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Phoenix Sinus Tarsi Stent is an implant stabilization device used in the treatment of talotarsal joint instability in adult and pediatric patients four years of age and older. The stent is designed to stabilize the talus to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion.

The Phoenix Sinus Tarsi Stent is a non-pyrogenic type IIB extra-osseous talotarsal stabilization (EOTTS) device used in the treatment of talotarsal joint instability per Graham Et al. EOTTS classification system. The stent system consists of an implant designed to be inserted into the sinus tarsi and has corresponding instrumentation to facilitate the insertion. All stents are manufactured from Ti6Al-4V ELI per ASTM F136 and have 5 sizes with varying diameter.

The Phoenix Sinus Tarsi Stent System is a medical device, and the provided FDA 510(k) clearance letter focuses on its substantial equivalence to predicate devices based on non-clinical performance testing. This type of submission does not typically involve the kind of AI/ML performance evaluation criteria and studies that would address human-in-the-loop performance, multi-reader multi-case studies, or detailed ground truth establishment as requested.

The provided document describes non-clinical performance testing to demonstrate the device's physical and biological properties. It does not involve AI or algorithms, nor does it refer to human interpretation of medical images or data. Therefore, many of the requested categories (such as human readers, AI assistance, ground truth for AI, etc.) are not applicable to this specific device and its regulatory submission.

However, I can extract the acceptance criteria and study information that is present in the document regarding the device's physical and material performance.

Acceptance Criteria and Study for the Phoenix Sinus Tarsi Stent System (Non-Clinical Performance)

The Phoenix Sinus Tarsi Stent System's acceptance criteria and performance are established through a series of non-clinical tests designed to demonstrate its safety and functionality as a physical implant. These tests do not involve AI/ML components or human interpretation studies.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states: "All testing showed the subject device performed as intended. All testing met applicable predetermined acceptance criteria."

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

• Sample Size: Not explicitly stated for each test (e.g., number of stents tested for pullout, bending, etc.). For physical and material tests, sample sizes are typically determined by relevant ISO/ASTM standards.
• Data Provenance: The tests are non-clinical, implying laboratory-based testing of the device itself (e.g., physical specimens of the stent and its materials), not patient data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" studies are not applicable in this context.

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

• Not Applicable. For non-clinical performance testing of a physical implant, "ground truth" is established by adherence to recognized international standards (e.g., ASTM, ISO, AAMI, USP) and predefined pass/fail criteria for material and mechanical properties. There are no human "experts" establishing ground truth in the sense of medical diagnosis or interpretation for this type of testing.

4. Adjudication Method for the Test Set:

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation of data where consensus on ground truth is required. For the non-clinical tests described, outcomes are typically objectively measured against predefined criteria specified in the test standards.

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

• No. An MRMC study is designed to evaluate the performance of diagnostic devices, especially those involving human interpretation (e.g., radiologists reading images), often with and without AI assistance. The Phoenix Sinus Tarsi Stent System is a physical implant, not a diagnostic device involving human interpretation; thus, MRMC studies are not applicable.

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

• No. This device does not incorporate any AI or algorithm component. Its performance is purely based on its physical and material properties.

7. The Type of Ground Truth Used:

• Scientific Standards and Predetermined Criteria: For mechanical tests (e.g., screw pullout, cantilever bending), ground truth is defined by the requirements and methodologies outlined in the applicable ASTM standards (e.g., ASTM F543, ASTM 2193), with specific performance thresholds (e.g., minimum pullout strength, maximum deflection).
• Biological/Material Standards: For biocompatibility (Endotoxin, Cytotoxicity) and sterilization, ground truth is based on meeting the specifications and acceptable limits defined by international standards (e.g., AAMI ST72, USP , ISO 10993-5, ISO 11137-1/2).
• Packaging Integrity: For shelf-life, ground truth is meeting parameters defined by ISO 11607-1 and relevant ASTM standards regarding package integrity.

8. The Sample Size for the Training Set:

• Not Applicable. This device does not use AI/ML, therefore, there is no "training set."

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

• Not Applicable. There is no training set for this device.

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The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most Gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture for Enterobacterales and Non-Enterobacterales and most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus, and Streptococcus.

This premarket notification is for the BD Phoenix Automated Microbiology System with Imipenem-relebactam at a concentration of 0.0625/4-16/4 µg/mL. Testing is indicated for Acinetobacter calcoaceticus-baumannii complex, Enterobacterales, and Pseudomonas aeruginosa, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC).

The BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) has demonstrated acceptable performance with the following organisms:

• Acinetobacter calcoaceticus-baumannii complex
• Enterobacterales (Citrobacter amalonaticus, Citrobacter braakii, Citrobacter farmeri, Citrobacter freundii, Citrobacter koseri, Citrobacter youngae, Enterobacter cloacae, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, and Serratia marcescens)
• Pseudomonas aeruginosa

The Phoenix AST method is a broth-based microdilution test. The Phoenix panel is a sealed and self-inoculating molded polystyrene tray with 136 micro-wells containing dried reagents. The ID/AST combination panel includes an ID side (51 wells) with dried substrates for bacterial identification and an AST side (85 wells). The AST panel contains a wide range of two-fold doubling dilution concentrations of antimicrobial agents and growth and fluorescent controls at appropriate well locations. The AST panel does not include wells for isolate identification.

