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The NavajoTM PTA balloon dilatation catheter is intended to dilate stenoses in the peripheral arteries (iliofemoral, popliteal, infra popliteal, renal arteries); and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

The Navajo™ PTA Balloon Dilatation Catheter is an over-the-wire Percutaneous Transluminal Angioplasty (PTA) catheter consisting of a proximal adaptor, coaxial lumen shaft, and a distal dilatation balloon. The Navajo PTA Balloon Dilatation Catheter is compatible with guide wires with a maximum diameter of 0.035" and with 5F to 7F introducer sheaths, depending on the diameter and balloon length of the dilatation balloon. The catheter is provided with a hydrophilic coating on the shaft and is available in useable catheter lengths of 80, 100, 120 and 130cm.

The provided document describes the Navajo™ PTA Balloon Dilatation Catheter and its substantial equivalence to a predicate device, the AgilTrac .035 Peripheral Dilatation Catheter (K022738). The document summarizes performance testing but does not provide specific acceptance criteria or detailed study results with exact performance metrics in a way that directly translates to the requested table format for "reported device performance."

Therefore, the response below will reconstruct the information where possible and explicitly state what is not available based on the provided text.

Acceptance Criteria and Device Performance

The document states, "All tests confirmed the products met the pre-defined acceptance criteria." However, the specific quantitative acceptance criteria for each performance test are not explicitly provided, nor are the exact numerical "reported device performance" values. Instead, a list of performance tests is given. For some characteristics (e.g., Rated Burst Pressure), the comparison to the predicate device implies acceptable performance.

Note: The table below summarizes the types of performance characteristics tested. Actual numerical acceptance criteria and reported performance values are not detailed in this document.

Detailed Study Information (Based on provided text):

The document describes pre-clinical (bench) testing rather than a clinical study involving patients or human readers. Therefore, several requested categories are not applicable.

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

   • Sample Size: Not explicitly stated for specific tests. The document refers to "Navajo™ PTA Balloon Dilatation Catheters" in plural, implying multiple units were tested.
   • Data Provenance: Not specified, but generally refers to in-house laboratory testing (bench testing) as implied by the nature of the "Performance Testing" listed. It is retrospective in the sense that the tests were completed and then reported.

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

   • Not Applicable. This was not a study requiring expert readers to establish ground truth for clinical outcomes or image interpretations. The "ground truth" was established by engineering specifications and objective measurements against defined standards.

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

   • Not Applicable. No human adjudication process is mentioned or implied for these types of engineering performance tests.

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

   • No. This was not an AI-assisted diagnostic or interpretative device, nor was it a human factors study. It was a physical medical device performance study.

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

   • Not Applicable. This device does not involve an algorithm performed in a standalone manner.

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

   • The "ground truth" for the performance tests was based on engineering specifications, regulatory standards (ISO), and objective physical measurements. For example, a "Rated Burst Pressure" test would compare the actual burst pressure of the balloon against a predetermined, specified safe operating pressure.

7. The sample size for the training set:

   • Not Applicable. This is a physical medical device, not an AI or machine learning model that undergoes "training."

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

   • Not Applicable. As above, no training set for an algorithm was involved.

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The Curasa AUTO CPAP (Continuous Positive Airway Pressure) with heated humidifier system is intended for the treatment of Obstructive Sleep Apnea only in spontaneously breathing patients weighing >30 kg. It is for use in the home or hospital /institutional environment.

The Curasa AUTO CPAP System with heated humidifier is used on adult patients for treatment of obstructive sleep apnea (OSA). The Auto CPAP system provides a stable continuous positive airway pressure (CPAP). The Auto mode detects breathing phenomena (e.g. snore, hypopnea) and automatically adjusts the delivered pressure. The humidifier provides warm, humidified air for comfort to the patient, reducing nose and airway dryness. The Curasa AUTO CPAP system includes the following accessories: a power supply, a Patient Air Circuit, and a U-tube connection between CPAP and humidifier. All of the accessories provided with the Curasa AUTO CPAP are identical to those provided with the predicate Curasa CPAP SD (K123897).

The Auto CPAP system has been modified based Curasa CPAP SD (K123897) hardware and software. The design of the humidifier and humidifier interface is identical to the referenced predicate device (Curasa CPAP SD, K123897). The basic function and performance characteristics of Curasa AUTO CPAP are similar to the referenced predicate device (Curasa CPAP SD K123897). The Auto mode of operation is similar to the referenced predicate, Respironics Remstar Auto CPAP (K012554).

