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Ask a specific question about this device

Ask a specific question about this device

FG Bone Graft B is recommended 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).

FG Bone Graft B is a sterile, synthetic, multi-porous biocompatible ceramic matrix in granular form for filling bone defects. The material with microporous structure supports rapid ossification with local bone. With its phase purity of >= 99%, the ceramic material complies with US standard specification ASTM F 1088-04. The validated manufacturing process guarantees batch conformity and reproducibility.

The FDA 510(k) clearance letter for FG Bone Graft B indicates that the device is substantially equivalent to a predicate device (CERASORB M DENTAL). The clearance letter references non-clinical tests performed to demonstrate this equivalence, focusing on chemical composition, physical properties, and performance in vivo.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, 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

• Sample size for the test set: The document states that the in vivo study used a "Beagle dog" model, and the animals were "divided into groups: test group (FG Bone Graft B), positive control group (Cerasorb, a commercial β-TCP), and a negative control (empty defect)." However, the exact number of animals in each group or total animal count is not specified in the provided text.
• Data provenance: The study was a prospective in vivo animal study performed on Beagle dogs. The location/country of origin of the study is not explicitly stated in the provided text, but the submitter "Full Golden Biotech Co., Ltd." is located in Taiwan.

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

• Number of experts: Not explicitly stated. The histological and radiographic analyses were likely performed by trained professionals (e.g., veterinary pathologists, radiologists), but the number of reviewers or their specific qualifications are not detailed in the provided text.
• Qualifications of experts: Not specified beyond the implied expertise in conducting and analyzing in vivo studies (e.g., histology, micro-CT).

4. Adjudication Method for the Test Set

• Adjudication method: Not explicitly stated. For animal studies, consistency and blinding are typically employed, but a formal "adjudication method" in the sense of multiple human readers for consensus is not described for this non-AI bone graft device. The results are presented as quantitative measurements and observations (e.g., "new bone formation increased," "minimal to mild inflammatory response").

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• MRMC study: No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI/image analysis devices where the AI's impact on human reader performance is being assessed. This document describes a traditional preclinical performance study for a bone graft material.

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

• Standalone performance: N/A. This is a bone graft material, not an algorithm or AI device. The "performance" refers to the biological and physical properties of the material itself, not the output of a software algorithm.

7. The Type of Ground Truth Used

• Type of ground truth: The ground truth for the in vivo study (which is the primary performance study) was established through direct anatomical, histological, and radiographic assessments of the bone defects in the animal model.
  • Histological analysis: Quantified new bone formation, material degradation, and inflammatory response. This involves microscopic examination of stained tissue sections, which is considered a gold standard for assessing tissue regeneration and integration.
  • Radiographic analysis: Used micro-CT to assess bone density and bone volume, providing quantitative structural data.
  • Comparison to predicate: The "ground truth" for showing substantial equivalence was the performance of the established predicate device (Cerasorb) under the same study conditions.

8. The Sample Size for the Training Set

• Sample size for training set: N/A. This device is a bone graft material, not an AI or machine learning algorithm. Therefore, there is no "training set."

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

• Ground truth for training set: N/A. As there is no AI component, there is no training set and no ground truth establishment for such a set.

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The CareSuperb™ COVID-19/Flu A&B Antigen Combo Home Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigens directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to SARS-CoV-2 and influenza can be similar. This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older.

All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza, SARS-CoV-2, or other pathogens.

Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough, and/or shortness of breath, should seek follow up care from their healthcare provider.

Positive results do not rule out co-infection with other respiratory pathogens and therefore do not substitute for a visit to a healthcare provider for appropriate follow-up.

The CareSuperb™ COVID-19/Flu A&B Antigen Combo Home Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of SARS-CoV-2 nucleocapsid antigen, Influenza A nucleoprotein antigen, and Influenza B nucleoprotein antigen from anterior nasal swab specimens.

The CareSuperb™ COVID-19/Flu A&B Antigen Combo Home Test utilizes an adaptor-based lateral flow assay platform integrating a conjugate wick filter to facilitate sample processing. Each test cassette contains a nitrocellulose membrane with immobilized capture antibodies for SARS-CoV-2, Influenza A, Influenza B, and internal control. Following specimen application to the sample port, viral antigens, if present, bind to labeled detection antibodies embedded in the conjugate wick filter. The resulting immune complexes migrate along the test strip and are captured at the respective test lines (C19 for SARS-CoV-2, A for Influenza A, and B for Influenza B), forming visible colored lines. A visible control line (Cont) confirms proper sample migration and test validity. The absence of a control line invalidates the test result.