The Phoenix System utilizes a redox indicator for the detection of organism growth in the presence of an antimicrobial agent. The organism to be tested must be a pure culture and be preliminarily identified as Gram-positive or Gram-negative. Colonies are then suspended in ID broth and equated to a 0.5 McFarland suspension using a nephelometer device. A further dilution is made into AST broth (a cation-adjusted formulation of Mueller-Hinton broth containing 0.010% Tween 80), to which the redox-buffered oxidation-reduction AST indicator solution is added producing a blue color in the wells. The concentration of organisms in the final AST broth suspension is approximately 5 X 10^5 CFU/mL.

The Phoenix AST Broth is poured into the inoculation port of the AST panel and the inoculum flows into the panel, filling panel wells. Polyethylene caps are applied to seal the inoculation ports. An air admittance port is located in the panel lid to ensure adequate oxygen tension in the panel for the duration of the test. Inoculated panels are barcode scanned and loaded into the BD Phoenix Automated Microbiology System instrument where panels are continuously incubated at 35 °C ± 1 °C.

Continuous measurements of changes to the indicator as well as bacterial turbidity are used in the determination of bacterial growth. The instrument takes readings every 20 minutes. Organisms growing in the presence of a given antimicrobial agent reduce the indicator (changing it to a pink color). This signals organism growth and resistance to that antimicrobial agent. Organisms killed or inhibited by the antimicrobial agent do not cause reduction of the indicator and therefore do not produce a color change. The Phoenix instrument reads and records the results of the antimicrobial tests contained in the panel and interprets the reactions (based on the organism identification) to give a minimal inhibitory concentration (MIC) value and category interpretations (susceptible, intermediate, resistant, or not susceptible). AST results are available within 16 hours. This is an auto read result; no manual readings are possible with this system.

Additional comments concerning specific organism/antimicrobial combinations are provided from the software-driven expert system (BDXpert), using rules derived from CLSI documentation and/or the FDA-approved drug labeling.

The provided FDA 510(k) clearance letter describes the acceptance criteria and the study that proves the BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) device meets those criteria for Antimicrobial Susceptibility Testing (AST).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criteria for AST devices are related to Essential Agreement (EA) and Category Agreement (CA) with a reference method. The study aims to demonstrate that the device's performance is substantially equivalent to the established reference method.

Note: The document mentions "The performance of the BD Phoenix Imipenem-relebactam met the combined acceptance criteria for all tested organisms, with overall EA and CA rates greater than 90%." This implicitly sets the 90% for EA and CA as the acceptance threshold.

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

• Clinical Isolates (Test Set):

  • Total: 1,111 isolates (862 fresh, 249 stock)
  • Organisms:
    • Acinetobacter baumannii/calcoaceticus complex (83 isolates)
    • Citrobacter freundii (21 isolates)
    • Citrobacter species (9 isolates)
    • Citrobacter koseri (26 isolates)
    • Enterobacter cloacae (60 isolates)
    • Escherichia coli (359 isolates)
    • Klebsiella aerogenes (58 isolates)
    • Klebsiella oxytoca (47 isolates)
    • Klebsiella pneumoniae (198 isolates)
    • Pseudomonas aeruginosa (176 isolates)
    • Serratia marcescens (74 isolates)
  • Provenance: Conducted at three U.S. clinical sites. Data consists of fresh and stock isolates, implying a mix of retrospective (stock) and prospective (fresh) collection.

• Challenge Isolates (Test Set):

  • Total: 85 isolates (these are specific strains with known resistance mechanisms)
  • Organisms:
    • Acinetobacter baumannii (7 isolates)
    • Citrobacter freundii (2 isolates)
    • Citrobacter koseri (2 isolates)
    • Enterobacter cloacae (12 isolates)
    • Escherichia coli (19 isolates)
    • Klebsiella aerogenes (4 isolates)
    • Klebsiella pneumoniae (24 isolates)
    • Pseudomonas aeruginosa (15 isolates)
  • Provenance: Tested at "each study site" (implying the same three U.S. clinical sites as for clinical isolates). These are typically retrospective isolates chosen to challenge the system.

• Reproducibility Isolates:

  • Total: 15 on-scale isolates (tested in triplicate over three days at three sites, for 405 data points).
  • Organisms: Enterobacter cloacae (2), Escherichia coli (5), Klebsiella aerogenes (1), Klebsiella pneumoniae (3) and Pseudomonas aeruginosa (4).
  • Provenance: Conducted at three clinical sites (for manual method) and three internal BD sites (for Phoenix AP instrument).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of medical device (automated microbiology system for AST) does not typically involve human experts to establish "ground truth" in the same way an imaging AI might.

• Ground Truth Establishment: The ground truth for antimicrobial susceptibility testing is established by a reference method, specifically the CLSI frozen broth microdilution reference panel, prepared according to CLSI M07 guidelines. This is a standardized, laboratory-based method, not dependent on expert visual interpretation.
• No "experts" in the human-reader sense are described as establishing ground truth for the test set. The expertise lies in adherence to CLSI standards and methodologies.

