Search Results

Ask a specific question about this device

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates.

This 510(k) is for amikacin in the dilution range of 0.25-256 µg/mL for testing non-fastidious gram-negative isolates on The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System. Testing is indicated for Acinetobacter spp., Enterobacterales, and Pseudomonas aeruginosa, as recognized by the FDA Susceptibility Test Interpretive Criteria (STIC) webpage.

The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 µg/mL demonstrated acceptable performance with the following organisms:

Acinetobacter spp. (Acinetobacter baumannii)

Enterobacterales (Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Serratia marcescens)

Pseudomonas aeruginosa

Not Found

The provided FDA 510(k) clearance letter pertains to The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin. This device is an in vitro diagnostic product for clinical susceptibility testing of non-fastidious isolates, specifically for amikacin in the dilution range of 0.25-256 µg/mL for testing non-fastidious gram-negative isolates on the system. The indications for use specify its application for Acinetobacter spp., Enterobacterales, and Pseudomonas aeruginosa.

Unfortunately, the provided document does not contain the detailed information required to specifically answer your questions about acceptance criteria, study methodology (sample size, data provenance, expert qualifications, adjudication), MRMC studies, standalone performance, or training set details. This clearance letter is a formal notification of substantial equivalence and outlines the intended use and regulatory classifications, but it does not include the full summary of safety and effectiveness data that would typically contain such study specifics.

To get the information you're looking for, you would generally need to refer to the 510(k) Summary document, which is usually part of the full 510(k) submission and is publicly available through the FDA's 510(k) database. This summary typically provides a more detailed overview of the performance studies conducted to support the clearance.

Therefore, I cannot populate the table or answer most of your specific questions based solely on the provided text.

However, I can extract what is implied about acceptable performance:

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

Based only on the statement "The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 µg/mL demonstrated acceptable performance with the following organisms," we can infer that the device met the manufacturer's internal acceptance criteria for performance for these organisms, as the FDA has cleared it. Without the 510(k) summary, specific numeric thresholds for performance metrics (e.g., Essential Agreement, Category Agreement) for in vitro diagnostic susceptibility tests are not provided in this letter.

• Acinetobacter spp. (Acinetobacter baumannii)
• Enterobacterales (Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Serratia marcescens)
• Pseudomonas aeruginosa |

The following questions cannot be answered from the provided document:

2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance. (Note: This device is an in vitro diagnostic for antimicrobial susceptibility testing, not typically an AI-assisted diagnostic read by a human expert in the context of imaging or pathology. An MRMC study is highly unlikely for this type of device.)
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done. (The device itself is the "standalone" test; human interpretation is involved in setting up the test and reading the results, although it's an automated or semi-automated system. Performance is typically measured against a reference method.)
7. The type of ground truth used. (For AST devices, the ground truth is typically a reference method like broth microdilution or agar dilution, performed according to CLSI guidelines.)
8. The sample size for the training set. (While there might be "training" in the sense of model development for an automated reader, a primary training set in the AI/ML sense is not typically discussed for this type of in vitro diagnostic device, which relies on chemical reactions and optical detection.)
9. How the ground truth for the training set was established. (Similar to point 8, this question's premise might not directly apply to this type of device.)

Ask a specific question about this device

The Jarvis Glenoid Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff.

The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The glenoid baseplate is intended for cementless application with the addition of screws for fixation.

The JARVIS Glenoid Reverse Shoulder Prosthesis is used for reverse shoulder prosthesis, intended for primary, fracture or revision shoulder replacement. The JARVIS Glenoid Reverse Shoulder Prosthesis is made up of three components – glenophere, baseplate, and fixation component (screw or post). All components are offered in varying sizes to accommodate patient anatomy. The baseplate and screw components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3, while the glenophere is manufactured from wrought cobalt chromium molybdenum alloy per ASTM F1537/ISO 5832-12. All components are provided sterile via gamma irradiation.

The subject submission seeks to gain clearance for design modifications to the existing device components.

The provided FDA 510(k) clearance letter for the JARVIS Glenoid Reverse Shoulder Prosthesis does not contain any information regarding clinical studies, acceptance criteria for an AI/CADe device, or performance data related to AI assistance.

