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510(k) Data Aggregation
(119 days)
Synthecure Synthetic Calcium Sulfate
Synthecure Synthetic Calcium Sulfate is an implant intended to fill bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Synthecure Synthetic Calcium Sulfate resorbs and is replaced with bone during the healing process.
Synthecure is provided sterile for single use only. Synthecure is biodegradable and biocompatible and may be used at an infected site.
Synthecure Synthetic Calcium Sulfate is indicated to be implanted into defects not intrinsic to the structural stability of the skeletal system. Synthecure is biocompatible and may be implanted at an infected site. Synthecure Synthetic Calcium Sulfate is presented as a powder and mixing solution which when mixed together forms a paste which may be injected, digitally implanted or applied to a mold provided to produce pellets.
The provided FDA 510(k) clearance letter pertains to a medical device called "Synthecure Synthetic Calcium Sulfate," a resorbable calcium salt bone void filler. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.
Based on the provided text, the device is a bone void filler and not a device that would typically have the acceptance criteria in the format requested. The document does not describe a study involving a "test set" with ground truth, expert adjudication, or human reader performance with or without AI assistance, as these are concepts more relevant to diagnostic or AI-powered devices.
Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) are not applicable to the information contained in this FDA clearance letter. The letter focuses on demonstrating the physical, chemical, and biological safety and performance of the bone void filler device through a series of non-clinical tests.
However, I can extract the acceptance criteria as described for the non-clinical tests and the reported performance based on the information provided.
Acceptance Criteria and Study for Synthecure Synthetic Calcium Sulfate
The Synthecure Synthetic Calcium Sulfate is a resorbable calcium salt bone void filler. The provided 510(k) summary outlines non-clinical testing performed to demonstrate its safety and substantial equivalence to predicate devices, rather than a clinical study with a detailed test set and ground truth as might be expected for diagnostic or AI devices.
1. A table of acceptance criteria and the reported device performance
| Performance Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sterilization Validation | Sterilization must achieve a Sterility Assurance Level (SAL) of $1 \times 10^{-6}$ for the worst-case construct, in compliance with recognized standards. | Sterilization validation has been completed on the worst-case construct to an SAL of $1 \times 10^{-6}$. |
| Bacterial Endotoxin Testing | Testing must be performed according to ANSI/AAMI ST72:2011 and demonstrate acceptable endotoxin levels. | Testing is performed according to ANSI/AAMI ST72:2011, "Bacterial endotoxins – Test methods, routine monitoring and alternatives to batch testing." (Implies acceptable levels were met). |
| Packaging Validation | Packaging performance must be validated in accordance with ISO 11607-1:2019 and ISO 11607-2:2019 to ensure product integrity and sterility throughout its shelf life. | Packaging performance validation, in accordance with ISO 11607-1:2019 and ISO 11607-2:2019, was performed on the final packaging and sterilized device. (Implies successful validation). |
| Biocompatibility | Biological safety evaluation must be completed according to ISO 10993-1 requirements and FDA Guidance Document "Use of International Standard ISO 10993-1," demonstrating all materials are biocompatible for their intended use. | A biological safety evaluation has been completed for Synthecure according to ISO 10993-1 requirements and FDA Guidance Document "Use of International Standard ISO 10993-1." All materials contained in the proposed Synthecure have been evaluated in accordance with recognized standards and are characterized as being biocompatible. |
| Performance Testing - Bench | Chemical composition and physical properties (e.g., work and setting time) must be equivalent to predicate devices and maintain performance after aging, as per current industry standards and FDA guidance. | The chemical composition and physical properties of the subject and predicate devices were evaluated and demonstrated to be equivalent. Additionally, work and setting time tests were conducted on real-time aged samples to support that the device maintains its performance after aging. |
| Performance Testing - Animal | An in-vivo implantation study must demonstrate appropriate biological response, resorption, and replacement with bone at specified endpoints (e.g., 3, 6, and 12 weeks) in an animal model, showing performance comparable to expectations for bone void fillers. | An implantation study was conducted using New Zealand White Rabbits with study endpoints at 3, 6, and 12 weeks. (Implies successful outcomes demonstrating expected performance for bone void fillers, leading to substantial equivalence). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in terms typically used for diagnostic or AI studies. For the animal study, the sample size is not explicitly stated number of New Zealand White Rabbits, but it's an animal model.
- Data Provenance: The document implies that all testing (bench, animal, etc.) was conducted by or for Austin Medical Ventures, Inc. in support of their 510(k) submission. It's not applicable in terms of "country of origin for human data" as these are non-clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a bone void filler, and its evaluation relies on physical, chemical, and biological testing, not on expert interpretation of diagnostic images or clinical assessments to establish ground truth in the way a diagnostic device would.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This device does not involve adjudication of expert opinions or interpretations.
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 diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not a software algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this type of device, "ground truth" is established through:
- Established standards and regulations: e.g., ISO 10993-1 for biocompatibility, ISO 11607 for packaging.
