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MSC SFM is a liquid tissue culture medium product intended for human ex-vivo tissue and cell culture processing applications.

MSC SFM is a serum-free medium specially formulated for the growth and expansion of human mesenchymal stem cells (MSCs). MSC SFM contains MSC SFM Basal Medium and MSC SFM supplement, MSC SFM supplement is a growth factor that should be added to the MSC SFM Basal Medium when use. Using MSC SFM, human MSCs can be expanded for multiple passages while maintaining their trilineage mesoderm potential (i.e., ability to differentiate into osteogenic and adipogenic lineages). Each container is aseptically filled.

The provided text is a 510(k) Premarket Notification from the FDA for a device called "MSC SFM" by Yocon Biology Technology Company. This document primarily describes the regulatory review process and establishes substantial equivalence to a predicate device.

Crucially, this document is for a "Tissue Culture Media For Human Ex Vivo Tissue And Cell Culture Processing Applications" (Product Code: NDS). This is a biological reagent, not an AI/ML-driven medical device that analyzes images or patient data to produce diagnostic or prognostic outputs. Therefore, many of the requested elements regarding acceptance criteria and study design for AI/ML devices (e.g., number of experts for ground truth, MRMC study, effect size of human improvement with AI, standalone performance) are not applicable to this type of product and are not found in the provided text.

The acceptance criteria discussed in this document pertain to the performance and safety of the tissue culture media itself, not the performance of an AI algorithm.

However, based on the information provided, here's what can be extracted and inferred, addressing the spirit of the request where applicable to this specific product, and explicitly stating when information is not applicable or not provided in the document for AI/ML-specific criteria.

Device Type: Tissue Culture Media for Human Ex Vivo Tissue and Cell Culture Processing Applications (Biological Reagent)

1. Table of Acceptance Criteria and Reported Device Performance

The document refers to performance standards established in the FDA Guidance Document "Class II Special Controls Guidance Document: Tissue Culture Media for Human Ex Vivo Tissue and Cell Culture Processing Applications; Final Guidance for Industry and FDA Reviewers," issued May 16, 2001. While the specific numerical acceptance criteria for each test are not explicitly detailed in this 510(k) summary, the types of tests performed and the general findings are mentioned.

Note: The FDA 510(k) summary typically summarizes the results of the testing that support substantial equivalence, rather than providing the detailed raw data or specific numerical acceptance ranges for each test (unless failure of a specific range was a critical point to address). The "Special Controls Guidance Document" would contain the full details of the appropriate acceptance criteria.

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

• Test Set Sample Size: The document does not specify exact sample sizes for each test (e.g., how many batches were tested for sterility, how many cells for performance assay). It refers to "non-clinical data" and "Performance Assay."
• Data Provenance: The manufacturing company is YOCON BIOLOGY TECHNOLOGY COMPANY, located in Beijing, China. The testing would have been conducted by the manufacturer, presumably in China. The data would be prospective in the sense that it was generated for the purpose of demonstrating device performance for this FDA submission.

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

Not Applicable. This is a biological reagent, not an AI/ML device requiring human expert annotation of data for ground truth. The "ground truth" for this product is based on established laboratory testing methods, chemical properties, and biological assays (e.g., cell viability, proliferation, differentiation markers, endotoxin levels).

4. Adjudication Method for the Test Set

Not Applicable. As there are no human expert readers generating subjective interpretations, there is no need for an adjudication method. Laboratory tests have defined protocols and result 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/ML device meant to assist human readers.

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

Not Applicable. This document describes a tissue culture medium, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance of this tissue culture media is established through a combination of:

• Laboratory Standard Tests: Such as USP for Endotoxin, pH, Osmolality, Sterility Testing.
• Biological Performance Assays: Demonstrating the medium's ability to "support of tissue and cell growth" and "lack of potential toxicity" for human mesenchymal stem cells (MSCs), including maintaining their "trilineage mesoderm potential."
• Compliance with Standards: Adherence to ISO 10993-1 for biocompatibility.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device with a training set. The "training" for this product would be the research and development involved in formulating the medium to meet the desired performance characteristics.

