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The "Astrasono A3Pro Bladder Scanner" is B-mode pulsed-echo ultrasound device. It is intended as a handheld battery-operated device. The device projects ultrasound energy through the lower abdomen of the patient to obtain images of the bladder which is used to calculate bladder volume noninvasively. It is intended to be used only by qualified medical professionals.

Environments of intended use: Professional medical environments

The intended patient population: Adult patients who require bladder volume measurement (not applicable to pediatric patients).

The "Astrasono A3Pro Bladder Scanner" is a hand-held battery-operated device, it provides non-invasive bladder volume measurement utilizing real-time ultrasound imaging.

The "Astrasono A3Pro Bladder Scanner" measures the bladder volume in the range of 0 – 999 mL.

There are three scanning modes (all B-modes): Easy Mode, Expert Mode, and Empower Mode:

• Easy Mode: Under this mode, the screen displays a real-time image of bladder silhouette.
• Expert Mode: Under this mode, the screen displays a real-time image of bladder.
• Empower Mode: Under this mode, the screen displays a real-time image of bladder projection.

This device consists of a console (including a rechargeable Li-ion battery pack and built-in printer), a probe, and a medical switching power supply.

The obtained ultrasound images and calculated bladder volume results can be downloaded to USB drive as encrypted Data.

N/A

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ASTRA and AVANT Navigated Reusable Instruments are indicated for preparation and placement of SpineCraft ASTRA Spine system pedicle screws during thoracolumbar sacroiliac spinal surgery to assist surgeon in precisely locating anatomical structures in either open, minimally invasive procedures, or percutaneous, procedures.

ASTRA and AVANT Navigated Reusable Instruments are specifically designed for use with Medtronic StealthStation® System S8 (V1.2.0), which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure such as a vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Use of the ASTRA and AVANT Navigated Reusable Instruments is limited to use only with ASTRA Spine System implants.

ASTRA-OCT Navigated Reusable instruments are indicated for preparation and placement of SpineCraft ASTRA-OCT Spine screws during cervico-thoracic spinal surgery to assist surgeon in precisely locating anatomical structures in open procedures.

ASTRA-OCT Navigated Reusable Instruments are specifically designed for use with Medtronic StealthStation® System S8 (V1.2.0), which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where reference to a rigid anatomical structure such as a vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Use of the ASTRA-OCT Navigated Reusable Instruments is limited to use only with ASTRA-OCT Spine System implants.

The ASTRA, AVANT and ASTRA-OCT Navigation instruments are non-sterile, reusable surgical instruments designed for compatibility with the Medtronic NavLock Trackers and to ultimately provide seamless interaction with the Medtronic StealthStation® System. The ASTRA and AVANT Navigation instruments are for use with ASTRA Spine System pedicle screws and the ASTRA-OCT Navigation instruments are for use with ASTRA-OCT Spine System pedicle screws. The instruments are manufactured from medical grade stainless steel. The ASTRA-OCT navigation instruments are available in same or similar diameters and lengths as the corresponding predicate Medtronic navigated instruments. This includes awls, probes, drill bits, taps and screwdrivers.

This looks like a 510(k) summary for a medical device rather than a study evaluating the performance of an AI/ML powered device. As such, it does not contain the specific information requested in the prompt regarding acceptance criteria and a study proving the device meets those criteria for an AI/ML system.

However, I can extract information related to the device's performance testing based on the provided document:

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

The document provides a list of performance tests conducted according to ASTM F2554-18, implying that the device performance demonstrated it "perform[s] as designed, are suitable for their intended use and are substantially equivalent to the cited corresponding predicate devices under the same test conditions." However, specific numerical acceptance criteria (e.g., "accuracy must be greater than X") and corresponding numerical performance results are not provided in this summary.

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

This document describes non-clinical performance testing of physical surgical instruments, not a study involving patient data or an AI/ML algorithm's test set. Therefore, information regarding "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) is not applicable in the context of this 510(k) summary. The testing was laboratory-based.

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

This is not applicable as the document describes non-clinical performance testing of physical instruments, not an AI/ML algorithm requiring expert ground truth for a test set.

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

This is not applicable for the reasons stated above.