- Bench testing methodologies: Measuring physical and chemical properties.
- In-vivo animal models: Observing biological response, resorption rates, and bone ingrowth over time (e.g., 3, 6, and 12 weeks endpoints). The "truth" here is the biological reaction within the animal model.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device.
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(42 days)
Calcium2
The Calcium2 assay is used for the quantitation of calcium in human serum, plasma, or urine on the ARCHITECT c System.
Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
The Calcium2 assay is an automated clinical chemistry assay. Arsenazo III dye reacts with calcium in an acid solution to form a blue-purplex. The color developed is measured at 660 nm and is proportional to the calcium concentration in the sample.
Methodology: Arsenazo III
The provided text describes the performance validation of the Calcium2 assay, specifically for its use in quantitating calcium in human serum, plasma, or urine on the ARCHITECT c System. This is a Class II medical device (Calcium test system), regulated under 21 CFR 862.1145, product code CJY.
Here's an analysis based on the request:
Device: Calcium2 assay
Intended Use: Quantitation of calcium in human serum, plasma, or urine on the ARCHITECT c System. Used in the diagnosis and treatment of parathyroid disease, various bone diseases, chronic renal disease, and tetany.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly outline a pre-defined table of "acceptance criteria" against which each test result is measured, as would be common for AI/ML performance studies. Instead, it presents various performance characteristics with their measured values, often referencing CLSI guidelines for the methodology. The "acceptance" can be inferred from the reported values and the conclusion of substantial equivalence. For quantitative assays like this, performance is typically assessed against established industry standards for precision, accuracy, linearity, and interference.
However, we can infer some "acceptance criteria" implicitly from the context of "acceptable performance" and the ranges presented.
| Performance Characteristic | Acceptance Criteria (Implicit/Standard) | Reported Device Performance |
|---|---|---|
| Reportable Interval (Serum/Plasma) | ||
| Analytical Measuring Interval (AMI) | Defined as the range demonstrating acceptable linearity, imprecision, and bias. | 2.0 – 24.0 mg/dL |
| Reportable Interval | Extends from LoD to upper AMI. | 0.2 – 24.0 mg/dL |
| Reportable Interval (Urine) | ||
| Analytical Measuring Interval (AMI) | Defined as the range demonstrating acceptable linearity, imprecision, and bias. | 2.0 – 24.0 mg/dL |
| Extended Measuring Interval (EMI) | Requires acceptable dilution performance (recovery, imprecision). | 24.0 – 96.0 mg/dL (Dilution recovery within 100% ± 10%, imprecision ≤ 5 %CV for automated dilution, ≤ 6 %CV for manual dilution) |
| Reportable Interval | Extends from LoD to upper EMI. | 0.2 – 96.0 mg/dL |
| Precision (Within-Laboratory - Serum, 20-Day) | ||
| %CV (Control Level 1) | Implied to be acceptable based on CLSI EP05-A3 guidance. | Within-Run: 0.8%; Within-Laboratory: 0.8% (Range 0.8-0.9%) |
| %CV (Control Level 2) | Implied to be acceptable based on CLSI EP05-A3 guidance. | Within-Run: 0.7%; Within-Laboratory: 0.7% (Range 0.6-0.9%) |
| %CV (Panel C, highest conc.) | Implied to be acceptable based on CLSI EP05-A3 guidance. | Within-Run: 0.6%; Within-Laboratory: 0.9% (Range 0.9-0.9%) |
| Precision (System Reproducibility - Serum) | ||
| %CV (Control Level 1) | Implied to be acceptable based on CLSI EP05-A3 guidance. | Repeatability: 0.9%; Within-Laboratory: 1.1%; Reproducibility: 1.4% |
| %CV (Panel A, lowest conc.) | Implied to be acceptable based on CLSI EP05-A3 guidance. | Repeatability: 1.5%; Within-Laboratory: 1.5%; Reproducibility: 2.6% |
| Accuracy (Bias) | ||
| Bias against NIST SRM 956d | Implied to be acceptable. | Ranged from -3.7% to -0.6% |
| Lower Limits of Measurement (Serum) | ||
| LoB | 95th percentile from zero-analyte samples. | 0.1 mg/dL |
| LoD | Lowest concentration detected with 95% probability. | 0.2 mg/dL |
| LoQ | Lowest concentration at which max 20%CV met. | 0.4 mg/dL |
| Interference (Serum, Endogenous & Exogenous) | ||
| No significant interference | Interference within ± 5%. | Most substances showed no significant interference (e.g., Bilirubin up to 40 mg/dL, Hemoglobin up to 1000 mg/dL, Acetaminophen up to 160 mg/L). One exception: Ca-dobesilate at 60 mg/L showed 6% interference (95% CI: 5%, 6%). |
| Method Comparison (Serum & Urine) | ||
| Correlation Coefficient | Implied to be close to 1.00 for equivalence. | Serum: 1.00; Urine: 1.00 |
| Slope | Implied to be close to 1.00 for equivalence. | Serum: 1.02; Urine: 0.96 |
| Intercept | Implied to be close to 0.00 for equivalence. | Serum: -0.1; Urine: 0.1 |
| Dilution Verification (Urine) | ||
| %Recovery | Within 100% ± 10%. | Acceptable performance demonstrated. |
| Imprecision (Automated Dilution) | ≤ 5 %CV. | ≤ 5 %CV. |
| Imprecision (Manual Dilution) | ≤ 6 %CV. | ≤ 6 %CV. |
2. Sample Size Used for the Test Set and the Data Provenance
The provided information is for an in-vitro diagnostic (IVD) test, not an AI/ML model for image analysis. Therefore, the "test set" and "training set" terminology from an AI/ML perspective doesn't directly apply in the same way. Instead, the studies involved various types of samples (controls, panels, human serum/plasma/urine samples) tested under specific experimental designs.
