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The Ascend VBR System is intended for use in skeletally mature patients in the cervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e., fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

The Ascend VBR System is 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, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The Ascend VBR System is intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material with the Ascend VBR System is optional.

The Ascend NanoTec VBR System with advanced NanoTec surface treatment is intended for use in skeletally mature patients in the cervical spine (C2-T1) and in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e., fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders.

The Ascend NanoTec VBR System is 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, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.

The Ascend NanoTec VBR System is intended to be used with supplemental spinal fixation systems cleared for use in the cervical, thoracic, and/or lumbar spine. The use of bone grafting material with the Ascend NanoTec VBR System is optional.

The Ascend VBR Systems are cervical and thoracolumbar vertebral body replacement systems designed to be inserted in the anterior, anterolateral, and posterior approaches. The implants consist of VBR cores and endplates offered in a range of diameters and heights, endplates, footprints, and lordotic angles to accommodate individual patient anatomy.

The cores are made of titanium alloy per ASTM F136 and the endplates are made of titanium alloy per ASTM F136 or are made of hybrid titanium consisting of commercially pure porous titanium CP-Ti Grade 2 per ASTM F67 and titanium alloy per ASTM F136.

The modular endplates are offered with an optional 20-40 nanometer thin hydroxyapatite surface treatment. The surface treatment presents nano-scale topography on the entirety of the implant surface, in addition to macro-/micro-scale topography existing from prior to treatment.

This document is a 510(k) premarket notification for a medical device – the Ascend™ VBR System and Ascend™ NanoTec™ VBR System, which are vertebral body replacement devices. The content focuses on demonstrating substantial equivalence to legally marketed predicate devices, as required for FDA clearance.

The provided text does not contain any information about an AI/ML-based device or its performance criteria. The entire document pertains to physical medical devices (spinal implants) and their mechanical, chemical, and biological performance characteristics.

Therefore, it is not possible to describe acceptance criteria and a study proving an AI/ML device meets those criteria based on the provided input. The document details traditional medical device testing, such as:

• Static and Dynamic Axial Compression per ASTM F2077
• Static and Dynamic Torsion per ASTM F2077
• Static Subsidence per ASTM F2267
• Static Push-out
• Gravimetric Analysis per ASTM F1714
• Particulate Analysis per ASTM F1877
• Bacterial endotoxin testing (BET) per ANSI/AAMI ST72:2019
• Biocompatibility Testing per ISO 10993-1

These tests are standard for evaluating the mechanical and biocompatibility properties of physical implants, not the performance of an AI/ML algorithm.

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ASCEND Image Viewer is a software-only medical device intended for use by trained clinicians to display medical images. ASCEND Image Viewer provides viewing of and measurements on echocardiograms from compatible ultrasound systems that support transthoracic echocardiogram, transesophageal echocardiogram, stress echocardiogram, cath, and vascular study types.

ASCEND Image Viewer is for prescription use only.

The ASCEND Image Viewer is a Medical Device for viewing and measuring cardiovascular echocardiograms in DICOM format.

The software has features for displaying and measuring cardiovascular images acquired from echocardiograms. Images supported include:

• . 2D
• Color Doppler
• M-mode
• . Spectral Doppler (Pulsed Wave and Continuous Wave)

The ASCEND Image Viewer provides Cine play review and control.

Standard Review supported study types include:

• TTE
• TEE
• Cath
• . Stress Echo
• Vascular

Supported Measurements include:

• Linear
• . Volume (method of discs)
• Velocity time integral
• Pressure half-time
• . Area
• Time
• Velocity
• Angle (measurement of two lines with a common vertex drawn on the image) .

The user can make measurements which persist for later use within the ASCEND Image Viewer.

Here's a breakdown of the acceptance criteria and study information for the ASCEND Image Viewer, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes the ASCEND Image Viewer as a software-only medical device for displaying and measuring echocardiograms. The comparison is made against a predicate device, TomTec-Image Arena (K132544). The clinical testing and "Brief Discussion of Test Results Submitted: Bench Testing" section indicate that the device performed effectively and was found to be substantially equivalent to the predicate where functionality intersected.

