical, and mechanical testing. It does not include the details of a clinical effectiveness study with acceptance criteria, human reader performance, or ground truth establishment as would be expected for a diagnostic AI device.

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