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

Not Applicable. As there is no AI/ML training set, this question is not relevant. The "ground truth" during product development would be empirical lab results guiding formulation optimization, similar to the performance tests listed in section 7.

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MoFi is a liquid culture medium intended for human ex vivo tissue and cell culture processing applications.

MoFi is a basal medium based on Iscove's Modified Dulbecco's Medium (IMDM) and cell-degradabe polysaccharide, made of water, carbohydrate, amino acid and salt. It can be mixed with various serums or additional additives to form a complete medium, which can be used to culture suspension/adherent primary cultured cells or cell lines. MoFi provides cells with energy to maintain survival and promote growth.

The provided document describes the FDA 510(k) premarket notification for "MoFi" Cell Culture Basal Medium. This K-submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing details on a study performed by the applicant (DuoGenic StemCells Corporation) to prove performance against specific acceptance criteria for an AI/ML powered device. The document describes a biologically-based product (cell culture medium), not an AI/ML-powered medical device.

Therefore, the requested information regarding acceptance criteria, AI/ML study design (sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance), and training set details for an AI/ML device cannot be extracted from this document as it does not pertain to such a device.

The document discusses the following performance characteristics for the MoFi Cell Culture Basal Medium:

1. Acceptance Criteria and Reported Device Performance (for a cell culture medium, not an AI/ML device):

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PRIME-XV FreezIS DMSO-Free MD is for use in human ex vivo tissue and cell culture processing applications.

PRIME-XV Freez/S DMSO-Free MD is a liquid medium intended for use in human ex vivo tissue and cell culture processing applications.

It is a chemically defined cryogenic preservation solution for human cells for use in a professional Healthcare Facility that performs cell culture and cell handling. It has comparable post-thaw cell viability as solutions containing dimethyl sulfoxide (DMSO), maintains potency of stem cells throughout cryopreservation, eliminates the risk of DMSO in stem cell therapy applications, is animal componentfree, enables cell preservation at -80°C to -196°C environments and is manufactured under cGMP conditions.

The provided text describes a medical device, PRIME-XV FreezIS DMSO-Free MD, which is a tissue culture medium. It presents the device's indications for use, technological characteristics, and a comparison to predicate devices, but it does not contain information about an AI-powered device or a study involving human readers or a test set to establish ground truth for performance metrics like sensitivity or specificity.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance data for an AI device. The document is a 510(k) summary for a biological/chemical product, not a software device or an AI diagnostic tool.

The acceptance criteria provided in the document relate to the quality and performance of the tissue culture medium itself, such as:

• High cell viability, robust cell expansion post-cryopreservation, maintenance of cell function, phenotype and differentiation potential: To demonstrate lack of potential toxicity and support of tissue/cell growth.
• **Endotoxin testing per USP , mycoplasma testing per USP **: To demonstrate lack of endotoxin or pyrogen contamination.
• Compliance with GMP requirements regarding aseptic processing: For validation of Aseptic Processing and Sterility Assurance Level (SAL).
• Incoming raw materials are of high quality and are lot-tested for identity and purity: To demonstrate chemical purity.
• 24-month shelf life when stored at 2 – 8 °C: Based on stability testing confirming pH, osmolality, non-cytotoxicity, and protection against microbial contamination.

These are established through laboratory testing directly on the medium and its interaction with cells, not through studies involving expert readers or ground truth adjudication as would be relevant for an AI diagnostic device.

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CT-STOR is a liquid culture media intended for ex vivo cell and tissue processing applications

CT-STOR is a tissue culture media intended for human ex vivo tissue and cell culture processing applications. AIM-V® is the predicate device and is also a tissue culture media intended for human ex vivo tissue and cell culture processing applications. CT-STOR and AIM-V® are composed of chemically defined nutrient materials in solution (with or without supplements) that are essential for the survival and development of tissue or cells of human or other animal origin. These nutrients are provided in liquid form for use in supporting the growth or maintenance of human tissue and cells.

Here's a breakdown of the acceptance criteria and study information for the CT-STOR device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

(Note: The table in the document only provides a single acceptance criterion for CT-STOR stability, which is "Seeding Comparison (%)" with an "Acceptable Limit: > 75%". The reported device performance exceeds this limit at both 8 and 128 days aged.)