The document describes a traditional medical device (a shoulder prosthesis), not an artificial intelligence (AI) or computer-assisted detection/diagnosis (CADe/CADx) device. Therefore, it lacks the specific details requested in your prompt, such as:

• Table of acceptance criteria and reported device performance for an AI/CADe system.
• Sample sizes, data provenance, expert qualifications, or adjudication methods for a test set.
• Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Ground truth types and methods for establishing ground truth.
• Training set sample size and ground truth establishment for AI.

The "Performance Testing" section explicitly states: "Engineering analysis was conducted on the modified locking screws and concluded that the compressive force of the subject screws is equivalent to that of the predicate and therefore locking capabilities are equivalent. Therefore, all previous performance testing and validations are still applicable and no additional testing is necessary." This refers to mechanical testing of the physical implant components, not performance of an AI algorithm.

In summary, the provided text is for a physical medical implant, not an AI-based or software-as-a-medical-device (SaMD) product that would require the kind of data and studies you are asking about.

Ask a specific question about this device

The LED Light Therapy Mask (Model: FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne.

FCM902, FCM905, FCM906, FCM908:
a.Red light: Treatment of full-face wrinkles.
b.Blue+Infrared light: Treatment of mild to moderate inflammatory acne.
c.Yellow+Infrared light: Treatment of full-face wrinkles.

11-001-RBMASK:
a.Red+Infrared light: Treatment of full-face wrinkles.
b.Blue light: Treatment of mild to moderate inflammatory acne.

FCM910:
a.Red+Infrared light: Treatment of full-face wrinkles.
b.Blue light: Treatment of mild to moderate inflammatory acne.
c.Yellow+Infrared light: Treatment of full-face wrinkles.

The LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) adopts light emitting diodes (LED) in the red (630nm ±5nm) , infrared (880nm±5nm) and blue (415±5nm) spectrum to irradiate on the face to realize its therapeutic effect.

For FCM902, FCM905, FCM906, FCM908 and FCM910, it also contain yellow (590±5nm) spectrum and green (520±5nm) spectrum.

The LED Light Therapy Mask adopts the form of a mask that contains LEDs on the inner surface of the main unit. A controller is connected to the main unit to control the device, such as turn on/off the device, switch mode (LED color). To use the device, user should place the mask over the face and use the controller to operate. The device will automatically turn off after each treatment. To prevent irradiation of LED lights to eyes during the treatment, LED Light Therapy Mask has incorporated protective eye-shield which blocks light energy from LEDs.

a. Red light: Treatment of full-face wrinkles.
b. Blue+Infrared light: Treatment of mild to moderate inflammatory acne.
c. Yellow+Infrared light: Treatment of full-face wrinkles.
d. Green Light: light in wavelength 520nm(±5nm). Green light makes users feel like they are outside in a green world, which may make users relax, which has no medical therapeutic effect.
e. Red+Infrared light: Treatment of full-face wrinkles.
f. Blue light: Treatment of mild to moderate inflammatory acne.

The provided FDA 510(k) Clearance Letter concerns an LED Light Therapy Mask for treating wrinkles and mild to moderate inflammatory acne. However, this document is a clearance letter and a 510(k) summary, not a clinical study report. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical testing.

Therefore, the document does NOT contain the details required to answer many of the specific questions about acceptance criteria and the study that proves the device meets those criteria, particularly those related to clinical performance, human reader studies, or expert ground truth.

The information provided is mostly about device specifications, comparison to predicates, and compliance with non-clinical safety standards (electrical safety, biocompatibility, photobiological safety). It states that "Non-clinical testings have been conducted to verify that the LED Light Therapy Mask meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device."

Based on the provided text, I can only address what is explicitly mentioned or can be reasonably inferred. Most of the questions below would require a separate clinical study report, which is not part of this 510(k) summary.

Acceptance Criteria and Device Performance (Based only on the provided 510(k) Summary):

The acceptance criteria for this device, as inferred from the 510(k) summary, are primarily centered around Substantial Equivalence (SE) to legally marketed predicate devices for the specified indications for use, and compliance with relevant safety and performance standards for an OTC device. The "performance" reported is largely in terms of meeting these technical and safety standards, rather than clinical efficacy metrics from a new human study.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the study that proves the device meets the acceptance criteria:

Based solely on the provided 510(k) summary, the "study" proving the device meets acceptance criteria appears to be a non-clinical testing program focused on product safety and performance standards for substantial equivalence. There is no mention of a human clinical study, an AI component requiring a test set for diagnostic accuracy, or experts establishing ground truth in a clinical context within this document.

Therefore, I cannot provide answers for many of the following questions as the requested information is not present in the provided text.