4. Adjudication Method for the Test Set

• No human adjudication method (e.g., 2+1, 3+1) is mentioned or applicable for this type of device.
• The comparison is directly between the result from the BD Phoenix system and the CLSI frozen broth microdilution reference panel. Discrepancies are categorized as minor, major, or very major based on established AST definitions (Essential Agreement and Category Agreement).

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

• No, an MRMC study was NOT done. This type of study is relevant for diagnostic imaging interpretation devices where human reader performance is a key metric. For an automated microbiology system, the comparison is to a "gold standard" laboratory method (CLSI microdilution), not to human interpretation or human improvement with AI assistance.

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

• Yes, this is essentially a standalone (algorithm only) performance study. The BD Phoenix system is an automated device that reads and interprets the results without human subjective input in the interpretative step. The "human-in-the-loop" aspects are limited to initial inoculum preparation (though automated options are also available and validated) and loading the panel, not interpreting the results. The comparison is the device's output (MIC and category) against the reference method.

7. The Type of Ground Truth Used

• The ground truth used is the CLSI frozen broth microdilution reference panel, which serves as the gold standard reference method for antimicrobial susceptibility testing.

8. The Sample Size for the Training Set

• The document does not explicitly state a separate "training set" sample size. For this type of automated system, which uses a growth-based detection principle rather than a machine learning model trained on large datasets of examples, the concept of a distinct "training set" in the modern AI sense is typically not applicable.
• The system's "training" or development would involve extensive internal R&D, algorithm refinement, and validation using proprietary data over time, which precedes a 510(k) submission. The data provided in the 510(k) is for the validation/test set to demonstrate performance.

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

• As a conventional, growth-based automated system rather than a machine learning device, there isn't a "training set" with ground truth established in the sense of human labeling or annotation.
• The system operates based on predefined biochemical reactions and growth kinetics, and its algorithms are built upon established microbiological principles and CLSI guidelines. Any internal development and testing would likewise use CLSI reference methods to establish expected outcomes for algorithm development and calibration.

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The BD Phoenix Automated Microbiology System is intended for the in vitro rapid identification (ID) and the quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most Gram-positive bacteria from pure culture belonging to the genera Staphylococcus, other gram positive cocci and gram positive bacilli and of most Gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture for Enterobacteriaceae and Non-Enterobacteriaceae.

BD Phoenix is an automated system for the rapid identification (ID) and antimicrobial susceptibility testing (AST) of clinically relevant bacterial isolates. The BD Phoenix System utilizes a redox indicator to detect organism growth in the presence of an antimicrobial agent. Measurements of changes to the indicator as well as bacterial turbidity are used in the determination of bacterial growth. Each AST panel configuration contains several antimicrobial agents with a wide range of two-fold doubling dilution concentrations. The Phoenix instrument reads and records of the antimicrobial tests contained in the panel and interprets the reactions (based on the organism identification) to give a minimal inhibitory concentration (MIC) value and category interpretations (susceptible, intermediate, resistant, or not susceptible).

The BDXpert™ System is a rule-based software tool that provides expert advice based on organism ID and AST results obtained by broth micro-dilution on the BD Phoenix Instruments. BDXpert rule development is based on published information available through standards organizations, current scientific literature, and FDA's STIC; custom rules may be user defined if desired. The BDXpert System rule logic is applied to the susceptible, intermediate, and resistant (SIR) result, which is based on the breakpoint table and interpretation rule set included either in the BDXpert System on the standalone Phoenix instruments or through the BDXpert System on the connected BD EpiCenter™ data management system (EpiCenter) or BD Synapsys™ Informatics Solution (Synapsys). The resulting instrument report contains information such as: MIC interpretation, BDXpert rules, special messaging, resistance markers, etc. The expert results can then be sent to the Laboratory Information System (LIS).

Synapsys is a browser-based software platform operating in the clinical lab setting, offering secure connectivity and data storage, integrated workflows, and analytics tools. Synapsys consists of software servers operating the application and database, securely networked through a facility IT infrastructure to diagnostic instrumentation, external healthcare IT systems such as the LIS, and browser-enabled client devices for operating the system. Synapsys connects BD lab automation and diagnostic instruments to a common database and provides a single user interface to integrate laboratory workflows. Synapsys provides bi-directional communication with BD Phoenix and is able to process ID and AST results received from a BD Phoenix instrument. The system will automatically associate a known organism ID result, regardless of source, to any ID/AST or AST only Phoenix panel(s) that have the same accession/isolate number and lack an organism ID.

While the provided text describes an FDA 510(k) premarket notification for the BD Phoenix™ Automated Microbiology System, it does not contain the detailed information necessary to answer your specific questions regarding acceptance criteria and the study that proves the device meets them.

The document primarily focuses on:

• Regulatory clearance: The FDA's determination of substantial equivalence to a predicate device.
• Device description: How the BD Phoenix system works for identification (ID) and antimicrobial susceptibility testing (AST).
• Comparison to predicate: Highlighting similarities and differences, particularly in data management connectivity (Synapsys vs. EpiCenter).
• General compliance: Mentioning adherence to standards like ISO 13485, IEC 62304, and ISO 14971, and FDA guidance on software functions.

