Search Results

SPECTRUM® GV Bone Cement is indicated for the fixation of the REMEDY® & REMEDY SPECTRUM® GV Spacers, and for the fixation of prostheses to living bone in the second stage of a two-stage revision of a total joint arthroplasty after the initial infection has been cleared.

SPECTRUM® GV Bone Cement is a radiopaque, PMMA bone cement with gentamicin and vancomycin. The bone cement is single-use and provided sterile. SPECTRUM® GV Bone Cement is a traditional bone cement in that the liquid is contained in a vial and the powder in a sachet. The two components are mixed manually immediately before use. The device is protected from bacterial adhesion due to the presence of gentamicin and vancomycin.

This FDA 510(k) clearance letter is for a bone cement, not a medical device that utilizes AI or requires complex studies to demonstrate performance through acceptance criteria in the way you've described.

The document indicates that SPECTRUM® GV Bone Cement is substantially equivalent to a previously cleared predicate device (K231556), and therefore, extensive new studies to prove acceptance criteria in the context of device performance metrics (like sensitivity, specificity, or reader improvement with AI) were not required.

Here's why and what information is provided:

• Device Type: This is a Polymethylmethacrylate (PMMA) bone cement, a physical material used for fixation. It's not a diagnostic imaging device, a software as a medical device (SaMD), or an AI algorithm.
• Substantial Equivalence: The clearance is based on the device being "substantially equivalent" to a legally marketed predicate device. This means the FDA has determined it is as safe and effective as the predicate, often due to identical or very similar technological characteristics and intended use.
• No New Performance Data (for the requested criteria): The document explicitly states: "Non-clinical testing was not required as the subject device is identical to that of the predicate." This confirms that specific performance metrics, sample sizes for test sets, expert adjudication, or AI-related studies were not performed for this specific submission because the device itself hasn't changed.

Therefore, I cannot provide the detailed information requested in your prompt because the provided 510(k) letter does not contain the type of acceptance criteria and study analysis that would be relevant for an AI-powered diagnostic device. The questions about sensitivity, specificity, MRMC studies, ground truth establishment, and training/test set sizes are pertinent to AI/software device clearances, not to the material science and manufacturing consistency demonstrated for a bone cement via substantial equivalence.

Ask a specific question about this device

OSTEOPAL® V bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a vertebroplasty or balloon kyphoplasty procedure.

OSTEOPAL® V is a PMMA bone cement for use in vertebroplasty. It is formed from powder and liquid by exothermic polymerization.

This document is a 510(k) premarket notification for a medical device called OSTEOPAL® V, which is a polymethylmethacrylate (PMMA) bone cement. The purpose of the submission is to gain clearance for modifications to an existing device (K050085). Based on the provided text, the device itself is a material (bone cement), and thus the acceptance criteria and study described are for the performance of the material, not for an AI/software device. Therefore, many of the requested fields are not applicable.

Here's the information derived from the provided document regarding the acceptance criteria and the study that proves the device meets them:

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 primarily discusses non-clinical testing for material properties and risk assessments. There is no mention of a "test set" in the context of patient data or clinical imaging. The studies performed are mechanical testing, stability testing, and risk assessments. For these non-clinical tests, specific sample sizes are not provided in this summary. The data provenance is implied to be from Heraeus Medical GmbH in Germany, where the device is manufactured and where the tests would typically be performed. The tests are prospective in nature (i.e., new tests performed on the modified device).

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 is not applicable as there is no "test set" or "ground truth" related to expert opinions on medical images or diagnoses for this device. The evaluation is based on engineering standards, material science, and risk assessment.

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

This is not applicable as there is no "test set" requiring adjudication by experts.

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 is not applicable. OSTEOPAL® V is a bone cement, not an AI/software device, and no MRMC study with human readers assisting with AI was performed or is relevant.

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

This is not applicable. OSTEOPAL® V is a bone cement, not an algorithm.

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

For the non-clinical tests (mechanical, stability, material characterization), the "ground truth" is established by adherence to recognized international standards (e.g., ISO 5833, ASTM F451, DIN EN ISO 14971) and validated laboratory testing methodologies. For the MR safety assessment, the "ground truth" is based on the material properties and scientific rationale. For the labeling and risk assessments, the "ground truth" is derived from clinical evaluations of the device's performance in the field (implicitly from the predicate device's history and relevant medical literature), coupled with the risk assessment process. There is no specific "expert consensus" or "pathology" ground truth mentioned as would be relevant for a diagnostic device.