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

For the non-clinical performance testing of CT-STOR stability:

• Sample Size: The study used "Primary HDFa cells were purchased from American Type Culture Collection (ATCC, PCS-201-012, Primary Dermal Fibroblast; Normal, Human, Adult (HDFa), Manassas, VA)".
  • Specifically, cells were "plated at 10,000 cells per well on a 24-well plate." The exact number of wells or replicates is not explicitly stated, but it implies multiple wells were used for testing and control.
• Data Provenance: The cells were purchased from ATCC, a common biological resource. The study itself appears to be a prospective non-clinical study performed by Energy Delivery Solutions to validate the stability of CT-STOR. The origin of the human dermal fibroblasts (HDFa) is stated as "Normal, Human, Adult."

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

This information is not provided in the document. The study described is a non-clinical, in-vitro stability study using cell culture, not a study requiring expert clinical assessment for ground truth. The "ground truth" here is the measured cell proliferation compared against a predefined acceptable limit.

4. Adjudication Method for the Test Set

This information is not applicable as the described study is a non-clinical, in-vitro stability study measuring cell proliferation, not a study requiring human interpretation or 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

This information is not applicable. The device, CT-STOR, is a "liquid culture media intended for ex vivo cell and tissue processing applications," not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.

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

This information is not applicable. As stated above, CT-STOR is a culture medium, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the non-clinical stability study was established by quantitative measurement of cell proliferation (seeding comparison percentage) compared against a pre-defined acceptable limit (> 75%). This can be considered an objective, laboratory-based ground truth.

8. The Sample Size for the Training Set

This information is not applicable. CT-STOR is a chemical composition (culture media), not a machine learning algorithm that requires a training set. The "formula for CT-STOR has remained the same since it was first manufactured with only a few minor alterations to composition."

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

This information is not applicable as there is no training set for this type of device. The formulation of CT-STOR is based on established scientific principles regarding essential nutrients for cell and tissue viability, as well as modifications over time based on apparently non-ML-driven optimization. The document mentions that the product's efficacy has been "well established in scientific publications included in this submission," suggesting reliance on existing biological and chemical knowledge.

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OpTmizer™ CTS™ T-Cell Expansion SFM is a liquid tissue culture media product intended for human ex vivo tissue and cell culture processing applications.

OpTmizer™ CTS™ T-Cell Expansion SFM has been developed for the growth and expansion of human T lymphocytes. OpTmizer™ CTS™ T-Cell Expansion SFM is a complete serum-free and xeno-free 1X medium consisting of the OpTmizer™ T-Cell Expansion Basal Medium with the addition of the OpTmizer™ T-Cell Expansion Supplement. OpTmizer™ CTS™ T-Cell Expansion Medium is designed for the expansion of CD3+ densities of > 3 x 10° cells/mL in static conditions and > 2 x 10′ cells/ML in Wave bags.

Acceptance Criteria and Device Performance Study for OpTmizer™ CTS™ T-Cell Expansion SFM

Based on the provided 510(k) summary (K113566), the OpTmizer™ CTS™ T-Cell Expansion SFM is a tissue culture medium intended for human ex vivo tissue and cell culture processing applications. The device's performance is demonstrated through pre-clinical testing aligning with the "Class II Special Controls Guidance Document: Tissue Culture Media for Human Ex Vivo Tissue and Cell Culture Processing Applications".

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a specific "test set" sample size in terms of number of human subjects or distinct samples for the OpTmizer™ CTS™ T-Cell Expansion SFM. The pre-clinical testing outlined refers to:

• OpTmizer QC Performance Assay: This assay would involve specific sample sizes of cells or tissues tested under defined conditions. The exact number is not provided.
• LAL test: This is a standard test for endotoxins and would be performed on samples of the manufactured medium. The specific number of lots or samples tested is not detailed.
• Sterility Assurance Level (SAL): This is a validation process typically involving multiple sterilization cycles and microbiological challenging, not a "sample size" in the conventional sense of a clinical study.
• Incoming Raw Material testing: This is a quality control process for the components of the medium.
• Stability/Shelf-Life testing: This involves testing "a minimum of one new production lot of OpTmizer™ CTS™ T-Cell Expansion SFM" each year. Retained product stored at 2-8°C is also tested (no specific number of retained lots specified).