- Precision Studies (Serum & Urine, 20-Day):
- Sample Size: 80 replicates per sample type (2 controls, 3 human panels) for each of the 3 reagent lot/calibrator lot/instrument combinations in the 20-day study. (e.g., 5 samples * 80 replicates = 400 total data points per combination shown in the table).
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies are "within-laboratory" meaning they were conducted in a controlled lab setting, likely at the manufacturer's site or a designated testing facility. The nature of these samples (human serum/urine panels) suggests they are likely representative, but the specific collection method or origin (retrospective/prospective collection from patients) is not detailed.
- System Reproducibility Studies (Serum & Urine):
- Sample Size: 90 replicates per sample type (2 controls, 3 human panels).
- Data Provenance: Same as above, not explicitly stated.
- Accuracy Study:
- Sample Size: Not explicitly stated for replicates, but involved 2 concentrations of NIST SRM 956d standard.
- Data Provenance: NIST standard reference material, a highly controlled and traceable source.
- Lower Limits of Measurement Studies (Serum & Urine):
- Sample Size: n ≥ 60 replicates for zero-analyte and low-analyte level samples for LoB, LoD, and LoQ determination.
- Data Provenance: Not explicitly stated.
- Linearity Studies (Serum & Urine):
- Sample Size: Not explicitly stated how many points were measured across the range, but demonstrated linearity from 2.0 to 24.0 mg/dL.
- Data Provenance: Not explicitly stated.
- Interference Studies (Serum & Urine):
- Sample Size: Not explicitly stated how many replicates, but each substance was tested at 2 levels of the analyte.
- Data Provenance: Not explicitly stated.
- Method Comparison Studies (Serum & Urine):
- Sample Size: 120 serum samples, 112 urine samples.
- Data Provenance: Patient samples. Not explicitly stated if retrospective or prospective collection.
- Tube Type Equivalence Study (Serum):
- Sample Size: Samples from 78 donors.
- Data Provenance: Donor samples. Not explicitly stated if retrospective or prospective.
- Dilution Verification (Urine):
- Sample Size: 5 samples prepared with calcium stock. Replicates for dilution recovery and imprecision were performed but the exact number isn't specified beyond "demonstrated acceptable performance."
- Data Provenance: Prepared samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of IVD device (quantitative chemical assay) relies on objective measurement against a known reference (e.g., NIST standard) or internal validated methods, rather than subjective expert consensus. Therefore, "ground truth" is established through highly controlled laboratory procedures and certified reference materials, not typically through multiple human experts adjudicating results. The "experts" involved are likely laboratory scientists and metrologists operating under strict quality systems (CLSI guidelines, ISO standards).
4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set
Not applicable for a quantitative chemical assay. Results are objectively measured by the instrument and verified through calibration and quality control. There is no subjective interpretation requiring adjudication.
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 an in-vitro diagnostic test, not an AI/ML-driven imaging or diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is a standalone quantitative assay. The Calcium2 device automatically measures calcium concentration. Human involvement is in sample preparation, loading, and interpreting the numerical output. Its performance is evaluated entirely as an automated system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device's performance validation is established primarily through:
- Reference Materials: For accuracy (e.g., NIST SRM 956d for bias estimation).
- Known Concentrations: For linearity, lower limits of measurement, and dilution verification, samples are prepared with known concentrations of calcium or spiked with calcium.
- Comparative Methods: For method comparisons, the "ground truth" is implicitly the performance of the legally marketed predicate device (Abbott Clinical Chemistry Architect/Aeroset Calcium, K062855), which serves as the comparator.
- Statistical Models/Guidelines: CLSI guidelines (EP05-A3, EP09c, EP17-A2, EP06, EP07, EP34) provide the statistical framework and methodology for validating performance characteristics like precision, linearity, and interference.
8. The Sample Size for the Training Set
Not applicable in the typical AI/ML sense. This is a chemistry assay, not a machine learning model that undergoes a "training" phase with a large dataset. The "training" for such a device involves rigorous engineering, chemical formulation, and calibration development, rather than data-driven model training.