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 multi-reader multi-case (MRMC) comparative effectiveness study was not performed as this device is a set of navigated surgical instruments, not an AI/ML assistance system for human readers. No clinical studies were performed.

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

This refers to an AI/ML algorithm. The device described, "ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System," is a set of non-sterile, reusable surgical instruments designed for compatibility with a navigation system (Medtronic StealthStation® System S8). It is not a standalone AI/ML algorithm. Non-clinical performance testing was done on the instruments themselves.

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

For the non-clinical performance testing, the "ground truth" would be established by the precise measurement systems and methodologies outlined in ASTM F2554-18 for determining positional accuracy. This is a technical standard measurement, not expert consensus, pathology, or outcomes data typically associated with AI/ML clinical studies.

8. The sample size for the training set

This is not applicable as there is no AI/ML algorithm being trained by this device.

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

This is not applicable for the reasons stated above.

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The ASTRA Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities of the thoracic, lumbar, and sacral spine.

The ASTRA Spine System is indicated for non-cervical (T)-S2/Ilium) pedicle fixation and non-pedicle fixation in skeletally mature patients as an adjunct to following indications: degenerative disc disease (DDD - defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies); severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; trauma (i.e., fracture and/or dislocation); spinal stenosis; deformities (scoliosis, lordosis and/or kyphosis); spinal tumor; and failed previous fusion (pseudo-arthrosis).

When used in a percutaneous, posterior approach with AVANT Spine MIS instrumentation, the ASTRA Spine System is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (DDD - defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion in skeletally mature patients . Levels of fixation are for the thoracic, lumbar and sacral spine.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the ASTRA Spine System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, kyphosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the ASTRA Spine System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The ASTRA fenestrated screw when used with other components of the ASTRA Spine System is indicated to provide the surgeon with an open or minimally invasive approach for posterior spinal surgery. The ASTRA fenestrated screw is intended to be used with saline or radiopaque dye.

The ASTRA Spine System consists of Ø 5.5mm, Ø 6.0mm and Ø 6.2mm longitudinal, lordosed, contoured and revision rods, pedicle screws (monoaxial, and uniplanar), cannulated pedicle screws (standard and reduction monoaxial, standard, reduction & extended tab polyaxial and standard & reduction uniplanar), fenestrated screws (standard, reduction & extended tab standard & reduction uniplanar), hooks (standard & reduction), lateral iliac connectors, rod-to-rod connectors and transverse (cross) connectors. Most of the components are available in a variety of sizes to more closely match the patient's anatomy.

The safety and effectiveness of the ASTRA fenestrated screw has not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.g.,osteoporosis, osteopenia). This device is intended only to be used with saline or radiopaque dye.

Materials: Titanium alloy per ASTM F136 and CoCr alloy per ASTM F1537

This document is a 510(k) summary for a medical device (ASTRA Spine System), not a study evaluating an AI/ML powered device. As such, it does not contain the information required to answer your questions regarding acceptance criteria and a study proving the device meets those criteria for an AI/ML product.

Specifically, the document states: "No clinical studies were performed" (Page 6, Section 8), and the non-clinical tests described are mechanical tests for orthopedic implants (ASTM F1717 and ASTM F1798), not performance evaluations of an AI/ML algorithm.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This document reports mechanical test results against predicate devices, not AI performance metrics.
2. Sample sizes used for the test set and the data provenance: Not applicable to a mechanical device test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document describes a spinal implant system, which is a physical device, and its substantial equivalence is demonstrated through mechanical testing against predicate devices, not through a study involving AI/ML performance.

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The ASTRA Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic. lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra: degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudo-arthrosis).

The ASTRA Spine System is also a sacral/iliac screw fixation system of the indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudo-arthrosis).

When used in a percutaneous, posterior approach with AVANT Spine MIS instrumentation, the ASTRA Spine System is intended for non-cervical pedicle fixation for the following indications: degenerative disc discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudo-arthrosis, and failed previous fusion in skeletally mature patients . Levels of fixation are for the thoracic, lumbar and sacral spine.