The Curasa AUTO CPAP with Heated Humidifier System is intended for the treatment of Obstructive Sleep Apnea (OSA). The studies performed for this device included compliance with a number of electrical safety, biocompatibility, and performance standards, as well as a clinical study.

1. Table of Acceptance Criteria and Reported Device Performance

• Pressure Range: 4-20 cm H2O
• Pressure Stability: 4-20 cm H2O, +/- 2.0 cm H20
• Maximum Flow: 35 LPM | Pass (ISO 17510 compliant:
• Pressure Range: 4-20 cm H2O
• Pressure Stability: 4-20 cm H20 +/- 2.0 cm H20
• Maximum Flow: 35 LPM) |
  | Biocompatibility | ISO 10993-3: Genotoxicity, Carcinogenicity and Reproductive Toxicity
  ISO 10993-5: Tests for in vitro cytotoxicity
  ISO 10993-6: Test for local effect after implantation
  ISO 10993-10: Tests for irritation and skin sensitization
  ISO 10993-12: Sample Preparation and reference materials | Pass (Biocompatibility Tests - leveraged from predicate) |
  | Software | IEC 62304: Medical Device Software Software Life Cycle Process | Pass (Software Verification Testing) |
  | Environmental | IEC 60068-2-6: Environmental Testing -- Test FC: Vibration (sinusoidal)
  IEC 60068-2-34: Environmental Testing Test FC: Vibration (Random)
  IEC 60068-2-27: Basic Environmental Testing Procedure: Test Ea and guidance: Shock | Pass (Shock and Vibration Testing) |
  | Sound | Not explicitly defined, but generally related to acceptable noise levels for medical devices. | Pass (Sound Testing) |
  | Air Quality | Not explicitly defined, but related to user safety regarding airborne particles and volatile organic compounds. | Pass (VOC and PM2.5 Testing) |
  | Predicate Comparison (Functional Equivalence) | No statistical difference in AHI and SpO2 compared to predicate Respironics Auto CPAP. | Results showed that the Curasa AUTO CPAP is effective and that there is no statistical difference between the Curasa AUTO CPAP and the predicate Respironics Auto CPAP device based on AHI (Apnea/Hypopnea Index), minimum SpO2, and average SpO2. |
  | System and User Interface | Not explicitly defined, but generally refers to the device's operational functionality and ease of use. | Pass (System and User Interface Testing) |
  | IFU Validation | Not explicitly defined, but generally refers to ensuring the Instructions for Use are clear, complete, and accurate. | Pass (IFU Validation Testing) |
  | Safety (IPX1 / ESD) | IPX1 (Drip Proof Equipment) and Class II Electrical shock protection. | Pass (IPX1 / ESD) |
  | Reliability | Not explicitly defined, but generally refers to the consistent performance over time. | Pass (Reliability Test - leveraged from predicate) |
  | Packaging | Not explicitly defined, but generally refers to the ability of the packaging to protect the device during transport and storage. | Pass (Packaging Test - leveraged from predicate) |

2. Sample Size for the Test Set and Data Provenance

• Sample Size: 60 adult patients diagnosed with Obstructive Sleep Apnea (OSA).
• Data Provenance: Clinical study conducted at two (2) hospitals in China.
• Retrospective or Prospective: Prospective, as patients were enrolled and underwent a 3-night study protocol specifically for this evaluation.

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

The document does not specify the number or qualifications of experts used to establish the "ground truth" for the test set in the clinical study. However, the study involved Polysomnography (PSG) for diagnosing OSA and recording AHI and SpO2, which implies interpretation by trained sleep specialists or technicians.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the test set. It mentions that AHI, minimum SpO2, and average SpO2 were recorded by PSG, and p-values were calculated for before and after treatment groups, and for trial and control groups. This implies direct measurement and statistical comparison rather than a human reader adjudication process for the primary endpoints.

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

A MRMC comparative effectiveness study involving human readers and AI assistance was not performed. The clinical study compared the Curasa AUTO CPAP system's performance to a predicate device (Respironics Auto CPAP) in treating OSA patients, not the performance of human readers with or without AI assistance.

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

The device itself is an automated CPAP system, implying it operates "standalone" in its function of automatically adjusting pressure based on detected breathing phenomena. The clinical study evaluated the effectiveness of this automated function. However, the term "standalone performance" often refers to an algorithm's performance against a ground truth in an AI/imaging context, which is not directly applicable here. The clinical study assessed the overall device (hardware + embedded algorithms) performance in vivo.