9. How the Ground Truth for the Training Set Was Established
As above, "training set" is not a concept for this type of device. The accuracy and reliability of the assay are built into its chemical design, reagent formulation, and instrument calibration process. These processes rely on highly accurate reference standards (like NIST) and established analytical chemistry principles to ensure the device measures calcium correctly across its analytical range.
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(166 days)
Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax +
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(74 days)
DSM Biomedical Calcium Phosphate Cement
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
| Acceptance Criteria / Performance Metric | Subject Device (1cc DSM Biomedical Calcium Phosphate Cement) Reported Performance | Predicate Device (DSM Biomedical Calcium Phosphate Cement, K173362) |
|---|---|---|
| Indications for Use | To fill bony voids or gaps of the skeletal system (extremities and pelvis), surgically created or from traumatic injury. Not for intrinsic stability. Augments provisional hardware. Temporary support, resorbs and replaced by bone. | Identical Indications for Use |
| Material Composition | Calcium phosphate powder with bovine collagen mixed with saline to form hydroxyapatite | Calcium phosphate powder with bovine collagen mixed with saline, patient's blood, or patient's bone marrow aspirate to form hydroxyapatite |
| Form | Injectable, sculptable, drillable, and fast setting calcium phosphate cement that converts to hydroxyapatite | Injectable, sculptable, drillable, and fast setting calcium phosphate cement that converts to hydroxyapatite |
| Packaging | Powder pre-packaged in a female luer syringe, packaged with accessories to aid in mixing and delivery. | Powder prepackaged in a mixing and delivery syringe, packaged with accessories to aid in mixing and delivery. |
| Sterilization | Sterile by gamma irradiation (validated per ISO 11137-1 and ISO 11137-2). | Sterile by gamma irradiation |
| Reusable | Single Use Device | Single Use Device |
| Biocompatible | Yes (acceptance based on ISO 10993-1, -3, -5, -10, -11, -17, ISO 22442-2, -3, USP) | Yes |
| Sizes Offered | 1cc | 5cc |
| Shelf Life | Confirmed by stability testing | Not specified in table, but generally implied for predicate. |
| Product Appearance | Met | Not explicitly stated, implied to be acceptable for predicate. |
| Handling | Met | Not explicitly stated, implied to be acceptable for predicate. |
| Injectability | Met | Not explicitly stated, implied to be acceptable for predicate. |
| Setting Time | Met | Not explicitly stated, implied to be acceptable for predicate. |
| Compressive Strength | Met | Not explicitly stated, implied to be acceptable for predicate. |
| X-ray Diffraction | Met | Not explicitly stated, implied to be acceptable for predicate. |
| Porosity | Met | Not explicitly stated, implied to be acceptable for predicate. |
| Anchor Pull Out Strength | Met | Not explicitly stated, implied to be acceptable for predicate. |
| Bacterial Endotoxins (BET) | Not more than 20 Endotoxin Units per device (met specifications per USP and AAMI ANSI ST72: 2019) | Not explicitly stated, implied to be acceptable for predicate. |
| Packaging Integrity | Met requirements of ISO 11607-1 | Not explicitly stated, implied to be acceptable for predicate. |
| New Bone Formation (animal study at 12 weeks) | 5.8% ± 2% | 6.3% ± 3.2% |
| Implant Material Remaining (animal study at 12 weeks) | 84.2% | 86.6% |
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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(536 days)
Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen
Medicon Hellas Albumin: Reagent for the quantitative measurement of albumin in serum. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
Medicon Hellas Calcium: Reagent for the quantitative measurement of calcium in serum or urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Medicon Hellas Creatinine: Reagent for the quantitative measurement of creatinine in serum and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.
Medicon Hellas Glucose: Reagent for the quantitative measurement of glucose in serum and urine. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Medicon Hellas Direct Bilirubin; Reagent for the quantitative measurement of direct bilirubin (conjugated) in serum. Measurements of the level of direct bilirubin is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall blader block.
Medicon Hellas Total Bilirubin: Reagent for the quantitative measurements of total bilirubin in serum. Measurements of the levels of total bilirubin is used in the diagnosis and treatment of liver. hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
Medicon Hellas Urea Nitrogen: Reagent is for the quantitative measurement of urea nitrogen in serum and urine. Measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.
The Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Glucose, Medicon Hellas Direct Bilirubin, Medicon Hellas Total Bilirubin, and Medicon Hellas Urea Nitrogen are reagents for use with Diatron Pictus 500 Clinical Chemistry Analyzers. They are test systems for the quantitative measurement of albumin, calcium, creatinine, glucose, direct and total bilirubin, and urea nitrogen in human serum and urine where clinically applicable. The methods employed are photometric, utilizing reactions between the sample and reagents to produce a colored chromophore or a change in absorbance that is proportional to the concentration of the analyte. The analyzer photometer reads the absorbances at time intervals dictated by the method application stored in the analyzer memory, and the change in absorbance is calculated automatically.
