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The Red Light is intended to treat full face wrinkles.
The Blue Light is intended to treat mild to moderate inflammatory acne.
The Yellow Light is intended to treat wrinkles.

The GLAM LED light therapy mask is a home use wearable light emitting diode phototherapy device whose purpose is to produce an even, cool, narrow band of light for the treatment of full face wrinkles and mild to moderate acne of the face. The outer shell of the mask is manufactured from Polyethylene terephthalate (PET). The inner shell is a clear Polycarbonate (PC). The Light emitting diodes are mounted behind the clear Polycarbonate. The LEDs generate the light. The ear hooks are made of Acrylonitrile butadiene styrene (ABS) and the silicone goggle protect the eyes from LED lights. Unfold the ear hooks and place the mask on your face, the mask will automatically activate the light therapy mode. The LEDs produce blue, red and yellow light in the visible spectrum (Blue:415nm +/- 10nm, Yellow: 590nm +/-10nm, Red: 625nm +/-10nm.). The device works by emitting the specified wavelengths to treat full face of wrinkles or to treat mild to moderate inflammatory acne. Press the touch switch on the right ear hook twice to select the light therapy mode you want to use. Each mode operates in a 15-minute cycle. After 15 minutes, the device automatically deactivates the light mode and enters the standby mode.

This FDA 510(k) clearance letter for the GLAM LED Facial Mask (TB-2386F) does not include any information regarding clinical testing, acceptance criteria for device performance related to efficacy (e.g., wrinkle reduction or acne treatment), or studies comparing the device's performance against such criteria.

The letter focuses on the substantial equivalence based on:

• Technological Comparison: Comparing light wavelengths, power density, and treatment time to predicates.
• Safety Standards Compliance: Verification through non-clinical tests (electrical safety, EMC, biocompatibility, photobiological safety, software verification).

Therefore, I cannot provide details on the specific acceptance criteria for efficacy or a study proving the device meets those criteria from the provided document. The 510(k) summary explicitly states: "No animal or clinical study is included in this submission."

However, if we were to hypothesize what acceptance criteria and a study might look like for a device with these indications, and then illustrate what would be missing from this document:

Hypothetical Acceptance Criteria and Performance Study (Not Found in Provided Document):

Since the provided document explicitly states no clinical study was included, the following tables and sections represent what would typically be expected for a device claiming therapeutic efficacy, but none of this information is present in the provided 510(k) clearance letter.

Hypothetical Acceptance Criteria and Reported Device Performance (If Clinical Data Existed)

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Fetal & Maternal Monitor (Model: F15A, F15A Air) is intended for providing Non-Stress testing or fetal monitoring for pregnant women from the 28th week of gestation. It is intended to be used only by trained and qualified personnel in antepartum examination rooms, labor and delivery rooms.

Fetal & Maternal Monitor (Model: F15A, F15A Air) is intended for real time monitoring of fetal and maternal physiological parameters, including non-invasive monitoring and invasive monitoring:

Non-invasive physiological parameters:

• Maternal heart rates (MHR)
• Maternal ECG (MECG)
• Maternal temperature (TEMP)
• Maternal oxygen saturation (SpO2) and pulse rates (PR)
• Fetal heart rates (FHR)
• Fetal movements (FM)
• FTS-3

Note: SpO2 and PR are not available in F15A Air.

Invasive physiological parameters:

• Uterine activity
• Direct ECG (DECG)

The F15A series fetal and maternal monitor can monitor multiple physiological parameters of the fetus/mother in real time. F15A series can display, store, and print patient information and parameters, provide alarms of fetal and maternal parameters, and transmit patient data and parameters to Central Monitoring System.

F15A series fetal and maternal monitors mainly provide following primary feature:

Non-invasive physiological parameters:

• Maternal heart rates (MHR)
• Maternal ECG (MECG)
• Maternal temperature (TEMP)
• Maternal oxygen saturation (SpO2) and pulse rates (PR)
• Fetal heart rates (FHR)
• Fetal movements (FM)
• FTS-3

Note: SpO2 and PR are not available in F15A Air.

