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

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

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

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

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

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

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

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

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

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

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

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

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

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

This is not applicable for the reasons stated above.

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

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

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

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

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

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

8. The sample size for the training set

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

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

This is not applicable for the reasons stated above.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Here's why and what the document does describe:

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

What the document does state regarding testing:

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

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

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For the ASTRA TEE® -

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

For the ASTRA VR™ -

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

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

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

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

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

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

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

What can be extracted:

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

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

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

Based on the available information, here is the breakdown:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Materials:
Titanium alloy
CoCr alloy

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. The Type of Ground Truth Used

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

8. The Sample Size for the Training Set

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

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

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

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Implants:

OsseoSpeed™ Plus implants of the Astra Tech Implant System Plus are intended to be used:

• · To replace missing teeth in single or multiple unit applications within the mandible or maxilla
• · For immediate placement in extraction sites and partially or completely healed alveolar ridge situations
• · For both one- and two-stage surgical procedures
• · Especially well in soft bone applications where implants with other implant surface treatments may be less effective
• · Together with immediate loading protocol in all indications, except in single tooth situations in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate.

Abutments:

Astra Tech Implant System Plus abutments are intended to be used in conjunction with the Astra Tech Implant System Plus in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.

OsseoSpeed Plus implants are straight, self-tapping, threaded, root-form dental implants provided in multiple diameters and lengths with the previously cleared OsseoSpeed™ surface. Implants are available in diameters of 3.6 mm, 4.2 mm and lengths of 9 mm, 11 mm and 13 mm. The neck portion of the implant includes the MicroThread™ design. A new anti-rotation interface with 6 keyway cross section connections allows for six abutment positions. All other features and procedures of OsseoSpeed Plus implants are the same as presently cleared OsseoSpeed implants.

OsseoSpeed Plus abutment components consist of cover screws, healing abutments and abutments with corresponding screws. Cover screws and healing abutments are provided in sizes to match the implant platform. Healing abutments are provided in sizes to match the implant platform and various gingival diameters and gingival heights. OsseoSpeed Plus abutments have three design types, cylindrical, asymmetric and angled (20°). Each abutment design type is provided in three platform diameters (3.6, 4.2 and 4.8 mm), two prosthetic margin diameters (4.5 and 5.5 mm or 5.5 and 7.0 mm) and two gingival heights (low = 1.5- 2.5 mm and high = 2.5-3.5 mm) for a total of eleven abutment design combinations.

To assist in preoperative treatment planning of position and direction of implant placement, transparent radiographic implant guide sheets are provided with magnifications from 1.0X to 1.8X. The radiographic implant guides are usable with all OsseoSpeed Plus implants.

Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary for the Astra Tech Implant System Plus:

Important Note: This 510(k) summary is for a dental implant system. The information provided is typical for medical devices that aim to demonstrate substantial equivalence to previously cleared predicate devices, rather than a clinical study establishing efficacy from scratch. Therefore, many of the typical "AI/algorithm performance study" criteria you listed (like MRMC studies, training set details, or ground truth establishment for a test set in the AI context) are not applicable to this type of device submission.

The "study" in this context refers to performance testing designed to show that the new device's technological changes do not raise new issues of safety or efficacy compared to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:
The primary acceptance criterion for this 510(k) submission is to demonstrate substantial equivalence to legally marketed predicate devices. This is achieved by showing that the subject device has the same intended use, technological characteristics, materials, and provides similar performance without raising new issues of safety or efficacy. The specific performance test mentioned is compliance with ISO 14801.

Reported Device Performance:
The document states: "Performance testing was provided to demonstrate substantial equivalence and included methods described in ISO 14801."

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

• Sample Size for Test Set: Not specified in the summary. For mechanical testing under ISO 14801, a specific number of implants would be tested, but this number is not disclosed in the provided text.
• Data Provenance: The testing was conducted by or for Astra Tech AB, a Swedish company. The summary doesn't specify if the testing itself was performed in Sweden or elsewhere, nor does it specify if human data (e.g., retrospective or prospective patient data) was used. Given it's ISO 14801, it is almost certainly bench-top mechanical testing, not human patient data.

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

This information is not applicable as the "test set" in this context refers to mechanical performance testing, not human-interpreted data requiring expert consensus or ground truth establishment in the way it would be for an AI algorithm.

4. Adjudication Method for the Test Set

This information is not applicable for mechanical performance testing.

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

No. An MRMC comparative effectiveness study was not performed. This type of study is typically done for diagnostic or screening devices, especially those involving human interpretation of images, to assess reader performance with and without an AI aid. This 510(k) is for a physical medical implant device.

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

Not Applicable. This device is a physical dental implant, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The Type of Ground Truth Used

For the mechanical performance testing (ISO 14801), the "ground truth" would be the objective measurements of force, cycles to failure, or displacement as defined by the standard, measured by calibrated equipment. It is not expert consensus, pathology, or outcomes data in the usual sense.

