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The Falcon HST is an EEG and respiratory signal recorder. The device is intended for use by adult patients in the home or clinical environment, under the direction of a qualified healthcare practitioner, to aid in the diagnosis of sleep disorders.

The Falcon HST comprises hardware and software which provide separate parameters for recording, review, and analysis of collected and stored physiological parameters, including EEG, EOG, ECG and respiratory signals, which are then used as an aid in the diagnosis of respiratory and/or cardiac related sleep disorders by qualified physicians.

The Falcon system consists of the main unit and the charging cradle. The main unit is a small device that is worn on the patient's chest over clothing. It is equipped with a touch-screen LCD and contains various channel inputs such as for the inductive plethysmography bands, and electrodes. The Falcon charging cradle is used to charge the device, as well as provide a USB interface for transferring study data to the PC.

The manufacturer, Compumedics Limited, demonstrates the substantial equivalence of the Falcon HST to its predicate devices for aid in the diagnosis of sleep disorders. The acceptance criteria and the study that proves the device meets the acceptance criteria are described below.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Falcon HST are based on establishing substantial equivalence to its predicate devices, the Zmachine Synergy (K172986) and Zmachine DT-100 (K101830). The performance of the Falcon HST was deemed acceptable if its capabilities for recording EEG, respiratory effort, respiratory airflow, body position, and pulse oximetry, as well as its software's ability to produce AHI and sleep staging results, were found to be substantially equivalent to the predicate devices and gold standard polysomnography (PSG) data.

Study Details:

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

   • Bench Testing (Side-by-Side Comparison): The text does not specify the exact number of devices or data points used for the side-by-side bench comparison tests between the Falcon HST and Zmachine Synergy for EEG input, respiratory effort, respiratory airflow, body position, and pulse oximetry. The description implies at least one of each device was used, subject to repeated measurements or simulated inputs.
   • Clinical Performance Testing (Profusion PSG Software): The text does not provide a specific sample size for the clinical performance testing used to validate the software's ability to calculate AHI and sleep staging.
   • Data Provenance: The document does not explicitly state the country of origin or whether the data for the mentioned tests was retrospective or prospective. For bench testing, it involved simulated inputs or direct comparison against predicate devices. For clinical performance testing of the software, it's compared against "gold standard polysomnography data," implying real patient data.

2. 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):

   • For the clinical performance testing of the Profusion PSG software, the ground truth for AHI and sleep staging was established through "expert review of gold standard polysomnography data." The number of experts and their specific qualifications (e.g., years of experience, specific certifications) are not specified in the provided text.

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

   • The document does not specify an adjudication method for establishing ground truth, particularly for the clinical performance testing where expert review was used.

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:

   • The provided text does not mention an MRMC comparative effectiveness study involving human readers or any AI assistance. The study focuses on the device's equivalence to existing technology and the accuracy of its software against expert-reviewed data, not on human reader performance with or without AI assistance. The Falcon HST is an EEG and respiratory signal recorder, and its software is used to aid in the diagnosis by processing these signals, not primarily as an AI assistance tool for human interpretation in the context of what would typically be considered an MRMC study for AI.

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

   • For the hardware components (EEG, respiratory effort, airflow, body position, pulse oximetry), standalone performance testing was conducted by comparing the Falcon HST's output directly against that of the predicate devices or against angular references/simulated inputs.
   • For the Profusion PSG software 5.1, its ability to calculate AHI and sleep staging was validated by comparing its outputs directly against "expert review of gold standard polysomnography data." This indicates a standalone performance evaluation of the algorithm's output against established ground truth, effectively without human-in-the-loop for the algorithm's calculation step itself. The device is intended "to aid in the diagnosis," implying that its output will be reviewed by a human practitioner.

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

   • For testing the accuracy of AHI and sleep staging calculations by the Profusion PSG software, the ground truth used was expert review of gold standard polysomnography data.
   • For the bench testing of individual physiological parameters (EEG, respiratory effort, airflow, body position, pulse oximetry), the ground truth was established by comparison to the predicate device (Zmachine Synergy) or by using controlled simulated inputs and angular references.