Invasive physiological parameters:

• Uterine activity
• Direct ECG (DECG)

The provided FDA 510(k) clearance letter and summary for the Fetal & Maternal Monitor (F15A, F15A Air) do not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study that proves the device meets them.

The document focuses primarily on demonstrating substantial equivalence to a predicate device (Edan Instruments, Inc., F9 Express Fetal & Maternal Monitor, K173042) through comparison of intended use, technological characteristics, and conformance to various safety and performance standards. It mentions "functional and system level testing to validate the performance of the devices" and "results of the bench testing show that the subject device meets relevant consensus standards," but it does not specify quantitative acceptance criteria for each individual physiological parameter (e.g., FHR accuracy, SpO2 accuracy) nor the specific results of those tests beyond stating that they comply with standards.

Specifically, the document does not include information on:

• A table of acceptance criteria with specific quantitative targets for each parameter and the reported device performance values against those targets. It only states compliance with standards.
• Sample sizes used for a "test set" in the context of clinical performance evaluation (it mentions "bench testing," but this is typically laboratory-based and doesn't involve patient data in a "test set" sense for AI/algorithm performance validation).
• Data provenance for such a test set (e.g., country of origin, retrospective/prospective).
• Number or qualifications of experts used to establish ground truth.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) studies or human reader improvement data with AI assistance.
• Standalone (algorithm-only) performance, as this is a monitoring device, not a diagnostic AI algorithm.
• Type of ground truth (beyond "bench testing" which implies engineered signals or controlled environments).
• Sample size for a training set or how ground truth for a training set was established. This device is a traditional medical device, not an AI/ML-driven diagnostic or interpretative algorithm in the way your request implies.

Therefore, based solely on the provided text, I can only address what is present or infer what is missing.

Here's a breakdown based on the available information:

Analysis of Acceptance Criteria and Performance Testing based on Provided Document

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (F9 Express Fetal & Maternal Monitor, K173042) by showing that the new device (F15A, F15A Air) has the same intended use and fundamentally similar technological characteristics, with any differences not raising new safety or effectiveness concerns.

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

The document does not provide a specific table with quantitative acceptance criteria for each physiological parameter (e.g., FHR accuracy, SpO2 accuracy) and the corresponding reported performance values obtained in testing. Instead, it states that the device was assessed for conformity with relevant consensus standards. For example, it lists:

• IEC 60601-2-37:2015: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment (relevant for FHR).
• ISO 80601-2-61:2017+A1:2018: Particular requirements for basic safety and essential performance of pulse oximeter equipment (relevant for SpO2).
• ISO 80601-2-56:2017+A1:2018: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (relevant for TEMP).
• IEC 60601-2-27:2011: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment (relevant for MECG/DECG).

Acceptance Criteria (Inferred from standards compliance): The acceptance criteria are implicitly the performance requirements specified within these listed consensus standards. These standards set limits for accuracy, precision, response time, and other performance metrics for each type of measurement.

Reported Device Performance: The document states: "The results of the bench testing show that the subject device meets relevant consensus standards." This implies that the measured performance statistics (e.g., accuracy, bias, precision) for each parameter fell within the acceptable limits defined by the respective standards. However, the specific measured values are not provided in this summary.

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

The document mentions "Bench Testing" which implies laboratory-based testing using simulators, controlled signals, or phantoms, rather than a "test set" involving patient data. There is no information provided regarding:

• Sample size (e.g., number of recordings, duration of recordings, number of simulated cases) for the bench tests for each parameter.
• Data provenance (e.g., country of origin, retrospective or prospective) as this is not a study involving patient data collection for performance validation.

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 is not applicable and not provided. For a traditional physiological monitor, ground truth for bench testing is typically established using:

• Calibrated reference equipment/simulators: e.g., ECG simulators to generate known heart rates, SpO2 simulators to generate known oxygen saturation levels.
• Physical standards/phantoms: e.g., temperature baths at known temperatures.
• Known physical properties: e.g., precise weights for pressure transducers.

Clinical experts are not involved in establishing ground truth for bench performance of these types of physiological measurements.

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

This is not applicable and not provided. Adjudication methods are relevant for human expert review of complex clinical data (e.g., medical images for AI validation) to establish a consensus ground truth. For bench testing of physiological monitors, ground truth is objectively determined by calibrated instruments or defined physical parameters.