Missing Information:

The document explicitly states under "V. Performance Characteristics (if/when applicable)": "Performance testing was conducted to verify compliance with specified design requirements... Software verification and validation activities demonstrate that BD Phoenix Instrument connected to Synapsys will perform as intended when used in accordance with device labeling." However, it does not provide the results of these performance tests, nor does it detail the specific acceptance criteria or the methodology of the study that generated those results.

Therefore, I cannot populate the table or answer the specific questions about the study design, sample sizes, ground truth establishment, or expert involvement based solely on the provided text. This type of detailed performance data is typically found in the full 510(k) submission, which is more extensive than this summary letter.

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The BD Phoenix™ Automated Microbiology System is intended for in vitro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration (MIC) of most Gram-negative and facultative anaerobic bacteria isolates from pure culture for Enterobacteriaceae and most Gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus, and Streptococcus, This premarket notification is for the BD Phoenix™ Automated Microbiology System with Ciprofloxacin at a concentration of 0.0156-4 ug/mL. Ciprofloxacin has been shown to be active in vitro against most strains of microorganisms listed below, as described in the FDA-approved package insert for this antimicrobial agent.

This submission is for a range extension of a single antimicrobial cleared for use on BD Phoenix ID/AST or AST only panels. The ID portion of the ID/AST combination panel was not subject to review in this submission.

The Phoenix AST method is a broth-based microdilution test. The Phoenix panel is a sealed and self-inoculating molded polystyrene tray with 136 micro-wells containing dried reagents. The ID/AST combination panel includes an ID side (51 wells) with dried substrates for bacterial identification and an AST side (85 wells). The AST panel contains a wide range of two-fold doubling dilution concentrations of antimicrobial agents and growth and fluorescent controls at appropriate well locations. The AST panel does not include wells for isolate identification.

The Phoenix System utilizes a redox indicator for the detection of organism growth in the presence of an antimicrobial agent. The organism to be tested must be a pure culture and be preliminarily identified as Gram-positive or Gram-negative. Colonies are then suspended in ID broth and equated to a 0.5 McFarland suspension using a nephelometer device. A further dilution is made into AST broth (a cation-adjusted formulation of Mueller-Hinton broth containing 0.010% Tween 80), to which the redox-buffered oxidation-reduction AST indicator solution is added producing a blue color in the wells. The concentration of organisms in the final AST broth suspension is approximately 5 X 105 CFU/mL.

The Phoenix AST Broth is poured into the inoculation port of the AST panel and the inoculum flows into the panel, filling panel wells. Polyethylene caps are applied to seal the inoculation ports. An air admittance port is located in the panel lid to ensure adequate oxygen tension in the panel for the duration of the test. Inoculated panels are barcode scanned and loaded into the BD Phoenix Automated Microbiology System instrument where panels are continuously incubated at 35 ℃ ± 1 ℃.

Continuous measurements of changes to the indicator as well as bacterial turbidity are used in the determination of bacterial growth. The instrument takes readings every 20 minutes. Organisms growing in the presence of a given antimicrobial agent reduce the indicator (changing it to a pink color). This signals organism growth and resistance to that antimicrobial agent. Organisms killed or inhibited by the antimicrobial agent do not cause reduction of the indicator and therefore do not produce a color change. The Phoenix instrument reads and records the results of the antimicrobial tests contained in the panel and interprets the reactions (based on the organism identification) to give a minimal inhibitory concentration (MIC) value and category interpretations (susceptible, intermediate, resistant, or not susceptible). AST results are available within 16 hours. This is an auto read result; no manual readings are possible with this system.

Additional comments concerning specific organism/antimicrobial combinations are provided from the software-driven expert system (BDXpert), using rules derived from CLSI documentation and/or the FDA-approved drug labeling.

The BD Phoenix Automated Microbiology System - GN Ciprofloxacin (0.0156-4 ug/mL) is an antimicrobial susceptibility testing system. The provided text describes the performance characteristics of this device, particularly for Salmonella species, and the study conducted to demonstrate its performance against acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

(Note: The document states "The BD Phoenix Ciprofloxacin performance met the acceptance criteria for Salmonella with overall EA and CA greater than 90%." The specific numerical acceptance criteria for Min, Maj, Vmj are usually found in the referenced guidance documents but are not explicitly detailed as numerical percentages in the provided text for the device itself, other than the observed performance.)

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

• Clinical Isolates: 47 (fresh: 7 (14.9%), stock: 40 (85.1%))
  • Organisms: Salmonella species (43 isolates), Salmonella enterica ssp. enterica serovar Typhi (4).
  • Provenance: "Clinical testing was conducted at three U.S. sites." (Suggests prospective and retrospective clinical data from U.S. sources).
• Challenge Isolates: 82 stock isolates
  • Organisms: Salmonella species (79), Salmonella enterica ssp. enterica serovar Typhi (3).
  • Provenance: "Additional stock challenge isolates were tested at each study site." (Implying laboratory-controlled challenge strains, likely geographically diverse or from culture collections, but no specific country of origin is mentioned beyond "U.S. sites" for the clinical part which also conducted challenge testing).
• Reproducibility Study Isolates: 14 isolates of non-fastidious Gram-negative organisms (including Pseudomonas aeruginosa (1), Salmonella enterica ssp. enterica serovar Paratyphi A (1), and Salmonella species (11)).

