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The Stryker iVAS® Bone Biopsy Kit can be used as a biopsy tool to remove sample tissue from bone or vertebral body using a coring, cutting or aspiration technique.

The Stryker iVAS® Bone Biopsy Kit can be used as a biopsy tool to remove sample tissue from bone or vertebral body using a coring, cutting or aspiration technique. The subject device is disposable, intended for single use, and is provided sterile to the end user. The mechanism of action for obtaining a biopsy is manual and the principle of operation is through suction. The biopsy device will be sold in a kit configuration consisting of a coaxial biopsy needle, obturator and syringe. The subject biopsy kit is used with an access cannula and stylet of compatible size. The access cannula and stylet are sold separately and are Class I exempt per 21 CFR 888.4200, product code OAR (injector, vertebroplasty (does not contain cement).

The provided text describes the Stryker iVAS® Bone Biopsy Kit and its substantial equivalence to a predicate device, focusing on non-clinical (bench) testing. There is no information about a study proving the device meets acceptance criteria in the context of AI/ML performance, multi-reader multi-case studies, or human-in-the-loop performance.

The document is a 510(k) summary for a medical device and is primarily concerned with establishing substantial equivalence to a legally marketed predicate device, rather than assessing an AI's performance.

Here's the information extracted from the provided text, keeping in mind that the request is geared towards AI/ML device studies, and this document does not describe such a study:

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

The document mentions acceptance criteria but does not provide a table specifying the criteria values alongside reported performance for each test. It broadly states that "All samples surpassed all acceptance criteria" for each test.

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

The document states "All samples" passed the tests, but does not specify the exact number of samples (sample size) used for each bench test.

Data Provenance: Not applicable in the context of "country of origin of the data" or "retrospective or prospective" as these were bench tests performed on physical device samples, not clinical or historical data.

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

Not applicable. The tests are mechanical bench tests on the device's physical properties. There is no ground truth established by experts in the context of interpretation or diagnosis for these types of tests.

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

Not applicable. Adjudication methods are typically relevant for human interpretation of data, such as medical images. These were objective mechanical tests.

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 MRMC comparative effectiveness study was mentioned or performed. This document does not pertain to AI/ML software.

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

No standalone algorithm performance study was mentioned or performed. This document does not pertain to AI/ML software.

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

Not applicable. For the bench tests, the "ground truth" would be the engineering specifications and performance requirements that the device needed to meet.

8. The sample size for the training set

Not applicable. This document describes a physical medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. As noted above, this document does not pertain to AI/ML software, so there is no training set or ground truth in that context.

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The K2M Fenestrated Tap System is intended for use as a standalone biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using an aspiration technique, as well as to provide and maintain access to the same surgical site.

When used as a cement dispenser, the K2M Fenestrated Tap System is intended to dispense cement cleared for use in the spine into a vertebral body for vertebral body augmentation using a vertebroplasty procedure.

The K2M Fenestrated Tap System consists of surgical instruments designed to access vertebral bodies via a posterior surgical approach.

Function: The K2M Fenestrated Tap System can be used to access the vertebral body for obtaining bone biopsies. This system can also be used for the injection of bone cement into the vertebral body using vertebroplasty or kyphoplasty procedures.

The provided text is a 510(k) summary for the K2M Fenestrated Tap System, a medical device. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than detailing extensive clinical trials with acceptance criteria, ground truth establishment, or multi-reader studies as one might find for AI/ML-based devices.

Therefore, much of the requested information regarding acceptance criteria, study details, expert qualifications, and ground truth origin is not available in this document.

However, based on the provided text, here is what can be inferred:

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

The document does not explicitly state quantitative acceptance criteria or performance metrics in a table. The "performance" is implicitly evaluated against its intended use and comparison to predicate devices.

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 mentions "cadaver testing" but does not specify the sample size (i.e., number of cadavers or tests performed). It also does not specify the provenance (country of origin, retrospective/prospective).

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 provided in the document. Given it's a physical device and not an AI/ML algorithm, the "ground truth" would likely relate to the observed functional performance during cadaver testing, and any expert assessment involved is not detailed.

