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The Aero Jet Ventilation Catheter is indicated to be used as a device for ventilating the patient by the administration of oxygen and air, a technique referred to as jet ventilation.

The Aero Jet Ventilation Catheter is a sterile, single-use, prescription medical device that consists of a three lumen PTFE extrusion, a PEBAX centering feature at the distal end, three (3) MABS female luer connectors, silicone extrusion to connect the connectors to the main shaft, and four (4) polyolefin color coded marker bands for identification of connectors and depth marking. A removable stainless-steel stylet is included to support the device during insertion. It has a nominal insertion length of 23 cm and nominal OD of 3.85 mm. It is inserted orally and placed subglottic. It provides jet ventilation and allows for monitoring of pressure and EtCO2.

This document is a 510(k) clearance letter for a medical device called the "Aero Jet Ventilation Catheter." 510(k) clearances are for demonstrating substantial equivalence to a predicate device, not for proving new claims of safety and effectiveness through clinical trials with strict acceptance criteria based on new performance metrics.

Therefore, the provided document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria in the way described in the prompt (e.g., related to AI/algorithm performance, MRMC studies, specific effect sizes, ground truth establishment, or sample sizes for test/training sets in the context of diagnostic/AI performance).

The "performance testing summary" in the document refers to standard engineering and biocompatibility tests to show the device functions as intended and is safe, similar to the predicate device. It is not a study to establish performance against specific clinical or diagnostic metrics with human readers or AI in the way implied by the prompt's detailed questions.

Based on the provided text, I cannot complete the table or answer the questions as they pertain to a study proving device performance against acceptance criteria in a clinical/diagnostic context (like an AI study). The 510(k) process for this device relies on demonstrating equivalence to an existing device, primarily through engineering and bench testing, not through comparative clinical studies as you've outlined for diagnostic/AI devices.

Here's what I can extract from the document regarding "acceptance criteria" in the context of a 510(k) submission for this type of medical device:

The acceptance criteria for a 510(k) submission for a device like the Aero Jet Ventilation Catheter are implicitly tied to demonstrating substantial equivalence to a predicate device. This typically involves showing:

• Same Indications for Use: The new device is intended for the same uses as the predicate.
• Same Technological Characteristics: The new device has similar design, materials, and operating principles.
• Differences Do Not Raise New Questions of Safety/Effectiveness: If there are differences, testing must show they do not negatively impact safety or effectiveness.

The "studies" performed are primarily non-clinical functional and performance testing alongside biocompatibility testing. These tests are designed to show that the device performs its intended mechanical functions reliably and safely, and interacts biocompatibly with the body, similar to the predicate.

Therefore, the table and answers below reflect the type of "acceptance criteria" and "proof" found in this specific 510(k) document, which differs significantly from criteria for AI/diagnostic performance studies.

Acceptance Criteria & Device Performance (Based on K243579)

Since this is a 510(k) for a physical medical catheter, the "acceptance criteria" are not focused on diagnostic accuracy or AI performance, but rather on physical and functional characteristics to demonstrate substantial equivalence to a predicate device. The "performance" is implicitly tied to meeting these engineering and biocompatibility standards.

Table of Acceptance Criteria and the Reported Device Performance

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Puritan PurSafe Plus Collection and Transport System is an enclosed system intended for the collection, inactivation, and preservation of human upper respiratory specimens suspected of containing SARS-CoV-2. Puritan PurSafe Plus Collection and Transport System can be used for collection, transport, and storage of specimens at 2-4°C and 25-30°C. Specimens collected and stored in the PurSafe Plus Collection and Transport System are suitable for use with legally marketed molecular diagnostic devices.

Puritan PurSafe Plus Collection and Transport System is comprised of a peel pouch containing a sterile polyester flock swab applicator for collecting clinical specimens and a polypropylene vial containing 1mL PurSafe Plus buffer. PurSafe Plus MK buffer ensures stability of Sars Cov-2 during sample transport/storage at refrigerated to ambient temperature (4-30°C) and is intended to inactivate Sars Cov-2.