However, the document does not explicitly list quantitative acceptance criteria for specific performance metrics (e.g., accuracy of measurements, speed of image display) or provide reported numerical performance values for the ASCEND Image Viewer in a table format. Instead, the acceptance is based on demonstrating substantial equivalence in functionality, intended use, technological characteristics, and typical users, along with adherence to design specifications and risk assessment.

The document states:

• "The Graphic User Interface conforms to the ASCEND Image Viewer functional specification."
• "The comparison ASCEND Image Viewer with the predicate devices shows that the ASCEND Image Viewer has similar functionality, intended use, technological characteristics, and typical users as the predicate devices."
• "Verification and validation activities ensure that the design specifications are met, and that ASCEND Image Viewer does not introduce new issues concerning safety and effectiveness."

Given this, I will describe the characteristics compared rather than specific quantitative acceptance criteria and reported performance, as those are not provided in a measurable format.

Study Information

The document describes both Bench Testing and Clinical Testing.

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

   • Test Set Sample Size: Not explicitly stated as a number of cases or images for either bench or clinical testing.
   • Data Provenance:
     • Bench Testing: The test plan covered "all aspects of the functionality, exercising every user interface, all menus and submenus, as well as the measurement tools." No specific data type or origin is given for the bench tests beyond general functional and DICOM compliance verification.
     • Clinical Testing: The testing occurred "in US city-hospital environments." The data used would have been clinical echocardiograms from these environments. The studies appear to be prospective in the sense that the device was evaluated during its development cycle with "clinical testers" in a real-world setting, but it's not a formal prospective clinical trial for efficacy.

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

   • Clinical Testing: The test involved "resident cardiologists, cardiology fellows, and sonographers." The number of these experts is not specified. Their role was to assess the effective performance of the device's intended use and its substantial equivalence to the predicate. The document doesn't explicitly state they established a "ground truth" for specific diagnostic findings, but rather that they evaluated the device's functional performance in a clinical context.
   • Bench Testing: No experts are mentioned for ground truth establishment during bench testing.

3. Adjudication method for the test set:

   • Not specified. The clinical testing describes users evaluating the device's performance, rather than an adjudication process for a diagnostic outcome.

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

   • No, a formal MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted or described. The ASCEND Image Viewer is described as an image viewing and measurement tool, not an AI-assisted diagnostic algorithm in the sense of providing automated interpretations. The comparison was to a predicate image viewer.

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

   • The device itself is a "software-only medical device intended for use by trained clinicians to display medical images." Its performance is inherently linked to human interaction (displaying images and making measurements). The bench testing would represent a form of standalone functional testing of the algorithm's capabilities (e.g., DICOM compliance, measurement calculations), but not an evaluation of its diagnostic performance in a "standalone" context separate from clinical use. The clinical testing explicitly involved "trained clinicians."

6. The type of ground truth used:

   • For Bench Testing: "Ground truth" was conformity to the ASCEND Image Viewer functional specification and DICOM standard compliance. Risk analysis according to ISO 14971 was also a benchmark.
   • For Clinical Testing: "Ground truth" was implicitly based on the consensus or clinical judgment of the "resident cardiologists, cardiology fellows, and sonographers" during their use of the device, where they determined if it "performed effectively its intended use" and was "substantially equivalent" to the predicate. It was an evaluation of the tool in practice rather than against a predefined diagnostic gold standard (e.g., pathology report) for individual cases.

7. The sample size for the training set:

   • Not applicable/Not provided. The ASCEND Image Viewer is described as an image viewing and measurement system, not a machine learning or AI algorithm that would typically require a "training set" in the context of image analysis. The functionality described (display, measurements, Cine play) suggests a deterministic software rather than one that learns from data.

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

   • Not applicable, as no training set for a machine learning model is mentioned.

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The Ascendant™ Cervical Spacer System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease at one disc level from C2-T1. Degenerative Disc Disease (DDD) is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Ascendant™ Cervical Spacer System is to be used with autogenous bone graft and supplemental fixation (i.e., an anterior cervical plate), and is implanted via an open, anterior approach. Patients with previous non-fusion spinal surgery at involved level may be treated with the device.