The data provenance is not explicitly stated as retrospective or prospective in the context of a "study" involving human data. Instead, it refers to ongoing quality control and product development testing within Life Technologies Corporation. The data originates from internal company testing and adherence to established regulatory and scientific methodologies for tissue culture media. There is no mention of country of origin for the data as it pertains to clinical data, but the manufacturing facility is in Grand Island, New York, implying internal testing would be conducted within the US or its affiliated labs.

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

This information is not applicable and not provided. The "ground truth" for this device is based on established scientific and regulatory standards for biocompatibility, sterility, chemical purity, and functional performance of tissue culture media. There is no mention of external "experts" establishing a "ground truth" for a test set in the way one would for diagnostic imaging. Rather, the device's performance is validated against predefined technical specifications and regulatory guidelines.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human interpreters are assessing and classifying data, and disagreements need to be resolved. This is not a human-in-the-loop diagnostic device requiring such an adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of results, often with AI assistance, and aims to measure the improvement in human performance. The OpTmizer™ CTS™ T-Cell Expansion SFM is a consumable tissue culture medium, not a diagnostic or AI-assisted interpretation tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the testing described is effectively "standalone" performance, as it evaluates the properties and functionality of the medium itself without human intervention in operating the device for its core function. The "device" (the medium) performs its function (supporting cell growth, sterility, etc.) inherently. The performance is assessed by laboratory assays and quality control measures.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on objective laboratory measurements and established scientific and regulatory standards. This includes:

• Cell growth and viability metrics: Quantifiable measures of cell expansion (e.g., cell counts, viability percentages), functionality, and lack of cytotoxicity as measured by the OpTmizer QC Performance Assay.
• Microbiological testing: Absence of endotoxins (LAL test) and demonstration of sterility (SAL determination).
• Chemical purity specifications: Conformance to USP, ACS, FCC, GIBCO, or Cell Culture requirements for raw materials.
• pH specifications: Maintaining pH within a defined range over time.
• Container/closure integrity: Absence of microbial contamination.

There is no "expert consensus," "pathology," or "outcomes data" in the clinical sense directly establishing a ground truth for the medium itself, as it is a foundational research/manufacturing material rather than a diagnostic or therapeutic medical device applied directly to patients where clinical outcomes are the primary ground truth.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. The development of OpTmizer™ CTS™ T-Cell Expansion SFM involved research and development, where various formulations and conditions would have been tested to optimize its performance ("OpTmizer™ CTS™ T-Cell Expansion SFM has been developed for the growth and expansion of human T lymphocytes"). This iterative development process would have involved numerous experiments and data points, but these are not quantified as a "training set" in the presented information.

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

Given that a "training set" in the AI/machine learning sense is not explicitly discussed, the "ground truth" for product development and optimization would have been established through:

• Experimental results: Direct measurements of cell growth (e.g., T-cell expansion, viability) under various medium formulations.
• Literature and scientific understanding: Utilizing existing knowledge about nutrient requirements for T-cell growth and factors affecting cell culture media performance.
• Internal research and development objectives: Setting specific performance targets (e.g., target CD3+ cell densities) and developing formulations to achieve these targets.
• Adherence to regulatory guidelines: Ensuring that the medium's components and intended use comply with relevant standards.

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StemPro® MSC SFM Medium is a liquid tissue culture medium products intended for human ex vivo tissue and cell culture processing applications.

StemPro® MSC SFM is a serum-free medium (SFM) specially formulated for the growth and expansion of human mesenchymal stem cells (MSCs). StemPro® MSC SFM enables human MSC growth and increased consistency compared to classical serum-supplemented medium. In addition, human MSCs can be expanded for multiple passages while maintaining their multipotential phenotype (i.e. ability to differentiate into osteogenic, chondrogenic, adipogenic lineages). StemPro® MSC SFM contains two components: StemPro® MSC SFM Basal Medium and StemPro® MSC SFM Supplement.

This is a 510(k) premarket notification for a tissue culture medium, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device studies are not applicable.