When used for posterior non-cervical pedicle screw fixation in pediatric patients, the ASTRA Spine System implants are indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the ASTRA Spine System is intended to treat pediatric patients diagnosed with the following conditions:

spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. These devices are intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

The subject ASTRA Spine System is top loading, multiple components, posterior system which consists of rods, cannulated and non-cannulated monoaxial, uniplanar and polyaxial screws, hooks, iliac connectors, rod connectors, and cross connectors. Most of the components are available in a variety of sizes to match the patient's anatomy more closely.

The subject ASTRA Spine System includes the pediatric use in the indications and other labeling updates to provide more clarity to the device insert.

The provided text is a 510(k) premarket notification for the ASTRA Spine System, which is a medical device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials as typically done for new drug applications or certain high-risk medical devices.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Here's why and what the document does describe:

• Acceptance Criteria & Reported Device Performance: This section is explicitly missing because the submission is not focused on proving the device meets specific performance criteria through new studies. Instead, it argues that the device's design, materials, and function are similar enough to existing, legally marketed predicate devices to be considered substantially equivalent.
• Sample size used for the test set and the data provenance: Not applicable. No new test set in this context.
• Number of experts used to establish the ground truth for the test set and qualifications of those experts: Not applicable. No new ground truth establishment study.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. The document explicitly states "No clinical studies were performed in support of this submission."
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical spinal implant system, not a software algorithm.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable. No training set for an algorithm.
• How the ground truth for the training set was established: Not applicable.

What the document does state regarding testing:

• Non-clinical Test Summary: "Non-clinical tests were not performed in support of this submission." This means no new bench testing or material testing data was submitted for this particular 510(k). The assumption is that the materials and design are already established as safe and effective by the predicate devices they are referencing.
• Clinical Test Summary: "No clinical studies were performed in support of this submission." This further reinforces that no human studies were conducted for this specific submission to prove performance or safety.

In summary, for a 510(k) premarket notification like this one, the "proof" the device meets acceptance criteria is primarily based on its substantial equivalence to already cleared predicate devices, meaning it shares similar technological characteristics and indications for use, and does not raise different questions of safety and effectiveness.

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The ASTRA-OCT Spine System implants are intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1-C7) and the thoracic spine (T1-T3):

• · Traumatic spinal fractures and/or Traumatic dislocations;
• Instability or deformity;
• · Failed previous fusions (e.g. pseudoarthrosis);
• · Tumors involving the cervical/thoracic spine: and
  · Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The ASTRA-OCT Spine System implants are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the ASTRA-OCT Spine System rods may be connected to other occipital cervical thoracic or thoracolumbar stabilization rod systems ranging in diameter from 3.5mm, including the ASTRA or APEX Spine Systems, using corresponding connectors.

The ASTRA-OCT Spine System consists of a series of polyaxial screws, occipital screws, occipital plates, hooks, rods, lateral connectors, rod-to-rod connectors, set screws, and cross connectors.

Materials:
Titanium alloy per ASTM F136 CoCr allov per ASTM F1537

This FDA 510(k) summary describes a new medical device, the ASTRA-OCT Spine System, and its substantial equivalence to a predicate device. The information provided is for a traditional medical device (spinal implant) and does not include acceptance criteria or a study proving device meets acceptance criteria in the context of an AI/ML powered device.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI/ML device.

The document states:

• "No clinical studies were performed" for the ASTRA-OCT Spine System.
• The substantiation for equivalence is based on non-clinical mechanical testing and comparison to predicate systems.

The requested information is typically found in submissions for AI/ML powered devices, which are assessed differently from traditional hardware devices like the ASTRA-OCT Spine System.

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The Astral 100/150 provides continuous or intermittent ventilatory support for patients weighing more than 11lb (5kg) who require mechanical ventilation.

The iVAPS mode with optional AutoEPAP is intended for patients weighing more than 66lb (30kg).

The Astral device is intended to be used in home, institution/hospital and portable applications for both invasive and noninvasive ventilation.