8. The sample size for the training set

This is not applicable as there is no "training set" for an AI/software model. The device is a physical product (bone cement).

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

This is not applicable as there is no "training set."

Ask a specific question about this device

SPECTRUM® GV Bone Cement is indicated for the fixation of a REMEDY SPECTRUM® GV Spacer, and for the fixation of prostheses to living bone in the second stage revision of a total hip arthroplasty after the initial infection has been cleared.

SPECTRUM® GV Bone Cement is a radiopaque, PMMA bone cement with gentamicin and vancomycin. The bone cement is single-use and provided sterile. SPECTRUM® GV Bone Cement is a traditional bone cement in that the liquid is contained in a vial and the powder in a sachet. The two components are mixed manually immediately before use. The device is protected from bacterial adhesion due to the presence of gentamicin and vancomycin.

The provided text describes a 510(k) premarket notification for a medical device called "SPECTRUM® GV Bone Cement." This document focuses on the substantial equivalence of the new bone cement to a legally marketed predicate device (SPECTRUM® GV Bone Cement, K172906).

Crucially, this document does NOT describe the acceptance criteria and study proving a device meets acceptance criteria in the context of an AI/Machine Learning (ML) enabled medical device.

The content details the regulatory clearance process for a traditional medical device (bone cement) and the performance testing conducted to demonstrate its physical, chemical, and biological properties, as well as its substantial equivalence to a predicate device.

Therefore, I cannot fulfill the request to provide information about acceptance criteria for an AI/ML device, sample sizes for test sets, expert ground truth, MRMC studies, or training set details from the provided text.

The closest relevant sections in the provided text are "Performance Testing of Subject SPECTRUM® GV Bone Cement," which lists the types of tests performed (mechanical, elution, biocompatibility, sterilization, shelf life), but these are for a physical substance, not a software algorithm.

In summary, the provided document is not about an AI/ML medical device, and thus does not contain the information requested regarding AI/ML device acceptance criteria and validation studies.

Ask a specific question about this device

Bone Cement LV and HV are indicated for the fixation of joint prostheses to living bone in orthopedic musculoskeletal surgical procedures for rheumatoid arthritis, sickle cell anemia, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions and revision of previous arthroplasty.

Bone Cement Genta are intended for the fixation of prosthesis to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

The Bone Cement Genta are PMMA, radiopaque bone cements, containing gentamicin designed for the fixation of prosthesis to the living bone. The devices are a traditional bone cement product. The liquid is contained in a vial and the powder in a sachet; these components are packaged in unitary blister with Tyvek lid, which is placed in an aluminum bag. The components are manually mixed immediately prior to use. The devices are sold disposable and sterile. The Bone Cement Genta are available in a low and high viscosity version.

The Bone Cement are PMMA, radiopaque bone cements designed for the fixation of prosthesis to the living bone. The devices are a traditional bone cement product. The liquid is contained in a vial and the powder in a sachet; these components are packaged in unitary blister with Tyvek lid, which is placed in an aluminum bag. The components are manually mixed immediately prior to use. The devices are sold disposable and sterile. The Bone Cement are available in a low and high viscosity version.

The provided text is a 510(k) summary for polymethylmethacrylate (PMMA) bone cements. It details the device's characteristics, intended use, and comparison to predicate devices. However, this document does not contain the specific acceptance criteria or the study results in the format or level of detail requested for the device performance.

The section titled "PERFORMANCE DATA" (starting on page 9) lists the types of performance testing conducted but does not provide quantitative acceptance criteria or the reported device performance. It only states that the performance data demonstrate that the new devices are substantially equivalent to the predicate devices, and meet the requirements of the Special Controls Guidance Document.

Therefore, I cannot complete the table of acceptance criteria and reported device performance from the provided document. Similarly, details about sample sizes, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, or training set specifics for an AI/algorithm are not present as this document pertains to a bone cement, not an AI or imaging device.

If this were an AI/imaging device submission, the provided information would be insufficient to answer most of the requested points.