7. The sample size for the training set:

   • The document does not provide any information regarding a training set size. This might be because the device's algorithms or software features (like sleep staging) may have been developed and validated previously, or the submission focuses on demonstrating equivalence to established technologies rather than novel algorithm training. The software, Profusion PSG software 5.1, is mentioned to be identical to versions previously cleared (K072201 and K093223), suggesting its core functionality and training (if any) happened prior to this submission.

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

   • As no information about a training set is provided, how its ground truth was established is not detailed in the document.

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The Falcon/Xpress is intended for use in the noninvasive evaluation of peripheral vascular pathology in patients. The Falcon/Xpress is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field. The Falcon/Xpress is to be used only by trained medical personnel in hospitals, clinics and physicians' offices by prescription or doctor's orders

The Falcon/Xpress is intended for use in the noninvasive evaluation of peripheral vascular pathology in patients . The Falcon/Xpress is a new model that is added to the cleared Falcon product family (K111416), which already includes the Falcon/Pro, Falcon/Quad and Falcon/ABI+ models. The Falcon/Xpress is similar to the other Falcon models in terms of technology, operation, software, intended use, applications, and accessories. The main differences are that the Falcon/Xpress supports 2 independent pressure channels (compared to 10 for the Pro and 4 for the Falcon/Quad and Falcon/ABI+), 2 PPG sensors (compared to 5 for the Pro and 4 for the Quad and ABI+), 2 Doppler ports (compared to 3 for the Pro and Quad and 0 for the ABI+), and no temperature sensor (compared to 1 for the Pro, Quad and ABI+). In addition, the Falcon/Xpress supports operation with an external battery and supports an 8-channel pressure selector (not available with the other Falcon models). The Falcon/Xpress supports an optional tablet, and can be mounted on a cart or within a dedicated bag. The Falcon/Xpress system is smaller in size, with dimensions of roughly 27x20x5.5 cm, compared to the Falcon legacy models with dimensions of 34x31x9.5 cm. In addition, the Falcon/Xpress system weighs roughly 2 kg, compared to roughly 4 kg for the Falcon legacy models. Similar to the other Falcon models, the Falcon/Xpress is based on pneumatic technology to measure systolic blood pressures and Pulse Volume Recording waveforms (PVR) at various peripheral limb sites. Similarly, the Falcon/Xpress includes the same Continuous Wave (CW) Doppler technology as the other Falcon models to allow measurements of blood flow velocities in peripheral blood vessels. The Falcon/Xpress also supports the same Photo-Plethysmography technology (PPG) as the other cleared Falcon models. The above-mentioned technologies allow the Falcon/Xpress to perform peripheral vascular diagnosis measurements in a similar manner to the cleared Falcon models (K111416), including the measurements of segmental systolic blood pressures, the Ankle-Brachial pressure index, PVR measurement, PPG measurements, and blood flow velocity measurements. The measurements support dedicated specialty test protocols such as measurements under various stress conditions, thoracic outlet syndrome, raynaud's syndrome, pulse wave velocity, penile function, venous reflux, venous capacitance and outflow, palmar arch test, arterio-venous fistula, and similar. All of the specialty tests simply use the measurements according to dedicated protocols and display for the evaluation of specific medical conditions. The pressure cuffs are connected to the air tubes via "Bayonet" connectors or Viasonix Vfit connectors. Both of these options are designed to avoid potential misconnections by being incompatible with standard Luer connectors or other connectors used for nonvascular applications.

The provided text is an FDA 510(k) summary for the Falcon/Xpress device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for assessing performance against specific acceptance criteria for AI integration.

Therefore, many of the requested details, particularly regarding acceptance criteria for AI performance, sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone AI performance, and AI-specific training/ground truth, are not available in this document. The document explicitly states "No clinical study was conducted to support this application."

However, I can extract information related to the device's characteristics and the non-clinical testing performed to show its equivalence to the predicate device.

Here's an attempt to answer your questions based on the provided text, while acknowledging the limitations:

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

The document does not specify quantitative acceptance criteria in terms of AI model performance (e.g., AUC, sensitivity, specificity) because it's not a study of AI performance, but rather a submission for substantial equivalence based on device characteristics. Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to the predicate device and compliance with relevant standards. The reported performance is an assertion of equivalency of the new model to the predicate device through non-clinical testing.