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 is not applicable and not provided. An MRMC study is typically performed to evaluate the diagnostic accuracy of AI-assisted human interpretations versus unassisted human interpretations for AI-driven diagnostic devices. The Fetal & Maternal Monitor is a physiological monitoring device, not an AI-assisted diagnostic imaging or interpretation system. It measures and displays physiological parameters; it does not provide AI-driven assistance for human "readers" to interpret complex clinical information.

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

The device is a monitor that directly measures physiological parameters. It is not an "algorithm only" device in the sense of an AI model providing a diagnostic output. Its performance (e.g., FHR accuracy) is its standalone performance, as it directly measures these parameters. The document states "functional and system level testing to validate the performance of the devices," which would represent this type of standalone performance for the measurement functionalities. However, specific quantitative results are not given, only compliance with standards.

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

As explained in point 3, the ground truth for bench testing of physiological monitors is established using calibrated reference equipment/simulators and physical standards.

8. The sample size for the training set

This is not applicable and not provided. This device is a traditional physiological monitor, not a machine learning model that requires a "training set." Its algorithms for parameter measurement are based on established physiological principles and signal processing techniques, not on statistical learning from large datasets.

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

This is not applicable and not provided for the same reasons as point 8.

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The Heager Medical Laser Family device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures. The device's 980nm laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology. The device is further indicated for laser assisted lipolysis. The device's 1470nm laser is intended for delivery of laser light to soft tissue in non-contact mode during general surgery procedures, indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

The Heager Medical Laser Family generates a 980nm wavelength laser to act on a target tissue to achieve hemostasis, ablation, and coagulation of the target tissue. The Heager Medical Laser Family generates a 1470 nm wavelength laser that acts on the water molecules of the target tissue to achieve the function of treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

The Heager Medical Laser Family has following characteristics:

• Dual wavelengths
• Temperature monitoring system

This document is a 510(k) clearance letter for a medical laser device, not a study report. Therefore, it does not contain the specific details about acceptance criteria and study results you requested in the format typically found in a clinical or performance study.

Based on the provided FDA 510(k) clearance letter for the Heager Medical Laser Family, here's what can be extracted and what information is not available within this document:

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

The document does not explicitly state acceptance criteria in a quantitative, measurable way for device performance in terms of clinical outcomes or diagnostic accuracy. Instead, it demonstrates substantial equivalence to predicate devices based on technical specifications and adherence to recognized electrical and safety standards.

The "reported device performance" is primarily presented as technical specifications and compliance with safety standards rather than clinical 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)

This information is not available in the provided document. As this is a 510(k) for a laser surgical instrument, the primary "test set" would be the device itself tested against engineering and safety standards, not a clinical data set in the way an AI/diagnostic device would have. The document explicitly states: "No clinical study implemented for the Diode laser therapy device."

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 available. Given that "No clinical study implemented," there would be no ground truth established by experts in a clinical context for the purpose of a study demonstrating effectiveness. The "ground truth" here is the adherence to engineering standards and technical specifications.

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

This information is not available. Adjudication methods are typically associated with clinical studies involving human observers or raters, which were not conducted for this 510(k) submission.

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

This information is not applicable and not available. This is a laser surgical instrument, not an AI software/diagnostic device that would involve human readers or AI assistance in interpretation.

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

This information is not applicable and not available. This is not an algorithm or AI device.

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

The "ground truth" in this 510(k) context is primarily compliance with recognized electrical, safety, and performance standards (e.g., IEC standards) and technical specifications of the device, demonstrated through non-clinical testing.

8. The sample size for the training set

This information is not applicable and not available. There is no "training set" in the context of an AI/machine learning model for this type of laser device 510(k) submission.

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

This information is not applicable and not available for the same reason as point 8.

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CRYOcheck Chromogenic Factor VIII is for clinical laboratory use in the quantitative determination of factor VIII activity in 3.2 % citrated human plasma. It is intended to be used in identifying factor VIII deficiency and as an aid in the management of hemophilia A in individuals aged 2 years and older. For in vitro diagnostic use.

