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NP Cements Genta / NP Cement System 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 NP Cements Genta and NP Cements System Genta are PMMA, radiopaque bone cements, containing gentamicin and color additives to impart a green color, designed for the fixation of prosthesis to the living bone. The devices contain the same individual chemical constituents, but are supplied in different ways:

1. NP Cements Genta 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.
2. NP Cements System Genta stores the powder and liquid components separately within a closed syringe-like device that serve as both mixing chamber and extrusion device. The device is provided with a vacuum tube and a cannula with the pusher rod. The product is packaged in a double blister, the external blister is sealed with a Tyyek lid, and then placed in an aluminum bag.
   The devices are sold disposable and sterile. The NP Cements Genta are available in a low and high viscosity version. The NP Cements System Genta are also available in a low and high viscosity version.

The provided document describes a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and performance data in the typical sense. Therefore, many of the requested elements for a detailed study description are not explicitly present.

However, based on the available information, I can construct a response that addresses what is provided and what can be inferred.

Here's the breakdown of the acceptance criteria and the study (or, in this case, performance data submitted to demonstrate substantial equivalence) for the "NP Cements Genta / NP Cement System Genta":

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in a formal table with pass/fail values. Instead, it states that "Performance testing was performed to characterize the bone cements in accordance with special controls guidance document" and that "The performance data demonstrate that the new devices are substantially equivalent to the predicate device, and meet the requirements of the Special Controls Guidance document."

The "acceptance criteria" are thus implicitly defined by the properties and performance of the predicate device (Tecres Cemex Genta HV) and the requirements outlined in the "FDA Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement; Guidance for Industry and FDA" dated July 17, 2002. The reported device performance is that it met these implicit criteria and demonstrated substantial equivalence.

Summary of Performance Goals (Implicit Acceptance Criteria based on Guidance and Predicate):

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

The document does not provide specific sample sizes for each performance test. The data provenance is also not explicitly stated in terms of country of origin, but the submission is from "Cossington Ltd, United Kingdom," suggesting the testing could have been conducted there or by affiliated entities. The data is retrospective in the sense that it supports a premarket notification for a device that has been developed and tested.

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

This type of information is generally not applicable to a submission for a bone cement device. The "ground truth" here is objective physical and chemical properties measured in laboratory settings, not subjective interpretations by human experts.

4. Adjudication Method for the Test Set

Not applicable for objective physical and mechanical property testing.

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-driven diagnostic device that involves human readers.

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

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

7. The Type of Ground Truth Used

The ground truth used for this type of device and submission is based on:

• Established material science and engineering principles: Properties like mechanical strength, chemical composition, thermal behavior, etc., are measured using validated scientific methods.
• International standards: Adherence to ISO standards (e.g., ISO 10993 for biocompatibility).
• FDA guidance documents: Compliance with specific guidance for PMMA bone cement.
• Predicate device's established performance: The predicate device (Tecres Cemex Genta HV) effectively serves as a benchmark for "ground truth" to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI model that requires a training set.

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

Not applicable.

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NP Cements / NP Cements System are intended to be used for the fixation of artificial joint prostheses to the host bone.

The NP Cements and NP Cements System are PMMA, radiopaque bone cements, containing color additives to impart a green color, designed for the fixation of prosthesis to the living bone. The devices contain the same individual chemical constituents, but are supplied in different ways:

1. NP Cements 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.
2. NP Cements System stores the powder and liquid components separately within a closed syringe-like device that serve as both mixing chamber and extrusion device. The device is provided with a vacuum tube and a cannula with the pusher rod. The product is packaged in a double blister, the external blister is sealed with a Tyvek lid, and then placed in an aluminum bag.
   The devices are sold disposable and sterile. The NP Cements are available in a low and high viscosity version. The NP Cements System are also available in a low and high viscosity version.

This document is a 510(k) Summary for a medical device called "NP Cements / NP Cements System." It focuses on demonstrating that the new device is substantially equivalent to a previously cleared predicate device, "Tecres Cemex Isoplastic."

Here's an analysis of the acceptance criteria and study information provided, focusing on what is present and what is not present given the nature of this submission:

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

The document does not explicitly present "acceptance criteria" in a typical quantitative pass/fail table format, as one might find for a software algorithm or diagnostic test. Instead, it demonstrates performance by comparing various characteristics of the new device to the predicate device and by stating that the device meets the requirements of the "FDA Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement; Guidance for Industry and FDA."

Here's a breakdown of the performance aspects mentioned:

Important Note: This type of 510(k) submission for a physical medical device (bone cement) does not involve the same kind of performance metrics (sensitivity, specificity, AUC) or study designs (e.g., expert reads, MRMC studies) as AI/ML software or diagnostic tests. The "performance data" here refers to the physical and chemical properties of the material itself.

For the following points (2-9), most are not applicable or not provided in this specific document because it describes a physical material, not an AI/ML or diagnostic device that relies on human interpretation of data/images.

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

• Not applicable/Not provided: This document describes laboratory testing of a bone cement, not a clinical study on a test set of data. The "tests" are on batches of the material.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not provided: This is not a diagnostic device where "ground truth" is established by human experts. The ground truth for material properties is established through standardized laboratory measurements and analytical chemistry.

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

• Not applicable/Not provided: Adjudication methods are relevant for expert consensus on ambiguous medical cases, which is not relevant for bone cement material properties.

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/Not provided: This is a physical bone cement, not an AI-powered diagnostic or assistive tool. MRMC studies are not relevant.

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

• Not applicable/Not provided: This is a physical bone cement, not an algorithm.

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

• For material properties: The "ground truth" is established through standardized physical, chemical, and mechanical testing methods as outlined in the "FDA Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement." This would involve precise measurements (e.g., tensile strength, setting time, polymerization temperature) using calibrated equipment, not expert consensus or pathology in a clinical sense.

8. The sample size for the training set

• Not applicable/Not provided: There is no "training set" in the context of material characterization for a physical medical device. The "training" would be the initial formulation and manufacturing process development, followed by quality control testing of manufacturing batches.

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

• Not applicable/Not provided: As above, there isn't a "ground truth for a training set" as understood in AI/ML development. The "ground truth" for the material's properties is inherent in its physical and chemical nature, measured against established industry and regulatory standards.

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