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

• Sample Size: Not applicable/not stated. The submission relies on non-clinical bench testing and substantial equivalence to a predicate device, not a clinical study with a specific test set of patient data for performance evaluation.
• Data Provenance: Not applicable, as there was no clinical data test set.

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

• Not applicable. No clinical test set with expert ground truth was used for this 510(k) submission.

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

• Not applicable. No clinical test set.

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. The document explicitly states: "No clinical study was conducted to support this application." This device is not an AI-assisted diagnostic tool in the sense of image interpretation for which an MRMC study would typically be performed.

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

• Not applicable. This is not an AI algorithm submitting standalone performance data. The device itself is a diagnostic instrument, not solely an AI algorithm. Its performance is evaluated through its physical and software functionality as a whole unit, which is compared to its predicate.

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

• For the non-clinical testing, the "ground truth" would be established by validated test methods, reference standards, and specifications against which the device's components and integrated system are measured. For example:
  • Pressure measurements: Calibration against known pressure standards.
  • Doppler frequencies: Measurement against known frequency sources.
  • Software functionality: Verification and validation against software requirements and design specifications.
  • Safety/EMC: Compliance with international standards (IEC 60601 series).

8. The sample size for the training set

• Not applicable. This document does not describe the development or performance of an AI model that would require a "training set" in the machine learning sense. It's a medical device.

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

• Not applicable, as there was no AI training set as described in the context of this submission.

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The Falcon Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the Falcon Spacer should be packed with autogenous bone graft (i.e. autograft).

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

The Falcon Spacer is intended to be used with supplemental fixation.

The Falcon Spacer is a radiolucent, oval-shaped spacer intended to be used as an interbody fusion device in conjunction with supplemental fixation. Pyramidal teeth that assist in further stabilization of the construct are located on the inferior and superior surfaces of the spacer. The Falcon Spacer implant may be used to accommodate varying anatomical requirements and is available in a range of heights, sizes and angles. The open architecture of the device is intended to be packed with autogenous bone (i.e., autograft).

The Falcon Spacer is manufactured from Invibio® PEEK-Optima® LT-1 (ASTM F2026) with four (4) tantalum radiopaque pins (ASTM F-560); The markers allow intra-operative radiographic assessment of the position of the implant.

The provided text describes the 510(k) summary for the Falcon Spacer. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state acceptance criteria in terms of specific thresholds or pass/fail conditions for each test. Instead, it lists the types of tests performed to demonstrate substantial equivalence to predicate devices. The "reported device performance" is implicitly that the device passed these tests and was deemed substantially equivalent.

• Static Axial Compression
• Dynamic Axial Compression
• Static Compression Shear
• Subsidence
• Expulsion
  Conclusion: Falcon Spacer is substantially equivalent to predicate devices based on contained information. |
  | Material Biocompatibility | Manufactured from Invibio® PEEK-Optima® LT-1 (ASTM F2026) with tantalum radiopaque pins (ASTM F-560), generally recognized as safe and biocompatible materials for implantable devices. | Materials Used: Invibio® PEEK-Optima® LT-1 (ASTM F2026) for the spacer body, and four (4) tantalum radiopaque pins (ASTM F-560) for markers. |
  | Radiopacity | Markers allow intra-operative radiographic assessment of implant position. | Radiopaque Markers: Four (4) tantalum radiopaque pins facilitate intra-operative radiographic assessment of position. |

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

The document describes non-clinical bench testing. For such tests, the "sample size" typically refers to the number of test articles (e.g., spacers) subjected to each specific test. This specific number is not explicitly stated in the provided 510(k) summary.

Data Provenance: The data is generated from bench testing conducted by Synthes Spine. It is not clinical data from patients. Therefore, terms like "country of origin" or "retrospective/prospective" are not applicable in the usual sense for clinical studies. It would be an internal lab study.

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

Not applicable. This device underwent non-clinical bench testing, not a study requiring expert-established ground truth related to patient data or image interpretation. The "ground truth" for these tests would be the established engineering standards, test methods (e.g., ASTM F-2077), and performance characteristics of the predicate devices.