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

This information is 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

A multi-reader multi-case study is typically relevant for interpretative devices, especially AI/ML. This is a physical device (biopsy tool/cement dispenser), and therefore, an MRMC study is not applicable and was not performed.

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

"Standalone algorithm performance" is relevant for AI/ML devices. This is a physical device, so this concept is not applicable. The device itself is used by a human surgeon.

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

The document states "The functional characteristics were evaluated in cadaver testing." The "ground truth" for a physical device in cadaver testing would likely involve the observable physical outcomes and performance characteristics, such as successful biopsy sample removal or successful cement dispensing, assessed by those performing the tests. However, the specific method of determining this "ground truth" (e.g., whether success was confirmed by imaging, physical inspection, or expert assessment) is not detailed.

8. The sample size for the training set

This device does not involve a "training set" in the context of machine learning. Thus, this information is not applicable.

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

As there is no "training set" for this physical device, this information is not applicable.

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Refobacin® Bone Cement R is indicated for use as bone cement in arthroplasty procedures of the hip, knee, and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is indicated for use in the second stage revision for total joint arthroplasty after the initial infection has been cleared.

Refobacin® Bone Cement R is a fast setting polymer containing gentamicin, for use in bone surgery. Mixing of the two component system, consisting of a powder and a liquid, produces a paste, which is used to anchor the prosthesis to the bone. The hardened bone cement allows stable fixation of the prosthesis and transfers all stresses produced in a movement to the bone via the large interface. Insoluble zirconium dioxide is included in the cement powder as an X ray contrast medium. The chlorophyll additive in the liquid component serves as optical marking of the bone cement at the site of the operation.

This document describes a 510(k) premarket notification for the "Refobacin Bone Cement R" and does not contain information about an AI/ML powered device. As such, I cannot extract information related to acceptance criteria, study plans, or ground truth for an AI-based system.

The document pertains to a medical device in the field of orthopedics, specifically bone cement used in arthroplasty procedures. The submission focuses on demonstrating substantial equivalence to a predicate device (Palacos® G Bone Cement) based on non-clinical testing of mechanical, chemical, physical, and handling characteristics. Clinical data was explicitly not required for this determination of substantial equivalence.

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PALACOS® R pro is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

PALACOS® R pro is an acrylic bone cement for use in orthopedic surgery. It is formed from powder and liquid by exothermic polymerization. It secures the fixation of the grafted artificial joint improving the transfer of forces at the interface implant - bone. The bone cement powder and liquid of PALACOS® R pro are pre-packed in a vacuum mixing and application system. This reduces the user steps and processing time during mixing of the bone cement. It also decreases the exposure to monomer fumes. PALACOS® R pro is available in one size: 75 g and is for single use. The PALACOS® R pro device includes: The mixing and application device pre-packed with the bone cement powder One ampoule of monomer liquid pre-packed in a monomer cartridge Accessories: a nozzle, a femur pressurizer, a vacuum sealed vacuum tube and in a separate box, an adaptor ring for the use with bone cement gun.

The provided document is a 510(k) summary for a medical device called PALACOS® R pro, a PMMA bone cement. It is a submission to the FDA for market clearance, asserting substantial equivalence to a predicate device. The information details non-clinical testing performed to demonstrate this equivalence, rather than a clinical study with acceptance criteria for device performance in human patients.

Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable within the context of this document, as it focuses on demonstrating bio-mechanical and material equivalence to an already approved device.

Here's an attempt to address your request based on the provided text, noting where information is not available or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are derived from the standards and tests applied to the predicate device and the reference device. The "reported device performance" indicates that PALACOS® R pro (or its relevant precursors) met these criteria, supporting substantial equivalence.

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

The document does not provide specific sample sizes for the individual non-clinical tests (e.g., number of specimens for compressive strength testing). It states that the tests were performed "per ISO 5833" and "per ISO 10993," which would implicitly define testing protocols and sample sizes within those standards.