Ask a specific question about this device

Bone Cement - Normal Viscosity is indicated for fixation of prostheses to live bone in musculoskeletal orthopedic surgical interventions in cases of rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe secondary destruction of the joints after trauma or other conditions and in the review of previous arthroplasty procedures.

The Bone Cement - Normal Viscosity is a self-curing, radiopaque, polymethyl methacrylatebased cements used for securing a metal or polymeric prothesis to living bone in arthroplasty procedures. The bone cement has no intrinsic adhesive properties but rely instead on close mechanical interlock between the irregular bone surface and the prosthesis.

The provided text is a 510(k) summary for a medical device called "Bone Cement - Normal Viscosity." It describes its indications for use, device description, equivalence to a marketed predicate device, and performance data. However, the document does not describe a study involving an AI/Machine Learning device or a study involving human-in-the-loop performance, expert ground truth adjudication, or statistical performance metrics like sensitivity/specificity or ROC curves typically associated with AI device performance and acceptance criteria.

Instead, this document pertains to a traditional medical device (bone cement) and focuses on demonstrating substantial equivalence to a predicate device through physical, chemical, and mechanical properties, as well as sterilization, shelf-life, and biocompatibility testing according to established FDA guidance for PMMA bone cement.

Therefore, I cannot fulfill the request to describe acceptance criteria, a study proving AI device performance, sample sizes for test/training sets, expert ground truth establishment, or MRMC studies, as this information is not present in the provided text.

The document explicitly states: "No clinical data were included in this submission." This further confirms that the type of study outlined in the request (which heavily implies clinical or reader studies for AI performance) was not part of this 510(k) submission.

Summary of why the request cannot be fully answered based on the provided text:

• Device Type: The device is bone cement, not an AI/ML diagnostic or assistive device.
• Study Type: The studies performed are non-clinical, testing physical, chemical, and mechanical properties, sterilization, shelf-life, and biocompatibility. They are not AI performance studies.
• Lack of AI-related metrics: There are no mentions of sensitivity, specificity, AUC, human reader improvement with AI assistance, or any other metrics relevant to AI device performance.
• No Human-in-the-loop or standalone AI performance: The concepts of human readers, expert adjudication, or AI algorithms acting in standalone mode are not applicable to the studies described for bone cement.
• No Training/Test Set Data for AI: There is no mention of training sets, test sets, or ground truth for an AI model because no AI model is being evaluated.

Therefore, for the sake of completeness, I can only state what is described regarding performance criteria for this specific device, which differs significantly from the AI/ML framework requested.

What is described for "Bone Cement - Normal Viscosity" performance testing (non-AI related):

The performance data to establish substantial equivalence were conducted in accordance with the "FDA Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement; Guidance for Industry and FDA" dated July 17, 2002.

Acceptance Criteria and Reported Device Performance (as gathered from the "PERFORMANCE DATA" section):

• Chemical Composition
• Molecular weight
• Physical Properties
• Stability of Components
• Thermal Properties
• Mechanical properties | "The performance data demonstrate that the new device Bone Cement - Normal Viscosity substantially equivalent to the predicate device application K053003." (This implies the results met the established criteria for substantial equivalence to the predicate as per the guidance document.) |
  | Sterilization and Shelf Life | - Validation of ethylene oxide method
• Validation of membrane filter sterilization | "The sterilization process, including the ethylene oxide method and the membrane filter sterilization has been validated and the sterility of the subject device has been verified according to ISO 11135 and ISO 13408-1/2." |
  | Endotoxins | - Assessment on the presence of endotoxins | "The assessment on the presence of endotoxins was carried out in accordance with USP 43 - NF 38, 2020 Bacterial Endotoxins Test." (Implies compliance with the standard.) |
  | Biocompatibility | - Biological evaluation | "The biological evaluation of subject device was performed in accordance with ISO 10993-1 in accordance with the 'Biological evaluation of medical devices - Part 1: evaluation and testing within a risk management process', issued September 20202018.'" (Implies compliance with the standard.) |

Regarding the AI/ML specific questions:

1. Sample size for test set and data provenance: Not applicable. This is not an AI/ML device study.
2. Number of experts and qualifications for ground truth: Not applicable. Ground truth for AI is not established.
3. Adjudication method: Not applicable.
4. MRMC comparative effectiveness study: Not applicable.
5. Standalone performance (algorithm only): Not applicable.
6. Type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the adherence to material and manufacturing standards for bone cement, not diagnostic accuracy.
7. Sample size for the training set: Not applicable. No AI model is being trained.
8. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

OGM® 1 is a PMMA bone cement 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.