Acceptance Criteria and Device Performance Study for Puritan PurSafe Plus Collection and Transport System

This document outlines the acceptance criteria and reports on the study that demonstrates the Puritan PurSafe Plus Collection and Transport System meets these criteria, based on the provided FDA 510(k) clearance letter.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • LOD Study: N=24 for the initial assessment (6 concentrations x 2 replicates x 2 lots). N=20 for the confirmatory LOD (20 replicates at 64 genome copies/mL).
  • Stability Study: N=72 (4 lots x 5 time points x 2 incubation temperatures x 2 replicates).
• Data Provenance: The data was generated using heat-inactivated SARS-CoV-2 virus (BEI Resources; ATCC # VR-1986HK) spiked into clinically negative human nasal matrix (Lee Biosolutions, Maryland Heights, MO). This suggests retrospective analysis on a prepared sample matrix rather than prospective patient samples. The country of origin of the data is not explicitly stated, but the vendors for the virus and nasal matrix are US-based.

3. Number of Experts and Qualifications for Ground Truth

• The document does not mention the use of human experts to establish ground truth for the performance studies.
• The ground truth for the studies was based on the known concentration of spiked heat-inactivated SARS-CoV-2 virus and the analytical performance of the Cepheid GeneXpert® IV system and droplet digital PCR.

4. Adjudication Method for the Test Set

• No adjudication method is described. The studies rely on quantitative measurements of viral RNA detection using laboratory instruments (Cepheid GeneXpert® IV and ddPCR) and direct observation of viral inactivation.

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

• No MRMC comparative effectiveness study was done. This device is a collection and transport system, not an interpretive diagnostic AI algorithm that would typically involve human readers. Therefore, the effect size of human readers improving with or without AI assistance is not applicable.

6. Standalone Algorithm Performance Study

• A standalone performance study was done. The studies described (LOD, Stability, Inactivation) assess the performance of the Puritan PurSafe Plus Collection and Transport System (the "device" or "algorithm" in this context) directly, without human interpretation or intervention in the diagnostic process beyond laboratory procedures. The system's ability to preserve and inactivate the virus, and not interfere with downstream molecular detection, is evaluated independently.

7. Type of Ground Truth Used

• The type of ground truth used was analytical ground truth and virological ground truth.
  • Analytical Ground Truth: For the LOD and Stability studies, known concentrations of heat-inactivated SARS-CoV-2 (quantified in genome copies/mL) were spiked into confirmed clinically negative nasal matrix. The expected outcome was the detection of this known concentration by the downstream molecular diagnostic device.
  • Virological Ground Truth: For the Inactivation study, the presence or absence of viable SARS-CoV-2 virus after exposure to the buffer was the ground truth, assessed by exposing VeroE6 cells to the treated virus.

8. Sample Size for the Training Set

• The document does not specify a training set sample size. This is because the device is a physical collection and transport system, not an AI or machine learning model that typically requires a separate training set. The performance studies described are for validation, not model training.

9. How Ground Truth for the Training Set Was Established

• As there is no explicit training set for an AI/ML model, the concept of establishing ground truth for a training set is not applicable to this device. The ground truth described in point 7 is for the validation of the device's functional performance.

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The Tiger 2 System is a pedicle screw system 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 deform-ities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impair-ment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Tiger 2 System when used as anterior thoracic/lumbar screw fixation systems, is indicated for degenerative disc disease (defined as discogenic back pain with degener-ation of the disc confirmed by history and radios), spondylolisthesis, trauma (fracture and/or dislocation), spinal stenosis, deformities (scoliosis, lordosis and/or kyphosis), tumor, and previous failed fusion (pseudarthrosis).

The Tiger 2 System Fenestrated Screws are intended to be used with saline and radiopaque dye.

The Tiger 2 System is comprised of pedicle screws, rods, hooks, rod connectors and cross connectors. The Tiger 2 System can be used for single or multiple level fixations. The pedicle screws have various options in length and diameters. The rods are available in straight and prelordosed (curved) configurations. The system has variable length cross connectors.

The provided text is a 510(k) summary for the Tiger 2 System, a medical device for spinal fixation. It details the device's indications for use, materials, and mechanical testing results. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/software performance.