The provided text describes the performance of several Medicon Hellas assays (Albumin, Calcium, Creatinine, Glucose, Direct Bilirubin, Total Bilirubin, and Urea Nitrogen) when run on the Diatron Pictus 500 Clinical Chemistry Analyzer, demonstrating their substantial equivalence to predicate devices (Beckman Coulter AU reagents on AU2700 analyzer, and Abbott Architect Direct Bilirubin on Architect c8000 analyzer).
Here's an analysis of the provided information, structured to address your specific points regarding acceptance criteria and study details:
1. A Table of Acceptance Criteria and the Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a single, overarching table with pass/fail remarks. Instead, it describes each performance characteristic and then presents the results. The "Summary" sections for each study type imply that the results met the pre-defined acceptance criteria for demonstrating substantial equivalence. For instance, for accuracy, it states "Accuracy studies completed on at least three lots of each candidate reagent confirm that Medicon albumin... are substantially equivalent to the related predicate devices." This implies that the statistical analyses (Deming regression, R2, slope, intercept) fell within acceptable ranges. Similarly, for precision, it states "All lots passed acceptance criteria for each applicable sample type at each level."
Since explicit acceptance criteria are not presented, they are inferred from the demonstrated performance and the statement that the devices "passed acceptance criteria" or "met statistical acceptance criteria." Below is a table summarizing the reported device performance for each analyte. The "Acceptance Criteria" column will reflect the general statements of success or the implied ranges from the results themselves, as explicit numerical targets for individual tests are not given.
Implied Acceptance Criteria and Reported Device Performance
| Analyte | Performance Characteristic | Implied/General Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Medicon Hellas Albumin | |||
| Accuracy (Method Comparison) | R2 Correlation | Values suggesting substantial equivalence (>0.98 is generally good) | R2 = 0.9862 |
| Slope | Values close to 1 | Slope = 1.0180 | |
| Intercept | Values close to 0 | Intercept = 0.05 | |
| Reportable Range (Serum) | Comparable to predicate device | 1.50 - 6.00 g/dL | 1.50 - 6.00 g/dL |
| LOD (Serum) | Acceptable for clinical use | 0.40 g/dL | 0.40 g/dL |
| LOQ (Serum) | Acceptable for clinical use | 0.50 g/dL | 0.50 g/dL |
| Precision (Serum) | CV% within acceptable clinical limits (e.g., typically |
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(348 days)
CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV
CALCIUM-CRESOLPHTHALEIN: Reagent for the measurement of calcium concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.
GLUCOSE: Reagent for the measurement of glucose concentration in human serum and plasma. The obtained values are useful as an aid in the diagnosis and treatment of the diabetes mellitus. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.
UREA/BUN - UV: Reagent for the measurement of urea concentration in human serum, plasma or urine. The obtained values are useful as an aid in the diagnosis of certain renal and metabolic diseases. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.
Not Found
This document is an FDA 510(k) clearance letter for three BioSystems S.A. reagents: CALCIUM-CRESOLPHTHALEIN, GLUCOSE, and UREA/BUN-UV. As such, it does not contain the information requested regarding acceptance criteria and study details for an AI/ML medical device.
The information typically provided in a 510(k) summary for in vitro diagnostic (IVD) reagents like these focuses on analytical performance characteristics (e.g., linearity, precision, accuracy, interference, stability) and correlation with a predicate device, rather than the AI/ML-specific criteria requested in the prompt.
Therefore, it is impossible to answer the questions based on the provided text. The document is about chemical reagents for laboratory testing, not an AI-powered diagnostic device.
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(63 days)
Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe
Yumizen C1200 Calcium AS reagent is a diagnostic reagent for quantitative in vitro determination of calcium in human serum, plasma and urine based on colorimetric method, using the clinical chemistry analyzer. Measurement of calcium is used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Yumizen C1200 Creatinine Jaffé reagent is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffé method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
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The provided FDA 510(k) summary describes the analytical performance characteristics of the Yumizen C1200 Calcium AS and Yumizen C1200 Creatinine Jaffé reagents when used with the Yumizen C1200 clinical chemistry analyzer. The document focuses on demonstrating substantial equivalence to predicate devices.
Here's an analysis of the acceptance criteria and study designs based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document presents performance data across several analytical characteristics. For some categories, explicit "acceptance criteria" are mentioned (e.g., CV limits for precision), while for others, the results are presented as factual measurements from the studies conducted.
Yumizen C1200 Calcium AS
| Acceptance Criteria Category | Acceptance Criteria (if stated) | Reported Device Performance |
|---|---|---|
| Measuring Range | Determined according to CLSI EP17-A2 (Detection & Quantitation) and EP06-A (Linearity) | Serum/Plasma: |
- Limit of detection: 0.12 mmol/L (0.48 mg/dL)
- Limit of quantitation: 0.14 mmol/L (0.57 mg/dL)
- Linearity: 0.00 to 4.84 mmol/L (0.00 to 19.40 mg/dL)
- Measuring range: 1.00 - 4.50 mmol/L (4.0 - 18.05 mg/dL)
- Post-dilution: Up to 13.5 mmol/L (54.15 mg/dL)
Urine: - Limit of detection: 0.06 mmol/L (0.24 mg/dL)
- Limit of quantitation: 0.16 mmol/L (0.64 mg/dL)
- Linearity: 0.00 to 4.84 mmol/L (0.00 - 18.60 mg/dL)
- Measuring range: 0.16 to 4.5 mmol/L (0.64 - 18.05 mg/dL)
- Post-dilution: Up to 13.5 mmol/L (54.15 mg/dL) |
| Precision (Serum/Plasma) | Within run (CV limits): 1.2% for low (1.8 mmol/L), middle (2.4 mmol/L), high (3.4 mmol/L) levels.