7. The Type of Ground Truth Used

The ground truth for the clinical study was established using objective physiological measurements from Polysomnography (PSG). Specifically, AHI (Apnea/Hypopnea Index), minimum SpO2 (Pulse Oximeter Oxygen Saturation), and average SpO2 were recorded by PSG. These are standard, objective metrics for assessing the severity and treatment effectiveness of Obstructive Sleep Apnea.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" sample size. The clinical study enrolled 60 patients to evaluate the device's performance, implying this dataset was for verification/validation rather than training a machine learning model from scratch. Given the device's "Auto mode" functionality is described as "similar to the referenced predicate, Respironics Remstar Auto CPAP (K012554)," it's likely the auto-adjusting algorithm was developed and refined using prior knowledge and potentially internal datasets, but this information is not provided for the Curasa device.

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

As no "training set" is explicitly mentioned for the Curasa AUTO CPAP's auto-adjustment algorithm within this document, the method for establishing its ground truth for training is not provided. If the auto-mode algorithm was adapted from the predicate, then its initial ground truth would have been established during the predicate's development.

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The K Series CPAP System, is designed for the treatment of Obstructive Sleep Apnea only in spontaneously breathing patients weighing >30 kg. It is intended to be used in the home or hospital/institutional environment.

The K Series CPAP systems are used on adult patients for treatment of obstructive sleep apnea (OSA). The K Series CPAP Systems has 3 commercially available models, Curasa CPAP (K120285), Floton CPAP (K120285), and Curasa CPAP SD (K123897). This 510(k) application adds the Curasa CPAP EUT model to the currently commercially available selection of models. as well as the AutoManager PC Software accessory. The K series CPAP system provides a stable continuous positive airway pressure (CPAP). The humidifier, which works with all the K Series CPAP Systems, provides warm, humidified air for comfort to the patient, reducing nose and airway dryness. Each K Series CPAP system also includes the following accessories: a power supply, a Patient Air Circuit, and a U-tube connection between CPAP and humidifier. The Curasa CPAP EUT has the same electronic design and similar software as the Curasa CPAP SD, except for the addition of EUT (expiratory unload trigger) feature. The EUT feature detects patient exhalation phase and reduces output pressure. EUT feature has 3 levels of pressure reduction. The CPAP EUT also works with a special accessory PC software tool, AutoManager™ AutoManager™ is used by the service provider to analyze the patient's CPAP compliant data and, if needed, update the CPAP pressure setting via the CPAP's SD card. The AutoManager™ software collects/updates CPAP device data via an SD card. The AutoManager™ PC software is an independent accessory to the CPAP device and runs on a stand-alone PC and not on the CPAP device itself.

This document describes the Curasa CPAP EUT with AutoManager PC Software accessory, a device intended for the treatment of Obstructive Sleep Apnea. The information provided focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and study results for a novel device. As such, many of the requested elements (like sample size for test set, number of experts, adjudication methods, MRMC studies, specific ground truth types for training, effect size with AI) are not directly applicable or available in the provided text, as this is a 510(k) submission primarily focused on demonstrating equivalence through standard compliance and comparative design.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table of specific acceptance criteria with quantitative thresholds for performance metrics. Instead, it lists compliance with various standards and successful completion of design verification tests, all reporting "Pass." The "acceptance criteria" here are implicitly linked to meeting the requirements of these standards and completing the specified tests without failure, thus demonstrating substantial equivalence rather than a novel performance claim.

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

• Sample Size: The document mentions "IFU Validation Testing (patients)", indicating that some patient data was used. However, the specific sample size for this test or any other test set is not provided.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.

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

This information is not provided in the document. The study described focuses on technical compliance and equivalence.

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

This information is not provided.

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

• MRMC Study: No MRMC comparative effectiveness study was done or mentioned. This submission does not involve AI for diagnostic purposes or human reader assistance.
• Effect Size of AI Improvement: Not applicable, as this device does not incorporate AI for diagnostic assistance.

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

• Standalone Performance: The "Software Verification Testing" and "AutoManager Software Verification Testing" represent standalone testing of the software components. However, this is for functional verification of the CPAP device and its accessory software, not for an algorithm-only diagnostic or AI performance evaluation. The device itself is "algorithm only" in its automated pressure adjustment, but its primary function is therapeutic, not diagnostic.

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

The document does not explicitly state the type of ground truth used for performance evaluation, as it primarily relies on established engineering and safety standards. For the "IFU Validation Testing (patients)", the ground truth would likely be related to patient comprehension and ability to use the device as intended, potentially assessed through observation or questionnaires, but this is not detailed. For software testing, the ground truth would be the expected functional behavior based on design specifications.

