Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in the edentulous or partially edentulous maxilla or mandible to provide support for cement-retained or screw-retained prosthetic restorations.

All digitally designed abutments for use with Inclusive Titanium Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture.

Compatible Implant System: Dentsply Implants Astra Tech Implant System® EV

Inclusive® Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV, which are the subject of this submission, are designed and fabricated to be compatible exclusively with Dentsply Implants Astra Tech Implant System EV, and have a prefabricated, precision interface (implant/abutment connection) compatible with the primary predicate device connection. The proposed product line includes stock abutments and abutments intended for fabrication of patient-specific custom abutments using CAD/CAM technology. Each patient-specific abutment is individually prescribed by the clinician and manufactured by an authorized milling center validated by Prismatik Dentalcraft.

The subject devices are manufactured from titanium alloy conforming to ASTM F136, and have a taper followed by a keyway connection feature that prevents rotation of the abutment. The abutments are compatible exclusively with the Astra Tech OsseoSpeed EV implant line (cleared under K120414) in the following diameters: 3.0S, 3.6S, 4.2S, 4.2C, 4.8S, 4.8C, 5.4S mm. The subject device includes the following components: Titanium Abutment Blanks, intended to fabricate all-titanium, patientspecific abutments using CAD/CAM technology; Titanium Abutment 4.5mmH and Titanium Abutment 6mmH, intended to be used for support of CAD/CAM fabricated crowns/bridges or zirconia copings; Titanium Esthetic Abutments, prefabricated abutments intended to be connected directly to an endosseous implant for retention of a prosthesis in straight and 15° angled designs; and Titanium Screws, indicated for the temporary or long-term retention of the abutments to the compatible dental implant fixtures. All subject device components are provided non-sterile.

Titanium Abutment 4.5mmH are two-piece abutments. The crowns/bridges or zirconia copings produced at the validated milling center compose the second part of the two piece abutment.

The provided text describes the 510(k) premarket notification for Inclusive® Titanium Abutments compatible with Dentsply Implants Astra Tech Implant System® EV. This document is a regulatory submission for a dental device, not an AI/ML medical device. Therefore, the information requested in your prompt regarding acceptance criteria and study proving performance for an AI/ML device (e.g., sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable to this document.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through non-clinical performance data.

Here's an analysis based on the information that is available in the document:

Device Type: Dental Implant Abutment (Hardware, not Software/AI)

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

Since this is a hardware device submission, the "acceptance criteria" are related to mechanical, material, and biological compatibility, and "performance" refers to demonstrating equivalence to a 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):

• Test Set Sample Size: Not explicitly stated as "sample size" in the context of statistical testing for AI/ML. For mechanical testing, it would refer to the number of abutments tested, which is not detailed in the summary (e.g., "Worst-case constructs were subjected to static compression and compression fatigue testing.").
• Data Provenance: The studies are non-clinical, likely conducted in a lab environment rather than on human patients. The document does not specify a country of origin for the testing data, beyond the manufacturer being in Irvine, CA, USA.
• Retrospective/Prospective: Not applicable, as this refers to non-clinical lab testing of a hardware device.

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

• Not Applicable. This is a hardware device not requiring human interpretation of medical images or data for "ground truth" establishment in the AI/ML sense. The "ground truth" here is adherence to engineering specifications and performance standards, validated by accredited testing methods.

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

• Not Applicable. No human adjudication process is described or implied for the performance validation of this hardware device.

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 hardware device; no human reader or AI assistance is involved in its use or evaluation for regulatory purposes. The document explicitly states: "No clinical data were included in this submission."

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

• Not Applicable. There is no algorithm for standalone performance. This device is a physical component used in dental procedures.

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

• For Hardware Devices: The "ground truth" is defined by established engineering and material standards, validated through laboratory tests:
  • Mechanical Integrity: Conformance to ISO 14801 (static compression and fatigue limits).
  • Biocompatibility: Conformance to ISO 10993 series.
  • Sterilization: Conformance to ISO 17665-1.
  • Dimensional Accuracy: Verified through reverse engineering and dimensional analysis against OEM specifications.

8. The sample size for the training set:

• Not Applicable. This is a hardware device, not an AI/ML algorithm that requires a training set.

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

• Not Applicable. As above, no training set for an AI/ML algorithm is involved.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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

Ask a specific question about this device

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.

Ask a specific question about this device

The GUS ASTRA TEE™ automated reprocessor facilitates high-level disinfection and rinsing of 1 or 2 transsophageal ultrasound probes using FDA cleared and PCI Medical approved high-level liquid disinfectants.

The GUS ASTRA VR™ automated reprocessor facilitates high-level disinfection and rinsing of 1 or 2 endovaginal and/or endorectal ultrasound probes using FDA cleared and PCI Medical 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 GUS ASTRA TEE and GUS ASTRA VR are automated reprocessors which are identical with the exception of the disinfection chamber configuration necessary to compensate for two different types of ultrasound probes. The GUS ASTRA TEE is an automated reprocessor which enables high-level disinfection and rinsing for transesophageal (TEE) ultrasound probes. The GUS ASTRA VR is an automated reprocessor which enables high-level disinfection and rinsing for endovaginal and/or endorectal ultrasound probes.

Both ASTRA systems utilize predefined programs based upon the high-level liquid disinfectant (HLD) used during the disinfection and potable water rinsing cycles. The system controls the HLD temperature and cycle times which are fixed, no user configuration is available. The device will perform the defined automated disinfection and rinsing cycles based upon the HLD specifications. The microprocessor controlled interface monitors temperature and liquid levels of the HLD in the disinfection chamber and the reservoir. Optical sensors are used for HLD reservoir presence and probe identification. Additional user inputs include unique probe identification (for disinfection records) and the results entry of the Minimum Recommended Concentration (MRC) test using test strips and minimum concentration levels as defined by the HLD manufacturer. A sensor located on the disinfection chamber door is used to initiate the cycle after the user has input the required information. User retrievable data/information regarding reprocessing is accessible through a USB port.

This appears to be a 510(k) premarket notification for a medical device, specifically automated reprocessors for ultrasound probes. The document focuses on demonstrating substantial equivalence to a predicate device ("TD-100 Transesophageal Probe Disinfector").

The information provided does not describe an AI/ML-based device, a comparative effectiveness study with human readers, or an algorithm-only standalone study. Therefore, sections pertaining to these aspects (2, 3, 4, 5, 6, 7, 8, 9) cannot be answered from the provided text.

The acceptance criteria relate to the physical and functional performance of the device, focusing on its ability to control the high-level disinfectant (HLD) process and user safety. The "study" mentioned refers to verification and validation testing to ensure the device meets these performance specifications and is substantially equivalent to the predicate.

Here's the breakdown of the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Ask a specific question about this device

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.

Ask a specific question about this device