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

The ground truth was established using the CLSI frozen broth microdilution reference panel, prepared according to CLSI M07 guidelines. This is a standardized laboratory reference method, implicitly implying experts in microbiology and antimicrobial susceptibility testing were involved in its execution and interpretation, rather than individual "experts" reviewing each case for a ground truth panel. The document does not specify the number or qualifications of "experts" as individuals but relies on the standardized, recognized reference method.

4. Adjudication Method for the Test Set:

Not applicable in the typical sense of expert adjudication for diagnostic imaging or similar devices. The ground truth is determined by a universally accepted reference laboratory method (CLSI frozen broth microdilution). The comparison involves measuring agreement between the device and this reference method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The study focuses on the standalone performance of the automated system against a reference method, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance:

Yes, a standalone performance study was conducted. The "BD Phoenix Automated Microbiology System" is an automated device, and its performance was evaluated against a reference method (CLSI frozen broth microdilution) without human intervention in the MIC determination or category interpretation on the device side. The reported Essential Agreement (EA) and Category Agreement (CA) metrics represent this standalone algorithmic performance.

7. Type of Ground Truth Used:

The ground truth used was expert consensus methodology/reference standard, specifically the CLSI frozen broth microdilution reference panel prepared according to CLSI M07 guidelines. This is the gold standard for antimicrobial susceptibility testing.

8. Sample Size for the Training Set:

The document does not explicitly state the sample size for a training set. This type of device (AST system) is typically developed and validated against extensive datasets during its initial creation and subsequent range extensions. However, the provided text describes the validation/test set used for this specific premarket notification (47 clinical isolates and 82 challenge isolates for Salmonella). This suggests a re-evaluation of performance based on updated breakpoints rather than a new algorithm development requiring a separate training set description in this 510(k) summary.

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

As no explicit training set sample size is provided, the method for establishing its ground truth is also not detailed. However, if a training phase was involved in the initial development of the BD Phoenix system, it would have traditionally relied on similar reference methodologies like CLSI broth microdilution to establish accurate MIC values and corresponding susceptibility categories.

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General ophthalmic imaging including retinal, corneal, and external structures of the eye.

The Phoenix ICON system is an updated cart based retinal imaging system covering the design changes to date on the predicate device, Phoenix ICON. The Phoenix ICON GO retinal imaging system is a portable version of the predicate device, Phoenix ICON (K170527) including the design changes in the Phoenix ICON system.

Both the Phoenix ICON and Phoenix ICON GO are wide-field, handheld, high resolution, real-time retinal imaging devices. They are intended to be used for general ophthalmic imaging including retinal, corneal, and external structures of the eye. The intended users of the Phoenix ICON and Phoenix ICON GO are clinical imaging technicians, ophthalmic technicians, nurses, and physicians. The devices may be used in hospitals, medical clinics, and physician's offices.

The Phoenix ICON platform consists of either a cart based (Phoenix ICON) or portable (Phoenix ICON GO) control box used in conjunction with a hand-held camera (Handpiece) using interchangeable LED based light sources (White and Blue light). The Phoenix ICON cart contains an AC mains power attachment, a battery module, a keyboard interface, a monitor, and a computer with Phoenix ICON software. The Phoenix ICON GO contains a portable control box with battery function and has an interface for attachment to a specified laptop computer which runs the Phoenix ICON software. Both systems may be used with a Foot Pedal, White Light Module (standard), Blue Light Module (FA) and/or Diffuser accessory.

The Phoenix ICON Handpiece contains a wide-field, high resolution camera is used in three (3) modes, External Imaging (White Light), Retinal Imaging (White Light), and Fluorescein Angiography (Blue Light). For external imaging, the Diffuser accessory is placed over the lens tip to diffuse the light and provide for images of the outer surfaces of the eye. Both Retinal Imaging and Fluorescein Angiography are performed with the glass lens of the Handpiece coupled to the cornea via an imaging gel. In these imaging methods, LED light is emitted into the eye to illuminate the retina for image capture.

Both the Phoenix ICON and Phoenix ICON GO are software-controlled systems which can capture either video or still images and store them on the control box (Cart computer or GO laptop) for later review. The Phoenix ICON system may be connected to IT networks under IT supervision.

The provided document does not contain details about specific acceptance criteria for a device's performance in a clinical study or a study proving that the device meets those criteria. Instead, it is a 510(k) summary for the NeoLight Phoenix ICON and Phoenix ICON GO ophthalmic cameras, aimed at demonstrating substantial equivalence to a predicate device (K170527, Phoenix ICON by Phoenix Technology Group, LLC).

The document focuses on comparing technological characteristics and safety testing, not on clinical performance acceptance criteria or a study to demonstrate such.

However, based on the Performance Testing section (Table 5.3) related to Simulated Use, it states:
Characteristic: Image Clarity - Comparison between subject and predicate images to ensure equivalent visual quality of the captured images.
Results: Pass.