Each kit includes a single-use test cassette, assay buffer dropper vial, nasal swab, and Quick Reference Instructions (QRI). Test results are visually interpreted 10 minutes after swab removal.

The provided document describes the CareSuperb™ COVID-19/Flu A&B Antigen Combo Home Test, an over-the-counter lateral flow immunoassay for lay users. The study aimed to demonstrate its substantial equivalence to a predicate device and its performance characteristics for qualitative detection and differentiation of SARS-CoV-2, Influenza A, and Influenza B antigens in anterior nasal swab samples.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

While specific acceptance criteria (i.e., pre-defined thresholds the device must meet for clearance) are not explicitly stated as numbered points in this 510(k) summary, they can be inferred from the reported performance data and common FDA expectations for such devices. The performance data presented serves as the evidence that the device met these implied criteria.

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

• Clinical Performance Test Set (Human Samples): N=1644 total participants.
  • Self-collecting: N=1447 (individuals aged 14 or older testing themselves)
  • Lay-user/Tester Collection: N=197 (adults testing individuals aged 2-17 years)
• Data Provenance:
  • Country of Origin: United States ("13 clinical sites across the U.S.").
  • Retrospective/Prospective: The clinical study was prospective, as samples were collected "between November of 2023 and March of 2025" from "symptomatic subjects, suspected of respiratory infection."
• Analytical Performance Test Sets (Contrived/Spiked Samples): Sample sizes vary per study:
  • Precision Study 1: 360 results per panel member (negative, 1x LoD positive, 3x LoD positive).
  • Precision Study 2: 36 sample replicates/lot (for negative and 0.75x LoD positive samples).
  • LoD Confirmation: 20 replicates per LoD concentration.
  • Co-spike LoD: 20 replicates per panel (multiple panels tested).
  • Inclusivity: 5 replicates per strain (for identifying lowest reactive concentration).
  • Competitive Interference: 3 replicates per of 19 sample configurations.
  • Hook Effect: 5 replicates per concentration.
  • WHO Standard LoD: 20 replicates for confirmation.
  • Cross-Reactivity/Microbial Interference: 3 replicates per microorganism (in absence and presence of analytes).
  • Endogenous/Exogenous Substances Interference: 3 replicates per substance (in absence and presence of analytes).
  • Biotin Interference: 3 replicates per biotin concentration.
  • Real-time Stability: 5 replicates per lot at each time point.
  • Transportation Stability: 5 replicates per sample type per lot for each condition.
• Usability Study: 1,795 participants.
• Readability Study: 50 participants.

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

• Clinical Performance (Reference Method - Test Set Ground Truth): The ground truth for the clinical test set was established using FDA-cleared molecular RT-PCR comparator assays for SARS-CoV-2, Influenza A, and Influenza B.

  • This implies that the "experts" were the established and validated molecular diagnostic platforms, rather than human expert readers/adjudicators for visual interpretation.

• Usability/Readability Studies:

  • Usability Study: "Observer agreement with user-interpreted results was 98.7%." This suggests trained observers (likely not "experts" in the sense of clinical specialists, but rather study personnel trained in test interpretation as per IFU) established agreement with user results.
  • Readability Study: The study focused on whether lay users themselves could interpret results after reading the QRI. Ground truth for the mock devices would be pre-determined by the device manufacturer based on their design.

4. Adjudication Method for the Test Set

• Clinical Performance: No human adjudication method (e.g., 2+1, 3+1) is mentioned for the clinical test set. The direct comparison was made against molecular RT-PCR as the gold standard, which serves as the definitive ground truth for the presence or absence of the viruses. This type of diagnostic test typically relies on a definitive laboratory method for ground truth, not human interpretation consensus.
• Usability/Readability Studies: The usability study mentioned "Observer agreement with user-interpreted results," implying direct comparison between user interpretation and a pre-defined correct interpretation or an observer's interpretation. The readability study involved participants interpreting mock devices based on the QRI, with performance measured against the pre-determined correct interpretation of those mock devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No AI Component: This device (CareSuperb™ COVID-19/Flu A&B Antigen Combo Home Test) is a lateral flow immunoassay for visual interpretation. It is not an AI-powered diagnostic device, nor does it have a human-in-the-loop AI assistance component. Therefore, an MRMC study related to AI assistance was not applicable and not performed.