The Ascendant™ Cervical Spacer System is an anterior cervical interbody device consisting of a PEEK Optima® LT1 (polyetheretherkeytone) implant cage with CP titanium coating and tantalum radiographic markers. It is intended for use as an interbody fusion device and is offered in a variety of heights, footprints and lordotic angles to accommodate varying anatomical conditions. The device features an enclosed chamber intended to be filled with autogenous bone graft material.

The Ascendant™ Cervical Spacer System is intended to be used with supplemental fixation (i.e., an anterior cervical plate).

The provided text is a 510(k) premarket notification for a medical device called the "Ascendant™ Cervical Spacer System." This document is for a spinal implant, not an AI/ML powered medical device or a diagnostic device. Therefore, the information required to answer the prompt, such as acceptance criteria for performance metrics like sensitivity, specificity, or AUC, as well as details about training/test sets, ground truth establishment, expert adjudication, or MRMC studies, is not present in this document. The document describes mechanical performance testing for the device's physical properties.

However, I can extract the information related to the device's mechanical performance and present it as acceptance criteria and reported performance, even though it doesn't align with the type of acceptance criteria typically expected for AI/ML devices.

Here's the information derived from the document:

1. Table of acceptance criteria and the reported device performance:

Note: The document broadly states "The results of this non-clinical testing show that the strength of the Cervical Spacer System, Ti Coated is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." Specific numerical acceptance values or reported outcomes are not provided in this summary, only the conclusion that the device's strength is sufficient.

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

This information is not applicable to the mechanical testing described. Mechanical tests typically use a certain number of physical samples of the device, not a "test set" in the context of data or images. The document does not specify the number of device samples used for each test. Data provenance (country of origin, retrospective/prospective) is also not applicable for this type of mechanical testing.

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

This information is not applicable. The "ground truth" for mechanical performance is determined by the physical properties of the material and design, measured against engineering standards (e.g., ASTM standards), not by human expert opinion.

4. Adjudication method for the test set:

This information is not applicable, as ground truth is based on engineering standards and physical measurements, not on human adjudication.

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:

This is not applicable. The device is a physical spinal implant; it is not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable as the device is a physical medical implant, not an algorithm.

7. The type of ground truth used:

The "ground truth" in this context is the established mechanical engineering standards (e.g., ASTM F2077, ASTM F1854-09, ASTM F1044-05, ASTM F1147-05, ASTM F1160-05, ASTM F1978-00) for intervertebral body fusion devices. The device's performance is measured against these standards to demonstrate its "sufficient strength" and substantial equivalence to predicate devices.

8. The sample size for the training set:

This is not applicable as the document describes mechanical testing of a physical device, not an AI/ML model.

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

This is not applicable as the document describes mechanical testing of a physical device, not an AI/ML model.

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The ASCEND Electrode is intended for use as disposable, conductive, adhesive interface between the user's skin and a transcutaneous electrical nerve stimulator.

The ASCEND Electrode provides an electrically conductive interface between a transcutaneous electrical nerve stimulator and a user's skin. It is intended to be disposable and for single person use. It is provided non-sterile.

This document is a 510(k) Pre-Market Notification for a Class II medical device, the ASCEND Electrode. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about a study that establishes acceptance criteria and proves the device meets them in the way a clinical trial or performance study would for a more complex device.

Based on the provided text, the following information can be extracted, but with significant limitations due to the nature of the document being a substantial equivalence submission for an electrode:

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

The document does not explicitly provide a table of acceptance criteria for the ASCEND Electrode's performance. Instead, it states:
"Verification and performance testing demonstrated that the electrode met user needs as reflected in the functional specification." and "The ASCEND Electrode has the same technological characteristics as the predicate SENSUS Electrode that was validated with electrical and mechanical tests to show that the electrode met its target specifications over a range of operating and storage conditions."

However, no specific performance metrics or their acceptable ranges are listed. The focus is on demonstrating that it performs similarly to the predicate.

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

The document mentions "electrical and mechanical tests" and "verification and performance testing" but does not specify the sample size used for these tests. It also does not explicitly state the data provenance (country of origin, retrospective or prospective). Given that it's a 510(k) for an electrode, these tests would typically be laboratory-based rather than involving human subjects for performance evaluation in the way a clinical study would.