The Astral ventilator system uses a micro-processor controlled blower, which, along with valves and pressure and flow sensors, achieves pressure, flow and time regulation of air is directed to the patient via one of three ventilator breathing circuits; double circuit, single circuit with expiratory valve, or single circuit with intentional leak. Supplemental oxygen can be entrained at the inlet to the main turbine. The device provides both therapeutic alarms (e.g. tidal volume) and technical alarms (e.g. system fault), and a user interface allowing adjustment of clinical parameters and display of monitored clinical data. The Astral can use external AC or DC power supply and contains an integrated battery.

The Astral is capable of providing the following types of ventilatory support:

• Assist/Control and SIMV with either volume or pressure control -
• Continuous Spontaneous Ventilation in either Pressure Support or CPAP -
• -Volume Assurance and Apnea Ventilation

The provided text describes a 510(k) premarket notification for the ResMed Astral 100/150 ventilator, focusing on the addition of an AutoEPAP feature within its iVAPS therapy mode. This submission argues for substantial equivalence to a previously cleared predicate device.

Here's an analysis of the acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a formal table of "acceptance criteria" for the AutoEPAP feature in the same way one might find for diagnostic accuracy (e.g., sensitivity, specificity thresholds). Instead, it discusses the performance in terms of demonstrating non-inferiority to the predicate device's manual EPAP feature.

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

• Test Set Sample Size: The exact number of patients in the multi-center clinical trial is not explicitly stated in the provided text.
• Data Provenance: The data came from a multi-center, single-blind, randomized, cross-over clinical trial. This indicates a prospective study design. The country of origin is not specified, but the applicant (ResMed Ltd) is based in Australia, and the correspondent is in the USA.

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

The text describes a clinical trial comparing AutoEPAP to manual EPAP. For this type of study involving respiratory support, the "ground truth" isn't typically established by a panel of independent experts reviewing data for diagnostic accuracy. Instead, the ground truth is based on physiological measurements (like ODI4%) and clinical outcomes in patients under observation by medical professionals. The study design (clinical trial) itself serves as the method for assessing efficacy. Therefore, there's no mention of a specific number of experts establishing "ground truth" in the diagnostic sense, nor are their qualifications detailed in this context. Rather, the expertise lies within the medical professionals conducting and overseeing the clinical trial.

4. Adjudication Method for the Test Set

The study was a single-blind, randomized, cross-over clinical trial. In this setup, patients are switched between AutoEPAP and manual EPAP, and their outcomes (e.g., ODI4%) are compared within the same patient. The "adjudication" in this context refers to the assessment of clinical endpoints by the study investigators/medical team, rather than an independent expert review of specific cases for a diagnostic outcome. The text does not elaborate on a specific adjudication committee or process beyond the trial design itself.

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 performed. MRMC studies are typically used to evaluate the performance of diagnostic devices or algorithms where multiple readers interpret cases with and without AI assistance. This submission describes a clinical trial evaluating a therapeutic device (a ventilator with a new feature) where the performance is measured by physiological outcomes in patients.

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

Yes, the clinical trial described effectively evaluates the "standalone" performance of the AutoEPAP algorithm in conjunction with the iVAPS mode by comparing it directly to manual EPAP. While "human-in-the-loop" is always present in a therapeutic device setting (clinicians set parameters, monitor patients), the comparison focuses on the automatic adjustment provided by the AutoEPAP algorithm versus a constant manual setting, demonstrating the algorithm's performance in a real-world clinical application. Bench testing also verified the algorithm's response to simulated conditions, which is another form of standalone assessment.

7. The Type of Ground Truth Used

The primary "ground truth" or endpoint used in the clinical study was:

• Oxygen Desaturation Index (ODI4%) as a measure of upper airway obstruction.
• Safety outcomes (absence of serious adverse events or complications).

These are objective physiological measures and clinical safety data from patients.

8. The Sample Size for the Training Set

The text does not provide information on the sample size for the training set for the AutoEPAP algorithm. Algorithms typically undergo a development and training phase using data, but this submission focuses on the validation of the finalized algorithm through bench and clinical testing.

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

The document does not specify how the ground truth for the training set was established. Given that this is a therapeutic algorithm for a ventilator feature, the training would likely involve:

• Physiological models of respiratory mechanics.
• Data from patients with respiratory conditions and various levels of upper airway obstruction.
• Expert clinical knowledge and engineering principles to develop the algorithm to respond appropriately to changes in flow and apnea events, aiming to maintain optimal EPAP levels.