• Test set sample size: Not explicitly stated for each test, but implied by adherence to ISO standards.
• Data Provenance: The manufacturer, Heraeus Medical GmbH, is located in Wehrheim, Germany. The tests appear to be conducted as part of the product development and regulatory submission process, which is inherently prospective for demonstrating compliance. The data refers to non-clinical laboratory testing.

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

This concept is not applicable here. The "ground truth" for these tests are the established parameters and thresholds defined by international standards (ISO 5833, ISO 11135, ISO 10993) for bone cement properties and sterilization/biocompatibility. These are objective measurements, not subjective expert assessments.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for reconciling differing expert opinions in clinical ground truth establishment. Here, the "truth" is determined by direct physical and chemical measurements against defined standard limits.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, this was not done. MRMC studies are associated with evaluating diagnostic imaging devices where human readers interpret results, often to assess AI's impact on reader performance. This document concerns a bone cement, which is a therapeutic device, not a diagnostic one.

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

Not applicable. This device is a bone cement, a material used in surgery, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is based on established international standards and measurement methodologies for material properties, sterilization efficacy, and biocompatibility. For instance, compressive strength has a defined physical measurement and an acceptable range per ISO 5833.

8. The Sample Size for the Training Set

Not applicable. This device is a material product, not an AI/machine learning algorithm that requires a training set.

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

Not applicable for the same reason as point 8.

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PALACOS® R+G pro is indicated for use in the second stage revision for total joint arthroplasty after the initial infection has been cleared.

PALACOS® R+G pro is an acrylic bone cement for use in orthopedic surgery. It is formed from powder and liquid by exothermic polymerization. It secures the fixation of the grafted artificial joint improving the transfer of forces at the interface implant - bone. The bone cement powder and liquid of PALACOS® R+G pro are pre-packed in a vacuum mixing and application system. This reduces the user steps and processing time during mixing of the bone cement. It also decreases the exposure to monomer fumes. PALACOS® R+G pro is available in one size: 75 g and is for single use. The PALACOS® R+G pro device includes: The mixing and application device pre-packed with the bone cement powder One ampoule of monomer liquid pre-packed in a monomer cartridge Accessories: a nozzle, a femur pressurizer, a vacuum sealed vacuum tube and in a separate box, an adaptor ring for the use with bone cement gun

Based on the provided text, the device is PALACOS® R+G pro, a radiopaque bone cement with gentamicin. This document is a 510(k) summary for its premarket notification.

Here's the breakdown of the acceptance criteria and the study information:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative format as would be seen for diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, it describes a series of nonclinical tests performed according to international standards (ISO standards) to demonstrate that the PALACOS® R+G pro is substantially equivalent to a legally marketed predicate device (PALACOS® R+G, K031673). The reported device performance is that it characterized per ISO 5833, measured according to Dynstat test method, validated per ISO 11135, and performed per ISO 10993. The conclusion is that it is "substantial equivalent to PALACOS® R+G."

Given the nature of this medical device (bone cement), the "acceptance criteria" are implied by compliance with these standards and the demonstration of substantial equivalence.

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

The document indicates that nonclinical tests were performed. No specific sample sizes for these tests (e.g., number of test specimens for mechanical strength) are detailed in this summary. The data provenance is from Heraeus Medical GmbH, Germany. The tests are inherently prospective as they are conducted specifically for the purpose of demonstrating equivalence for this new product.

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

This question is not applicable. The device is a bone cement, not a diagnostic or AI device that requires expert adjudication for ground truth establishing. The "ground truth" for this device's performance is established through physical and biological testing against established standards, not expert consensus on medical images or clinical outcomes.

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

This question is not applicable for the same reasons as point 3. Testing of physical properties and biocompatibility does not involve human adjudication in the described manner.

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 question is not applicable. The device is a bone cement, not an AI or diagnostic tool. No MRMC study was performed or is relevant for this device.

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

This question is not applicable. The device is a bone cement, not an algorithm.