OGM® 1A is indicated for use in the second stage revision for total joint arthroplasty after the initial infection has been cleared.

A bundled Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance for modifications to OGM® 1 and OGM® 1A®. This submission encompasses multiple devices that have similar intended use and indications for use as well as rely on similar data.

OGM® bone cements without Gentamicin
OGM® 1 is polymethylmethacrylate (PMMA) bone cement:

• OGM® 1: is a standard-setting, high-viscosity, PMMA-based bone cement for orthopaedic surgery,
  The OGM® 1 consists of two components, a monomer liquid and a polymer powder. The liquid component contains the monomer, accelerator, and a stabilizer. The powder contains the polymer, X-Ray-opacifier, and initiator. They are intended for single-use and are provided sterile (ethylene oxide and sterile filtration).

OGM® bone cements with Gentamicin
OGM® 1A is polymethylmethacrylate (PMMA) bone cement, containing the antibiotic Gentamicin: - OGM® 1A is a standard-setting, high-viscosity, PMMA-based bone cement for orthopaedic surgery,
The OGM® 1A consists of two components, a monomer liquid and a polymer powder. The liquid component contains the monomer, accelerator, and a stabilizer. The powder contains the polymer, X-Ray-opacifier, initiator and the antibiotic Gentamicin. They are intended for single-use and are provided sterile (ethylene oxide and sterile filtration).

This document describes the acceptance criteria and study results for two PMMA bone cements, OGM® 1 and OGM® 1A. These devices were evaluated against various standards to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes for each mechanical or chemical test. The tests were performed "side by side mechanical testing" (page 7, 8) and "subject device and secondary predicate device contains 1g gentamicin sulfate, on the contrary primary predicate device contains 0.5g gentamicin sulfate. Gentamicin sulfate is bactericidal and is active against many strains of Gram-positive and Gram-negative pathogens. As per gentamicin sulfate ratio is higher than the primary predicate device antibacterial efficacy can be considered as substantially equivalent to primary predicate device. Antibacterial efficacy tests are performed to subject device. On the other hand, release ratio of Gentamicin is important both in dosage and total release duration. OGM® 1A is subjected to Gentamicin release test comparatively with the predicate device. Lastly, gentamicin has a negative effect on product mechanical and physical properties. ISO 5833 tests are applied to OGM® 1A and demonstrated compliance." (page 12) implying comparative testing.

The provenance of the data is not specified in terms of country of origin or whether it was retrospective or prospective. It is implied that these are laboratory-based, non-clinical tests conducted by the manufacturer or a contracted lab.

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

This document describes non-clinical performance and safety testing of a medical device (bone cement). The "ground truth" for these types of studies is typically based on established international standards (e.g., ISO, ASTM, USP) and scientific principles, not on expert consensus interpreting subjective data. Therefore, individual experts are not involved in establishing ground truth in the same way they would be for studies involving diagnostic image interpretation.

4. Adjudication Method for the Test Set

Not applicable. As described above, the "ground truth" is based on objective measurements against established international standards and specifications. There is no subjective interpretation requiring adjudication.

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

No. This document pertains to the premarket notification (510(k)) of a bone cement, which involves non-clinical performance and safety testing, not diagnostic imaging or human-in-the-loop AI assistance.

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

Not applicable. This is a medical device (bone cement), not a software algorithm or AI device.

7. The Type of Ground Truth Used

The ground truth for the performance and safety studies is based on:

• International Standards: ISO 5833, ASTM F2118, ASTM F451, ISO 11135, ISO 10993, DIN EN ISO 11135-1, DIN EN ISO 10993-7.
• Pharmacopoeial Standards: USP Endotoxin Reference Standard.
• Antibacterial Testing Standards: AATC.
• Comparison to Predicate Devices: For chemical compositions and gentamicin release profiles (OGM® 1A).

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device. The concept of a "training set" is relevant for machine learning algorithms, which are not involved here.

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

Not applicable, for the same reason as in point 8.