Here's the relevant information based on the provided text:

Device Name: StemPro® MSC SFM Medium

Predicate Device: Knockout™ SR Medium (K100616)

Intended Use: StemPro® MSC SFM Medium is a liquid tissue culture media product intended for human ex vivo tissue and cell culture processing applications. This device is a chemically defined tissue culture media used to support the growth or maintenance of human tissue or cells in culture.

Acceptance Criteria and Reported Device Performance

The device demonstrates substantial equivalence to its predicate by meeting performance standards outlined in a "Class II Special Controls Guidance Document: Tissue Culture Media for Human Ex Vivo Tissue and Cell Culture Processing Applications".

Study Details (Not applicable for AI/ML device)

This is a medical device submission for a tissue culture medium, not an AI/ML enabled device. Therefore, the following AI/ML-specific questions are not applicable:

• Sample size used for the test set and the data provenance: Not applicable. Performance testing involved laboratory assays rather than clinical data sets.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for performance studies of tissue culture media relies on established laboratory testing methodologies and specifications.
• Adjudication method for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: For performance tests like cytotoxicity, LAL, and chemical purity, the ground truth is established by the specified assay results conforming to pre-defined scientific and regulatory standards (e.g., USP monographs, internal specifications). For cell growth, it's the observed ex vivo cell proliferation and maintenance of phenotype.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

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Knockout™ SR Medium and Knockout™ SR Xenofree Medium are liquid tissue culture medium products intended for human ex vivo tissue and cell culture processing applications.

Knockout™ SR is a serum-free medium with a defined formulation that provides consistent growth conditions for human and mouse embryonic stem cell (ESC) and patient-specific induced pluripotent cell lines (iPSCs).
Knockout™ SR Xenofree is a serum-free and animal origin-free defined formulation that provides consistent growth conditions for human and mouse embryonic stem cell (ESC) and patient-specific induced pluripotent cell lines (iPSCs). All animal derived components have been replaced with human derived or synthetic components to yield a xenogeneic-free formulation.

The provided document describes the acceptance criteria and the study that demonstrates the performance of Knockout™ SR Medium and Knockout™ SR Xenofree Medium, which are tissue culture media. This is not a medical device in the typical sense of a diagnostic or therapeutic AI-powered tool. Therefore, many of the requested categories for AI-based device performance studies (like MRMC studies, number of experts for ground truth, sample size of test/training sets, adjudication methods, and standalone performance metrics of an algorithm) are not applicable to this type of product.

However, I can extract the relevant performance criteria and how the manufacturer demonstrates compliance.

1. Table of Acceptance Criteria and Reported Device Performance

1. pH continued to meet specifications.
2. Media was not cytotoxic and supported the growth of mammalian cells.
3. Container/closure integrity testing confirmed protection from microbial contamination. |

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

This is not applicable as the studies described are laboratory-based assays and stability tests for a cell culture medium, not clinical studies with patient data. The "test set" would refer to internal lab samples and batches of the media.

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

Not applicable. The "ground truth" for chemical purity, sterility, and cell growth support is established through standardized laboratory assays and protocols, not by expert human review in the context of radiology or pathology, for example.

4. Adjudication Method for the Test Set

Not applicable. Laboratory test results are typically objective measurements against predefined specifications, not subjective assessments 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 device is not an AI-powered diagnostic or therapeutic tool for human readers.

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

Not applicable. This device is a cell culture medium, not an algorithm.

7. The Type of Ground Truth Used

The ground truth is based on:

• Established laboratory assay specifications: For LAL test ( USP Monograph), SAL determination (≥ 10⁻³), and incoming raw material testing (USP, ACS, FCC, GIBCO, or Cell Culture requirements).
• Scientific and biological principles: For ES cell morphology, relative plate efficiency, and relative type 1 colonies, indicating proper cell growth and differentiation status.
• Physical and chemical specifications: For pH and container integrity over time.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI model that requires a training set. The development of the media involved formulation and optimization, but not in the sense of an algorithm training on data.