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

• Not applicable / Not provided. The document describes non-clinical testing of the device itself (electrical, photobiological, biocompatibility, software V&V), not a clinical test set from patients.

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

• Not applicable / Not provided. There is no mention of a test set requiring expert-established ground truth for performance evaluation in this 510(k) summary. This typically applies to AI/CADe devices or clinical efficacy studies, neither of which are detailed here.

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

• Not applicable / Not provided. Since no clinical test set or expert ground truth process is described, an adjudication method is irrelevant.

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, not done / Not applicable. This device is an LED light therapy mask, not an AI-assisted diagnostic tool. An MRMC study is completely irrelevant to this type of device and its 510(k) clearance.

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

• Not applicable. There is no "algorithm only" performance study as this is a physical light therapy device, not a diagnostic algorithm.

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

• Not applicable / Not provided for clinical efficacy. For the non-clinical tests, the "ground truth" would be the specified parameters and limits of the IEC/ISO standards (e.g., maximum allowable leakage current, certified photobiological safety levels, biocompatibility thresholds). There is no mention of a clinical ground truth (e.g., for wrinkle reduction or acne treatment) from a study in this document.

8. The sample size for the training set:

• Not applicable / Not provided. This device is cleared based on substantial equivalence and compliance with non-clinical performance standards. It implies a known or existing mechanism of action (light therapy) rather than a newly developed AI algorithm that requires a training set of data.

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

• Not applicable / Not provided. As no training set for an algorithm is mentioned, the method for establishing its ground truth is also not applicable.

Ask a specific question about this device

The Origin™ system is comprised of the Origin™ inline device and Origin™ App. The Origin™ system is indicated for use in conjunction with a compatible drainage system by a trained healthcare professional during postoperative recovery in a hospital setting. The Origin™ inline device is placed between the surgical drainage catheter and reservoir system to continuously measure the pH of drainage fluid to provide additional information on effluent characteristics. The device is not intended to diagnose or treat any clinical condition.

Origin™ is an inline biosensor system that is integrated between an off-the-shelf drainage catheter and reservoir system and is designed to monitor real-time changes in drained effluent characteristics. Origin™ system continuously monitors the pH of wound drainage. Origin™ App is a mobile application for displaying and analyzing data from the Origin™ inline device. Origin™ App is pre-installed on an Android mobile device supplied by FluidAI. The Origin™ inline device connects to Origin™ App via Bluetooth.

The provided FDA 510(k) clearance letter and summary document for the Origin™ system primarily focus on the non-clinical performance of the device, particularly its analytical performance in measuring pH. It does not describe a study involving human readers or multi-reader multi-case (MRMC) comparative effectiveness. Therefore, some of the requested information, particularly related to clinical studies, human expert involvement in ground truth establishment for a test set, and MRMC studies, is not present in the provided text.

However, based on the analytical performance studies described, we can extract the following information:

1. Acceptance Criteria and Reported Device Performance

The document implicitly defines acceptance criteria through the results presented. The "Overall" pH range for linearity, for example, is 0.1446 pH units from 5 to 9, and 0.1 pH units from 4-10 using buffer solutions. For precision, the "Within-Laboratory" precision (total) is 0.0922 SD (1.46% CV) for sample A (pH ~6.3) and 0.1650 SD (2.10% CV) for sample B (pH ~7.85).

Since the document presents the results of studies conducted to demonstrate that the device meets some internal performance goals, we can infer that the reported values met their pre-specified acceptance criteria for analytical performance. However, the specific numerical acceptance thresholds (e.g., "Max Deviation from Linearity must be

Ask a specific question about this device

The ClearTip FNA and FNB Types are intended for Ultrasonically Guided Fine Needle Aspiration, (FNA) of submucosal and extraluminal lesions of the Gastrointestinal Tract, (e.g., lymph nodes, abnormal tissue in the mediastinum).

The ClearTip is a manually operated endoscopic instrument intended to obtain tissue specimens of gastrointestinal tract (=digestive tract). The subject device mainly consists of a handle unit with an insertion part, a syringe, a stopcock, and a connector. ClearTip is offered in various needle gauges for insertion and aspiration. The available needle gauge sizes of 19, 22, and 25 gauge. The Needle which is dimpled for ultrasonic visualization is advanced into the target site for aspiration. The device allows for adjustment of the length of the coil sheath and the needle to enable the user to adjust for the working length of the endoscope and to control needle insertion depth. It is preloaded with a stylet to aid in inserting the Needle which is removed for injection and aspiration. This device passes through the working channel of endoscope, and the average contact time with mucosa of the human gastrointestinal tract is less than 1 hour. This device is supplied sterile for single-patient use and shall be not reused or re-sterilized.