8. The Sample Size for the Training Set

Not Applicable. This 510(k) is for a physical medical device, not an AI algorithm. Therefore, there is no "training set."

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

Not Applicable. As there is no training set for an AI algorithm, this question is irrelevant to this device submission.

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Astra Tech Implant System abutments are intended to be used in conjunction with the Astra Tech Implant System in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures. Highly angled abutments on small diameter implants are not recommended for use in the molar region. ZirDesign is not recommended for use in the molar regions.

The Astra Tech Implant System has been modified to increase treatment options by adding new abutment shapes in titanium and zirconia. Both abutment designs are provided in multiple sizes with straight and angled versions. The hex interlocking anti-rotation mechanism for indexing with the implant remains unchanged from the predicate devices. As with the predicate devices, Astra Tech's Conical Seal Design™ is used for the internal connection with the implant to achieve a tight and stable interface.

The provided text describes modifications to the Astra Tech Implant System, specifically the addition of new abutment shapes, and asserts their substantial equivalence to predicate devices, but it does not contain acceptance criteria for device performance or a study proving that the device meets such criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than detailing performance against specific acceptance criteria for a novel device.

Here's why the requested information cannot be extracted from the provided text:

• No Acceptance Criteria: The document does not define any specific numerical or categorical acceptance criteria for performance metrics (e.g., strength, durability, fit).
• No Performance Study Details: While it states "Performance testing was provided to demonstrate substantial equivalence and included methods described in ISO 14801," it does not provide any results from this testing, nor does it detail the study design elements requested (sample size, data provenance, ground truth establishment, expert qualifications, etc.).
• Focus on Substantial Equivalence: The entire submission hinges on the argument that the modified device is "substantially equivalent" to existing predicate devices, implying that its performance is expected to be similar, rather than proving it meets new, pre-defined acceptance criteria.

Therefore, I cannot populate the table or provide the requested details because the input text does not contain this information.

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The OsseoSpeed implants are intended to be used:

• to replace missing teeth in single or multiple unit applications within the mandible or . maxilla
• for immediate placement in extraction sites and partially or completely healed alveolar . ridge situations
• for both one- and two-stage surgical procedures o
• especially well in soft bone applications where implants with other implant surface . treatments may be less effective
• together with immediate loading protocol in all indications, except in single tooth ● situations in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate
• together with immediate loading protocol for single-tooth restorations on implants 8 mm . or longer
• with its 3.0 S product line for maxillary lateral incisors and mandibular lateral and . central incisors.

Astra Tech Implant System implants are intended to support prosthetic devices in edentulous or partially edentulous patients to restore esthetics and chewing function. The new components of the Astra Tech Implant System included in this submission are OsseoSpeed TX implants which have a narrower tapered apex design compared to OsseoSpeed implants (K053384). They are placed using a modified drilling protocol with new conical drill sizes. The modified drilling protocol is specifically designed for soft bone applications. All other features and procedures of OsseoSpeed TX implants remain the same as those for OsseoSpeed implants.

The purpose of this submission is to add the OsseoSpeed TX implants to the present product line and expand device claims regarding primary stability of Astra Tech Implant System implants.

The provided text describes a 510(k) premarket notification for the Astra Tech Implant System. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing new performance criteria for a novel device. Therefore, the "acceptance criteria" and "study proving the device meets acceptance criteria" as typically understood for a new therapeutic or diagnostic device (e.g., specific clinical endpoints, sensitivity/specificity thresholds) are not explicitly present in the document in the format requested.

Instead, the submission's goal is to show the new OsseoSpeed TX implants (with a narrower tapered apex design and modified drilling protocol for soft bone) are substantially equivalent to existing legally marketed devices. The "acceptance criteria" in this context would be the successful demonstration of this substantial equivalence, and the "study" is the comparison testing performed to support this claim.

Here's a breakdown based on the information provided, reinterpreting "acceptance criteria" and "study" for a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "Testing was performed to compare OsseoSpeed TX implants using the new soft bone drilling protocol with OsseoSpeed implants using the standard drilling protocol. Calculations also were made to determine bone to implant contact for the two implant/drilling protocol combinations."

• Sample Size: The exact sample size for this comparative testing is not specified in the provided text.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It is implied to be laboratory/non-clinical testing given the nature of comparing drilling protocols and bone-to-implant contact for implants.