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

• Not Applicable: As this is a visually interpreted antigen test, there is no "algorithm only" or standalone algorithm performance to evaluate. The device's performance is intrinsically linked to its chemical reactions and subsequent visual interpretation by the user (or observer in studies).

7. The Type of Ground Truth Used

• Clinical Performance Test Set: FDA-cleared molecular RT-PCR comparator assays (molecular ground truth). This is generally considered a highly reliable and objective ground truth for viral detection.
• Analytical Performance Test Sets: Generally contrived samples with known concentrations of viral analytes or microorganisms against negative pooled swab matrix. This allows for precise control of the 'ground truth' concentration and presence/absence.
• Usability/Readability Studies: For readability, it was pre-defined correct interpretations of "mock test devices." For usability, it was observation of correct procedural steps and comparison of user interpretation to trained observer interpretation.

8. The Sample Size for the Training Set

• Not explicitly stated in terms of a "training set" for the device itself. As a lateral flow immunoassay, this device is developed through biochemical design, antigen-antibody interactions, and manufacturing processes, rather than through machine learning models that require distinct training datasets.
• The document describes the analytical studies (LoD, inclusivity, interference, etc.) which inform the device's technical specifications and ensure it's robust. The clinical study and usability/readability studies are typically considered validation/test sets for the final manufactured device.
• If this were an AI/ML device, a specific training set size would be crucial. For this type of IVD, the "training" analogous to an AI model would be the research, development, and optimization of the assay components (antibodies, membrane, buffer, etc.) using various known positive and negative samples in the lab.

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

• Not applicable in the context of a machine learning training set.
• For the development and optimization of the assay (analogous to training), ground truth would have been established through:
  • Using quantified viral stocks (e.g., TCID₅₀/mL, CEID₅₀/mL, FFU/mL, IU/mL) to precisely spike into negative matrix (PNSM) to create known positive and negative samples at various concentrations.
  • Employing established laboratory reference methods (e.g., molecular assays) to confirm the presence/absence and concentration of analytes in developmental samples.
  • Utilizing characterized clinical samples (if available) with confirmed statuses from gold-standard methods early in development.

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WELLlife Flu A&B Home Test:
The WELLlife Flu A&B Home Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A and influenza B nucleoprotein antigens directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing other individuals aged 2 years or older.

All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza or other pathogens. Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath, should seek follow-up care from their healthcare provider.

Positive results do not rule out co-infection with other respiratory pathogens, and therefore do not substitute for a visit to a healthcare provider or appropriate follow-up.

WELLlife Influenza A&B Test:
The WELLlife Influenza A&B Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A and influenza B nucleoprotein antigens directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. This test is for use by individuals aged 14 years or older testing themselves, or adults testing other individuals aged 2 years or older.

All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza or other pathogens. Individuals who test negative and experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath, should seek follow-up care from their healthcare providers.

Positive results do not rule out co-infection with other respiratory pathogens.

Test results should not be used as the sole basis for treatment or other patient management decisions.

The WELLlife Flu A&B Home Test and WELLlife Influenza A&B Test is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A and influenza B protein antigens. The test has two versions, one for over the counter (OTC) use (WELLlife Flu A&B Home Test) and one for professional use (WELLlife Influenza A&B Test). Both versions of the WELLlife Influenza A&B Test that have an identical general design and are intended for the qualitative detection of protein antigens directly in anterior nasal swab specimens from individuals with respiratory signs and symptoms. Results are for the identification and differentiation of nucleoprotein antigen from influenza A virus, and nucleoprotein antigen from influenza B virus. The test cassette in the test kit is assembled with a test strip in a plastic housing that contains a nitrocellulose membrane with three lines: two test lines (Flu A line, Flu B line) and a control line (C line). The device is for in vitro diagnostic use only.