4. Adjudication method for the test set

Not applicable. As this was non-clinical bench testing, there was no "adjudication method" in the sense of reconciling divergent expert opinions on clinical findings. The results of the mechanical tests are objective measurements.

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

Not applicable. The Falcon Spacer is a physical medical device (interbody fusion spacer), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant.

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

Not applicable. The Falcon Spacer is a physical medical device, not an algorithm.

7. The type of ground truth used

The ground truth used for the non-clinical testing was based on established engineering standards, ASTM F-2077 guidance for spinal implant testing, and the known performance characteristics of the legally marketed predicate devices. The goal was to demonstrate that the Falcon Spacer performed mechanically equivalent to these predicates.

8. The sample size for the training set

Not applicable. This product is a physical medical device. It does not involve AI or machine learning, and therefore does not have a "training set" in that context.

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

Not applicable, for the same reasons as #8.

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The Falcon/Pro, Falcon/Quad, and Falcon/ABI+ are intended for use in the noninvasive evaluation of peripheral vascular pathology in patients.

The devices are not intended to replace other means of evaluating vital patient physiological processes, are not intended to be used in fetal applications, and are not intended to be used inside the sterile field.

They are to be used by trained medical personnel in hospitals, clinics and physicians offices by prescription or doctor's orders.

The Falcon/Pro, Falcon/Quad, and Falcon/ABI+ systems are part of the Falcon product family of non-invasive peripheral vascular diagnostic systems. The Falcon/Pro is a complete peripheral vascular system that supports 10 independent pressure channels, 5 PPG sensors, 3 Doppler frequencies, and a temperature sensor. The Falcon/Quad and the Falcon/ABI+ systems are merely sub-assemblies of the Falcon/Pro system. Both support only 4 pressure channels, 4 PPG sensors and a temperature sensor. The Falcon/Quad also includes support for the 3 Doppler frequencies, while the Falcon/ABI+ does not support any Doppler features.

The Falcon/Pro and its' sub-assemblies Falcon/Quad and Falcon/ABI+ share the same hardware and software. While the main printed circuit board (PCB) is identical, the pneumatic components such as pumps, valves, sensors and check valves are assembled in the Falcon/Quad and Falcon/ABI+ to support only 4 pressure channels. In addition, one PPG sensor is omitted from the assembly of these systems. Furthermore, the Doppler board with its' PCB mount probe connectors is not assembled in the Falcon/ABI+ system. The same metal enclosure and connectors are used for the Falcon/Pro. Falcon/Quad, and Falcon/ABI+. The only difference lies in the front panel which is adapted according to the number of PPG sensors and Doppler probes.

The software level of concern for the Falcon products is determined as Moderate. The software of the Falcon/Pro, Falcon/Quad, and Falcon/ABI+ systems is practically identical. The only software differences are as follows: the Falcon/Pro supports 10 pressure cuffs (tubing marked in red, blue, green, yellow, orange, and white with lines in red. blue, green, yellow, and orange), while the sub-assemblies support only 4 pressure cuffs (tubing marked in red, blue, green, yellow); the Falcon/Pro supports 5 color coded PPG sensors (red, blue, green, vellow and black) while the sub-assemblies support only 4 such sensors (red, blue, green, yellow); the default examination protocols are adapted according to the supported sensors and probes; the maximal protocol group allowed with the Falcon/Pro is 10. while the maximal allowed group for the sub-assemblies is 9: and the Falcon/ABI+ does not support any of the Doppler options and features.

All other software features are identical for the Falcon/Pro and the 2 sub-assemblies Falcon/Quad and Falcon/ABI+. Some of the main features include patient details and patient database management; Dicom connectivity; printing configuration and printing options; writing examination reports; summary screen support; configuration and management of examination protocols: measurement site configuration: export in various formats: import of VSX files; backup features; restoring backup data: online help options: and review stations. All of the standard signal control options and signal display options. as well as measurement calculations, are identical for all 3 systems (excluding Doppler related options for the Falcon/ABI+ system).