While this indicates some form of performance assessment related to image quality, it does not provide the specific acceptance criteria (e.g., quantitative metrics, thresholds) or the detailed methodology of the study. It also doesn't present the "reported device performance" in a manner typical for clinical trials (e.g., sensitivity, specificity, or reader agreement scores).

Therefore, a table of acceptance criteria and reported device performance, as well as several other requested details, cannot be fully extracted from the provided text.

Here's an attempt to answer the questions based only on the available information, noting where information is missing:

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

Note: The document only provides a high-level "Pass" result for "Image Clarity - Comparison between subject and predicate images to ensure equivalent visual quality of the captured images." It does not specify quantitative acceptance criteria or detailed performance metrics.

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

The document mentions "Simulated Use" testing for "Image Clarity - Comparison between subject and predicate images." However, it does not specify the sample size used for this comparison, nor does it provide any information on data provenance (e.g., country of origin, retrospective/prospective nature).

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 document does not provide any information about the number or qualifications of experts used for establishing ground truth or evaluating image clarity.

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

The document does not specify any adjudication method used for the image clarity comparison.

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

The document describes the device as an "Ophthalmic Camera" for "General ophthalmic imaging." It is a imaging acquisition device and does not include AI functionality. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not relevant to this submission, and no such study is mentioned.

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

This device is an ophthalmic camera. Its function is to capture images. It does not appear to incorporate an algorithm that independently processes or interprets images to provide a diagnosis or finding, nor does it claim AI capabilities. Therefore, a standalone algorithm performance study is not applicable and not mentioned. The "Simulated Use" test assesses the visual quality of the captured images, not the performance of an interpretive algorithm.

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

For the "Image Clarity" assessment, the implicit "ground truth" was a visual comparison to the predicate device's images to ensure equivalent visual quality. The document does not specify a separate, independent ground truth method like expert consensus on pathology, or outcomes data.

8. The sample size for the training set

The document concerns an ophthalmic camera, not an AI/ML algorithm requiring a training set. Therefore, this question is not applicable.

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

As the device is an ophthalmic camera and not an AI/ML algorithm, there is no training set and therefore no ground truth for a training set.

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Phoenix Contact Lens Case is indicated for storage of soft (hydrophilic), rigid gas permeable and hard contact lenses during chemical disinfection.

There are three models of the Phoenix Contact Lens Case:
CL-01 "Dome Top Flat Pack" - made with LDPE and has 1.5ml wells on each side
CL-02 "Classic Flat Pack" - made with LDPE and has 1.5 ml wells on each side
CL-03 "Sunglass Shape Flat Pack" made with Polypropylene and has 2.0 ml wells on each side
All three models have hinged self sealing caps and are available in white, black, blue, orange, green, and natural.
The Phoenix contact lens cases are intended for storage during chemical disinfection of soft, rigid gas permeable or hard contact lenses. It is not to be used with heat disinfection.

The provided document is a 510(k) premarket notification for Phoenix Contact Lens Cases (CL-01, CL-02, CL-03). It outlines the device's substantial equivalence to legally marketed predicate devices.

Based on the provided text, the device in question is a contact lens case, not an AI/ML medical device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, which are typical for studies proving the performance of AI/ML medical devices, is not applicable to this submission.

The document details non-clinical tests performed on the contact lens cases to demonstrate their substantial equivalence. These tests primarily focus on the biocompatibility and safety of the materials used in the contact lens cases, not on the performance of a diagnostic or therapeutic algorithm.

Here's a summary of the non-clinical tests and their conclusions, which serve as the "acceptance criteria" and "device performance" for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

The following numbered points are not applicable to this device, as it is a physical contact lens case and not an AI/ML software device.

2. Sample sizes used for the test set and the data provenance: Not applicable. The tests involved in vitro cell cultures and in vivo animal models, with sample sizes determined by the respective ISO standards and USP guidelines for biocompatibility testing (e.g., specific numbers of cells, guinea pigs, rabbits, or mice as per the standard). The provenance is "laboratory testing conditions" and "experimental conditions." These are typically prospective in nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these tests is based on objective biological responses measured in a laboratory setting per standardized protocols, not human expert consensus on images or clinical data.
4. Adjudication method for the test set: Not applicable. The tests evaluate direct biological and material responses, not subjective interpretations 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 study type is for AI/ML diagnostic performance, not for a physical medical device like a contact lens case.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This refers to AI/ML algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to an AI context. The "ground truth" for these biocompatibility tests is the presence or absence of a specific biological or toxicological reaction as defined by the international standards (e.g., cell viability, skin erythema/edema, systemic toxicity, fever induction, ocular irritation).
8. The sample size for the training set: Not applicable. This document describes pre-market testing for a physical device, not an AI/ML algorithm that requires training data.
9. How the ground truth for the training set was established: Not applicable.

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The I.T.S. Pelvic Reconstruction Systems (PRS RX & PRS Phoenix) are indicated to stabilize one or more pelvic bone fractures in the pelvis in an adult patient.