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

This type of information (expert review for ground truth) is typically relevant for diagnostic devices interpreting medical images or data. For a dental implant's mechanical stability and bone-to-implant contact, the "ground truth" would be established through direct physical measurements, imaging, or histological analysis, rather than expert consensus on interpretation. Therefore, this information is not applicable and not provided in the document for an implant device.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are primarily used in studies where multiple human readers interpret data, and discrepancies need to be resolved. Since the "testing" described involves comparing implant performance characteristics (mechanical stability, bone-to-implant contact) through presumably laboratory or animal studies, an adjudication method in this sense is not applicable and not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is relevant for comparing the performance of human readers, typically with and without AI assistance for diagnostic tasks. This submission is for a dental implant, which is a therapeutic device, not a diagnostic one involving human interpretation of cases. Therefore, this type of study was not done and is not applicable.

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

No. This question is also relevant for diagnostic devices, specifically AI algorithms. The Astra Tech Implant System is a physical dental implant, not an algorithm. Therefore, a standalone algorithm performance study was not done and is not applicable.

7. The Type of Ground Truth Used

For the performance testing described ("compare OsseoSpeed TX implants... with OsseoSpeed implants... Calculations also were made to determine bone to implant contact"), the ground truth would be based on:

• Direct measurements/experiments: For primary mechanical stability and bone-to-implant contact, this would typically involve biomechanical testing (e.g., insertion torque, removal torque, pull-out strength tests) and potentially histological analysis or micro-CT imaging to quantify bone-to-implant contact in animal models or ex vivo samples.
• The document implies these were obtained through calculations and comparative testing, which points to direct experimental data rather than expert consensus, pathology (in the clinical sense for a patient), or outcomes data (long-term clinical results).

8. The Sample Size for the Training Set

This question is applicable to machine learning algorithms. Since the Astra Tech Implant System is a physical medical device (dental implant) and not an AI/ML algorithm, there is no training set and therefore no specified sample size for it.

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

As there is no training set for an AI/ML algorithm, this question is not applicable.

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Astra Tech Implant System is intended to be used to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla. The device may be used equally well in a single-stage or two-stage surgical procedure. It is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate. The OsseoSpeed Narrow product line shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors.

The fluoride-modified implant surface, though having a fluoride ion level far below that needed for caries prevention in teeth, provides a favorable substrate for bone attachment and osseointegration. Astra Tech Implant System is especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective. Because initial stability may be difficult to obtain in Type IV bone, immediate loading of single tooth restorations may not be appropriate in such situations. Immediate loading of single tooth restorations is not recommended for the OsseoSpeed™ 4.0S - 6 mm implant.

Astra Tech Implant System implants, abutments, prosthetic components and accessories are intended for supporting prosthetic devices in edentulous or partially edentulous patients to restore esthetics and chewing function. All components of the Astra Tech Implant System are identical to those presently marketed. The purpose of this submission is to expand device claims.

This 510(k) summary for the Astra Tech Implant System (K091239) does not contain information on acceptance criteria or a study proving device performance against such criteria.

The document is a standard 510(k) submission summary, which focuses on demonstrating substantial equivalence to a predicate device. It defines the intended use and describes the device, but does not present specific performance metrics, clinical study data, or acceptance criteria that would typically be found in a study proving device performance.

Therefore, I cannot populate the table or answer the specific questions about sample sizes, ground truth establishment, expert qualifications, or MRMC studies, as that information is not present in the provided text.

The document states: "Astra Tech AB demonstrated that, for the purposes of FDA's regulation of medical devices, the Astra Tech Implant System is substantially equivalent in indications and design principles to predicate devices..." This implies that the 'study' conducted was a comparison to existing, legally marketed devices, rather than a de novo clinical trial with defined acceptance criteria and performance metrics. Substantial equivalence does not require new performance data if the new device is sufficiently similar to a predicate.

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Astra Tech Implant System abutments are intended to be used in conjunction with Astra Tech Implant System implants in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.

The Astra Tech Implant System has been modified to increase treatment options by adding a new component, an additional abutment for provisional restorations.

The provided text describes a 510(k) summary for a medical device modification, specifically the "Astra Tech Implant System, New Component." However, it does not contain information about acceptance criteria, the study that proves device meets acceptance criteria, detailed performance data, sample sizes, ground truth establishment, or expert involvement.

The document is a regulatory submission discussing the device's administrative information, intended use, description, and equivalence to a predicate device. It explicitly states that the modification "has the same intended use, uses the same operating principle, incorporates the same basic design, and is packaged using the same materials and processes" as the unmodified predicate device. This implies that the modification is considered substantially equivalent based on these similarities, rather than requiring a new, comprehensive performance study against specific acceptance criteria.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number of experts or their qualifications for ground truth.
• Adjudication method for the test set.
• MRMC comparative effectiveness study details.
• Standalone performance data.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This type of information is typically found in a clinical study report or a more detailed performance evaluation, which is not present in the provided 510(k) summary. The 510(k) process for device modifications often focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new, extensive performance studies with detailed acceptance criteria if the changes are minor and do not alter the fundamental safety or effectiveness of the device.

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