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

For a bone cement, the "ground truth" for its performance and safety is established through:

• Compliance with international standards: ISO 5833 for mechanical properties, ISO 11135 for sterilization, and ISO 10993 for biocompatibility.
• Physical and chemical characterization: Direct measurements of properties like stability, temperature, setting time, strength, etc.

8. The sample size for the training set

This question is not applicable. There is no concept of a "training set" for a physical medical device like bone cement. The manufacturing process and formulation are developed, and then the final product is tested against standards.

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

This question is not applicable for the same reason as point 8.

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The Stryker IVAS Bone Biopsy Kit can be used as a biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using a coring, cutting or aspiration technique.

The Stryker® Inflatable Vertebral Augmentation System (iVAS®) 8 Gauge Bone Biopsy Kit may be used as a biopsy tool to remove a sample of bone tissue from a vertebral body for diagnostic purposes using a coring, cutting or aspiration technique.

The Stryker® iVAS® 8 gauge bone biopsy kit is a disposable device, intended for single-use, individually packaged and provided sterile. The biopsy device will be sold in a kit consisting of a coaxial biopsy needle, obturator and syringe. The biopsy kit is used with access cannula and stylet accessories of compatible size. The access cannula and stylet are sold separately and are Class I exempt under 21 CFR 888.4200, product code OAR (Injector, vertebroplasty (does not contain cement).

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Important Note: The document consistently states that testing was performed to mitigate risk and ensure no new safety or effectiveness concerns, indicating that all acceptance criteria were met, even if the specific numerical results are not listed.

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

The document does not provide specific sample sizes for each non-clinical test. It generally refers to "verification and validation testing" without detailing the number of units tested for each criterion.

• Test Set Sample Size: Not specified.
• Data Provenance: The testing was non-clinical (laboratory/bench testing) performed by Stryker Instruments. The country of origin for the data is implicitly the USA (Kalamazoo, Michigan), where Stryker Instruments is located. The tests were prospective as they were performed to evaluate the modified device.

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

Given that this is a 510(k) submission for a physical medical device (bone biopsy kit) and involves non-clinical bench testing, the concept of "experts establishing ground truth for a test set" in the context of image analysis or diagnostic performance is not directly applicable.

The "ground truth" for the non-clinical tests is established by the engineering specifications and regulatory standards (e.g., ISO 14971, ISO 11137-1/2) that define the performance metrics and their acceptance limits. The experts involved would be the design engineers, quality assurance personnel, and regulatory affairs specialists within Stryker who designed the tests, conducted them, and interpreted the results against these established standards. Their qualifications would be in engineering, materials science, and medical device regulations. The document does not specify the exact number of such individuals involved.

4. Adjudication Method for the Test Set

Again, for non-clinical bench testing of a physical device, an "adjudication method" as typically understood in studies involving human interpretation (e.g., 2+1 consensus) is not directly relevant.

The "adjudication" in this context would involve:

• Verification and validation testing protocols: These define how each test is to be performed and how results are to be interpreted.
• Quality control procedures: Internal company procedures ensure that testing is conducted correctly and documented accurately.
• Review and approval processes: Engineering and quality management teams would review the test results against the acceptance criteria. Any discrepancies or failures would lead to further investigation or device redesign.

The document states that a "Risk Management File (RMF), in compliance with EN ISO 14971:2012" was completed, indicating a structured process for risk assessment and verification activities.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical testing was deemed necessary for this 510(k)." Therefore, there is no information on how much human readers improve with AI vs. without AI assistance, as AI is not part of this device or its evaluation.

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

No, a standalone algorithm performance study was not done. This device is a physical bone biopsy kit, not an algorithm or AI-powered system.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is based on:

• Engineering specifications: Design requirements for physical strength, torque resistance, impact resistance, and functional performance (e.g., sample size retention).
• Regulatory standards: Compliance with international standards for sterilization (ISO 11137-1 and ISO 11137-2 for VDmax25, SAL 10-6) and risk management (EN ISO 14971:2012).
• Predicate device characteristics: The modified device's performance is compared to the established performance and safety profile of the predicate device (Stryker Bone and Vertebral Body Biopsy Kit K032943) to ensure substantial equivalence.