This FDA 510(k) clearance letter pertains to a medical device, and as such, it does not detail acceptance criteria or a study that would demonstrate the device meets those criteria in the way typically seen for AI/software-as-medical-device (SaMD) products. This document describes a traditional medical device (a biopsy instrument), not an AI system.

The "acceptance criteria" and "device performance" mentioned in your request are usually quantifiable metrics (e.g., sensitivity, specificity, AUC) for SaMD products, often against a ground truth for diagnostic accuracy. For a physical device like the ClearTip FNA and FNB Types, acceptance criteria typically relate to physical properties, functionality, safety, and compatibility, which are assessed through non-clinical (engineering, bench) tests rather than clinical performance studies against a diagnostic "ground truth."

Therefore, I will extract the information provided based on the context of a physical medical device submission, focusing on the nearest equivalents to your requested categories.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical device, the "acceptance criteria" are implied by the performance standards for the non-clinical tests conducted. The reported "device performance" is typically that the device met these standards. The document does not provide specific numerical acceptance criteria or performance metrics for each test, but rather lists the types of tests performed.

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

This document does not describe a "test set" in the context of clinical data for diagnostic performance. The "tests" mentioned are non-clinical (bench/engineering) tests conducted on the physical device itself. Therefore, information on sample size for a "test set" or "data provenance" (country of origin, retrospective/prospective) is not applicable or provided given the nature of the device and the submission.

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

Not applicable. This is not an AI/SaMD product requiring expert-established ground truth for diagnostic accuracy. The "ground truth" for a physical device's performance often relates to engineering specifications and regulatory standards.

4. Adjudication Method for the Test Set

Not applicable. No "test set" requiring adjudication in a clinical context is described.

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

No. An MRMC study is typically for evaluating diagnostic performance of imaging or AI systems with human readers. This clearance is for a physical biopsy instrument.

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

No. This is not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on engineering specifications, material standards, and regulatory requirements (e.g., for sterility, biocompatibility, mechanical strength). It is not pathology, outcomes data, or expert consensus in the diagnostic sense.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" as it is not an AI/machine learning system.

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

Not applicable. There is no training set for this device.

Ask a specific question about this device

CHLOE BLAST is indicated to provide adjunctive information on events occurring during embryo development that may predict further development to the blastocyst stage on Day 5 of development. This adjunctive information aids in the selection of embryo(s) for transfer on Day 3, when, following morphological assessment, there are multiple embryos deemed suitable for transfer or freezing.

CHLOE BLAST is to be used only for the analysis of images captured by the EmbryoScope version D incubator system.

CHLOE BLAST is a decision support tool designed to automatically analyze time lapse videos of developing embryos, retrieved from EmbryoScope (version D) Time Lapse Incubators (TLI) system. It is intended to provide adjunctive information on developmental events up to Day 3 that may predict progression to the blastocyst stage by Day 5.

CHLOE BLAST is a cloud-based software as a medical device (SaMD) that uses a convolutional neural network (CNN) to analyze TLI videos from insemination to Day 3. The output is the "CHLOE Score", which is a blastocyst development prediction value associated with the likelihood of the embryo reaching blastocyst stage at Day 5.

This information aids in the selection of embryo(s) for transfer on Day 3, when, following morphological assessment, there are multiple normally fertilized embryos deemed suitable for transfer or freezing. In a clinical setting, the CHLOE score is intended to be used by the embryologist as adjunctive information, to be used only after the embryologists complete their independent morphological assessments based on the lab's standard of care (e.g., Istanbul Consensus Grading).

The main user interaction is via the graphic user interface (GUI) available via Chrome browsers. It includes screens for treatments overview, manual embryo assessment, and score presentation, and integrates with the day-to-day normal operation in IVF clinics using TLI.

Here's a breakdown of the acceptance criteria and the study proving the device meets those criteria, based on the provided FDA clearance letter:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document presents acceptance criteria primarily as "AUC lower bound >0.8" for various performance metrics. It also establishes an Odds Ratio (OR) greater than 1 as the primary endpoint for clinical utility.