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 to the information provided. For an electrode, "ground truth" would typically relate to objective physical or electrical measurements, not expert interpretation of diagnostic images or clinical outcomes.

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

This is not applicable. Adjudication methods are typically used in studies where multiple human readers interpret data, which is not the case for the described testing of an electrode's physical properties.

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

This is not applicable. The device is an electrode, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was performed.

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

This is not applicable as the device is an electrode, not an algorithm.

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

For the non-clinical testing mentioned, the "ground truth" would be established through objective electrical and mechanical standards and specifications (e.g., conductivity measurements, adhesive strength tests, impedance measurements, biocompatibility standards). The document references "functional specification" directly.

8. The sample size for the training set

This is not applicable as the device is an electrode and does not involve machine learning or a "training set."

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

This is not applicable as there is no training set for this device.

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The Ascendra Balloon Aortic Valvuloplasty Catheter is indicated for balloon aortic valvuloplasty.

The Edwards Ascendra Balloon Aortic Valvuloplasty Catheter is used for balloon aortic valvuloplasty. The device consists of a coaxial polyamide catheter with a distal inflatable polyamide balloon intended to dilate (perform valvuloplasty on) the stenotic aortic valve prior to implantation of a bioprosthesis. Two radiopaque marker bands indicate the dilating section of the balloon and aid in balloon placement. At the proximal end of the catheter, there is a standard "Y" connector for balloon inflation and a guidewire lumen. An inflation device may be connected directly or indirectly (using the supplied extension tubing) to the balloon inflation luer port of the catheter. The balloon is inflated by injecting a diluted contrast medium solution through the luer port (marked "BALLOON") on the "Y" connector. The device is supplied sterile for single use only. The BAVC is provided in a 20 mm size and is compatible with a 0.035" guidewire and a 14F sheath.

This document is a 510(k) summary for the Ascendra Balloon Aortic Valvuloplasty Catheter. It does not describe an AI/ML device or algorithm. Therefore, many of the requested fields are not applicable.

Here's an analysis based on the provided text, focusing on the device and its assessment, and stating "Not Applicable" for AI-specific questions:

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

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 for non-clinical or clinical assessment. For non-clinical tests, it would refer to the number of devices tested for each functional criterion. For the clinical assessment, it
  refers to a "literature review, comparison to currently marketed devices and complaint analysis" and the results of clinical trials (P110021 and P130009), but specific sample sizes of patients/cases used in the literature review or complaint analysis are not provided in this summary.
• Data Provenance: Not specified in this 510(k) summary (e.g., country of origin). The clinical assessment relies on literature and existing PMA clinical trials.
• Retrospective/Prospective: The literature review and complaint analysis would inherently involve retrospective data. The PMA clinical trials (P110021 and P130009) would have been prospective studies, but details are not provided here.

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

Not Applicable. This is a medical device (catheter), not an AI/ML diagnostic or image analysis device that requires expert-established ground truth for a test set. The clinical assessment relies on scientific literature, comparison to predicate devices, and results from pre-market approval (PMA) clinical trials.

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

Not Applicable, as this is not an AI/ML device relying on human expert adjudication for image interpretation or diagnosis.

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 medical device, not an AI/ML reading assistance tool.

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

Not Applicable. This is a physical medical device (catheter), not an AI algorithm.

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

For the non-clinical testing, the "ground truth" would be established engineering specifications, ISO standards, and predicate device performance. For the clinical assessment, the "ground truth" on safety and feasibility is derived from comprehensive clinical outcomes data from literature reviews, comparison with predicate devices, complaint analysis, and the results of clinical trials (P110021 and P130009) that likely involved patient outcomes, physiological measurements, and possibly pathology or imaging interpretation in the context of valuloplasty.

8. The sample size for the training set

Not Applicable. This device does not use a training set as it is not an AI/ML algorithm.

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

Not Applicable. This device does not use a training set.

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ASCEND is intended for use as a transcutaneous electrical nerve stimulation device for temporary relief of pain associated with sore and aching muscles in the lower extremities due to strain from exercise or normal household and work activities.

