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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 <85>, 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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The DSM Biomedical Dental Bone Graft Plus is indicated for:

• Augmentation or reconstructive treatment of the alveolar ridge
• Filling of infrabony periodontal defects
• Filling of defects after root resection, apicoectomy, and cystectomy
• Filling of extraction sockets to enhance preservation of the alveolar ridge
• Elevation of the maxillary sinus floor
• Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
• Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)

The DSM Biomedical Dental Bone Graft Plus is a non-pyrogenic porous bone mineral and collagen matrix for use in periodontal, oral, and maxillofacial surgery. The DSM Biomedical Dental Bone Graft Plus is composed of anorganic porcine bone granules combined with bovine collagen to form small cylinders. The device is provided in sizes ranging from 100 - 500mg. DSM Dental Bone Graft Plus is supplied sterile by gamma irradiation and is for single use only.

This document is a 510(k) Premarket Notification from the FDA regarding the "DSM Biomedical Dental Bone Graft Plus." It concerns the substantial equivalence of this new device to a predicate device, not the results of a clinical study demonstrating the device's performance against predefined acceptance criteria for a new AI/software medical device.

Therefore, I cannot provide the requested information as the document does not contain:

1. Acceptance criteria and reported device performance (table): The document discusses the equivalence of a bone graft material to a predicate, focusing on material properties, indications for use, and a demonstration in an animal model. It does not present quantitative performance against specific clinical acceptance criteria typically seen for AI/software medical devices (e.g., sensitivity, specificity, AUC).
2. Sample size and data provenance for a test set: The document mentions an "animal study" but does not detail the sample size (number of animals or cases in a test set), nor does it describe data provenance in terms of country of origin or retrospective/prospective nature, as would be relevant for clinical data in AI/software evaluation.
3. Number and qualifications of experts for ground truth: This is relevant for AI/software devices whose ground truth is often established by expert consensus. This document pertains to a physical bone graft material, and the ground truth for an animal study would be based on histological or imaging analysis, not expert interpretation of outputs of an AI algorithm.
4. Adjudication method for the test set: Not applicable for a physical medical device.
5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study: This is a study design specifically for evaluating the impact of AI assistance on human reader performance, which is not relevant for a bone graft material.
6. Standalone (algorithm only) performance: This is for software, not a physical device.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.): While animal study results (likely histological or imaging evidence of bone formation) serve as ground truth for the performance of the bone graft, the nature of "ground truth" establishment for AI/software (e.g., expert reads, pathology reports) is not present.
8. Sample size for the training set: This refers to AI/machine learning models, which are not discussed in this document.
9. How ground truth for the training set was established: Also refers to AI/machine learning models.

The document primarily focuses on establishing "substantial equivalence" of the new bone graft material to an existing one, based on:

• Non-clinical testing data: Mechanical and physical testing, biocompatibility testing (ISO standards), and pyrogenicity testing.
• Animal Testing: A canine intrabony defect animal study comparing the new device to the predicate device to evaluate bone healing.

In essence, this document is a regulatory submission for a physical medical device, not a performance study report for an AI/software medical device.

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The DPR Cable is intended for:

• Spinal applications include sublaminar and intraspinous process wiring for trauma applications.
• Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty.
• Sternotomy indications including the "rewiring" of osteomized sternums.
• Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring.
  The device is intended for single patient use only.

The DPR Cable is a flexible, multi-strand ultra-high molecular weight polyethylene (UHMWPE) cerclage cable. The device is intended to provide stabilization of bony segments.
The DPR Cable is made of woven ultra-high molecular weight polyethylene fibers which incorporate bismuth trioxide (Bi₂O₃). The addition of bismuth trioxide allows for radiographic visualization both during and after surgical procedures. The device is supplied sterile in double-layer packages. The DPR Cable is intended for single patient use only. DPR Cable is MR safe.

The provided text is a 510(k) Premarket Notification for a medical device called the "DPR Cable." This document primarily focuses on establishing substantial equivalence to a predicate device for regulatory approval, rather than detailing a clinical study with acceptance criteria for an AI/algorithm-based device.

Therefore, many of the requested details regarding acceptance criteria, study design for proving device performance (especially for an AI/algorithm), ground truth establishment, sample sizes for training/test sets, expert adjudication, and MRMC studies do not apply to this type of regulatory submission for this medical device.

The document discusses biomechanical testing to show equivalence in performance characteristics to predicate devices, but this is not an AI/algorithm study.

Here's an attempt to extract relevant information, highlighting where the requested details are not applicable based on the provided text's context as a 510(k) for a physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on demonstrating equivalence to predicate devices through biomechanical testing, rather than explicit criteria for an AI's accuracy or clinical performance. The table in the document (Page 5) compares the technological characteristics and certain performance metrics with the predicate device.

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

• Sample Size: The document does not specify exact sample sizes for biomechanical tests like tensile strength or fatigue strength, only the results of these tests. This is not a clinical "test set" in the context of an AI/algorithm.
• Data Provenance: Not applicable. The data comes from in-vitro biomechanical testing of the device itself, not from clinical patient data.

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

• Not applicable. Ground truth, in the context of AI studies, refers to expert labeling of data. For this physical device, "ground truth" would be established by validated engineering tests and measurements, comparing against known standards or predicate device performance. No human experts are detailed for "ground truth" establishment in this context.

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

• Not applicable. This concept pertains to resolving discrepancies in expert labeling of data, which is not relevant for biomechanical testing of a physical device.

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.):

• For biomechanical testing, the "ground truth" is provided by established engineering standards and measurements for properties like tensile strength, fatigue strength, creep, and knot strength. It's an objective measurement of physical properties.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning study.

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

• Not applicable.

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