The provided FDA Clearance Letter for the WELLlife Flu A&B Home Test includes details on the device's performance based on non-clinical and clinical studies. Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for performance are generally implicit in these types of submissions, aiming for high agreement with a comparative method. The reported performance is presented through Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA).

Table 1: Acceptance Criteria and Reported Device Performance (Implicit Criteria)

Study Details

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

• See Table 1 above. The acceptance criteria are inferred from what is typically expected for a diagnostic device of this type seeking FDA clearance (e.g., high sensitivity and specificity, consistent performance).

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

• Test Set Sample Size:
  • Clinical Study: 680 evaluable subjects (from 766 enrolled) were used for clinical performance evaluation.
  • Non-clinical Studies: Sample sizes vary by study:
    • Lot-to-Lot Precision: 180 results per sample type (3 lots x 3 operators x 2 replicates x 2 runs per day x 5 days).
    • Site-to-Site Reproducibility: 135 replicates per sample type (3 sites x 3 operators x 5 days).
    • LoD: 20 replicates for confirmatory testing.
    • Analytical Reactivity: Triplicates for initial range finding, then triplicates for two-fold dilutions.
    • Cross-Reactivity/Microbial Interference: 3 replicates per organism/virus.
    • Endogenous Interfering Substances: 3 replicates per substance.
    • High Dose Hook Effect: 9 replicates (across 3 lots).
    • Competitive Interference: 9 replicates for each combination.
• Data Provenance:
  • Clinical Study: "A prospective study was performed... between January 2025 and March 2025... at six (6) clinical sites." The country of origin is not explicitly stated, but the FDA clearance implies US-based or FDA-accepted international clinical trials. It's a prospective study.
  • Non-clinical Studies: Performed internally at one site (Lot-to-Lot Precision) or at three external sites (Site-to-Site Reproducibility). These are also prospective experimental studies.

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)

• The ground truth for the clinical test set was established using an "FDA-cleared molecular comparator method." This is a laboratory-based, highly sensitive, and specific molecular test, which serves as the gold standard for detecting influenza RNA/DNA.
• There is no mention of human experts (e.g., radiologists, pathologists) being used to establish the ground truth for this in vitro diagnostic device. The comparator method itself is the "expert" ground truth.

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

• The document does not describe an adjudication method for conflicting results between the investigational device and the comparator method. Results from the WELLlife Flu A&B Home Test were compared directly to the FDA-cleared molecular comparator method. For an in-vitro diagnostic, typically the molecular comparator is considered the definitive truth.

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 study was performed. This device is a lateral flow immunochromatographic assay, a rapid antigen test that produces visible lines interpreted directly by the user (either a lay user at home or a professional user). It does not involve "human readers" interpreting complex images or AI assistance in the interpretation of results in the way an imaging AI device would. Therefore, this question is not applicable to the WELLlife Flu A&B Home Test.

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

• This question is primarily relevant for AI/ML-driven software as a medical device (SaMD) where an algorithm provides an output. The WELLlife Flu A&B Home Test is a rapid diagnostic test interpreted visually. Its performance is inherent to the chemical reactions on the test strip, and it's designed for human interpretation (either self-testing or professional use). Therefore, a "standalone algorithm-only" performance study is not applicable in the context of this device's technology. The "device performance" metrics (PPA, NPA) are effectively its standalone performance as interpreted by a human user following instructions.

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

• The ground truth for the clinical study was an FDA-cleared molecular comparator method (e.g., PCR or equivalent), considered the gold standard for influenza detection.

8. The sample size for the training set

• The provided document describes clinical and non-clinical performance evaluation studies. For IVD devices like this one, it's common that the "training set" is not a distinct, formally defined dataset as it would be for a machine learning model. Instead, the device's design, reagent formulation, and manufacturing processes are optimized and validated through iterative development and verification testing (analogue to "training" and "internal validation"). The studies described in this summary are primarily validation studies demonstrating the final product's performance. Therefore, a specific "training set sample size" as one might see for an AI model is not applicable/not explicitly defined in this context.