Study Details Proving Device Meets Acceptance Criteria

2. Sample Sizes and Data Provenance

• Non-Clinical Performance (Algorithm Validation):
  • Morphokinetic Events Detection: 1,094 embryos from 143 slides. Collected from two sites: one in the US and one in Norway. The data provenance is retrospective, as it's a "test dataset... entirely independent from the dataset utilized in the CHLOE BLAST clinical study."
  • Blast Prediction: 1,726 embryos from 233 slides. Collected from two sites: one in the US and one in Norway. The data provenance is retrospective.
• Clinical Performance (CHLOE BLAST Clinical Study):
  • 703 embryos from 59 mothers.
  • Data collected from three different sites located in the United States.
  • Data provenance: Prospective collection for the purpose of this study (described as a "pivotal, multicenter, single arm, observational, prospective assessment study").

3. Number of Experts and Qualifications for Ground Truth

• Non-Clinical Performance (Algorithm Validation):
  • Morphokinetic Stages and Blast Annotations: Three independent embryologists.
  • Qualifications: "The annotators were not involved in the training or tuning of the model and were blinded to each other's labels." No explicit years of experience are stated for these annotators.
• Clinical Performance (CHLOE BLAST Clinical Study):
  • Morphology Grading (Assessors): Three embryologists.
  • Qualifications: "blinded to CHLOE information," and performed grading according to SART standards. No explicit years of experience are stated.
  • Clinical Assessment (Panelists): Five independent embryologists.
  • Qualifications: All "in practice during the study period and from a range of geographical areas within the United States." 3 were senior embryologists with over 10 years of clinical embryology experience each, and the other 2 were junior embryologists with less than 3 years of clinical embryology experience.

4. Adjudication Method for the Test Set

• Non-Clinical Performance (Algorithm Validation):
  • Ground Truth: "Each embryo video was viewed by three independent embryologists who provided their morphokinetic stages and Blast annotations based on the time-lapse videos. The annotators were not involved in the training or tuning of the model and were blinded to each other's labels." It implies a consensus-based approach, but directly states, "The TLI videos were annotated at a frame level with the ground truth of one of the morphokinetic stages and at a video level with blastulation results."
• Clinical Performance (CHLOE BLAST Clinical Study):
  • Morphology Grading (Assessors): "Then, the following parameters were categorized by majority agreement (at least 2 of 3 Assessors): Severe asymmetry (yes/no), Fragmentation > 25% (yes/no), Number of cells (1 through 8, 9≤)." This is a clear 2 out of 3 (2+1) consensus method for specific parameters.
  • Clinical Assessment (Panelists): No explicit adjudication method is stated for the Panelists' predictions. Each Panelist performed their own independent predictions, and the study analyzed the collective performance as well as individual improvements.

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

• Yes, an MRMC comparative effectiveness study was done as part of the clinical performance study.
• Effect Size of Human Readers Improvement with AI vs. without AI assistance:
  • The primary endpoint focused on the Odds Ratio (OR) for predicting blastocyst formation in Good/Fair embryos.
  • Without AI assistance (Morphology Only): OR = 3.77 (95% CI: 2.97, 4.79)
  • With AI assistance (Morphology + CHLOE Score): OR = 5.67 (95% CI: 4.6, 6.99)
  • This represents an improvement in the Odds Ratio from 3.77 to 5.67 for the primary endpoint.
  • For all embryos, the OR improved from 6.93 (without CHLOE) to 8.51 (with CHLOE).
  • For subject-level sensitivity, it improved from 80.36%-83.93% (traditional morphology) to 87.50%-92.86% (with CHLOE).
  • For Top 2 Embryo analysis, the OR improved from 3 (without CHLOE) to 10.73 (with CHLOE).

6. Standalone (Algorithm Only without Human-in-the-Loop) Performance

• Yes, a standalone performance assessment was done as part of the "Non-Clinical Performance – Algorithm Validation" section.
• The algorithm's performance in predicting blastocyst formation was assessed independently, yielding an AUC of 0.88 (95% CI: 0.86, 0.90). This demonstrates the algorithm's capability on its own.

7. Type of Ground Truth Used

• For Non-Clinical Performance (Algorithm Validation):
  • Expert Consensus: Morphokinetic stages and blast annotations were established by three independent embryologists.
  • Outcomes Data: The "blastulation results" (blastocyst Yes/No) are actual outcomes.
• For Clinical Performance (CHLOE BLAST Clinical Study):
  • Expert Consensus: Morphology grading by three "Assessors" with majority agreement (2 out of 3).
  • Outcomes Data: The "actual blastocyst outcome" (Yes/No) which the algorithm and human readers are predicting.