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For the ASTRA TEE® -

The ASTRA TEE® automated reprocessor facilitates high-level disinfection and rinsing of 1 or 2 transesophageal ultrasound probes using FDA cleared and Civco Medical Solutions approved high-level liquid disinfectants.

For the ASTRA VR™ -

The ASTRA VR™ automated reprocessor facilitates high-level disinfection and rinsing of 1 or 2 endovaginal/endorectal ultrasound probes using FDA cleared and Civco Medical Solutions approved high-level liquid disinfectants.

The ASTRA Product Family of automated reprocessors are floor standing electromechanical lab equipment that facilitate high-level liquid disinfection of ultrasound probes that have been enzymatically pre-cleaned.

The provided document is a 510(k) Pre-Market Notification for medical devices (ASTRA TEE® Transesophageal Probe Reprocessor and ASTRA VR™ Endovaginal/Endorectal Probe Reprocessor). It outlines the device description, intended use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence. The document primarily discusses the device's technical specifications and the testing conducted to ensure its safety and effectiveness in controlling high-level disinfection processes.

Unfortunately, the provided document does not contain the specific details required to answer all parts of your request about acceptance criteria met by a "device" in the context of an AI/human-in-the-loop study. The device in question here is an automated reprocessor for ultrasound probes, not an AI-powered diagnostic tool, and the performance criteria are related to disinfection efficacy, not diagnostic accuracy.

Therefore, I cannot populate most of the requested table and details, as they pertain to performance metrics and study designs common for AI-based diagnostic devices (e.g., sensitivity, specificity, reader performance studies, expert adjudication for ground truth).

However, I can extract the information relevant to the device's operational performance and the studies conducted to support its substantial equivalence.

Here's what can be extracted and what cannot be from the provided text:

What can be extracted:

• Acceptance Criteria (Performance Attributes): The core performance attribute for this device is its ability to "control the HLD temperature, soak time, and rinse cycle to facilitate ≥6 Log reduction of M. terrae using Metricide OPA Plus, Cidex OPA, and Resert XL." This is the primary functional performance claim.
• Study That Proves the Device Meets Acceptance Criteria:
  • Performance Testing Summary:
    • "The ASTRA system maintains time and temperature required for disinfection as per HLD manufacturers' specifications."
    • "The ASTRA system passed Safety and EMC testing."
    • "The ASTRA system passed Simulated use and Residual testing."
    • "The ASTRA system passed In-use testing."
  • Efficacy (Disinfection and Residual testing): "Pass as per simulated use (6log reduction of M. terrae), In-use Testing (complete kill) and residual testing (ISO10993-5 cytotoxic effect of <= 2)."
  • Ground Truth Type for Efficacy: The efficacy is measured against a "6 log reduction of M. terrae" (a microbial standard) and "complete kill" for in-use testing. "Residual testing" uses "ISO10993-5 cytotoxic effect of <= 2." This indicates microbiological testing standards and biocompatibility standards are used as ground truth.
  • Ground Truth for Functionality: The device controls time, temperature, and rinse cycles "as per HLD manufacturers' specifications." This implies that the ground truth for these parameters is the specified parameters from the high-level disinfectant manufacturers.

What cannot be extracted (and why, given the nature of the device):

• Reported Device Performance (in the context of AI metrics): The document reports passing tests, but not specific percentages for sensitivity, specificity, or AUC, as these are not relevant metrics for a disinfection reprocessor.
• Sample size used for the test set and data provenance (e.g., country of origin, retrospective/prospective): The document mentions "Simulated use," "In-use testing," "Safety and EMC testing," "Residual testing," but does not provide specific sample sizes (e.g., number of probes, cycles, test samples) or the data provenance details (country, retrospective/prospective).
• Number of experts used to establish ground truth and qualifications: This is irrelevant for a device that performs automated disinfection based on physical parameters and microbiological efficacy. There are no human experts "reading" or adjudicating the output for diagnostic purposes.
• Adjudication method for the test set: Not applicable.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This device does not involve human readers interpreting images.
• Standalone (algorithm only without human-in-the-loop performance) was done: The device itself is an automated system; its performance is "standalone" in the sense that it operates without continuous human interaction during the disinfection cycle. However, this is not in the context of an AI algorithm's diagnostic performance.
• Sample size for the training set: Not applicable, as this is not an AI/machine learning model that undergoes a "training" phase. The device is a fixed-function electro-mechanical system.
• How the ground truth for the training set was established: Not applicable.