Total precision (CV limits): 1.6% for low (1.8 mmol/L), middle (2.4 mmol/L), high (3.4 mmol/L) levels. | Within-Run (%CV): - Control N: 0.6%
- Control P: 0.5%
- Sample 1: 0.8%
- Sample 2: 0.6%
- Sample 3: 0.5%
Total (%CV): - Control N: 1.5%
- Control P: 1.4%
- Sample 1: 1.7%
- Sample 2: 1.6%
- Sample 3: 1.8%
(Note: "Although the %CV of Total Precision is superior to the Acceptance criteria for some samples, the p-value with 5% acceptable remains acceptable for all the samples tested.") |
| Precision (Urine) | Within run (CV limits): 3.0% for low (1.0mM), middle (2.5mM), high (4.0mM) levels.
Total precision (CV limits): 4.0% for low (1.0mM), middle (2.5mM), high (4.0mM) levels. | Within-Run (%CV): - Control L1: 0.7%
- Control L2: 0.5%
- Sample 1: 1.6%
- Sample 2: 0.8%
- Sample 3: 0.7%
- Sample 4: 0.6%
- Sample 5: 0.6%
Total (%CV): - Control L1: 3.8%
- Control L2: 3.9%
- Sample 1: 2.6%
- Sample 2: 2.1%
- Sample 3: 2.0%
- Sample 4: 1.7%
- Sample 5: 1.6%
(Note: "The results are within the specifications.") |
| Interferences | Acceptable bias is +/-10% of the value without interfering substances. | Highest values for which no interferences > 10% were observed provided for Hemoglobin, Triglycerides, Total Bilirubin, Direct Bilirubin, Acetylsalicylic Acid, Ascorbic Acid, Ibuprofen, Acetaminophen (for serum/plasma) and additionally Glucose for urine. |
| Matrix Comparison | Not explicitly stated, but high correlation values (e.g., 0.997) suggest equivalence to predicate. | Calcium (mmol/L): Intercept 0.1159, Slope 0.9423, Correlation 0.997. (Plasma vs. Predicate) |
| Method Comparison (Serum/Plasma) | Not explicitly stated, but high correlation values (e.g., 0.976) suggest equivalence to predicate. | Calcium (mmol/L): Intercept 0.06, Slope 1, Correlation (r2) 0.976. (Native serum vs. Predicate) |
| Method Comparison (Urine) | Not explicitly stated, but high correlation values (e.g., 0.995) suggest equivalence to predicate. | Calcium (mmol/L): Intercept +0.1381, Slope 0.9436, Correlation (r2) 0.995. (Native urine vs. Predicate) |
| Closed Reagent Stability | Stable up to the expiry date on the label if stored at 2-8°C. Shelf life claim: 24 months. | Claim supported by CLSI EP25-A. |
| Open Reagent Stability | Supported by CLSI EP25-A. | Reagent stability claim: 6 weeks (on board). |
| Reference Range | Verification studies support established ranges from literature. | Serum/Plasma (Adults): 2.15 - 2.55 mmol/L (8.6 - 10.2 mg/dL)
Urine (24h): Women 10% were observed provided for Hemoglobin, Triglycerides, Total Bilirubin, Direct Bilirubin, Acetylsalicylic Acid, Ascorbic Acid, Ibuprofen, Acetaminophen, Glucose, Total Proteins (for serum/plasma) and additionally Glucose for urine (not listed, but implied from calcium's urine list). Note: Glucose for Creatinine urine interference is not listed in the table, but was for Calcium urine. Acetaminophen listed for Creatinine serum/plasma but not urine, similar to Calcium. |
| Matrix Comparison | Not explicitly stated, but high correlation values (e.g., 0.999) suggest equivalence to predicate. | Creatinine (µmol): Intercept -7.102, Slope 1.087, Correlation 0.999. (Plasma vs. Predicate) |
| Method Comparison (Serum/Plasma) | Not explicitly stated, but high correlation values (e.g., 0.995) suggest equivalence to predicate. | Creatinine (µmol/L): Intercept 9.158, Slope 0.9633, Correlation (r2) 0.995. (Native serum vs. Predicate) |
| Method Comparison (Urine) | Not explicitly stated, but high correlation values (e.g., 0.997) suggest equivalence to predicate. | Creatinine (mmol/L): Intercept -41.4, Slope 0.9483, Correlation (r2) 0.997. (Native urine vs. Predicate) |
| Closed Reagent Stability | Stable up to the expiry date on the label if stored at 2-8°C. Store protected from light. Shelf life claim: 24 months. | Claim supported by CLSI EP25-A. |
| Open Reagent Stability | Supported by CLSI EP25-A. | Reagent stability claim: 7 days (on board). |
| Calibration Stability | At least 3 days (Predicate). | 24 hours (Candidate). (Note: Candidate's calibration stability is shorter than predicate.) |
| Reference Range | Verification studies support established ranges from literature. | Serum/Plasma: Mens: 62-106 µmol/L (7-12 mg/dL), Womens: 44-80 µmol/L (5-9 mg/dL)
Urine (24h): Men: 14-26 mg/kg/day (124-230 µmol/kg/day), Women: 11-20 mg/kg/day (97-177 µmol/kg/day) |
2. Sample sizes for the test set and data provenance:
-
Yumizen C1200 Calcium AS:
- Matrix Comparison (Plasma): 108 individual plasma samples. Data provenance: Not specified (but likely from within France, given the manufacturer's location).