Ask a specific question about this device

PALACOS® MV pro is indicated 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® MV pro is a standard-setting, medium viscosity, radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). It contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field, it has been colored with chlorophyllcopper-complex (E141). The bone cement consists of two components and is prepared immediately before use by mixing the polymer powder) with the monomer liquid (= liquid). A ductile dough forms that sets within a few minutes.

The provided text describes a 510(k) premarket notification for a medical device called PALACOS® MV pro, a polymethylmethacrylate (PMMA) bone cement. This submission aims to demonstrate substantial equivalence to a legally marketed predicate device.

The information provided does not describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML powered device, or any diagnostic device subject to performance metrics like sensitivity, specificity, AUC, etc. Instead, it focuses on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway.

Therefore, many of the requested items (e.g., performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance) are not applicable or mentioned in this document.

Here's an analysis based on the information provided in the document:

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

The document doesn't explicitly state acceptance criteria in terms of specific numerical thresholds for performance metrics commonly associated with AI/ML or diagnostic devices (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" for demonstrating substantial equivalence are based on matching the predicate device's intended use, technological characteristics, and operating principle. The "reported device performance" is demonstrated through various tests designed to show that the subject device functions as intended and is safe and effective, aligning with the predicate.

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

• Test Set Sample Size: Not applicable in the context of an AI/ML test set. The document refers to various engineering and biological tests conducted on the device itself or representative materials. The 'sample size' for these tests would refer to the number of units tested, but this is not specified for each test.
• Data Provenance: Not applicable in the context of an AI/ML test set. The tests are laboratory-based and follow international standards. The manufacturer is Heraeus Medical GmbH, located in Germany.

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 diagnostic device or an AI/ML system requiring expert-established ground truth for a test set. The "ground truth" for this device's performance is established through adherence to recognized international standards and laboratory testing for physical, mechanical, chemical, and biological properties.

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

Not applicable. There is no expert adjudication process described, as it's not relevant for this type of device and submission.

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 a bone cement, not an AI-assisted diagnostic tool. No MRMC study was performed or is relevant.

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

Not applicable. This is a PMMA bone cement, not an algorithm.

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

The "ground truth" for this device's safety and effectiveness, in the context of substantial equivalence, is rooted in:

• International Standards: Adherence to established mechanical (ISO 5833, ASTM F451), sterilization (ISO 11135), biocompatibility (ISO 10993-1), and pyrogenicity (ANSI/AAMI ST72) standards.
• Predicate Device Performance: The demonstrated safe and effective use of the predicate device (PALACOS® R pro) acts as a benchmark. The subject device is shown to be equivalent in its properties to this predicate.
• Laboratory Testing Results: Direct measurements of physical, chemical, and biological properties in controlled laboratory settings.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. There is no "training set" or associated ground truth establishment process for this device as it is not an AI/ML product.

Ask a specific question about this device

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

PALACOS® R pro is a standard-setting, high-viscosity, radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). It contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141). The bone cement consists of two components and is prepared immediately before use by mixing the polymer powder (= powder) with the monomer liquid (= liquid). A ductile dough forms that sets within a few minutes.
PALACOS® R+G pro is a standard-setting, high-viscosity, radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). It contains the aminoglycoside antibiotic gentamicin to protect the cured bone cement and contiguous tissue against colonization by bacteria that are sensitive to gentamicin. It contains the X-ray contrast medium dioxide. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141). The bone cement consists of two components and is prepared immediately before use by mixing the polymer powder (= powder) with the monomer liquid (= liquid). A ductile dough forms that sets within a few minutes.
PALACOS® MV+G pro is a standard-setting, medium viscosity, radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). It contains the aminoglycoside antibiotic gentamicin to protect the cured bone cement and contiguous tissue against colonization by bacteria that are sensitive to gentamicin. It contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141). The bone cement consists of two components and is prepared immediately before use by mixing the polymer powder (= powder) with the monomer liquid). A ductile dough forms that sets within a few minutes.

This FDA 510(k) Premarket Notification is for PALACOS® R pro, PALACOS® R+G pro, and PALACOS® MV+G pro bone cements. It does not describe an AI/ML device, a clinical study with human readers, or a ground truth established by experts. Instead, it focuses on demonstrating substantial equivalence to previously cleared predicate devices through non-clinical performance testing.