Indications for use of the I.T.S. Pelvic Reconstruction System (PRS RX) include:

• Fractures of the acetabulum
• Fractures of the pelvic ring
• Fractures of the quadrilateral surface
• Fractures of the symphysis
• Fractures of the ilium
• Fractures of the SIJ
• Ilio-iliac distance osteosynthesis
• Symphysis pubis disruptions, osteotomies, arthrodesis and sacroiliac joint dislocations
• Revision surgery of pseudoarthroses, non-unions and mal-unions
  The I.T.S. PRS RX System is not intended for spinal use.

Indications for use of the I.T.S. Pelvic Reconstruction System (PRS Phoenix) include:

• Fractures involving the Posterior Wall & Posterior Column
• Fractures involving the Anterior Column of the Acetabulum
• Fractures involving the Quadrilateral Surface
• Symphyseal Disruptions & Para-symphyseal Fractures
• Fractures of the ilium
• Fractures of the SIJ
• Dorsal neutralization plating for posterior pelvic ring fractures
• Osteotomies, arthrodesis and sacroiliac joint dislocations
• Revision surgery of pseudoarthroses, non-unions and mal-unions
  The I.T.S. PRS Phoenix System is not intended for spinal use.

Indications for use of the I.T.S. Infra-acetabular screw placement include:

• Fractures involving the anterior column, e.g. anterior column plus posterior hemitransverse (ACPH) and associated both column (ABC) fractures
  The I.T.S. Infra-acetabular screw is not intended for spinal use.

Indications for use of the I.T.S. 8.5mm Cannulated Screws & Washer include:

• Pelvic fractures
  The I.T.S. 8.5mm Cannulated Screws & Washer are not intended for spinal use.

The I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) encompasses a number of fracture fixation subsystems of multiple plate designs for fracture fixation and reconstruction of pelvic ring fractures in the pelvis. The I.T.S. Pelvic Reconstruction Plating System (PRS RX & PRS Phoenix) consists of the following plate types: 1) A Curved Plate at a 2.5mm thickness with 4 to 16 hole length sizes, 2) A Straight Plate at a 2.5mm thickness with 10 to 14 hole length sizes, 3) A SIJ Closed Plate at a 2.5mm thickness in a 4-hole size, 4) A SIJ L-Plate at a 2.5mm thickness in a 5-hole size, 5) A J-Plate at a 2.5mm thickness with 6 to 16 hole length sizes, 6) A Symphysis Plate at a 4.0mm thickness in a 4 & 6 hole size, 7) A Symphysis Plate Curved at a 4.0mm thickness in a 6 & 8 hole size, 8) A RIM Plate at a 2.5mm thickness in a 10 & 14 hole, Right & Left size. 9) A Posterior Wall Plate at a 2.5mm thickness in a 6 hole, Right & Left size. 10) A Posterior Wall Plate II at a 2.5mm thickness in a 7 & 8 hole, Right & Left size, 11) A Quadrilateral Column Plate at a 2.5mm thickness in a Small & Large, Right & Left size, 12) A Quadrilateral Supporting Plate at a 2.5mm thickness in a Right & Left size. 13) A Posterior Wall Plate Extended at a 2.5mm thickness in a Small & Large, Right & Left size, 14) A Posterior Column Plate at a 2.5mm thickness in a 8-hole, Right & Left size, All plate designs are low profile in thickness and made from Implant Grade 2 CP Titanium material (to ASTM F67). The PRS RX & PRS Phoenix Plating System encompasses a 3.5mm Cortical Locking and Standard Screw and a 4.2mm Cancellous Locking Screw in various lengths. All bone screws are pre-drilling and self-tapping in design and manufactured from Implant Grade 5 high strength 6-4 Alloyed Titanium (to ASTM F136). A threaded Spike allows inter-operative plate fixation to bone fragments. The Spike is also manufactured from Implant Grade 5 high strength 6-4 Alloyed Titanium material (to ASTM F136). All components (plates, screws, spike) have a anodize 'DOTIZE' Type II surface treatment preparation. Ancillary instrumentation (Drills, Drill Guides, Insertion Guides, Clamps, Bending Heaver, Measuring Gauges, and Screwdrivers) is made available for bone fragment reduction and plate/screw placement and insertion. All plates, screws, spike are provided Non-Sterile for single-use.

This document describes a medical device submission, K210935, for the I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix). This device is a metallic bone fixation appliance used to stabilize pelvic bone fractures.

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

The document does not explicitly state "acceptance criteria" in the traditional sense of performance metrics with thresholds. Instead, the substantial equivalence decision is based on comparisons to predicate devices through performance testing and engineering analysis. The "performance" described is the successful completion of these tests in accordance with recognized standards.

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

The document does not specify exact sample sizes for the performance tests (e.g., number of plates or screws tested). It states "Performance testing as a consensus standard was performed under ASTM F543 for all bone screws and under ASTM F382 for bone plates and in addition a FEA analysis simulation following ASTM F382."

The data provenance is from non-clinical testing (bench testing and simulations). No human clinical data was submitted.

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

This information is not applicable as there was no clinical study, and therefore no ground truth established by medical experts for a clinical test set. The evaluation relies on engineering and material science standards.