Based on the available information, here is the breakdown:

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

2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes for the "Simulated use," "In-use testing," "Safety and EMC testing," or "Residual testing." It does not provide information on data provenance (e.g., country of origin, retrospective/prospective). These types of details are less common for an electro-mechanical device validation compared to a clinical study for a diagnostic AI.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. The ground truth for this device's performance is based on established engineering, microbiological, and biocompatibility standards, not human expert interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no human adjudication process involved in assessing the device's disinfection performance.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is not an AI diagnostic tool and does not involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is an automated system for high-level disinfection. Its performance metrics (time control, temperature control, log reduction of M. terrae, residual levels) are inherently "standalone" in function, as it performs its designated tasks without continuous human intervention. This is not in the context of an AI algorithm's diagnostic performance without human input.

7. The type of ground truth used
The ground truth used for this device's performance validation includes:
* Microbiological standards: Achieving a "≥6 Log reduction of M. terrae" and "complete kill" in simulated and in-use testing for disinfection efficacy.
* Biocompatibility standards: ISO10993-5 for cytotoxic effect.
* Manufacturer specifications: Adherence to temperature, time, and rinse parameters defined by the High-Level Disinfectant (HLD) manufacturers.
* Safety and Electrical standards: UL 61010-1/CSA C22.2 No. 61010-1, EN 60601-1-2 / EN 61326-1 for electrical safety and electromagnetic compatibility.
* Quality System and Risk Management Standards: 21 CFR Part 820.30 Design Controls, ISO 14971, ANSI/AAMI/IEC 62304 for software, ANSI/AAMI HE75 for human factors.

8. The sample size for the training set
Not applicable. This is not an AI/machine learning model.

9. How the ground truth for the training set was established
Not applicable.

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The Astral 100/150 provides continuous or intermittent ventilatory support for patients weighing more than 5kg (11 lb) who require mechanical ventilation.

The iVAPS mode is intended for patients weighing more than 66lb (30kg).

The Astral device is intended to be used in home, institution/hospital and portable applications for both invasive and non-invasive ventilation.

The Astral ventilator system uses a micro-processor controlled blower, which, along with valves and pressure and flow sensors, achieves pressure, flow and time regulation of air is directed to the patient via one of three ventilator breathing circuit, single circuit with expiratory valve, or single circuit with intentional leak. Supplemental oxygen can be entrained at the main turbine. The device provides both therapeutic alarms (e.g. tidal volume) and technical alarms (e.g. system fault), and a user interface allowing adjustment of clinical parameters and display of monitored clinical data. The Astral can use external AC or DC power supply and contains an integrated battery.

The Astral is capable of providing the following types of ventilatory support:

• -Assist/Control and SIMV with either volume or pressure control
• -Continuous Spontaneous Ventilation in either Pressure Support or CPAP
• -Volume Assurance and Apnea Ventilation

The provided document is a 510(k) premarket notification for a medical device (ventilator). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria for AI or a new diagnostic tool.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance derived from a test set, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, training set information, or how ground truth was established for a new AI/diagnostic device.

The document discusses:

• Device Name: Astral 100/150
• Regulation Name: Continuous Ventilator
• Predicate Device: ResMed Astral 100/150 (K133868)
• Reference Device: Respironics Trilogy 200 (K093416)
• Reason for Submission: New device (specifically, the addition of the iVAPS therapy mode).
• Non-Clinical Performance Data: Stated that design and verification activities were performed, including accuracy of ventilation, volume & pressure controls and monitoring, waveform performance, accuracy and repeatability of triggering and cycling, endurance and environmental testing, and alarm verification. It explicitly states, "All tests confirmed the product met the predetermined acceptance criteria." However, it does not list these specific acceptance criteria in a table or provide quantitative performance results against them. It also mentions side-by-side performance testing for the new therapy mode (iVAPS) and electrical changes testing.
• Conclusion: The device is substantially equivalent to the predicate and reference devices based on intended use, technological characteristics, and principles of operation. Clinical testing was not required for this submission.