Here's a breakdown based on the provided document:

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

The document does not present a formal table of acceptance criteria with reported numerical performance values in the way you might expect for an AI device (e.g., sensitivity, specificity, AUC). Instead, it states that the devices meet existing industry standards and guidance documents. The "acceptance criteria" are implied by adherence to these standards, and the "reported performance" is that the devices meet them.

• Concluded that possible transfer of leachables is low.
• Cytotoxicity test performed to support this conclusion.
• No negative impact estimated from changes. |
  | Mechanical & Functional | FDA Guidance document Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement - Guidance for Industry and FDA (July 17, 2002) (Annex I and Annex II) | - Tests conducted to demonstrate intended function, safety, and effectiveness.
• Data provided to state substantial equivalence to predicate device. |
  | Sterilization | ISO 11135 | - Validation performed using ethylene oxide gassing.
• Cycle designed for sterile units with a sterility assurance level (SAL) of 10⁻⁶.
• Chosen sterilization process considered valid, showing equivalence to predicate device. |
  | Pyrogenicity | ANSI/AAMI ST72 (LAL test) | - Subject device meets endotoxin limit specification of ≤ 20 EU/device.
• Shows equivalence to predicate device. |

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

This document details non-clinical laboratory testing, not a test set of patient data. Therefore, the concepts of "sample size used for the test set" and "data provenance (country of origin, retrospective/prospective)" as they relate to patient data or imagery do not apply. The testing was conducted in a laboratory setting, likely in Germany where the manufacturer is located, or by authorized testing facilities.

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

Not applicable. The ground truth for this type of device (bone cement) is not established by human experts in the context of medical image interpretation. The "truth" is determined by established physical, chemical, and biological testing standards and measurements.

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

Not applicable. There is no human adjudication process described, as the testing is based on objective laboratory measurements against defined standards.

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 an AI-assisted device.

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

Not applicable. This is not an algorithm.

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

The "ground truth" for this submission is based on:

• Established objective standards: International Standards (e.g., ISO 10993-1, ISO 11135, ANSI/AAMI ST72) and FDA Guidance documents (e.g., "Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement").
• Laboratory measurements: Results from specific tests (cytotoxicity, mechanical property measurements, sterility assurance level determination, LAL test for endotoxins) designed to objectively evaluate the device's conformance to these standards and demonstrate substantial equivalence to predicate devices.
• Chemical and material analysis: Confirmation of identical (or acceptably different) chemical composition and materials compared to predicate devices.

8. The sample size for the training set

Not applicable. This is not a machine learning device and therefore does not have a "training set" in that context.

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

Not applicable. As above, there is no "training set" for this type of device.

Ask a specific question about this device

BonOs® Inject bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using vertebroplasty or balloon kyphoplasty procedure.

When used in conjunction with NEO Pedicle Screw System™ BonOs® Inject is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

The NEO Pedicle Screw System™, when used as a posterior pedicle screw system, is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The system is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, tumor, pseudarthrosis, and/or failed previous fusion.

When used in conjunction with BonOs® Inject Cement, the NEO Pedicle Screw System™ is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. NEO Pedicle Screws augmented with BonOs® Inject Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.

BonOs® Inject:
BonOs® Inject is a radiopaque, injectable bone cement for use in spine surgery like percutaneous vertebral augmentation during vertebroplasty or kyphoplasty. It is a two-component system consisting of a powder and a liguid. Methylmethacrylate polymer is the primary constituent of the powder component. Zirconium dioxide is added as radiopacifier. Methylmethacrylate monomer is the primary constituent of the liquid component. Mixing the two separate sterile components, initially an injectable paste is produced which can be transferred into a syringe and which then can be injected under slight pressure into the vertebral body. After curing of the bone cement by exothermic polymerization it stabilizes the vertebral lesions and vertebral compression fractures.

Neo Pedicle Screw System™:
The Neo Pedicle Screw System™ consists of pedicle screws and connecting rods which differ in length and diameter. The system includes the relevant instruments which are single use, disposable and delivered sterile. All components and instruments are sterilized by gamma irradiation.

The screws are offered in diameters of 5.0 - 7.0 mm and lengths of 35 - 55mm. Three different types of rods are available: pre-bent, straight or special bent rod for S1/L5. All rods have a diameter of 5.5 mm. Pre-bent rods are offered in lengths of 40 - 100mm, straight rods in lengths from 30 - 300 mm and the special-bent rod in either 30 or 40mm length. All spinal implant components are made of titanium alloy (Ti6Al4V Eli) in accordance with ASTM F136. The screws are color coded for better identification of the different diameters. The screws are double threaded, cannulated, fenestrated and selftapping.