The quantitative measurements are the same for Falcon/Pro and the 2 sub-assemblies Falcon/Quad and Falcon/ABI+. The main measurement of the 3 systems is segmental systolic blood pressures. In general, the measurement is conducted by applying an appropriately sized cuff to the measured segment, obtaining a reference PPG or a Doppler signal in a location distal to the cuff placement, and then inflating the cuff to such a pressure that will occlude the blood vessels and prevent blood flow distal to the cuff location, which will result in disappearance of the reference signal. Then, a slow cuff deflation begins, and the instantaneous cuff pressure at which the reference signal reappears is typically defined as the segmental systolic blood pressure. While the software automatically places a cursor at the time location which is suspected as being the systolic pressure, it is the total responsibility of the system operator and the medical staff to modify the cursor location according to their medical training, and define the correct segmental pressure.

Based on the segmental pressures, the pressure indices are calculated, as the ratio between the systolic segmental pressure, and the higher of the 2 brachial systolic pressures. The ABI index is a commonly used index, which is a specific case of the above, calculated as the systolic right or left ankle pressure, divided by the higher of the right or left brachial systolic pressure.

The standard main Doppler parameters that are calculated (not for the Falcon/ABI+ system), include: Mean, representing the time-average value of the envelope (maximal velocity/frequency) over one cardiac cycle; Peak, representing the maximal systolic velocity/frequency during a cardiac cycle, in units of cm/sec or KHz; Diast, representing the minimal diastolic velocity/frequency during a cardiac cycle, in units of cm/sec or KHz; PI, representing the Gosling Pulsatility Index, calculated based on the peak envelope as (peak systolic velocity - minimal diastolic velocity) / mean velocity; RI. representing the Pourcelot Resistance Index. calculated based on the peak envelope as (peak systolic velocity - minimal diastolic velocity) / peak systolic velocity; S/D. representing the systolic to diastolic flow ratio, and is calculated based on the peak envelope as: (peak systolic velocity / minimal diastolic velocity); and HR, representing heart rate in beats (number of cardiac cycles) per minute.

Additional parameters that are displayed are related to the specialty tests. During stress testing, a digital timer indicates the duration of the exposure to stress (for example the total time the patient exercised), and the recovery time for each measurement (the time that passed since the end of stress exercise and the current measurement). During venous reflux testing the system automatically places vertical cursors that denote the minimal PPG signal after sequential leg dorsiflexions and the point in time that the PPG signal returns to pre-dorsiflexion baseline. The time difference between these 2 cursors is calculated and referenced as the VRT (venous refill time). It is the responsibility of the examiner to determine the correct vertical cursor position, hence adjusting the VRT parameter. Likewise, the MVO/SVC ratio is based on the horizontal baseline and plateau signals, and the rate of signal drop immediately after rapid deflation of the thigh cuff. Again, it is the responsibility of the examiner to determine the correct cursor positions for the parameter calculation.

The Falcon complies with Class B EMC requirements. Therefore, the Falcon is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

The provided text describes the Falcon/Pro, Falcon/Quad, and Falcon/ABI+ systems, which are non-invasive peripheral vascular diagnostic systems. However, it does not contain information about specific acceptance criteria or a study proving that the device meets those criteria with statistical measures of performance like accuracy, sensitivity, or specificity. Instead, it focuses on demonstrating substantial equivalence to predicate devices.

The document indicates that the devices have undergone "extensive safety, performance testing, and validation" and that "various performance testing" was conducted to ensure they meet their functional specifications. It also mentions compliance with several international safety and electrical standards (EN 60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62304, ISO 14971).

Since explicit acceptance criteria and corresponding performance data are not provided, the following table and subsequent sections highlight what is mentioned and what is missing.

Table of Acceptance Criteria and Reported Device Performance

Detailed Breakdown of Missing Information as Per Request:

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

   • As shown above, the document largely refers to compliance with safety and functional specifications broadly. There are no explicit, quantifiable acceptance criteria related to diagnostic performance (e.g., accuracy thresholds for ABI, Doppler velocity measurements) and no reported device performance data against such criteria. The submission states that "the devices meet all of their functional specifications," but these specifications are not detailed or quantified in terms of diagnostic output validity or reliability.

