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DSM Biomedical Calcium Phosphate Cement is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created from traumatic injury to the bone. The Calcium Phosphate Cement is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The Calcium Phosphate Cement cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary support media and is not intended to provide structural support during the healing process. The Calcium Phosphate Cement resorbs and is replaced by bone during the healing process.

The DSM Calcium Phosphate Cement is a line extension to the current DSM Calcium Phosphate Cement product line, which introduces the 1cc size and a new packaging configuration. DSM Calcium Phosphate Cement is an injectable, sculptable, drillable, fast self-setting bone substitute. DSM Calcium Phosphate Cement is composed of calcium phosphate, which converts to hydroxyapatite in vivo, and bovine collagen powder. The device can also be used to augment provisional hardware to help support bone fragments during the surgical procedure. The cement is provided in a powder form and is packaged in a female luer syringe. An empty male luer syringe is provided to allow for syringe-to-syringe mixing of the powder with saline at the required powder-to-liquid ratio. DSM Calcium Phosphate Cement is supplied sterile by gamma irradiation and is non-pyrogenic.

This document is a 510(k) premarket notification for the DSM Biomedical Calcium Phosphate Cement. It describes a line extension of an existing product, specifically a new 1cc size and packaging configuration. The submission aims to demonstrate substantial equivalence to the predicate device (DSM Biomedical Calcium Phosphate Cement, K173362).

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Non-Clinical Bench Testing (Material, Mechanical, Physical): The document does not specify the exact sample sizes for each type of bench testing (e.g., injectability, setting time, compressive strength). It just states that "Material characterization and performance testing... was completed." The provenance is likely internal testing by DSM Biomedical.
• Biocompatibility Testing: The number of samples for each biocompatibility test (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Genotoxicity, Subacute Systemic Toxicity, Pyrogenicity) is not specified. Provenance is likely contract labs performing testing according to ISO 10993 standards.
• Performance Animal Testing: The test set used an "ovine critical sized femoral defect model." The number of animals in the DSM + saline group and the Hydroset predicate group is not explicitly stated, but the percentages imply multiple subjects, and statistical variations (e.g., "± 2%") would necessitate a reasonable sample size for statistical significance. This appears to be a prospective animal study specifically designed for this submission or product line.

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

• Bench Testing: Ground truth for bench testing is established by recognized standards (FDA Guidance Document, ASTM F1185, USP , AAMI ANSI ST72: 2019, ISO 11607-1, ISO 11137-1/2, ISO 10993 series, ISO 22442-2/3). Experts are likely engineers and scientists within DSM Biomedical or independent testing laboratories with expertise in these standards. Their specific number and qualifications are not detailed.
• Animal Study: The animal study compared the device to a predicate and an empty defect control. The "ground truth" here is the biological response (new bone formation, implant remaining) observed in the ovine model. The evaluation of these outcomes would typically involve veterinary pathologists and/or histologists; however, their specific number and qualifications are not mentioned.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for human reviewers in a clinical context. The "adjudication" for bench and animal testing is inherent in the standardized methodologies and objective measurements.

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. This device is a bone void filler, not an AI-powered diagnostic or assistive technology for human readers.

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

This question is irrelevant for the DSM Biomedical Calcium Phosphate Cement, as it is a medical device material/implant and not an algorithm or AI product.

7. The Type of Ground Truth Used

• Bench Testing: Ground truth established through objective measurements against pre-defined performance specifications derived from recognized standards (ASTM, ISO, USP, FDA guidance).
• Biocompatibility Testing: Ground truth established through biological response assays compared against established criteria for acceptable biocompatibility (based on ISO 10993 series).
• Animal Study: Ground truth for "performance" (new bone formation, implant remaining) was established by histological and quantitative analysis of tissue samples from the ovine femoral defect model.

8. The Sample Size for the Training Set

This product is not an AI/ML algorithm requiring a training set. This question is not applicable.

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

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

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DSM Biomedical Calcium Phosphate Cement with Microspheres is indicated to fill bony voids or gaps of the sketal system (i.e. extremities and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. The Calcium Phosphate Cement with Microspheres is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The Calcium Phosphate Cement with Microspheres cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary support media and is not intended to provide structural support during the healing process. The Calcium Phosphate Cement with Microsheres resorbs and is replaced by bone during the healing process.

DSM Biomedical Calcium Phosphate Cement with Microspheres is an injectable, fast self-setting bone substitute. DSM Biomedical Calcium Phosphate Cement with Microspheres is composed of calcium phosphate which converts to hydroxyapatite in vivo, bovine collagen powder, and PLGA microspheres. The device can also be used to augment provisional hardware to help support bone fragments during the surgical procedure. The cement is provided in a powder form packaged in a mixing syringe. The mixing syringe allows for the combination of saline, the patient's blood, or the patient's bone marrow at the required powder-to-liquid ratio. DSM Biomedical Calcium Phosphate Cement with Microspheres is supplied sterile by gamma irradiation and is non-pyrogenic.