8. The Sample Size for the Training Set

This is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."

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

This is not applicable, as there is no training set for this physical device.

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The OnControl Bone Access and Bone Biopsy System is intended for use with a standard cement delivery system for the fixation of fractures of the vertebral body using vertebroplasty and/or for bone biopsy of the vertebral body and bone lesions.

The OnControl Bone Access and Bone Biopsy System by Vidacare consists of a reusable Power Driver and a disposable sterile needle set in a sealed tray. The sealed tray contains 1 coupler with driver sterile sleeve. 1 beveled needle set and 2 sharps protectors. The OnControl Bone Access System Needle Set is an 11 gauge, 152 mm cannula made of 304 stainless steel, with beveled cutting tip and stylet. The biopsy and vertebroplasty needle are the same needle. The needle sets are identical in gauge, length and materials to the predicate devices: the OnControl Bone Access System (cleared via K112468, The OnControl Bone Access System by Vidacare®) and 11g, the same as Clearview Plus Bone and Vertebral Body Biopsy Needles (cleared via K022169). The powered driver is identical to the predicate driver cleared via K112468, The OnControl Bone Access System by Vidacare®.

Under fluoroscopic imaging quidance, activation of the driver assists the clinician to insert the needle set through the cortex of the bone, into the vertebral body or area of lesion. The driver is then separated from the hub of the needle set by retracting the OnControl Connector release mechanism ring on the OnControl Connector. The needle set consists of two parts, an 11g outer cannula (3.05mm x 197mm) with an inner stylet (diameter of 2.54mm). The inner stylet is used only to penetrate the cortex and is then removed. A standard Luer lock (part of the 11 gauge cannula) permits attachment of the syringe for aspiration. The driver is activated and advanced to obtain the biopsy specimen and then withdrawn.

The driver is then separated from the needle assembly for specimen removal.

The provided text is a 510(k) summary for the OnControl™ Bone Access and Bone Biopsy System, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving device performance against those criteria.

Therefore, the requested information, specifically:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Cannot be extracted directly from the provided text.

The document describes the device, its intended use, and compares its technological characteristics to predicate devices (K112468, K022169, K962425) to establish substantial equivalence. It highlights similarities in anatomical sites, biocompatibility, dimensional specifications, driver design, energy type, environmental specifications, ergonomics, firmware, and indications for use.

The FDA's letter (pages 3-5) confirms the substantial equivalence determination based on the premarket notification, but it does not detail specific performance studies with acceptance criteria, sample sizes, or ground truth methodologies as would be found in a clinical study report. The 510(k) process primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through bench testing and comparison of technical characteristics, rather than de novo clinical efficacy trials against specific performance targets.

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The OnControl Bone Access System by Vidacare® is intended for use with a standard cement delivery system for the fixation of fractures of the vertebral body using vertebroplasty and for bone biopsy. This system does not contain cement.

The OnControl Bone Access System by Vidacare® consists of a reusable Power Driver and a disposable sterile needle set in a sealed tray. The sealed tray contains 1 coupler with driver sterile sleeve, 1 beveled needle set and 2 sharps protectors. The Vertebral (Access and) Biopsy Needle Set is an 11 gauge, 152 mm cannula made of 304 stainless steel, with beveled cutting tip and stylet. The biopsy and vertebroplasty needle are the same needle. The needle sets are identical in gauge, length and materials to the predicate devices: the Vertebral Access System (cleared via K081713) and 11g, the same as Clearview Plus Bone and Vertebral Body Biopsy Needles (cleared via K022169). The powered driver is identical to the predicate driver cleared via K081713.

Under fluoroscopic imaging guidance, activation of the driver assists the clinician to insert the vertebral needle set through the cortex of the bone, into the vertebral body. The driver is then separated from the hub of the needle set by retracting the OnControl Connector release mechanism ring on the OnControl Connector. The needle set consists of two parts, an 11g outer cannula (3.05mm x 197mm) with an inner stylet (diameter of 2.54mm). The inner stylet is used only to penetrate the cortex and is then removed. A standard Luer lock (part of the 11 gauge cannula) permits attachment of the syringe for aspiration. The driver is activated and advanced to obtain the biopsy specimen and then withdrawn.