CRYOcheck Chromogenic Factor VIII is used for determination of FVIII activity and contains the following four components, packaged in glass vials and provided frozen to preserve the integrity of the components:

• Reagent 1: Bovine FX and a fibrin polymerization inhibitor, with activators and stabilizer.
• Reagent 2: Human FIIa, bovine FIXa, calcium chloride and phospholipids.
• Reagent 3: FXa substrate containing EDTA and a thrombin inhibitor.
• Diluent Buffer: Tris buffer solution containing 1% BSA and a heparin antagonist.

In the first stage of the chromogenic assay, test plasma (containing an unknown amount of functional FVIII) is added to a reaction mixture comprised of calcium, phospholipids, human purified thrombin and FIXa, and bovine FX (Reagent 1 and Reagent 2). This mixture swiftly activates FVIII to FVIIIa, which works in concert with FIXa to activate FX. When the reaction is stopped, FXa production is assumed to be proportional to the amount of functional FVIII present in the sample. The second stage of the assay is to measure FXa through cleavage of a FXa-specific peptide nitroanilide substrate (FXa Substrate). P-nitroaniline is produced, giving a color that can be measured spectrophotometrically by absorbance at 405 nm.

Based on the provided FDA 510(k) Clearance Letter, the device in question is the CRYOcheck Chromogenic Factor VIII. This document details the clearance of a modified version of an existing device, emphasizing the differences from the previous version regarding interference claims and recovery of Factor VIII replacement therapies.

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for each performance claim in a quantified manner (e.g., "Interference must be less than X%"). Instead, it reports the limits of non-interference found in their studies, implying these served as the de facto acceptance criteria. For the Factor VIII replacement therapy recovery, the acceptance criterion appears to be "accurate evaluation" across a range of concentrations, with specific over/under recovery noted.

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

• Interference Studies: Plasma samples were "spiked with possible interferents," and "10 replicates were tested alongside 10 replicates of the corresponding blank matrix control." The total number of individual patient samples from which this plasma was derived is not specified, nor is the country of origin. The study design implies a prospective spiking experiment in a laboratory setting.
• Recovery of Factor VIII Replacement Therapy: "Congenital FVIII deficient plasma was spiked with 14 FVIII replacement therapies at seven concentrations." The number of individual patient plasma units or lots of deficient plasma used is not specified. The study design implies a prospective spiking experiment in a laboratory setting.

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

N/A. This is an in vitro diagnostic device for quantitative determination of factor VIII activity, not an AI/imaging device requiring expert human readers for ground truth generation. The ground truth for these studies is established by the known concentrations of spiked interferents or FVIII replacement therapies, and the intrinsic properties of the FVIII deficient plasma.

4. Adjudication Method for the Test Set

N/A. As this is a quantitative in vitro diagnostic device, an adjudication method in the context of human expert review of imaging or clinical data is not applicable. The results are measured spectrophotometrically.

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 AI imaging devices where human readers interpret medical images with and without AI assistance. This document describes an in vitro diagnostic device.

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

Yes, this entire submission describes the standalone performance of the CRYOcheck Chromogenic Factor VIII assay. The device itself performs the quantitative determination of FVIII activity, entirely without a "human-in-the-loop" once the sample is loaded and the assay run according to protocol.

7. The Type of Ground Truth Used

• Interference Studies: The ground truth was the known concentration of the spiked interferent (e.g., Hemoglobin, Intralipid, Bilirubin, etc.) added to plasma samples, and the corresponding blank matrix control.
• Recovery of Factor VIII Replacement Therapy: The ground truth was the known concentration of the spiked FVIII replacement therapy added to congenital FVIII deficient plasma at various concentrations.

8. The Sample Size for the Training Set

N/A. This document describes an in vitro diagnostic assay based on chromogenic principles, not an AI/ML algorithm that requires a "training set" in the computational sense. The device's components (reagents, diluent buffer) and their interaction define the assay, which is then validated through performance studies.

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

N/A. See point 8. The "ground truth" for developing and optimizing such a chromogenic assay would stem from extensive biochemical research, characterization of reagents, and titrations against known standards, which is inherent in the development of any diagnostic assay, but not referred to as a "training set" or "ground truth establishment" in the AI/ML context.