ASCEND is intended for use as a transcutaneous electrical nerve stimulation device for the symptomatic relief and management of chronic intractable pain.

The device may be used during sleep. The device is labeled for use only with compatible NeuroMetrix electrodes.

ASCEND is a single output-mode transcutaneous electrical nerve stimulator for symptomatic relief and management of chronic intractable pain that is available over the counter. The device utilizes a microprocessor running embedded software to control a high-voltage circuit that generates currentregulated stimulating pulses with specific technical characteristics including pulse shape, amplitude, duration, pattern, and frequency. The device is powered by an embedded rechargeable Lithium-Ion battery that is charged through a USB cable connected to an AC adapter.

The device delivers electrical stimulation to the user through disposable electrodes placed on the user's body. The device is labeled for use only with compatible NeuroMetrix electrodes (e.g. SENSUS Electrode, K121816), to which it connects through insulated female medical snap connectors embedded within its housing; no lead-wires are used. Compatible NeuroMetrix electrodes are comprised of four individual hydrogel pads arranged in a linear array. The hydrogel pads are electrically connected in pairs such that the two outer hydrogel pads constitute one electrode and the two inner hydrogel pads constitute a second electrode. The user interface consists of a push button and a two-color LED. The push button initiates and controls stimulation intensity. The LED indicates stimulation status, battery charging, and error conditions.

Here's a breakdown of the acceptance criteria and study as described in the provided 510(k) summary for ASCEND™:

Acceptance Criteria and Device Performance

Details of the Usability Study

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

• Sample Size: 29 participants.
• Data Provenance: The study was a prospective usability study, likely conducted in the US where NeuroMetrix, Inc. is located. The document does not explicitly state the country of origin, but given the sponsor's address.

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

• The study was a usability study focused on whether untrained users could operate the device based on its labeling. Therefore, the "ground truth" was the objective successful completion of predefined tasks by these users, not an expert assessment of a medical condition. No experts were used to establish ground truth in the traditional sense of medical diagnosis.

4. Adjudication method for the test set:

• Not applicable in the context of a usability study where success is objectively measured by task completion by the participants themselves.

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

• No MRMC comparative effectiveness study was done. This study was a usability study for an over-the-counter transcutaneous electrical nerve stimulator (TENS) device, not an AI-powered diagnostic tool.

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

• Not applicable. The device is a TENS unit, and the study was a human usability study.

7. The type of ground truth used:

• The "ground truth" for this usability study was the objective successful completion of specific device-operation tasks by study participants, as outlined in the device's labeling (instructional video and quick start instructions). It was not based on expert consensus, pathology, or outcomes data related to disease diagnosis or treatment efficacy, but rather on the ability of lay users to correctly operate the device.

8. The sample size for the training set:

• Not applicable. This was a usability study, not a machine learning model development study, so there was no "training set."

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

• Not applicable. As noted above, there was no training set for a machine learning model.

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The Ascendx™M VCF Repair System is indicated for the treatment of painful pathological fractures of the vertebral body that may result from osteoporosis. It is intended to be used in combination with AscendxTM Cement.

The Ascendx™ VCF Repair System consists of the Ascendx™ Acu-Cut Cutting Instrument, AscendxTM RDX Repair Device, and AscendxTM Inflation Syringe.

The Ascendx™ System is packaged with a previously cleared bone cement (Ascendx™ Cement, manufactured by TECRES S.p.A, K042415), as well as several class I tools, including manual orthopedic surgical instruments and cement mixing and dispensing tools.

Here's a breakdown of the acceptance criteria and study information for the Ascendx™ VCF Repair System, as derived from the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a discrete set of quantifiable "acceptance criteria" in a table format with corresponding "reported device performance" values for the clinical study endpoints. Instead, it describes various tests and states that the device "conforms to its design specifications," "functioned as intended," and "met the necessary specifications for its intended use." For the clinical study, it concludes that the device achieved "pain and functional relief" and that its "safety and effectiveness supported substantial equivalence to the predicate."