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

• As mentioned above, for a rapid diagnostic test, there isn't a "training set" in the sense of a machine learning model. Instead, the development process involves:
  • Analytical Validation: Establishing LoD, reactivity, specificity (cross-reactivity, interference) using reference strains, cultured microorganisms, and purified substances with known concentrations and characteristics. This essentially acts as the "ground truth" during the development phase.
  • Design Iteration: The test components (antibodies, membrane, buffer) are optimized to achieve desired sensitivity and specificity against known influenza strains and potential interferents. This iterative process, using well-characterized samples, ensures the device learns (is developed) to correctly identify targets.
  • The FDA-cleared molecular comparator assays serve as the ultimate "ground truth" against which the device's overall clinical performance is measured.

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RO handpiece, AGNES (F) RF handpiece and AGNES (B) RF handpiece of RFMagik are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

RFMagik is a medical device combined with RF current, to function as an electrosurgical device for use in dermatology and general surgical procedures. It is possible to select and change modes, parameters, outputs, etc. using the panel on the main body. It consists of the main device, LCD screen, two handpieces, single use electrodes, electrode pad, NE pad cable, food switch.

There are three handpieces. RO handpiece, AGNES (F) RF handpiece and AGNES (B) RF handpiece that delivers RF energy through the disposable electrode in the handpiece.

This document is an FDA 510(k) clearance letter for an RF Electrosurgical Device (RFMagik). It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided document does NOT contain information about acceptance criteria, device performance results, sample sizes, expert ground truth establishment, or clinical study details. The section on "Clinical Testing" explicitly states: "Clinical testing is not a requirement and has not been performed."

The document focuses on:

• Regulatory details: Device classification, product codes, indications for use.
• Technological comparison: Detailed comparison of the subject device (RFMagik) with a primary predicate device (RFMagik Lite) and a reference device (AGNES). This comparison highlights similarities and differences in handpieces, electrodes, output power, etc., and explains why these differences do not affect substantial equivalence.
• Non-clinical testing: Biocompatibility, sterility, shelf-life, and performance bench testing. An "Ex Vivo Study" was conducted on tissue types (liver, skin, muscle) for thermal testing.

Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, sample sizes for the test set, data provenance, number/qualifications of experts, adjudication methods, MRMC study details, standalone performance, type of ground truth, training set sample size, or how training ground truth was established. This information is typically found in specific study reports or sections of a 510(k) submission that go beyond what is published in the clearance letter itself.

The document indicates that the substantial equivalence was primarily demonstrated through bench testing and comparison to predicate devices, rather than clinical trials or extensive human-in-the-loop performance studies.

Summary of what CANNOT be provided from the given document:

1. Table of acceptance criteria and reported device performance: Not present.
2. Sample size for the test set and data provenance: No clinical test set. Ex vivo study mentioned, but specific sample sizes are not detailed.
3. Number of experts and qualifications for ground truth: Not applicable as no clinical study with expert ground truth review was performed.
4. Adjudication method for the test set: Not applicable.
5. MRMC comparative effectiveness study: Not conducted.
6. Standalone (algorithm only) performance: Not applicable as this is a physical electrosurgical device, not an AI algorithm.
7. Type of ground truth used: Not applicable for a clinical study. Ex vivo study used physical tissue, but no "ground truth" akin to medical image labeling.
8. Sample size for the training set: Not applicable as there is no mention of an AI/ML algorithm requiring a training set.
9. How ground truth for the training set was established: Not applicable.

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For use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting of cerebrospinal fluid (CSF) is indicated.

The Libertís™ Shunt Catheter includes a ventricular and distal (peritoneal) drainage catheter that are used as part of a cerebrospinal fluid (CSF) shunting system to treat hydrocephalus. Both catheters are attached to the valve portion of a shunting system. The ventricular catheter diverts excess CSF from the ventricles of the brain through the valve. After passing through the valve, the excess CSF is drained through the distal catheter into another part of the body, such as the peritoneal cavity, where it is reabsorbed into the bloodstream. The catheters have Endexo® polymer, a surface modifying macromolecule, blended into their base silicone. The catheters are subjected to a treatment process by which the silicone is impregnated with two antimicrobials, rifampicin and clindamycin hydrochloride. The Libertís™ Shunt Catheter has been shown in laboratory studies to reduce the colonization of gram-positive bacteria on the tubing surface. The catheters contain barium sulfate for radiopacity and have ink markings on the silicone tubing to aid in positioning of the catheter.