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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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The MBT Sepsityper is a qualitative in vitro diagnostic device consisting of an MBT-CA (Sepsityper) software extension and a reagent kit (MBT Sepsityper Kit US IVD) for use in conjunction with other clinical and laboratory findings to aid in the early diagnosis of bacterial and yeast infections from positively flagged blood cultures using the MALDI Biotyper CA System.

The MBT Sepsityper Kit US IVD is a disposable blood culture processing device that includes associated reagents that are intended to concentrate and purify microbial cells from blood culture samples identified as positive by a continuous monitoring blood culture system and confirmed to demonstrate the presence of a single organism as determined by Gram stain. This sample preparation manual method is performed by laboratory health professionals in a clinical diagnostic setting. Subculturing of positive blood cultures is necessary to recover organisms for identification of organisms not identified by the MBT-CA System, for susceptibility testing and for differentiation of mixed growth.

Positive MBT Sepsityper results do not rule out co-infection with organisms that may not be detected by the MBT-CA System. Results of the MBT Sepsityper should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Results of the MBT Sepsityper should be correlated with Gram stain results and used in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and yeast bloodstream infections.

Organisms recovered from positive blood culture bottles that are suitable for identification using the MBT Sepsityper Kit US IVD and MBT-CA Systems are listed in the MALDI Biotyper CA System Package Insert Reference Library.

The MALDI Biotyper CA System uses MALDI (matrix-assisted laser desorption/ionization) TOF (time of flight) mass spectrometry technology for the identification of organisms isolated from clinical samples. Identification can be performed from an isolated colony or from a cell extract. The sample material is transferred to a target plate, dried and overlaid with a matrix. The MBT FAST Shuttle US IVD is an optional hardware tool that may be used for drying the samples deposited on the MALDI target plate under controlled conditions.

The MALDI process transforms the proteins and peptides from the isolated microorganisms into positively charged ions. This is achieved by irradiating the matrix-sample composite with a UV laser. The matrix absorbs laser energy and transfers protons to the intact proteins or peptides in the gas phase. These ions are electrostatically accelerated and arrive in the flight tube at a mass-dependent speed. Because different proteins/peptides have different masses, ions arrive at the detector at different times (time of flight). The MBT-CA System measures the time (in the nanosecond range) between pulsed acceleration and the corresponding detector signal of the ions, and the time is converted into an exact molecular mass.

The highly abundant microbial ribosomal proteins result in a mass spectrum with a characteristic mass and intensity distribution pattern. This pattern is species-specific for many bacteria and yeasts and can be used as a 'molecular fingerprint' to identify a test organism. The spectrum of the unknown test organism, acquired through the software MBT Compass HT CA of the MBT-CA System, is electronically transformed into a peak list. Using a biostatistical algorithm, this peak list is compared to reference peak lists of organisms in the MBT-CA Reference Library and a log(score) between 0.00 and 3.00 is calculated. The higher the log(score), the higher the degree of similarity to a given organism in the MBT-CA Reference Library. The log(score) ranges reflect the probability of organism identification.

The FDA 510(k) submission document focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a traditional acceptance criteria study for a new device. Therefore, the "acceptance criteria" discussed are largely driven by proving that the new components (MBT Compass HT CA software and MBT FAST Shuttle US IVD) maintain or improve the performance and safety established by the predicate device.

Here's an analysis of the provided text to fulfill your request:

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" in this context isn't a single set of predefined thresholds for a novel device's performance against a clinical gold standard (e.g., sensitivity/specificity targets). Instead, it's about demonstrating that the new components do not negatively impact the established performance of the predicate device and potentially offer improvements (like accelerated drying time). The "reported device performance" is presented as evidence that these conditions are met.