8. The sample size for the training set:

Not applicable, as this device does not involve machine learning or AI models with a distinct "training set" in the context of this submission. The development process would involve iterative testing and refinement, but this is not a traditional AI training set.

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

Not applicable, for the same reasons as point 8.

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The BestFit™ and BestFit™2 Nasal Masks are intended for multiple use on adult patients (body weight >30kg) prescribed with using continuous positive airway pressure (CPAP) or bilevel ventilator system in hospital, clinic and/or home environment.

The BestFit™ Nasal Masks are patient interface devices used on adult patients prescribed with CPAP and Bi-Level Positive Airway Pressure therapy. The BestFit product family consists of two models, BestFit and and BestFit 2. Both models have same function and performance, except for a slight difference in the forehead design. Both devices are vented and can be used multiple times in a hospital, clinical and/or home environment. The nasal mask style covers and seals around the patient's nose and delivers positive pressure from the therapy device to the patient via the patient air circuit of the CPAP device. The BestFit Nasal Masks include the following accessories: headgear and Instructions for Use (IFU). The model BestFit Nasal mask is available in 4 different sizes: Small (S), Medium (M), Large (L), and Medium Wide (MW). The model BestFlt 2 Nasal mask is available in 3 different sizes: Small (S), Medium (M), and Large (L).

The provided K130663 submission describes the BestFit™ Nasal Masks and their substantial equivalence to a predicate device, Resmed Ultra Mirage II (K050359). The submission outlines various tests performed to demonstrate compliance with product specifications and relevant standards.

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

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly present a discrete "acceptance criteria" table for the BestFit Nasal Mask models. Instead, it provides a comparative table where the predicate device's performance is the de facto acceptance criterion for several parameters. The "Comparison" column in the table implicitly indicates whether the BestFit models meet or are comparable to the predicate.

Here's a summarized table derived from the "Comparison" section, highlighting parameters where specific performance values are listed:

Other tests, like Sound Test, Packaging Testing, System Test Protocol, Cleaning and Disinfection, and Biocompatibility, are stated to have been conducted in accordance with relevant standards (e.g., ISO 17510-2, ISO 10993 series) and confirmed that "the products met the pre-defined acceptance criteria." However, specific numerical acceptance criteria and reported performances for these tests are not detailed in the provided text. The "acceptance criteria" here implicitly refer to compliance with the standards mentioned.

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

The document does not provide specific sample sizes for any of the performance tests mentioned (e.g., Pressure-Flow, Dead Space, Sound Level, Resistance to Flow, etc.). The provenance of the data (e.g., country of origin, retrospective or prospective) is also not explicitly stated. It can be inferred that the testing was conducted by the manufacturer, Curative Medical Inc., but the location of the testing laboratories is not given.

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

This information is not provided in the submission. The submission relies on objective engineering and performance testing against industry standards and a predicate device, rather than subjective expert assessment to establish ground truth.

4. Adjudication Method for the Test Set

Since the ground truth was established through engineering and performance testing against standards and a predicate device, an adjudication method typically used for subjective assessment (e.g., 2+1, 3+1) is not applicable and not mentioned.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of images or other data. The BestFit Nasal Mask is a patient interface device, and its performance is evaluated through engineering and physical tests.

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

Yes, standalone testing was performed. The performance data presented (e.g., pressure-flow curves, dead space, sound level, resistance to flow) are all results of the device's inherent physical properties and design, tested independently without human interaction influencing the core function being measured. The "System Test Protocol and Report" and "Predicate Comparison Testing" are examples of standalone performance evaluations.

7. The Type of Ground Truth Used

The ground truth used for evaluating the BestFit Nasal Masks is based on:

• Compliance with established international and national standards: ISO 17510-2, ISO 10993 series, ISO 5356-1, and ISTA - 2A - 2008.
• Performance of a legally marketed predicate device: The Resmed Ultra Mirage II (K050359) serves as the benchmark for several key performance parameters.
• Internal specifications and risk analysis: As stated, "All tests confirmed the products met the pre-defined acceptance criteria."

8. The Sample Size for the Training Set

This information is not applicable and not provided. The BestFit Nasal Mask is a physical medical device, not an algorithm or AI model that requires a training set in the conventional sense.

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

This information is not applicable. As explained in point 8, there is no "training set" for this type of device.

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The K Series CPAP System, is designed for the treatment of Obstructive Sleep Apnea only in spontaneously breathing patients weighing >30 kg. It is intended to be used in the home or hospital/institutional environment.