The catheters are packaged with two accessories, a stylet and a right-angle adapter. The stylet is used to help introduce the ventricular catheter into the brain's ventricles. The right-angle adapter is used to fixate the ventricular catheter to the cranium.

This document is a 510(k) clearance letter for a medical device, specifically a shunt catheter. It does not describe an AI medical device or software. Therefore, most of the requested information regarding AI acceptance criteria, training/test sets, expert adjudication, MRMC studies, or standalone algorithm performance cannot be extracted from the provided text.

The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing and biocompatibility testing, rather than performance studies of an AI algorithm.

However, I can provide the acceptance criteria and performance information that is present in the document, which pertains to the physical and biological characteristics of the shunt catheter.

Acceptance Criteria and Device Performance (for the physical device, not an AI algorithm):

Since the provided document is for a medical device (shunt catheter) and not an AI/software device, the questions related to AI-specific criteria (e.g., sample size for test/training sets of AI, expert adjudication, MRMC studies, standalone algorithm performance, type of ground truth for AI) are not applicable.

The acceptance criteria here refer to the performance of the physical device as demonstrated through various bench and biocompatibility tests. The document states that all tests were "Pass," implying that the device met the pre-defined acceptance criteria for each test.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify general "sample sizes" in terms of patient data or typical "test sets" as one would for an AI model. Instead, it refers to "production equivalent devices" used for the various bench and biocompatibility tests. The specific number of devices or replicates for each test is not detailed.
• Data Provenance: The data is generated from laboratory studies and bench testing performed on the physical device. This is not clinical patient data. The provenance for this type of testing is typically the manufacturer's internal testing facilities or contract labs. No country of origin for data or retrospective/prospective nature is applicable as this is not patient data.

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

• Not applicable. This pertains to an AI/software device. The "ground truth" for a physical device is established by objective measurements and standardized test methods, not expert consensus on data interpretation.

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

• Not applicable. This pertains to an AI/software device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, not applicable. This pertains to an AI/software device evaluating human reader performance.

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

• No, not applicable. This pertains to an AI algorithm; the device is a physical shunt catheter.

7. The Type of Ground Truth Used

• For the performance bench tests and biocompatibility tests, the "ground truth" is defined by established international (ISO, ASTM) and FDA-recognized consensus standards, as well as pre-defined internal test methods and specifications. For instance, a "Pass" for biocompatibility means the device met the criteria specified in the relevant ISO 10993 standards. For thrombogenicity, the ground truth was a statistically significant reduction in thrombus deposition compared to the predicate device.

8. The Sample Size for the Training Set

• Not applicable. This pertains to an AI/software device. No training set is involved for validating a physical medical device.

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

• Not applicable. This pertains to an AI/software device.

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The Codman Libertís™ EVD Catheter with Bactiseal® and Endexo® Technology is indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume.

The Codman LibertísTM EVD Catheter with Bactiseal® and Endexo® Technology (LibertísTM EVD Catheters) include a ventricular catheter that is supplied with component accessories that facilitate placement and use of the catheter for reducing and controlling intracranial pressure due to excess cerebrospinal fluid (CSF). The ventricular catheter is subjected to a treatment process by which the silicone is impregnated with two antimicrobials, rifampicin and clindamycin hydrochloride. Laboratory studies show Bactiseal treated catheters reduce the colonization of gram-positive bacteria on the tubing surface. Additionally, LibertísTM EVD Catheters contain an Endexo® polymer additive; a surface modifying macromolecule (SMM) polymer blended into the catheter's base silicone. The ventricular catheter is placed in the ventricles of the brain and CSF enters the fluid conduit through the inlet holes near the tip of the catheter and drains into the external drainage system connected to the catheter. The catheter contains a barium sulfate stripe for radiopacity and includes numerical depth markings and circumferential bands, made of ink, from the proximal tip.

The provided document is a 510(k) clearance letter from the FDA for a medical device (Codman Libertís™ EVD Catheter). It describes the device, its intended use, a comparison to a predicate device, and summaries of nonclinical testing.

However, the question asks for details related to acceptance criteria and studies that prove a device meets acceptance criteria, specifically those typically associated with AI/software medical devices. This document does not describe an AI/software medical device; it describes a physical medical device (a catheter for draining CSF). Therefore, much of the information requested in the prompt, such as "number of experts used to establish ground truth," "adjudication method," "multi-reader multi-case (MRMC) study," "standalone performance," "training set size," and "how ground truth for training set was established," are not applicable to this type of device and are not present in the provided text.