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

Study Details

Based on the provided text:

1. Sample sizes used for the test set and the data provenance:

   • MBT FAST Shuttle - Repeatability: 120 mass spectra (presumably from 12 bacterial/yeast strains * 10 repeats * 2 runs across DT, eDT, Ext, Sepsityper workflows as indicated in Table 3 headers, although the text says "each out of 2 runs" for "each workflow/method" - suggesting 10 per method/workflow per run).
   • MBT FAST Shuttle - Reproducibility (Site-to-Site): 2700 samples for MBT workflow (900 samples per study site * 3 sites) and 1350 samples for Sepsityper workflow (450 samples per study site * 3 sites). The document mentions "10 microorganisms" used per study site.
   • MBT FAST Shuttle - Reproducibility (Device-to-device): 1080 samples for MBT workflow (360 samples per MBT FAST Shuttle * 3 shuttles) and 540 samples for Sepsityper workflow (180 samples per MBT FAST Shuttle * 3 shuttles).
   • MBT FAST Shuttle - Reproducibility (Operator-to-operator): 900 samples for MBT workflow (450 samples per operator * 2 operators) and 450 samples for Sepsityper workflow (225 samples per operator * 2 operators).
   • MBT FAST Shuttle - Reproducibility (Day-to-day): 900 samples for MBT workflow (180 samples per day * 5 days) and 450 samples for Sepsityper workflow (90 samples per day * 5 days).
   • MBT FAST Shuttle - Method Comparison (Drying): 279 mass spectra for air-dried and 279 mass spectra for MBT FAST Shuttle dried from three study sites (93 mass spectra per site per drying method). Ten (10) microorganisms and a blood culture, each spotted in triplicates.
   • MBT Compass HT CA - Low Confidence Results: 15,270 spectra in total, with 1,670 yellow log(scores) re-analyzed.
   • MBT Compass HT CA - IDealTune: Data collected from 133 BTS-QC runs at Site 1 (over 17 months) and 76 BTS-QC runs at Site 2 (over 14 months).

   Data Provenance: The studies were performed at multiple sites (at least 3 for reproducibility studies), and one study explicitly mentions that microorganisms were shipped to both US study sites. This implies the data is, at least in part, prospectively collected in a multi-center setting for verification/validation. The "low confidence results" study was a retrospective non-interventional validation using data from previous clearances.

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

   • The document does not specify the number or qualifications of experts used to establish ground truth for most of these performance studies. The studies primarily focus on performance consistency and equivalence compared to established methods using what appears to be common laboratory standards (e.g., identity confirmed organisms, BTS quality checks).
   • For the "low confidence results" study, it states: "Isolates from clinical routine were used to compare the results of the MBT-CA System against a gold standard (16S sequencing)." This suggests the ground truth was established by 16S sequencing, a molecular method, rather than solely by human experts, and then potentially interpreted by experts.

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

   • No adjudication method involving multiple human readers for conflict resolution is mentioned or appears to be applicable given the nature of the device (mass spectrometry-based organism identification). The performance is assessed on the agreement with an expected identification or log(score) thresholds.

4. 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 or human-in-the-loop comparative effectiveness study with human readers assisting or being assisted by AI is described in this document. The device is a "clinical mass spectrometry microorganism identification and differentiation system," not an AI-assisted diagnostic imaging tool.

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

   • Yes, the performance validation studies of the MBT FAST Shuttle US IVD and MBT Compass HT CA software are essentially standalone performance evaluations of these components within the overall MALDI Biotyper CA System. The "outputs" (identification results, log(scores)) are generated by the system (including the hardware, software, and reference library) without direct human interpretation of the raw mass spectra. Human involvement is in sample preparation and operating the system, but the core identification is algorithmic.

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

   • For the analytical performance of organism identification, the ground truth appears to be based on:
     • Reference strains/known microorganisms: Used in repeatability and reproducibility studies.
     • 16S sequencing: Explicitly stated as the "gold standard" for comparing results in the "low confidence results" study.
     • Internal quality control standards: Like the Bacterial Test Standard (BTS) for IDealTune validation.
   • This is primarily laboratory-based "gold standard" ground truth (molecular methods, established reference cultures), rather than expert consensus on clinical cases.

7. The sample size for the training set:

   • This document describes the validation of new components for an existing system. It does not provide details about the training set size for the underlying MALDI Biotyper CA System's reference library or analytical algorithms. The "reference library" (which acts as a form of "training data" for identifying unknown spectra) is mentioned as being continually updated, but its size is not specified.