The K Series CPAP systems are used on adult patients for treatment of obstructive sleep apnea (OSA). The K Series CPAP Systems has 2 commercially available models, Curasa CPAP and Floton CPAP (K120285). This special 510(k) adds the Curasa CPAP SD model to the currently commercially available selection of models. The K series CPAP system provides a stable continuous positive airway pressure (CPAP). The humidifier, which works with all the K Series CPAP Systems, provides warm, humidified air for comfort to the patient, reducing nose and airway dryness. Each K Series CPAP system also includes the following accessories: a power supply, a Patient Air Circuit, and a U-tube connection between CPAP and humidifier. The Curasa CPAP SD has similar electronic design and software as the Curasa CPAP, except for the addition of a SD card interface and associated software driver. The Curasa CPAP SD can store/read CPAP patient compliance data onto a SD card where it can be viewed by an external PC.

Here's a breakdown of the acceptance criteria and study information for the Curasa CPAP SD device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present specific quantitative acceptance criteria with corresponding performance metrics for the new SD card functionality. Instead, it relies on demonstrating that the new model (Curasa CPAP SD) is substantially equivalent to the predicate device (Curasa CPAP) and passes various design verification tests. The acceptance is implied by these tests passing.

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

The document does not specify a distinct "test set" in the context of clinical data for the new device. The testing focuses on compliance with standards and design verification for the modifications. There's no mention of a patient-based test set or its provenance (country of origin, retrospective/prospective). The tests referenced are primarily engineering and performance verification tests.

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

Not applicable. The study is not a clinical study involving experts establishing ground truth for patient outcomes or diagnoses. The "ground truth" for the engineering tests would be the established specifications and standards.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication method described as this is not a study requiring expert consensus on subjective interpretations.

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

Not applicable. This device is a CPAP machine with an added SD card for data storage, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. The device's primary function is to deliver CPAP therapy, and the SD card functionality is for data storage, not a standalone algorithm performing diagnostic or predictive tasks.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the engineering and performance tests, the ground truth would be defined by the established technical specifications, recognized industry standards (e.g., EN ISO 17510), and the performance of the predicate device. For example, "Pressure Stability" is compared against "4-20 cm H2O +/- 2.0 cm H20 ISO17510 compliant," indicating the ISO standard sets the ground truth.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-driven device that requires a training set. The changes are hardware and software modifications.

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

Not applicable, as no training set was used.

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The K Series CPAP with Heated Humidifier System is designed for the treatment of Obstructive Sleep Apnea only in spontaneously breathing patients weighing >30 kg. It is intended to be used in the home or hospital/institutional environment.

The K Series CPAP Systems with heated humidifier are used on adult patients for treatment of obstructive sleep apnea (OSA). The K Series CPAP Systems are available in two models: Curasa model and Floton model. The CPAP system provides a stable continuous positive airway pressure (CPAP). The humidifier works only with the K Series CPAP Systems and provides warm, humidified air for comfort to the patient, reducing nose and airway dryness. The K Series systems also include the following accessories: a power supply, a Patient Air Circuit, and a U-tube connection between CPAP and humidifier.

The provided text describes the K Series CPAP Systems for treating Obstructive Sleep Apnea. However, it does not contain the detailed information required to answer all parts of your request, specifically regarding acceptance criteria based on algorithm performance, sample sizes for test sets (beyond what can be inferred from the comparison table), data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone studies, training set details, or how training ground truth was established.

This document is a 510(k) summary focused on demonstrating substantial equivalence to a predicate device (Respironics Remstar Pro M Series) for a physical medical device (CPAP machine), not a software algorithm that requires performance metrics against a defined ground truth. The "Summary of Performance Data and Substantial Equivalence" section states that tests confirmed the product met "predefined acceptance criteria" and was "compliant with the following standards documents," but it does not specify what those criteria were in a numerical sense for algorithmic performance or provide the study details you're looking for.

Here's an attempt to answer your questions based only on the provided text, highlighting where information is missing:

Acceptance Criteria and Device Performance

The provided document does not specify acceptance criteria and device performance in the context of an AI/algorithm-based study with metrics like sensitivity, specificity, or accuracy compared to a ground truth. Instead, the "acceptance criteria" referred to in this 510(k) summary are related to the manufacturing conformance and safety/effectiveness of a physical medical device (CPAP machine) against established industry standards and its predicate device.

The table below summarizes the comparison parameters between the K Series CPAP and its predicate device, which serves as the "performance" demonstrated for substantial equivalence rather than algorithmic performance.

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