In summary, this document is a 510(k) submission for a ventilator, focusing on substantial equivalence to a predicate device and not a study validating a new AI/diagnostic device with the specific criteria you've outlined.

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The ASTRA System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion (pseudo-arthrosis).

The ASTRA Spine System is also indicated for pedicle screw fixation for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, with the device fixed or attached to the lumbar and sacral spine (levels of pedicle screw fixation are L3 to S1), and for whom the device is intended to be removed after solid fusion is attained.

The ASTRA System is also a sacral/iliac screw fixation system of the non-cervical spine indicated for degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radies), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudo-arthrosis).

When used in a percutaneous, posterior approach with AVANT Spine MIS instrumentation, the ASTRA Spine System is intended for non-cervical pedicle fixation for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis), tumor, pseudo-arthrosis, and failed previous fusion in skeletally mature patients . Levels of fixation are for the thoracic, lumbar and sacral spine.

The ASTRA Spine System is a top loading, multiple component, posterior spinal fixation system which consists of rods, cannulated and non-cannulated monoaxial, uniplanar and polyaxial screws, hooks, iliac connectors, rod connectors, and cross connectors. Most of the components are available in a variety of sizes to more closely match the patient's anatomy.

Materials:
Titanium alloy
CoCr alloy

Here's an analysis of the provided text regarding the ASTRA Spine System, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) summary for a medical device (Spine System), not an AI/ML device. Therefore, many of the requested fields related to AI/ML specific studies (like sample sizes for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance) are not applicable to this type of medical device submission. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical (mechanical) testing.

1. Table of Acceptance Criteria and Reported Device Performance

For this medical device, the "acceptance criteria" are implicitly defined by performance equivalence to predicate devices in standardized mechanical tests. The "reported device performance" is a statement of comparative equivalence.

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

This is a physical device, and the "test set" refers to the tested device components.

• Sample Size: Not explicitly stated in terms of number of components tested for each test, but standard engineering practices for medical device testing would involve a sufficient number (e.g., n=5 or n=10 per test) to ensure statistical significance, though the exact numbers are not provided in this summary.
• Data Provenance: The tests are non-clinical, meaning they were conducted in a laboratory setting. There is no patient data provenance (e.g., country of origin, retrospective/prospective) since no human data was used for these mechanical tests.

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

• Not Applicable. For mechanical testing of a physical device, ground truth is established by standardized testing protocols (e.g., ASTM standards) and measured physical properties, not by expert consensus on clinical data. Engineers and lab technicians perform and analyze the tests according to these standards.

4. Adjudication Method for the Test Set

• Not Applicable. There is no adjudication in the sense of reconciling human expert opinions for clinical images or data. The results of mechanical tests are objective measurements against defined criteria.

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 is a physical spinal implant, not an AI/ML diagnostic or assistive device. No MRMC studies were performed.

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

• Not Applicable. This is a physical spinal implant; there is no algorithm or standalone performance.

7. The Type of Ground Truth Used

• Mechanical Test Standards and Predicate Device Performance: The "ground truth" for the non-clinical tests is based on the established performance characteristics and safety profiles of legally marketed predicate devices, as defined by FDA regulations for substantial equivalence, and adherence to relevant ASTM standards (ASTM F1717 and ASTM F1798).

8. The Sample Size for the Training Set

• Not Applicable. This is a physical device; there is no AI/ML model or "training set" in the context of machine learning. The device design and materials are based on engineering principles and knowledge of predicate devices.

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

• Not Applicable. As there is no training set for an AI/ML model, this question is not relevant. The "ground truth" for developing the physical device is based on established biomechanical and medical understanding of spinal fixation and the performance of existing, cleared devices.

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The Astral 100/150 provides continuous or intermittent ventilatory support for patients weighing more than 5kg (11 lb) who require mechanical ventilation. The Astral device is intended to be used in home, institution/hospital and portable applications for both invasive and non-invasive ventilation.