- Method Comparison (Serum/Plasma): 166 native serum samples. Data provenance: Not specified.
- Method Comparison (Urine): 105 native urine samples. Data provenance: Not specified.
- Precision (Serum/Plasma & Urine): "N" is 240 for each sample type/control tested. This is for multiple runs/days/instruments. Samples are controls (Yumizen C1200 N/P Multi Control, Urine Level 1/2 Control) and individual "Samples" (1-5).
- Reference Range Verification (Serum/Plasma): 40 "normal samples" from blood bank.
- Reference Range Verification (Urine): Not explicitly stated, but inferred to be derived from literature and verified through internal testing.
- Limit of Quantitation/Linearity/Interferences: Sample sizes for these studies are not explicitly stated, but are implied to be sufficient for CLSI guidelines EP17-A2 and EP06-A.
-
Yumizen C1200 Creatinine Jaffé:
- Matrix Comparison (Plasma): 69 individual plasma samples. Data provenance: "individual donors from blood bank." Not explicitly stated country of origin.
- Method Comparison (Serum/Plasma): 131 native samples. Data provenance: Not specified.
- Method Comparison (Urine): 148 native samples. Data provenance: Not specified.
- Precision (Serum/Plasma & Urine): "N" is 240 for each sample type/control tested. Samples are controls (Yumizen C1200 N/P Multi Control, Urine Level 1/2 Control) and individual "Samples" (1-5).
- Reference Range Verification (Serum/Plasma): 35 "normal samples" from blood bank (Men), 25 "normal samples" from blood bank (Women).
- Reference Range Verification (Urine): Not explicitly stated, but inferred to be derived from literature and verified through internal testing.
- Limit of Quantitation/Linearity/Interferences: Sample sizes for these studies are not explicitly stated, but are implied to be sufficient for CLSI guidelines EP17-A2 and EP06-A.
Data Provenance (General): The general provenance of the "individual donors from blood bank" for Matrix Comparisons (plasma) is not specified geographically. The studies are described as analytical performance evaluations, suggesting they are prospective studies conducted in a controlled laboratory setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This document describes the performance of in-vitro diagnostic (IVD) reagents, which measure specific analytes in biological samples. The concept of "ground truth" here is tied to the accurate and precise measurement of these analytes by established laboratory methods, often against a reference method or predetermined values for controls/calibrators.
- Ground Truth Establishment: For IVD devices, "ground truth" is typically established by:
- Certified Reference Materials/Control Materials: These have assigned values determined by highly accurate reference methods or extensive inter-laboratory studies.
- Reference Methods: Highly accurate and precise analytical methods used to determine true values (e.g., isotope dilution mass spectrometry for some analytes).
- Predicate Devices: Comparison against an already cleared and widely accepted device.
- Expert Consensus/Pathology/Outcomes Data: These are generally relevant for diagnostic imaging or clinical decision support AI, not typically for quantitative chemical assays like Calcium and Creatinine.
The document does not mention the use of "experts" in the traditional sense (e.g., radiologists, pathologists) to establish ground truth for this type of IVD testing. The focus is on analytical performance metrics (linearity, precision, interference, method comparison to a predicate).
4. Adjudication method for the test set:
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where subjective interpretation (e.g., reading medical images) is involved and multiple experts are used to reach a consensus for ground truth. This document describes the analytical performance of quantitative chemical assays, where measurements are objective.
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. MRMC studies are used for evaluating diagnostic imaging or AI systems that assist human readers in interpretation. This document pertains to the analytical performance of reagents for quantitative chemical measurements, which do not involve human "readers" in the context of interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, in a sense. The studies described (e.g., measuring range, precision, interference, method comparison) evaluate the performance of the reagent and instrument system in generating a quantitative value for Calcium and Creatinine. This is akin to a "standalone" performance evaluation of the reagent system itself, without human interpretation of the final result, beyond standard laboratory quality control and result review. The device output is a numerical value, not an interpretation requiring human assistance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for these studies is established through:
- Reference Methods/Assigned Values: For precision studies, control materials with known target values are used. For linearity, serially diluted samples or spiked samples with known concentrations are employed.