8. Sample Size for the Training Set

• The document states: "The study dataset included data collected specifically for the purpose of this study according to the predefined inclusion and exclusion criteria and was segregated from algorithm training and verification datasets."
• "The dataset used for the performance test was entirely independent from the dataset utilized in the CHLOE BLAST clinical study described in section 9, and the clinics that provided data for the performance dataset were not used to collect data for the clinical study."
• The specific sample size for the training set is NOT PROVIDED in this document. It only clearly states that the various test sets were independent from the training data.

9. How Ground Truth for the Training Set Was Established

• The document implies that the training data exists and was used to develop the CNN, but it does NOT specify how the ground truth for the training set was established. It only focuses on how ground truth was established for the independent testing and clinical validation sets.

Ask a specific question about this device

The Intense Pulsed Light (IPL) System is an over-the-counter device intended for the removal of unwanted body hair.

Intense Pulsed Light (IPL) System, models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF, are a small over-the-counter device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the power adapter and its IPL emission activation is by a switch or auto light emission.

Intense Pulsed Light (IPL) System, all models, contains a Xenon arc flashlamp, and a touch chip to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses.

Intense Pulsed Light (IPL) System, models: T002AQ, T002AD, T002AF, contains a Xenon arc flashlamp, a touch chip to detect appropriate skin contact, and a skin color sensor to detect the skin color. In "Skin Color Recognition mode", the device's skin sensor automatically detects skin tone for your protection. If your skin tone is not in tone table suitable for treatment, the device must not be used. You need to identify your skin tone before treatment according to skin tone table, and confirm whether the product is applicable to you after the skin color sensor detects a skin tone.

Based on the cooling technology, Intense Pulsed Light (IPL) System, models: T033KQ, T033KD, T033KF, T055KQ, T055KD, T055KH, T050KQ, T050KD, T050KF, has cooling care functions. When the cooling care mode is enabled, it can reduce the excessive heat generated on the skin by the photon irradiation and do cooling compresses during hair removal.

Based on the dual pulse technology, Intense Pulsed Light (IPL) System, models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T050KQ, T050KD, T050KF, has single pulse and dual pulse functions.

The Intense Pulsed Light (IPL) System includes main unit, an adaptor and goggles.

This FDA 510(k) clearance letter and summary describe an Intense Pulsed Light (IPL) System for hair removal. However, it does not contain the detailed acceptance criteria or the specific study outcomes that prove the device meets these criteria in the context of an Artificial Intelligence (AI) enabled device. The provided document primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of technical specifications and non-clinical performance data (biocompatibility, electrical safety, eye safety, and general software V&V).

The request specifically asks about acceptance criteria and study data for an AI-enabled device. This document describes a traditional medical device (IPL) and lists "Software Verification and Validation" as a performance data point, but this typically refers to the functional soundness of the device's embedded software, not necessarily an AI algorithm. There is no mention of deep learning, machine learning, or algorithms that would perform diagnostic or treatment-related AI-driven functions.

Therefore, I cannot extract the requested information regarding AI acceptance criteria, specific study performance metrics for an AI component, sample sizes for AI test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, because this information is not present in the provided text.

Here's a breakdown of what can be extracted and what is missing:

Acceptance Criteria and Reported Device Performance (Non-AI Focused)

Since the document doesn't detail AI-specific acceptance criteria or performance metrics, the "acceptance criteria" can be broadly inferred from the tests performed to demonstrate substantial equivalence to the predicate device. The "reported device performance" is the successful completion of these tests.

Missing Information Regarding AI-Enabled Device Performance

The following information cannot be provided as it is not present in the provided FDA 510(k) clearance letter and summary for an AI-enabled device. This document describes a standard IPL device.

1. Sample sizes used for the test set and the data provenance: Not applicable/Not provided for an AI test set. The document refers to non-clinical tests (biocompatibility, electrical safety, etc.), which don't involve test sets of patient data in the context of AI.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. Ground truth establishment with experts is a key component of AI algorithm validation, which is not described here.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not provided.
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: Not applicable/Not provided. The device is not described as providing AI assistance to human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided.
7. The sample size for the training set: Not applicable/Not provided. Training sets are relevant for AI algorithms.
8. How the ground truth for the training set was established: Not applicable/Not provided.