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

   • Similar to the above, the document does not detail how the ground truth was established for the training data (the reference library) of the overall MALDI Biotyper CA System. However, standard practice for building such libraries involves:
     • Well-characterized bacterial and yeast strains: Often from culture collections, with identity confirmed by a variety of methods including 16S rRNA gene sequencing, traditional biochemical tests, and possibly whole-genome sequencing.
     • Internal validation and verification: Ensuring the spectral patterns are consistent and representative for each species.

In summary, this 510(k) submission successfully demonstrates substantial equivalence by showing that the new components (MBT Compass HT CA software and MBT FAST Shuttle US IVD) maintain the safety and effectiveness of the predicate device, and in some cases, enhance usability (faster drying time, improved instrument maintenance) without introducing new risks or compromising diagnostic accuracy. The studies presented are analytical validations focusing on performance characteristics relevant to microorganism identification in a laboratory setting.

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The MF SC GEN2 Facial Toning System is intended to stimulate the face. The device is intended for over the counter cosmetic use.

Not Found

The provided document is an FDA 510(k) clearance letter for the "MF SC GEN2 Facial Toning System." It confirms the device's substantial equivalence to legally marketed predicate devices for its stated indications for use.

Crucially, the document does NOT contain any information regarding acceptance criteria or a study proving the device meets these criteria.

This type of FDA letter is primarily a regulatory approval and does not detail the clinical or performance study data that the manufacturer submitted to support their 510(k) application. To provide the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.), one would need access to the actual 510(k) submission document itself, which is typically confidential business information and not released publicly by the FDA in detail.

Therefore,Based on the information provided in the FDA 510(k) clearance letter (K252218), it is not possible to describe the acceptance criteria and the study that proves the device meets these criteria.

The clearance letter primarily states that the device, "MF SC GEN2 Facial Toning System," is substantially equivalent to legally marketed predicate devices for its intended use (to stimulate the face, for over-the-counter cosmetic use). It does not contain the detailed performance data, study design, or acceptance criteria that would have been part of the manufacturer's 510(k) submission.

All sections of your request cannot be fulfilled as the necessary information is not present in the provided document.

To provide the requested details, one would need access to the full 510(k) submission document from Micro Current Technology, Inc., which is not publicly available in this correspondence.

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This device is intended for the delivery of high flow respiratory gases (within the limits of its stated technical specifications) to patients in a hospital by appropriately qualified healthcare professionals.

This product is not intended to be used on patients with bypassed upper airways.

This product is not intended to be life-sustaining or life-supporting.

This product is not intended for apneic ventilation.

The F&P Optiflow Air/Oxygen Flow Source is a respiratory high flow therapy device designed to generate a flow of air and/or oxygen. The device allows selectable flow rates up to 70L/min with selectable oxygen concentrations ranging from 21% to 100%.

The subject device is a multi-patient use prescription only device, provided in a non-sterile state. It operates at flow ranges between 0 to 70 L/min and is intended to be used by appropriately qualified healthcare professionals in hospitals.

The provided FDA 510(k) clearance letter and summary for the "F&P Optiflow Air/Oxygen Flow Source" is for a hardware device, a breathing gas mixer, not a software or AI-driven diagnostic device. Therefore, the majority of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for AI/software performance is not applicable based on the provided document.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of technological characteristics and compliance with general medical device standards. There is no information regarding AI-specific performance metrics, clinical studies involving human readers, or detailed ground truth establishment for diagnostic capabilities.

Below is a table summarizing the general performance data found, where applicable, according to the structure requested, along with an explanation for the absence of AI-specific information.

Acceptance Criteria and Device Performance for F&P Optiflow Air/Oxygen Flow Source

This device is a hardware breathing gas mixer, not an AI or software-driven diagnostic tool. As such, the typical acceptance criteria and study designs associated with AI performance (e.g., sensitivity, specificity, human reader improvement, adjudication, ground truth for AI training/testing) are not present in this 510(k) summary. The "performance data" section primarily refers to compliance with safety, electrical, and performance standards for medical electrical equipment and gas mixers.

1. Table of Acceptance Criteria and Reported Device Performance:

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