4. Adjudication method for the test set

This information is not applicable as there was no clinical study requiring adjudication of clinical outcomes or interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The submission explicitly states: "Clinical data was not submitted."

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

This is not applicable. The device is a physical implant (pelvic reconstruction system), not a software algorithm or AI component.

7. The type of ground truth used

This is not applicable in the context of clinical "ground truth." The "ground truth" for evaluating this device's performance is based on engineering standards and specifications (ASTM F543 for screws, ASTM F382 for plates) and the characteristics of legally marketed predicate devices.

8. The sample size for the training set

This is not applicable as the device is a physical medical implant and does not involve AI/machine learning, thus no "training set" is used.

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

This is not applicable for the same reasons as above.

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This is a digital mobile diagnostic x-ray system intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.

This is a modified version of our previous predicate mobile PHOENIX. The predicate PHOENIX mobile is interfaced with Konica – Minolta Digital X-ray panels and CS-7 or Ultra software image acquisition. PHOENIX mobile systems will be marketed in the USA by KONICA MINOLTA. Models with the CS-7 Software will be marketed as AeroDR TX m01. Models with the Ultra software will be marketed as mKDR Xpress. The modification adds two new models of compatible Konica-Minolta digital panels, the AeroDR P-65 and AeroDR P-75, cleared in K210619. These newly compatible models are capable of a mode called DDR, Dynamic Digital Radiography wherein a series of radiographic exposures can be rapidly acquired, up to 15 frames per seconds maximum (300 frames).

The provided text describes a 510(k) premarket notification for a mobile x-ray system. The document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study to prove the device meets specific performance-based acceptance criteria for an AI/algorithm.

Therefore, many of the requested details, such as specific acceptance criteria for algorithm performance, sample sizes for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable or not present in this type of submission.

The essence of this submission is that the entire mobile x-ray system, including its components (generator, panels, software), is deemed safe and effective because it is substantially equivalent to a previously cleared device, with only minor modifications (adding two new compatible digital panels and enabling a DDR function in the software, which is stated to be "unchanged firmware" and "moderate level of concern").

Here's an attempt to address your questions based on the provided text, while acknowledging that many of them pertain to AI/algorithm performance studies, which are not the focus of this 510(k):

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

The document does not specify performance-based acceptance criteria for an AI/algorithm. Instead, it demonstrates substantial equivalence to a predicate device by comparing technical specifications. The "acceptance criteria" in this context are implicitly met if the new device's specifications (kW rating, kV range, mA range, collimator, power source, panel interface, image area sizes, pixel sizes, resolutions, MTF, DQE) are equivalent to or improve upon the predicate, and it remains compliant with relevant international standards.

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

No specific test set or data provenance (country, retrospective/prospective) is mentioned for AI/algorithm performance. The "testing" involved "bench and non-clinical tests" to verify proper system operation and safety, and that the modified combination of components produced diagnostic quality images "as good as our predicate generator/panel combination." This implies physical testing of the device rather than a dataset for algorithm evaluation.

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

Not applicable. There was no specific test set requiring expert-established ground truth for an AI/algorithm evaluation. The determination of "diagnostic quality images" likely involved internal assessment by qualified personnel within the manufacturer's testing process.

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

Not applicable. No adjudication method is described as there was no formal expert-read test set for algorithm performance.

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. An MRMC study was not conducted as this submission is not about an AI-assisted diagnostic tool designed to improve human reader performance. It is for a mobile x-ray system.

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

No. This submission is for a medical device (mobile x-ray system), not a standalone AI algorithm. The software components (CS-7 and Ultra) are part of the image acquisition process, and the only software "modification" mentioned is enabling the DDR function, which is a feature of the new panels, not an AI for diagnosis.

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

Not applicable. The substantial equivalence argument relies on comparing technical specifications and demonstrating that the physical device produces images of "diagnostic quality" equivalent to the predicate, rather than an AI producing diagnostic outputs against a specific ground truth.

8. The sample size for the training set

Not applicable. This is not an AI/ML algorithm submission requiring a training set. The software components are for image acquisition and processing, not for AI model training.

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

Not applicable, as no training set for an AI/ML algorithm was used or mentioned.

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The Phoenix Digital Thermometer is intended to measure the human body temperature orally, rectally or under the arm. The Phoenix Digital Thermometer is reusable for clinical or home use on people of all ages.

Not Found

This document appears to be an FDA 510(k) clearance letter for a "Phoenix Digital Thermometer." As such, it grants market clearance based on substantial equivalence to a predicate device, but it does not contain the detailed acceptance criteria for device performance or the study details proving it meets those criteria, as typically found in a clinical study report or a more extensive submission summary.

The letter confirms the device is substantially equivalent to legally marketed predicate devices and is subject to general controls, but it does not describe a specific study proving the device meets particular acceptance criteria in the way you've outlined.

Therefore, I cannot provide the requested information in the structured format you've asked for based solely on the provided text. The document acts as an approval notice, not the validation study itself.

To answer your questions, I would need access to the actual 510(k) submission summary or supporting documentation that was reviewed by the FDA, which would detail the performance data, acceptance criteria, and study design used to demonstrate substantial equivalence.

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