The document focuses on demonstrating substantial equivalence to a predicate device through bench testing, biocompatibility, and sterilization validation, which are standard for physical medical devices.

Here's an attempt to answer the applicable parts of your request based on the provided text, and explicitly state where information is not available or not applicable.

Description of Acceptance Criteria and Proving Device Meets Criteria

The Codman Libertís™ EVD Catheter is a physical medical device. Its acceptance criteria are primarily demonstrated through a battery of nonclinical performance bench tests, biocompatibility testing, and sterilization validation, to show that it is substantially equivalent to a legally marketed predicate device. The performance criteria are generally considered a "Pass" or "Fail" based on established standards and internal methods.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria values but rather states a "Pass" or "Fail" for each test. The acceptance criterion for each test is implicitly that the device performs as expected according to the specified standard or internal method.

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

The document states, "All testing was performed on production equivalent devices." However, it does not specify the sample size for any of the individual bench tests.

Data provenance (e.g., country of origin of the data, retrospective or prospective) is not applicable in the traditional sense for these bench tests, which are conducted in a laboratory setting to evaluate physical properties and performance characteristics.

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

This concept is not applicable to this type of medical device (physical catheter). "Ground truth" in this context would refer to established engineering standards, material specifications, and validated test methods, rather than expert interpretation of medical images or clinical outcomes.

4. Adjudication method for the test set

This concept is not applicable to this type of medical device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple readers (e.g., radiologists) to resolve disagreements in interpretation, which is not relevant for bench 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

No MRMC comparative effectiveness study was done, as this is a physical medical device (catheter), not an AI/software device. Therefore, this question is not applicable.

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

This concept is not applicable since the device is a physical catheter, not a software algorithm.

7. The type of ground truth used

The "ground truth" for the performance tests of this physical device consists of:

• Established industry standards (e.g., ASTM F647, ISO 7197, ASTM F2503, ISO 10993-1, ASTM F1980, ISO 11607-1).
• Internal predefined functional and mechanical specifications.
• Validated laboratory methods for chemical content, antimicrobial efficacy (Zone of Inhibition), and sterility assurance (SAL 10-6).
• Usability requirements for the Summative Usability Study.

8. The sample size for the training set

This concept is not applicable as this is a physical medical device, not an AI/software device that would involve a "training set."

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

This concept is not applicable for the same reason as above.

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The Baby Gorilla®/Gorilla® Bone Plates and Bone Screws of the Baby Gorilla®/Gorilla® Plating System are indicated for use in stabilization and fixation of fractures or osteotomies; intra and extra articular fractures, joint depression, and multi-fragmentary fractures; revision procedures, joint fusion and reconstruction of small bones of the toes, feet and ankles including the distal tibia, talus, and calcaneus, as well as the fingers, hands, and wrists. The system can be used in both adult and pediatric patients. Specific examples include:

Forefoot:

• Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion)
• Metatarsal or phalangeal fractures and osteotomies
• Lesser metatarsal shortening osteotomies (e.g. Weil)
• Fifth metatarsal fractures (e.g. Jones Fracture)

Mid/Hindfoot:

• LisFranc Arthrodesis and/or Stabilization
• 1st (Lapidus), 2nd, 3rd, 4th, and 5th Tarsometatarsal (TMT) Fusions
• Intercuneiform Fusions
• Navicular-Cuneiform (NC) Fusion
• Talo-Navicular (TN) Fusion
• Calcaneo-Cuboid (CC) Fusion
• Subtalar Fusion
• Medial Column Fusion
• Cuneiform Fracture
• Cuboid Fracture
• Navicular Fracture

Ankle:

• Lateral Malleolar Fractures
• Syndesmosis Injuries
• Medial Malleolar Fractures and Osteotomies
• Bi-Malleolar Fractures
• Tri-Malleolar Fractures
• Posterior Malleolar Fractures
• Distal Anterior Tibia Fractures
• Vertical Shear Fractures of the Medial Malleolus
• Pilon Fractures
• Distal Tibia Shaft Fractures
• Distal Fibula Shaft Fractures
• Distal Tibia Periarticular Fractures
• Medial Malleolar Avulsion Fractures
• Lateral Malleolar Avulsion Fractures
• Tibiotalocalcaneal Joint Arthrodesis
• Tibiotalar Joint Arthrodesis
• Tibiocalcaneal Arthrodesis
• Supramalleolar Osteotomy
• Fibular Osteotomy

First metatarsal osteotomies for hallux valgus correction including:

• Opening base wedge osteotomy
• Closing base wedge osteotomy
• Crescentic Osteotomy
• Proximal Osteotomy (Chevron and Rotational Oblique)
• Distal Osteotomy (Chevron/Austin)

Arthrodesis of the first metatarsophalangeal joint (MTP) including:

• Primary MTP Fusion due to hallux ridgidus and/or hallux valgus
• Revision MTP Fusion
• Revision of failed first MTP Arthroplasty implant

Flatfoot:

• Lateral Column Lengthening (Evans Osteotomy)
• Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)
• Calcaneal Slide Osteotomy

Charcot:

• Medial column fusion (talus, navicular, cuneiform, metatarsal) for neuropathic osteoarthropathy (Charcot)
• Lateral column fusion (calcaneus, cuboid, metatarsal) for neuropathic osteoarthropathy (Charcot)

In addition, the non-locking, titanium screws and washers are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair and fracture fixation, appropriate for the size of the device.

The Baby Gorilla/Gorilla Plating System is comprised of bone plates, threaded bone screws, and washers. Gorilla Plates are offered in "mini" and "standard" set sizes in a variety of shapes based upon the anatomical fixation required. Screws are also offered in "mini" and "standard" sets and, in addition, in locking and non-locking versions. Size-matched washers are available for use with the non-locking screws when the latter are used for fixation without the plates. Size-matched plate washers are also available for use with plate holes when there is no desire to use a screw. The Baby Gorilla/Gorilla Plating System implants are manufactured from medical grade titanium (per ASTM F67), stainless steel (per ASTM F138), and titanium alloy (per ASTM F136).

The provided text is an FDA 510(k) clearance letter for the Baby Gorilla®/Gorilla® Plating System. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in the context of an AI/ML-driven medical device.

Therefore, many of the requested items regarding acceptance criteria, study details, expert involvement, and ground truth are not applicable to this type of document and product (a metallic bone fixation system). This clearance is based on mechanical performance and material equivalence, not diagnostic accuracy or clinical outcomes as would be relevant for an AI/ML device.

Here's a breakdown of the relevant information from the provided document:

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

• Acceptance Criteria: The document implies that the acceptance criteria are met if the modified design does not adversely affect the original testing performance and is "substantially equivalent" to the predicate device. Specific quantitative acceptance criteria are not detailed in this clearance letter. Instead, the focus is on demonstrating that the revised device's characteristics are similar enough to an already approved device to not raise new safety or effectiveness concerns.
• Reported Device Performance:
  • Performance: Shown not to be adversely affected by modifications.
  • Basic Design: Similar to the predicate.
  • Material: Similar to the predicate (medical grade titanium per ASTM F67, stainless steel per ASTM F138, and titanium alloy per ASTM F136).
  • Manufacturing: Similar to the predicate.
  • Sizes (dimensions): Comparable to those offered by the predicate systems.

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

• This information is not provided in the document. The clearance is based on engineering analysis and comparison to a predicate device, not a clinical study with a patient test set in the traditional sense.

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)

• This information is not applicable and not provided. This is a hardware device (bone plating system), not an AI/ML diagnostic device requiring expert interpretation for ground truth.

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

• This information is not applicable and not provided.

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 and not provided. This device is a bone plating system, not an AI-assisted diagnostic tool.

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

• This information is not applicable and not provided. This is a hardware device.

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

• The "ground truth" for this device's substantial equivalence is its physical and mechanical properties and performance, as determined through engineering analysis and comparison to a legally marketed predicate device (K203511). It's not a clinical "ground truth" derived from patient data or expert consensus.

8. The sample size for the training set

• This information is not applicable and not provided. As a physical medical device, there is no "training set" in the context of an AI/ML algorithm.

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

• This information is not applicable and not provided.

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