The driver is then separated from the needle assembly for specimen removal.

The provided text is a 510(k) summary for the Vidacare OnControl Bone Access System. This type of document is for premarket notification of a medical device to the FDA, demonstrating substantial equivalence to a legally marketed predicate device. It typically doesn't contain a full study protocol with acceptance criteria and detailed device performance data in the way a clinical trial report would. Instead, it focuses on comparing the new device's technological characteristics, indications for use, and safety/effectiveness to existing, cleared devices.

Therefore, many of the requested items (acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, standalone performance details, and ground truth establishment) are not present in this type of document.

The document states that the new device has "similar technological characteristics and to be equivalent" to its predicate devices in areas such as indications for use, target population, driver design, needle design, technique, sterility, biocompatibility, and anatomical sites. This "equivalence" is the primary "acceptance criterion" for a 510(k) submission, and the basis of the "study" (which is more accurately a comparison) presented.

Here's a breakdown of what can be extracted from the provided text, and where information is missing:

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

• Acceptance Criteria (Implied for 510(k) Equivalence):

  • Indications for Use: Equivalent to predicate devices.
  • Target Population: Equivalent to predicate devices.
  • Driver Design Features: Equivalent to predicate devices.
  • Needle Design: Equivalent to predicate devices (specifically, 11g, 152mm cannula of 304 stainless steel, beveled cutting tip and stylet, identical in gauge, length and materials).
  • Technique: Equivalent to predicate devices.
  • Sterility: Equivalent to predicate devices.
  • Biocompatibility: Equivalent to predicate devices.
  • Anatomical Sites: Equivalent to predicate devices.

• Reported Device Performance:

  • The document states that the new device was "found to have similar technological characteristics and to be equivalent" to the predicate devices across the criteria listed above.
  • Specifically, for the needle: "The Vertebral (Access and) Biopsy Needle Set is an 11 gauge, 152 mm cannula made of 304 stainless steel, with beveled cutting tip and stylet. The biopsy and vertebroplasty needle are the same needle. The needle sets are identical in gauge, length and materials to the predicate devices..."
  • For the driver: "The powered driver is identical to the predicate driver cleared via K081713."
  • The system "assists the clinician to insert the vertebral needle set through the cortex of the bone, into the vertebral body."

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

• Not provided. This document does not detail a specific "test set" with a sample size as it's a comparative equivalence submission, not a new clinical study with performance endpoints. The "test" is the comparison to predicates.

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. No explicit "ground truth" establishment process for a test set is described in this 510(k) summary. The ground for "equivalence" is based on comparing device specifications and intended use.

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

• Not applicable/Not provided. No 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

• No. This device is a mechanical bone access system, not an AI software. Therefore, an MRMC study related to AI assistance is not relevant or described.

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

• Not applicable/Not provided. This is a hardware device; the concept of "standalone algorithm performance" does not apply. The device description explicitly states it "assists the clinician."

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

• Not applicable/Not provided in the traditional sense. For a 510(k) submission, the "ground truth" for demonstrating substantial equivalence lies in the established performance and safety of the predicate devices. The new device is simply shown to be functionally and materially similar, therefore inheriting the "truth" of the predicate's clearance.

8. The sample size for the training set

• Not applicable/Not provided. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable/Not provided. As there is no training set, this information is not relevant.

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The ArthroCare® Parallax® Contour® Vertebral Augmentation Device – enhanced when used with the access needle kits are indicated for use during kyphoplasty or vertebral augmentation procedures to create a void in the vertebral body and fill the void with Parallax® Acrylic Resin (bone cement). The painful pathological vertebral body compression fractures may result from osteoporosis, benign or malignant lesions such as metastatic cancers and myeloma.

The ArthroCare Parallax Contour Vertebral Augmentation Device - enhanced is used to disrupt cancellous bone and create a void in the vertebral body and fill the void with Parallax Acrylic Resin (bone cement) during kyphoplasty or vertebral augmentation procedures.