The provided text is a 510(k) Summary for the DSM Biomedical Calcium Phosphate Cement with Microspheres, describing its design, indications, and the basis for substantial equivalence to a predicate device. It details the tests performed to demonstrate safety and performance but does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria specifically in the context of an AI/ML device.

The document discusses material characterization, bench testing, biocompatibility testing, viral inactivation, and an animal study for a medical device that fills bony voids. It compares the characteristics of the proposed device with a predicate device (Stryker® Injectable Cement).

Therefore, I cannot provide the requested information for an AI/ML device, as the provided text pertains to a traditional medical device (bone void filler) and does not mention any AI/ML components or related studies (like MRMC studies, standalone AI performance, or expert consensus for AI ground truth).

To answer your request, the input text would need to be a 510(k) summary for an AI/ML medical device.

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DSM Biomedical Calcium Phosphate Cement is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. The DSM Biomedical Calcium Phosphate Cement is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The DSM Biomedical Calcium Phosphate Cement cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary support media and is not intended to provide structural support during the healing process. The Calcium Phosphate Cement resorbs and is replaced by bone during the healing process.

DSM Biomedical Calcium Phosphate Cement as an injectable, fast self-setting bone substitute. DSM Biomedical Calcium Phosphate Cement is composed of calcium phosphate which converts to hydroxyapatite in vivo, and bovine collagen powder. The device can also be used to augment provisional hardware to help support bone fragments during the surgical procedure. The cement is provided in a powder form packaged in a mixing syringe. The mixing syringe allows for the combination of saline, the patient's blood, or the patient's bone marrow at the required powder-to-liquid ratio. DSM Biomedical Calcium Phosphate Cement is supplied sterile by gamma irradiation and is non-pyrogenic.

The provided text is a 510(k) summary for the DSM Biomedical Calcium Phosphate Cement. It states that the device is substantially equivalent to a predicate device based on various criteria, including performance data. However, the document does not contain the level of detail requested in the prompt regarding acceptance criteria, specific reported device performance values, sample sizes for test or training sets, expert qualifications, or adjudication methods for studies.

The document primarily focuses on establishing substantial equivalence to a predicate device (Stryker® Injectable Cement K060061) through comparisons of:

• Indications for Use
• Material Composition
• Technological Characteristics
• Performance Characteristics

It mentions that "material characterization, including chemical and material physical characterization, bench testing, biocompatibility testing, viral inactivation, and an animal study have been conducted to evaluate the performance characteristics and biological safety." It also states these were completed in accordance with FDA Guidance Document, "Resorbable Calcium Salt Bone Void Filler Device and ASTM F1185 Standard Specification for Composition of Hydroxylapatite for Surgical Implants."

An "ovine bilateral femoral defect animal study" was performed to evaluate bone healing.

Therefore, many of the specific details requested cannot be extracted from this document.

However, I can provide a summary of what is mentioned concerning performance and the basis for substantial equivalence:

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

The document does not provide a table with quantitative acceptance criteria and corresponding reported device performance values. It states that tests were conducted according to FDA guidance and ASTM standards, implying that the device met the requirements of those standards.

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

• Test Set Sample Size: Not explicitly stated for any of the tests.
• Data Provenance: The animal study was an "ovine bilateral femoral defect animal study." This suggests an animal model study, not human subject data.

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

Not applicable, as this is related to a medical image analysis or diagnostic device, which this bone void filler is not. The ground truth for performance would be based on the physical, chemical, and biological measurements from the lab and animal studies.

4. Adjudication method for the test set

Not applicable for this type of device and study.

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/imaging device.

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

Not applicable. This is not an AI/imaging device.

7. The type of ground truth used

For the performance of the material:

• Physical and chemical characterization data (e.g., setting time, mechanical strength, composition, resorption rate – though specific values are not listed).
• Biocompatibility test results (cytotoxicity, sensitization, irritation, acute systemic toxicity, genotoxicity, hemocompatibility, subacute toxicity, implantation).
• Viral inactivation study results.
• Residual chemical assessment results.
• Bone healing evaluation from the ovine animal study (comparison to predicate).

8. The sample size for the training set

Not applicable, as this is not an AI/machine learning device.

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

Not applicable, as this is not an AI/machine learning device.

Summary of Device Performance (as described in the document, without specific values):

The document concludes that "The bench, animal, and biocompatibility testing demonstrates that DSM Biomedical Calcium Phosphate Cement is substantially equivalent to the predicate device." This implies that the device met the performance requirements necessary to establish substantial equivalence based on the completed tests.

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