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

   • Not provided. The submission does not describe any specific clinical test set, its size, or its provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not provided. Since no specific test set or clinical study demonstrating diagnostic performance is described, there's no mention of experts establishing ground truth. The document mentions that it is the "total responsibility of the system operator and the medical staff to modify the cursor location according to their medical training" for segmental blood pressure and other parameters, indicating the device relies on expert interpretation during use.

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

   • Not applicable/Not provided. No specific test set for diagnostic performance is detailed in this submission.

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

   • Not applicable/Not provided. The device described is a non-invasive peripheral vascular diagnostic system, not an AI-assisted diagnostic tool for human readers in the typical sense of imaging review. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's description. The submission focuses on substantial equivalence based on device features and general function to predicate devices, not on a human-AI interaction study.

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

   • Not applicable/Not provided. The Falcon devices are diagnostic instruments that capture physiological signals (pressure, PPG, Doppler) and perform calculations based on these signals. While the software automatically places cursors for certain measurements, the submission explicitly states that "it is the total responsibility of the system operator and the medical staff to modify the cursor location according to their medical training." This indicates intended human-in-the-loop operation, and no mention of a standalone algorithm-only performance study is made.

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

   • Not provided. No specific ground truth methodology is described in relation to a study proving diagnostic accuracy. The device produces quantitative measurements (segmental systolic blood pressures, ABI, Doppler parameters, VRT, MVO/SVC ratio) that are then interpreted by medical staff. The document focuses on the correct functioning and calculation capabilities of the device itself, not on its diagnostic accuracy against a clinical gold standard.

8. The sample size for the training set:

   • Not applicable/Not provided. The device does not appear to be an AI/machine learning device that requires a "training set" in the conventional sense. It's a measurement and calculation device for physiological signals.

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

   • Not applicable/Not provided. As above, there is no mention of a training set or its associated ground truth establishment.

Summary of the Document's Focus:

This 510(k) submission primarily emphasizes:

• Device Description: Detailing the hardware and software components and functionality of the Falcon/Pro, Falcon/Quad, and Falcon/ABI+ systems.
• Substantial Equivalence: Comparing the new devices to legally marketed predicate devices (Vasoguard and Multilab Series II) based on features, intended use, performance capabilities (e.g., number of pressure channels, PPG sensors, Doppler frequencies, specialty tests), and compliance with general safety and performance standards.
• Safety and Standards Compliance: Stating that the devices meet various electrical and medical device standards (EN, IEC, ISO).
• User Responsibility: Highlighting that medical staff are ultimately responsible for interpreting the data and adjusting cursors for measurements.

The submission does not include data from clinical trials or performance studies that would typically provide specific acceptance criteria and detailed quantitative diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) against a defined ground truth for conditions like peripheral vascular pathology. The approval is based on demonstrating substantial equivalence to existing devices already on the market rather than on new clinical performance data.

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The FALCON® IVF Four Well Plate is sterile, nonpyrogenic, embryotoxicity tested, singleuse plasticware intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF) or other assisted reproduction techniques.

The FALCON® IVF Four Well Plate is sterile (SAL of 10%), non-pyrogenic by Limulus Amebocyte Lysate (LAL of

The provided text describes a 510(k) summary for the FALCON® IVF Four Well Plate, a medical device used in assisted reproduction. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria. The provided text focuses on the device description, intended use, and substantial equivalence to a predicate device, as required for a 510(k) submission.

Based on the available information, here's what can be extracted and what cannot:

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

The document mentions several characteristics that serve as performance criteria for the device. These are inherent properties of the plate that ensure its suitability for IVF procedures.

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The FALCON® IVF Round Dish is intended for use in preparing, storing, manipulating, or transferring human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other reproduction procedures.

The FALCON® IVF Round Dish is sterile, nonpyrogenic, embryotoxicity tested, single-use plasticware intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF) or other assisted reproduction techniques.

The FALCON® IVF Round Dish is sterile (SAL of 10.9), non-pyrogenic by Limulus Amebocyte Lysate (LAL) assay (LAL of

The provided document is a 510(k) summary for the FALCON® IVF Round Dish, a medical device for use in assisted reproduction. The information provided outlines the device description, intended use, and substantial equivalence to a predicate device. However, it does not contain any data from a clinical or performance study to prove the device meets specific acceptance criteria.