The Astral ventilator system uses a micro-processor controlled blower, which, along with valves and pressure and flow sensors, achieves pressure, flow and time regulation of air delivery. Air is directed to the patient via one of three ventilator breathing circuits; double circuit, single circuit with expiratory valve, or single circuit with intentional leak. Supplemental oxygen can be entrained at the inlet to the main turbine. The device provides both therapeutic and technical alarms, and a user interface allowing adjustment of clinical parameters and display of monitored clinical data. The Astral can use external AC or DC power supply and contains an integrated battery.

The Astral is capable of providing the following types of ventilatory support:

• Assist/Control and SIMV with either volume or pressure control
• Continuous Spontaneous Ventilation in either Pressure Support or CPAP
• Volume Assurance and Apnea Ventilation

Acceptance Criteria and Study for Astral 100/150 Ventilator

The provided documentation details the non-clinical performance evaluation of the Astral 100/150 ventilator to establish its substantial equivalence to predicate devices (Respironics Trilogy 200 and Pulmonetic LTV 1200).

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "All tests confirmed the product met the predetermined acceptance criteria." The specific numerical or qualitative values for these criteria are not provided in this summary but are implied to have been met for substantial equivalence.

2. Sample Size and Data Provenance

• Sample Size for Test Set: Not explicitly stated. The document refers to "Design and Verification activities" and "non-clinical side-by-side performance testing" for each therapy mode and supplementary feature. This suggests a comprehensive, but unquantified, series of tests.
• Data Provenance: The study was conducted as part of the device's design and verification by ResMed Corp., in San Diego, CA, USA. This indicates the testing was performed internally by the manufacturer, likely in a controlled laboratory environment. The data would be prospective as it was generated specifically for the 510(k) submission to demonstrate compliance.

3. Number of Experts and Qualifications for Ground Truth

• This information is not applicable as the study was a non-clinical performance evaluation of a medical device (ventilator). Ground truth in this context would refer to the established engineering specifications, performance standards, and the capabilities of the predicate devices, rather than expert interpretation of clinical data. The performance was assessed against these known standards and functional requirements.

4. Adjudication Method for the Test Set

• This information is not applicable. As a non-clinical performance study, there would be no human "adjudication" in the sense of resolving disagreements among experts on clinical findings. Performance was assessed against predefined technical specifications and standards using objective measurements.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The document explicitly states: "Clinical testing was not required." The evaluation was entirely non-clinical and focused on device performance against technical standards and comparison to predicate devices, not on human-in-the-loop performance or clinical outcomes.

6. Standalone (Algorithm Only) Performance Study

• Yes, a standalone performance study was done in the sense that the device's performance was evaluated independently without human intervention during the technical tests. The "Design and Verification activities" and "non-clinical side-by-side performance testing" assessed the device's inherent mechanical and software-driven functionalities (e.g., accuracy of volume/pressure controls, waveform generation, triggering, alarms). This is implicitly a standalone performance evaluation of the device as an engineered system.

7. Type of Ground Truth Used

• The ground truth used was based on established engineering specifications, performance standards, and the known operational characteristics of the predicate devices. The testing confirmed that the Astral device met "predetermined acceptance criteria" and demonstrated "substantially equivalent" performance to the predicates. This encompasses:
  • Applicable FDA guidance documents (e.g., Draft Reviewer Guidance for Ventilators, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices).
  • International standards (e.g., ASTM F 1246-91, ASTM F 1100-90, ISO 10651-2:2004, IEC 60601-1:2005, IEC 60601-1-2:2007).
  • The performance characteristics and range/accuracy of the predicate devices (Respironics Trilogy 200 and Pulmonetic LTV 1200).

8. Sample Size for the Training Set

• This information is not applicable. The Astral 100/150 is a medical device (ventilator) that relies on micro-processor controlled mechanics and software for its operation. It is not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "software based pressure, flow and time regulation" is developed through engineering and control system design, not through machine learning from data.

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

• This information is not applicable as there was no AI/machine learning training set. The "ground truth" for the device's design and functional parameters would have been established through established engineering principles, physics, medical requirements for ventilation, and regulatory standards.

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