Given the information, a table of the reported performance from the clinical study would look like this:

For non-clinical/bench testing, the document states:
"All bench testing confirmed that the product met the necessary specifications for its intended use."
This implies that for each of the numerous tests listed (e.g., compressive strength, maximum balloon inflation pressure, bond strength, fatigue testing, radiopacity, etc.), the device performed within predefined acceptable limits. Specific numerical acceptance criteria and performance values are not provided in this summary.

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

• Clinical Test Set Sample Size: 60 subjects treated with the Ascendx™ System and Ascendx™ Cement.
• Data Provenance: The document does not explicitly state the country of origin. It describes "clinical testing included evaluation of 60 subjects," which implies a prospective clinical study carried out by the manufacturer. It also mentions comparisons to "an investigation using the same cement without the Ascendx™ in 113 subjects" and "an investigation for 29 subjects undergoing treatment with the predicate device, and 31 subjects undergoing vertebroplasty." These comparison groups are likely from separate studies, but their temporal nature (retrospective/prospective) and provenance are not detailed here.

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

This information is not provided in the 510(k) summary. Clinical trials typically involve physicians assessing patient outcomes, but the specific number and qualifications of experts establishing "ground truth" (e.g., through blinded assessment of imaging or adjudicated outcomes) are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary.

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

This device is a medical device (VCF Repair System), not an AI/software device for diagnostic interpretation. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

As stated above, this is a medical device, not an AI/software algorithm. Therefore, a standalone algorithm performance study is not applicable and was not performed.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the clinical study, the ground truth was based on patient outcomes data including:

• Acute procedural success
• Pain levels
• Functional status
• Adverse events (leakage, subsequent fractures)
  These are typically assessed by treating physicians and reported by patients.

8. The Sample Size for the Training Set

This information is not applicable to this type of medical device. The device is a physical product, not an algorithm that requires a "training set" in the machine learning sense. The device was likely designed and refined through engineering iterations and bench testing, rather than an algorithmic training process.

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

This information is not applicable as it's not an AI/software algorithm. The "training" for such a device would involve engineering design, prototyping, and testing against design specifications, often in a lab setting (bench testing).

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The Ascend Shoulder System consists of a humeral stem, a mating humeral head, and an optional polyethylene glenoid. The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The Ascend Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain.

The Ascend Shoulder System is indicated for use as a replacement of shoulder joints disabled by:

• Rheumatoid arthritis with pain .
• Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) .
• Correction of functional deformity ●
• Fractures of the humeral head ●
• Traumatic arthritis ●
• Revision of other devices if sufficient bone stock remains .

All components are single use. The humeral stem is intended for cementless use, while the all polyethylene glenoid is intended for cemented use only.

The Ascend Shoulder System consists of a humeral stem Titanium Plasma Spray (Ti PS) coated and un-coated stem versions, a mating humeral head and an optional all polyethylene glenoid. The stem and head may be used alone, as a hemiarthroplasty if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total shoulder replacement system.

The present device submission corresponds to changes made to the version of the device cleared in 510(k) K120794.

This is a 510(k) premarket notification for the Tornier Inc. Ascend Shoulder System, specifically highlighting changes made to a previously cleared version of the device. This document describes a medical device, not an AI/ML algorithm. Therefore, many of the requested criteria related to AI/ML device studies (such as sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies) are not applicable.

Below is a summary based on the provided text, focusing on the available information regarding the device itself.

Acceptance Criteria and Device Performance for the Tornier Inc. Ascend Shoulder System (K121493)

The document primarily focuses on establishing "substantial equivalence" to a legally marketed predicate device (Tornier Ascend Shoulder System: K120794) for regulatory approval. This typically means demonstrating that the modified device is as safe and effective as the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This is a premarket notification for a physical medical device (shoulder prosthesis), and the "test set" refers to non-clinical testing of the device itself (e.g., mechanical testing, coating validation), not a dataset for an AI/ML algorithm.

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

Not applicable. This is not an AI/ML device where experts establish ground truth for a diagnostic output. The "ground truth" for a physical device is its material properties, mechanical performance, and biological compatibility, typically assessed through engineering standards and biological evaluations, not expert consensus on images.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are relevant for ambiguous cases in diagnostic studies, particularly with AI/ML. For a physical device, testing involves defined protocols and measurements.

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

No. This is not an AI/ML device that assists human readers.