Since it states that there were no changes made to the existing devices BonOs® Inject (K090460) and Neo Pedicle Screw System™ (K171582) and no additional testing was required or performed for these specific devices, I am unable to extract all the requested information for acceptance criteria and study details. However, I can provide the available information regarding the additional predicate device comparison.

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes for the axial pullout strength, cement flow, or bolus formation tests. The data provenance is not specified (e.g., country of origin, retrospective or prospective).

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

Not applicable. The tests mentioned are mechanical and biological performance tests, not those requiring expert consensus on clinical ground truth.

4. Adjudication Method for the Test Set

Not applicable. The tests mentioned are objective performance tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.

6. Standalone (Algorithm Only) Performance

Not applicable, as this is a physical medical device (bone cement and screw system), not a software algorithm.

7. Type of Ground Truth Used

For the axial pullout strength and cement flow/bolus formation, the "ground truth" was established by comparison to the performance of the predicate device (Kyphon™ Xpede™ Bone Cement Medtronic HV-R™ Fenestrated Screw Cement CD Horizon™ Fenestrated Screw Set) as per established ASTM standards.
For bacterial endotoxins and pyrogen limits, established regulatory standards (Ph. Eur., USP, FDA guidance) served as the ground truth.

8. Sample Size for the Training Set

Not applicable. This document describes the substantial equivalence of a physical medical device, not a machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set mentioned.

Ask a specific question about this device

BonOs® HV Genta, BonOs® MV Genta and BonOs® LV Genta are intended for the fixation of prothesis to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

BonOs® HV Genta, BonOs® MV Genta and BonOs® LV Genta are PMMA, radiopaque bone cements, containing gentamicin, designed for the fixation of prothesis to the living bone. BonOs® HV Genta, BonOs® MV Genta and BonOs® LV Genta are traditional bone cement products. The bone cement is made of two separate sterile components. When both components are mixed together, they become a self-hardening, radiopaque bone cement which fixes the implant and transfer stresses evenly to the bone. The liquid is contained in a vial and the powder in a pouch; these components are packed in blister with Tyvek lid or an aluminium pouch. The devices are sold disposable, singleuse and sterile.

This document is a 510(k) summary for the BonOs® HV Genta, BonOs® MV Genta, and BonOs® LV Genta bone cements. It does not describe a study involving an AI/ML powered device, but rather a traditional medical device (bone cement). Therefore, many of the requested fields are not applicable in this context.

Here's the information that can be extracted or noted as not applicable:

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

The document states that performance testing was conducted in accordance with the "FDA Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement; Guidance for Industry and FDA" dated July 17, 2002. It also notes compliance with several ASTM and ISO standards for mechanical and physical properties.

Specific acceptance criteria and reported numerical performance values are not provided in this summary. Instead, the summary generally states that "Results show comparable performances to the predicate device and are in compliance with ASTM F451-16, ISO 5833:2002, ISO 527:1/2, ASTM F2118-14, ASTM D2990-17, ASTM D732-17 and ASTM E399-20."

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

This information is not provided in the 510(k) summary. The document describes a traditional device and its performance testing against standards, not a clinical study with a "test set" in the context of an AI/ML device.

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 is not applicable as this is not an AI/ML device requiring human expert ground truth for its performance evaluation in that sense. The device's performance is established through laboratory testing against established physical, chemical, and mechanical standards.

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

This is not applicable as this is not an AI/ML device and does not involve human readers adjudicating findings.

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 is not applicable as this is not an AI/ML device.

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

This is not applicable as this is not an AI/ML device.

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

For this traditional medical device, the "ground truth" for performance is based on:

• Compliance with recognized international and national standards (ISO, ASTM).
• Laboratory test results for physical, chemical, mechanical, and biological properties, compared against pre-defined specifications and/or predicate device performance.

8. The sample size for the training set

This is not applicable as this is not an AI/ML device and therefore does not have a "training set."

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

This is not applicable as this is not an AI/ML device and therefore does not have a "training set" or corresponding ground truth.

Ask a specific question about this device