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

Not applicable, as there is no training set in the context of an AI device. The "ground truth" for the medium's development would have been empirically determined optimal conditions for cell culture based on literature, prior research, and internal experiments to achieve desired cell growth and maintenance characteristics. The company mentions a long history and substantial literature (300+ references) for Knockout™ SR, suggesting a robust scientific foundation for its formulation.

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AIM-V® Medium is a liquid tissue culture media product intended for human ex vivo tissue and cell culture processing applications.

AIM-V® Medium is a liquid tissue culture media product intended for human ex vivo tissue and cell culture processing applications. AIM-V® is a serum-free medium developed in 1987 to support adoptive immunotherapy (lymphokine-activated killer (LAK) cells) clinical trials. The formula for AIM-V® has remained the same since it was first manufactured with only slight quantity variations. AIM-V® Medium is prepared from a master formulation of Dulbecco's Modified Eagle Medium, HEPES buffer, human serum albumin.USP, human transferrin, and cholesterol, NF(which help promote growth of the cells and tissue).

This document is a 510(k) summary for the Invitrogen Corporation's AIM-V® Medium, a tissue culture media. It is important to note that this document is for a tissue culture media, not a diagnostic device or an AI/ML-based device that would typically have the requested acceptance criteria and study information.

Therefore, many of the requested sections (e.g., sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, types of ground truth for AI models) are not applicable to this type of regulatory submission. The submission focuses on demonstrating substantial equivalence to a predicate device (Dulbecco's Modified Eagle Medium - DMEM) based on shared intended use, principles of operation, and technological characteristics.

However, I can extract the relevant information from the provided text regarding acceptance criteria and the justification for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of product (tissue culture media), the "acceptance criteria" are not measured in terms of diagnostic performance metrics like sensitivity or specificity. Instead, acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device by showing comparable:

• Intended Use
• Principles of Operation
• Technological Characteristics
• Efficacy (generic cellular growth and maintenance)
• Safety (consistency in chemical content and formulation, biocompatibility with cells, and purity)

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. This is a 510(k) submission for tissue culture media, not a diagnostic device with performance testing against a specific test set of data. The "study" for substantial equivalence is a comparison of product characteristics and established scientific literature.

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. Ground truth, in the context of expert consensus, is not relevant for demonstrating substantial equivalence of tissue culture media. Efficacy is supported by "scientific publications."

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

• Not Applicable. No adjudication method is described or relevant for this type of submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This is not an AI/ML-based device.

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

• Not Applicable. This is not an AI/ML-based device.

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

• For "efficacy" (supporting cell growth and maintenance), the ground truth is established through scientific literature and established biological principles of cell culture, rather than a specific "ground truth" derived from expert consensus, pathology, or outcomes data in the context of a diagnostic AI product. The submission states efficacy is "well established in scientific publications included in this submission."

8. The sample size for the training set

• Not Applicable. This is not an AI/ML-based device.

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

• Not Applicable. This is not an AI/ML-based device.

Summary of the Study Proving Acceptance Criteria:

The "study" described in the 510(k) summary is a comparison of characteristics and scientific justification for substantial equivalence to a predicate device (Dulbecco's Modified Eagle Medium - DMEM), rather than a traditional clinical trial or performance study against a ground truth dataset commonly associated with AI/diagnostic devices.

The justification is based on:

• Direct comparison of Intended Use: Both AIM-V® and DMEM are for human ex vivo tissue and cell culture processing.
• Comparison of Principles of Operation and Technological Characteristics: Both provide essential nutrients for cell growth and maintenance. AIM-V®'s specific components (HEPES buffer, HSA, transferrin, cholesterol) are detailed, highlighting its formulation derived from DMEM.
• Reliance on Established Scientific Literature: The efficacy of AIM-V® in supporting cell survival, growth, and maintenance is declared "well established in scientific publications included in this submission." This suggests that previous research and published studies using AIM-V® serve as the evidence base for its performance.
• Compliance with Quality System Regulations (QSR): Both devices are manufactured under QSR and aseptically processed, ensuring safety and consistency.

In essence, the "study" is a regulatory assessment demonstrating that the new device (AIM-V®) is sufficiently similar to a previously approved device (DMEM) in its purpose, composition, and expected biological performance, supported by existing scientific knowledge.

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