The document primarily focuses on:

• Device Identification: Name, classification, and contact information.
• Substantial Equivalence: Claiming equivalence to existing devices based on regulatory reclassification.
• Device Characteristics: Describing it as sterile, non-pyrogenic, non-embryotoxic, made from specific materials, and with certain physical dimensions and features.
• Intended Use: For preparing, storing, manipulating, or transferring human gametes or embryos in IVF and other assisted reproduction procedures.
• FDA Clearance: The letter from the FDA confirming clearance based on substantial equivalence.

Therefore, I cannot provide a table of acceptance criteria with reported device performance or details about a study that proves the device meets those criteria, as this information is not present in the provided text.

Based on the nature of this 510(k) submission (which focuses on substantial equivalence for a labware device), a formal clinical trial with human subjects or a comparative effectiveness study with AI is highly unlikely to have been performed or required for this type of product clearance in 1999. The "studies" mentioned are laboratory tests to demonstrate sterility, non-pyrogenicity, and non-embryotoxicity, which are standard for this class of device.

Below is an outline of the types of information requested, with an explanation of why it cannot be provided from the given text:

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

• Cannot be provided from the text. The document lists characteristics like "sterile (SAL of 10.9)," "non-pyrogenic by Limulus Amebocyte Lysate (LAL) assay (LAL of

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The FALCON® IVF Round Dish is intended for use in preparing, storing, manipulating, or transferring human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other reproduction procedures.

The FALCON® IVF One Well Dish is sterile, nonpyrogenic, embryotoxicity tested, singleuse plasticware intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF) or other assisted reproduction techniques.

The FALCON® IVF One Well Dish is sterile (SAL of 10-9, non-pyrogenic by Limulus Amebocyte Lysate (LAL of

The provided text describes a 510(k) submission for the FALCON® IVF One Well Dish. This document, however, focuses on regulatory approval and substantial equivalence to a predicate device, rather than a clinical study evaluating the device's performance against specific acceptance criteria in the manner typically associated with medical imaging or diagnostic AI devices.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC study, training set, ground truth methods) are not applicable to the information provided.

Based on the provided text, here's what can be extracted and what cannot:

Acceptance Criteria and Device Performance:

The "acceptance criteria" for this device are primarily related to its manufacturing quality and safety for its intended use, rather than a quantifiable performance metric for accuracy or effectiveness in a clinical diagnostic sense. The text highlights the following characteristics:

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These anaesthesia machines are apparatus for providing continuous gas inhalation for adults and children (neonatal and paediatric). They allow the administration of operator selected gas mixtures of oxygen, nitrous oxide and air with any of the anaesthetic agents; Halothane, Isoflurane, or Sevoflurane. They provide safe and accurate gas flows to maintain patient respiration during anaesthesia, and incorporate a ventilator, an oxygen monitor and a respiratory monitor. The ventilator provides the necessary power, as air or oxygen, to generate volumes and pressures in the ventilating system to ventilate a patient connected to the anaesthesia machine. They are recommended for use only by trained physicians, in the operating room or similar surgical environments.

These anaesthesia machines are apparatus for providing continuous gas inhalation for adults and children (neonatal and paediatric). They allow the administration of operator selected gas mixtures of oxygen, nitrous oxide and air with any of the anaesthetic agents; Halothane, Isoflurane, or Sevoflurane. They provide safe and accurate gas flows to maintain patient respiration during anaesthesia, and incorporate a ventilator, an oxygen monitor and a respiratory monitor. The ventilator provides the necessary power, as air or oxygen, to generate volumes and pressures in the ventilating system to ventilate a patient connected to the anaesthesia machine. They are recommended for use only by trained physicians, in the operating room or similar surgical environments.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. The document is an FDA 510(k) clearance letter for the "MIE Falcon Anaesthesia Machine fitted with the Kestrel Anaesthesia Ventilator" and "Datex Flexima II Anaesthesia Machine fitted with the Flexivent II Anaesthesia Ventilator."

It outlines the FDA's "substantially equivalent" determination for these anesthesia machines for gas inhalation for adults and children, including administration of specific anesthetic agents and monitoring capabilities. However, it does not include the detailed technical performance criteria or the results of a study designed to prove the device meets such criteria.

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