- Comparison to a Predicate Device: For method comparison, patient samples are tested on both the candidate device and a legally marketed predicate device, with the predicate serving as the reference for equivalence.
- Literature Reference Intervals: For reference range verification, the device's measurements on "normal samples" are compared against established reference intervals from scientific literature.
8. The sample size for the training set:
Not applicable. This is an IVD reagent and instrument system, not an AI/Machine Learning model that undergoes a distinct "training" phase with a large dataset in the way a medical image analysis algorithm would. The development of reagents involves chemical formulation and optimization, and instrument calibration relies on calibrator materials, not necessarily "training datasets" in the AI sense.
9. How the ground truth for the training set was established:
Not applicable for the same reasons as point 8. The "ground truth" for calibrators (used for instrument calibration, which is analogous to "training" in the sense of setting up the system for accurate measurement) is typically established by the calibrator manufacturer using highly accurate reference methods and/or extensive certification processes. The document mentions "Yumizen C1200 Multical" as the calibrator for the candidate device.
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(85 days)
Randox Calcium (Ca)
The Randox Calcium (Ca) device is intended for the quantitative in vitro determination in serum, plasma and urine. This product is suitable for use on the RX series analyzer, RX daytona plus. Such measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases and chronic renal failure.
The Randox Calcium (Ca) kit consists of a ready to use reagent solution.
The Randox Calcium (Ca) device is an in vitro diagnostic intended for the quantitative determination of calcium concentration in serum, plasma, and urine on the RX series analyzer RX daytona plus. The device demonstrates substantial equivalence to the predicate device, the ADVIA Chemistry Calcium_2 (CA_2) Method (K083386), based on performance characteristics including precision, linearity, analytical specificity, and method comparison.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit from validation studies) | Reported Device Performance (Randox Calcium (Ca)) |
|---|---|---|
| Precision (Serum) | Total CV% for Serum: | Lot 1: Level 1: 4.1%, Level 2: 3.6%, Level 3: 3.7%, Level 4: 3.7% |
| - Level 1: ≤ 4.2% (based on predicate value) | Lot 2: Level 1: 4.2%, Level 2: 4.2%, Level 3: 4.1%, Level 4: 4.0% | |
| - Level 2: ≤ 4.2% (based on predicate value) | ||
| - Level 3: ≤ 4.1% (based on predicate value) | ||
| - Level 4: ≤ 4.0% (based on predicate value) | ||
| Precision (Urine) | Total CV% for Urine: | Lot 1: Level 1: 4.6%, Level 2: 4.0%, Level 3: 4.0%, Level 4: 3.9% |
| - Level 1: ≤ 4.0% (based on predicate value) | Lot 2: Level 1: 4.0%, Level 2: 4.1%, Level 3: 4.0%, Level 4: 3.7% | |
| - Level 2: ≤ 4.1% (based on predicate value) | ||
| - Level 3: ≤ 4.0% (based on predicate value) | ||
| - Level 4: ≤ 3.7% (based on predicate value) | ||
| Linearity (Serum) | Correlation Coefficient r ≥ 0.99 | Lot 1: r = 1.00; Lot 2: r = 1.00 |
| Reportable Range: 1.0 - 16 mg/dL | Lot 1: 1.0 - 16 mg/dL; Lot 2: 1.0 - 16 mg/dL | |
| Linearity (Urine) | Correlation Coefficient r ≥ 0.99 | Lot 1: r = 1.00; Lot 2: r = 1.00 |
| Reportable Range: 1.0 - 32 mg/dL | Lot 1: 1.0 - 32 mg/dL; Lot 2: 1.0 - 32 mg/dL | |
| Analytical Specificity | Deviation from control |
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(170 days)
DSM Biomedical Calcium Phosphate Cement with Microspheres
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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(159 days)
DSM Biomedical Calcium Phosphate Cement
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):
| Characteristic | DSM Biomedical Calcium Phosphate Cement (Proposed) | Assessment in Document |
|---|---|---|
| Material Characterization | Calcium phosphate powder with bovine collagen | Completed in accordance with FDA Guidance and ASTM F1185. |
| Physical Characteristics | Injectable, sculptable, fast setting, converts to hydroxyapatite | Compared to predicate device, deemed similar. |
| Biocompatibility | Biocompatible | Testing completed per ISO 10993-1. Results indicate acceptable biocompatibility. |
| Viral Inactivation | Conducted | Study performed. |
| Animal Study | Bone healing | Evaluated bone healing in an ovine bilateral femoral defect model compared to the predicate device. |
| Sterilization | Sterile, SAL 10-6 | Confirmed (stated in table). |
| Reusable | Single Use Device | Confirmed (stated in table). |
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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