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

No. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

For a physical orthopedic implant, the "ground truth" implicitly refers to:

• Engineering Standards and Specifications: Adherence to established mechanical, material, and performance standards for orthopedic implants.
• Biocompatibility Data: Evidence that the materials used are safe for implantation in the human body.
• Coating Validation Specifications: Specific criteria for the Titanium Plasma Spray (Ti PS) coating, such as adhesion strength, thickness, and morphology.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML algorithm.

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

Not applicable. This is a physical medical device, not an AI/ML algorithm.

Summary of Non-Clinical Testing:

The document explicitly states: "The modified Ascend Shoulder System was subjected to non-clinical testing (coating validation)." This indicates characterization and performance testing on the physical device, specifically focusing on the titanium plasma spray (Ti PS) coating. The results of these tests were deemed sufficient to conclude that the modified device is substantially equivalent to the predicate.

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The Ascend Shoulder System consists of a humeral stem, a mating humeral head, and an optional polyethylene glenoid. The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The Ascend Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain.

The Ascend Shoulder System is indicated for use as a replacement of shoulder joints disabled bv:

• Rheumatoid arthritis with pain .
• Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) .
• Correction of functional deformity ●
• Fractures of the humeral head .
• Traumatic arthritis .
• Revision of other devices if sufficient bone stock remains .

All components are single use. The humeral stem is intended for cementless use, while the all polyethylene glenoid is intended for cemented use only.

The Ascend Shoulder System consists of a humeral stem Titanium Plasma Spray (Ti PS) coated and un-coated stem versions, a mating humeral head and an optional all polyethylene glenoid. The stem and head may be used alone, as a hemiarthroplasty if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total shoulder replacement system.

The present device submission corresponds to changes made to the version of the device cleared in 510(k) K113413.

This document is a 510(k) premarket notification for the Tornier Inc. Ascend Shoulder System. It describes modifications to an already cleared device. As such, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not include information about acceptance criteria or a study proving the device meets those criteria in the context of AI/software performance metrics (e.g., sensitivity, specificity, accuracy).

Therefore, I cannot provide the requested information from the given text. The provided document is for a physical medical device (shoulder prosthesis) and evaluates its safety and effectiveness through mechanical and material testing, not through AI/software performance studies.

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The Ascend Shoulder System consists of a humeral stem, a mating humeral head, and an optional polyethylene glenoid. The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The Ascend Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and to relieve pain.

The Ascend Shoulder System is indicated for use as a replacement of shoulder joints disabled by:

• Rheumatoid arthritis with pain
• Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
• Correction of functional deformity
• Fractures of the humeral head
• Traumatic arthritis
• Revision of other devices if sufficient bone stock remains

All components are single use. The humeral stem is intended for cementless use, while the all polyethylene glenoid is intended for cemented use only.

The Ascend Shoulder System consists of a humeral stem, a mating humeral head and an optional all polyethylene glenoid. The stem and head may be used alone, as a hemiarthroplasty if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total shoulder replacement system.

The present device submission corresponds to changes made to the version of the device cleared in 510(k) K071147.

The provided text describes a Special 510(k) Premarket Notification for the Tornier Inc. Ascend Shoulder System, which is a medical device. This type of submission is for modifications to a previously cleared device and focuses on establishing substantial equivalence to a predicate device, rather than proving device performance against specific acceptance criteria through clinical studies.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not present in the provided document. The document focuses on regulatory classification, device description, indications for use, and a summary of non-clinical testing to demonstrate substantial equivalence to a predicate device (Tornier Nexa Orthopedics Total Shoulder System, K071147).

The non-clinical testing performed includes:

• Taper disassembly strength
• Mismatch evaluation
• Extraction testing
• Cadaveric evaluation

The document explicitly states: "The results of these non-clinical tests allow us to conclude that the Ascend Shoulder System described in this submission is substantially equivalent and as safe and effective as the original device." This indicates that no separate study proving the device meets specific acceptance criteria as defined by performance metrics (like sensitivity, specificity, accuracy, etc.) was conducted or reported in this submission format, as it's not typically required for a Special 510(k) for a modified Class II orthopedic implant.

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