Conclusion: The provided FDA 510(k) document is for a non-AI medical device (Intense Pulsed Light System). While it includes software verification and validation, this refers to the functional and safety aspects of embedded device software, not a sophisticated AI algorithm for interpretation or assistance that would require the detailed clinical validation metrics requested in the prompt.

Ask a specific question about this device

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:

Ask a specific question about this device

The Influenza A/B Typing Kit contains reagents and controls of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel and is intended for use in real-time RT-PCR (rRT-PCR) assays on an in vitro diagnostic real-time PCR instrument that has been FDA-cleared for use with this kit in conjunction with clinical and epidemiological information:

• For qualitative detection of influenza virus type A or B viral RNA in upper respiratory tract clinical specimens (including nasopharyngeal swabs [NPS], nasal swabs [NS], throat swabs [TS], nasal aspirates [NA], nasal washes [NW] and dual nasopharyngeal/throat swabs [NPS/TS]) and lower respiratory tract specimens (including bronchoalveolar lavage [BAL], bronchial wash [BW], tracheal aspirate [TA], sputum, and lung tissue) from human patients with signs and symptoms of respiratory infection and/or from viral culture.

• To provide epidemiological information for surveillance of circulating influenza viruses.

Performance characteristics for influenza were established during a season when seasonal influenza viruses A(H1N1) and A(H3N2) were the predominant influenza A viruses in circulation and during a season when the A(H1N1)pdm09 influenza virus was the predominant influenza A virus in circulation. Performance characteristics may vary with other emerging influenza A viruses.

Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.

If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted unless a BSL 3E facility is available to receive and culture specimens.

CDC Human Influenza Real-Time RT-PCR Diagnostic Panel: Influenza A Subtyping Kit (VER 4)

The Influenza A Subtyping Kit contains reagents and controls of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel and is intended for use in real-time RT-PCR (rRT-PCR) assays on an in vitro diagnostic real-time PCR instrument that has been FDA-cleared for use with this kit in conjunction with clinical and epidemiological information:

• For determination of the subtype of seasonal human influenza A viruses as seasonal A(H3) and/or A(H1)pdm09 from viral RNA in upper respiratory tract clinical specimens (including nasopharyngeal swabs [NPS], nasal swabs [NS], throat swabs [TS], nasal aspirates [NA], nasal washes [NW] and dual nasopharyngeal/throat swabs [NPS/TS]) and lower respiratory tract specimens (including bronchoalveolar lavage [BAL], bronchial wash [BW], tracheal aspirate [TA], sputum, and lung tissue) from human patients with signs and symptoms of respiratory infection and/or from viral culture;

• To provide epidemiological information for surveillance of circulating influenza viruses.

Performance characteristics for influenza were established during a season when seasonal influenza viruses A(H1N1) and A(H3N2) were the predominant influenza A viruses in circulation and during a season when the A(H1N1)pdm09 influenza virus was the predominant influenza A virus in circulation. Performance characteristics may vary with other emerging influenza A viruses.

Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.

If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted unless a BSL 3E facility is available to receive and culture specimens.

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit (VER 1.1 and 2)

The Influenza B Lineage Genotyping Kit contains reagents and controls of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel and is intended for use in real-time RT-PCR (rRT-PCR) assays on an in vitro diagnostic real-time PCR instrument that has been FDA-cleared for use with this kit in conjunction with clinical and epidemiological information:

• For the determination of the genetic lineage of human influenza B viruses as B/Victoria or B/Yamagata lineage from viral RNA in upper respiratory tract clinical specimens (including nasopharyngeal swabs [NPS], nasal swabs [NS], throat swabs [TS], nasal aspirates [NA], nasal washes [NW] and dual nasopharyngeal/throat swabs [NPS/TS]) from human patients with signs and symptoms of respiratory infection and/or from viral culture;

• To provide epidemiologic information for surveillance of circulating influenza viruses.

Performance characteristics for influenza B lineage genotyping were established during a season when influenza B/Victoria and B/Yamagata lineages were in circulation.

Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.

CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/H5 Subtyping Kit (VER 4)

The Influenza A/H5 Subtyping Kit contains reagents and controls of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel and is intended for use in real-time RT-PCR (rRT-PCR) assays on an in vitro diagnostic real-time PCR instrument that has been FDA-cleared for use with this kit in conjunction with clinical and epidemiological information:

• For the presumptive identification of virus in patients who may be infected with influenza A subtype A(H5) (Asian lineage) from viral RNA in human respiratory specimens, conjunctival swabs, and viral culture in conjunction with clinical and epidemiological risk factors;

• To provide epidemiologic information for surveillance of circulating influenza viruses.

Performance characteristics for influenza were established during a season when seasonal influenza viruses A(H1N1) and A(H3N2) were the predominant influenza A viruses in circulation and during a season when the A(H1N1)pdm09 influenza virus was the predominant influenza A virus in circulation. Performance characteristics may vary with other emerging influenza A viruses.

Testing with the influenza H5a and H5b primer and probe sets should not be performed unless the patient meets the most current U.S.Department of Health and Human Services (DHHS) clinical and epidemiologic criteria for testing suspect A(H5) specimens. The definitive identification of influenza A(H5) (Asian lineage) either directly from patient specimens or from virus cultures requires additional laboratory testing, along with clinical and epidemiological assessment in consultation with national influenza surveillance experts.

Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.

If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted unless a BSL 3E facility is available to receive and culture specimens.

The CDC Human Influenza Real-Time RT-PCR Diagnostic Panel is used in real-time RT-PCR (rRT-PCR) assays on an in vitro diagnostic real-time PCR instrument that has been FDA-cleared for use with the CDC device. The panel is configured in four separate kits. Each kit consists of oligonucleotide primers, fluorescently labeled hydrolysis probes, and controls which are used in rRT-PCR assays for the in vitro qualitative detection and characterization of influenza virus RNA in respiratory specimens from patients presenting with influenza-like illness (ILI) or from viral culture.

Oligonucleotide primers and probes for detection of influenza A, influenza B, and influenza A of swine origin were selected from highly conserved regions of the matrix (M), non-structural (NS), and nucleoprotein (NP) genes, respectively. Oligonucleotide primers and probes for characterization and differentiation of influenza A(H3) and A(H1)pdm09 viruses, avian influenza A(H5) viruses, and genetic lineages of influenza B were selected from highly conserved regions of their hemagglutinin (HA) genes. Oligonucleotide primers and probes to detect the human RNase P gene (RP) in control samples and clinical specimens is also included in the panel.

The provided document, K243274: CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, is an FDA 510(k) clearance letter. This document primarily describes the device, its intended use, and confirms its substantial equivalence to a previously cleared predicate device (K243931). Critically, it states that no analytical or clinical testing was performed for this specific modification, as the submission was to add a Predetermined Change Control Plan (PCCP).

Therefore, the document does not contain the detailed study results, acceptance criteria, sample sizes, ground truth establishment, or expert involvement for the original validation of the device's performance. It explicitly states that "The performance characteristics of the CDC Flu rRT-PCR Dx Panel... were previously established and remain the same as the predicate device (K243931)."

As such, I cannot provide the specific information requested in the prompt based on the provided text alone. The prompt asks for details of "the device" meeting acceptance criteria, and this document pertains to a modification that did not involve re-evaluating performance.

However, I can interpret what would typically be sought for such an analysis in the context of an in vitro diagnostic (IVD) PCR panel like the one described. I will outline what the acceptance criteria and the study that proves the device meets them would likely entail for an IVD, but with the explicit understanding that the provided document does not contain these details.

Based on the provided document, the device's performance characteristics were "previously established" for the predicate device (K243931) and are simply carried over here as "remaining the same." The current submission (K243274) is for adding a Predetermined Change Control Plan (PCCP) and states that "No analytical testing was performed for this modification" and "No clinical testing was performed for this modification."

Therefore, the detailed information regarding acceptance criteria, reported performance, sample sizes, expert involvement, and ground truth establishment for the original validation of this device is NOT present in the provided text. The tables and descriptions below represent what would typically be expected for an FDA cleared RT-PCR diagnostic panel, assuming the original studies were conducted to industry standards, but are not extracted directly from the given document.

Acceptance Criteria and Device Performance (Hypothetical for an RT-PCR IVD)

For a real-time RT-PCR diagnostic panel like the CDC Human Influenza Virus Panel, acceptance criteria and performance would typically focus on analytical sensitivity (Limit of Detection - LoD), analytical specificity (cross-reactivity, inclusivity), and clinical performance (sensitivity, specificity).

1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical)

Ask a specific question about this device