Here's an analysis of the provided text regarding the ArthroCare Parallax Contour Vertebral Augmentation Device - enhanced, focusing on the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on a Special 510(k) submission, which means the device is a modification of an already cleared predicate device (K100479). For such submissions, the primary focus is to demonstrate that the changes do not significantly affect safety or efficacy and that the modified device performs comparably to the predicate. Therefore, the "acceptance criteria" here are largely related to maintaining the performance and characteristics of the predicate device.

Note on "Acceptance Criteria": In a 510(k) for a modified device, the "acceptance criteria" are not typically expressed as specific quantitative thresholds like "90% sensitivity" or "tensile strength > X N." Instead, the key criterion is demonstrating substantial equivalence to the predicate device, primarily through comparative testing that shows the modified device performs similarly or meets the same functional requirements.

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

The document does not specify sample sizes for the functional performance testing (test set). It only states that "Functional performance testing of the device included torque, insertion and withdrawal, flexure, device attachment/deployment/ removal, and mechanical displacement of bone have been completed."

The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data. Given the nature of mechanical performance testing for a medical device submitted to the FDA in the US, it is highly likely that this testing was conducted in a controlled laboratory environment in the US (prospective testing for this submission).

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

This type of information is not applicable to this specific submission. The "ground truth" for mechanical functional testing is typically established by engineering standards, validated test methods, and direct measurement against known physical properties or the performance of the predicate device, not by expert medical opinion in the same way as, for example, image interpretation.

4. Adjudication Method for the Test Set

This is not applicable to the type of testing described. Adjudication methods (like 2+1, 3+1) are relevant for studies involving human interpretation or clinical endpoints where differing opinions need to be resolved. The testing mentioned (torque, insertion, etc.) is objective mechanical testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its Effect Size

No, an MRMC comparative effectiveness study was not done for this submission. MRMC studies are typically used to evaluate the impact of a diagnostic device (often image-based) on reader performance. This device is a surgical tool, and its evaluation focuses on mechanical performance and safety, not on improving human reader interpretation.

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

Not applicable. This device is a manual surgical instrument, not an algorithm or an AI system. Therefore, standalone performance (in the context of AI) is not relevant.

7. The Type of Ground Truth Used

For the functional performance testing, the "ground truth" would be established by:

• Engineering specifications and standards: The device must meet predefined mechanical strength, flexibility, and operational parameters.
• Performance of the Predicate Device: The modified device's performance is compared directly to the known and cleared performance characteristics of its predicate. The goal is to demonstrate that the new device performs within the acceptable range or equivalently to the predicate.

8. The Sample Size for the Training Set

Not applicable. This device is a physical surgical tool and does not involve AI or machine learning algorithms that would require a "training set."

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

Not applicable, as there is no training set for this device.

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The ArthroCare® Parallax® Contour® Vertebral Augmentation Device when used with the access needle kits are indicated for use during kyphoplasty or vertebral augmentation procedures to create a void in the vertebral body and fill the void with Parallax Acrylic Resin (bone cement). The painful pathological vertebral body compression fractures may result from osteoporosis, benign or malignant lesions such as metastatic cancers and myeloma.

The ArthroCare Parallax Contour Vertebral Augmentation Device is used to disrupt cancellous bone and create a void in the vertebral body and fill the void with Parallax Acrylic Resin (bone cement) during kyphoplasty or vertebral augmentation procedures.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the ArthroCare® Parallax® Contour® Vertebral Augmentation Device, structured according to your request.

Please note: The provided text primarily focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating acceptance criteria in a quantitative, pass/fail manner. The "reported device performance" are observations and outcomes from the studies conducted to support this equivalence.

Acceptance Criteria and Study Findings for ArthroCare® Parallax® Contour® Vertebral Augmentation Device

The information provided within the 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through functional performance testing, pre-clinical cadaveric studies, and a clinical study. The "acceptance criteria" are implied by the successful outcomes of these studies and the finding of substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

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