The document primarily focuses on the substantial equivalence of the Tiger 2 System to a predicate device based on:

• Mechanical Performance Data: Static and dynamic compression bending, and axial and torsional grip testing were performed according to ASTM F1717 and ASTM F1798.
• Technological Characteristics: Basic design (rod-based fixation system with polyaxial pedicle screws), materials (titanium alloy, cobalt chrome), and intended use.

The "device" in this context is a physical pedicle screw system, not an AI or software-driven device. Therefore, the questions regarding AI/software performance, such as sample sizes for test sets, expert ground truth, MRMC studies, or standalone algorithm performance, are not applicable to this document.

In summary, based solely on the provided text, it is not possible to answer the questions about acceptance criteria and study proving device meets acceptance criteria for an AI/software product. The document describes a traditional medical device clearance process focused on mechanical equivalence.

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When used as a cervical intervertebral body fusion device, the Zavation IBF implants are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graff in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.

When used as a lumbar intervertebral body fusion device, the Zavation IBF implants are intended to be used with autograft or allogenic bone graft comprised of cancellous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non -operative treatment. For all the above indications the Zavation IBF implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Pedicle Screw System and Zavation Cervical Plate System.

The VariSync Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

The VariSync Spacer is an interbody fusion device in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (0) weeks of non-operative treatment. The VariSync Spacer is to be filled with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. These devices are intended to be used with supplemental fixation such as the Zavation VariSync Plate, Zavation Midline Plate, Zavation EZ Plate, or Zavation Cervical Plate Systems. When used with the VariSync Plate, the assembly takes on the indications of the VariSync Spacer, with the VariSync Plate acting as the supplemental fixation.

When used as a cervical intervertebral body fusion device, the LABYRINTH implants are intended to be used with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graff in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.

When used as a lumbar intervertebral body fusion device, the LABYRINTH implants are intended to be used with autograft or allogenic bone graft comprised of cancellous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non -operative treatment. For all the above indications the LABYRINTH implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including Zavation Pedicle Screw System and Zavation Cervical Plate System.

The Zavation ALIF System is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the Zavation ALIF System is to be filled with autogenous bone graft material.

The Zavation ALIF System spacer and plate assembly are an integrated for stand-alone use when used with screws. When used with anchors only the recessed plate may be used, and the assembly is intended for use with additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine.

Hyperlordotic interbody devices (>20 degrees) must be used with supplemental fixation (e.g. posterior fixation) that has been cleared by the FDA for the use in the lumbar spine.

The Zavation IBF implants offers a variety of heights, widths, and lengths. There are six main configurations: ALIF, LLIF, TLIF, T-PLIF, PLIF and CIF. The different configurations allow for multiple surgical technique options. The implants are manufactured from medical grade PEEK (Polyetheretherketone) Superior Polymers Magnolia PEEK (ASTM F2026).

The Zavation IBF implants are available in a range of sizes, as well as parallel and lordotic angled implants, to accommodate variations in patients' anatomy. In addition, tantalum beads or pins are embedded in the implants as an option to help allow for radiographic visualization. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. This modification seeks clearance for the addition of an ion beam assisted deposition (IBAD) coating made from Grade 2 Commercially Pure Titanium that meets chemical composition requirements of ASTM F67 on previously cleared PEEK devices. The (IBAD) coated PEEK implants will be provided non-sterile.

The VariSync Plate is an anterior, cervical fixation device available in various heights and widths to fit the anatomical needs of a wide variety of patients. The plates are made from titanium alloy, as specified in ASTM F136. The Screws for use with the VariSync Plates are manufactured from titanium alloy, as specified in ASTM F136.

VariSync Spacers are anterior cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The spacers are available in various heights and footprints to fit the anatomical needs of a wide variety of patients. These devices are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. The VariSync Spacers are manufactured from Superior Polymers Magnolia PEEK, with tantalum markers, as specified in ASTM F2026 and F560. This modification seeks clearance for the addition of an ion beam assisted deposition (IBAD) coating made from Grade 2 Commercially Pure Titanium that meets chemical composition requirements of ASTM F67 on previously cleared PEEK devices. The (IBAD) coated PEEK implants will be provided non-sterile.

The LABYRINTH implants offer a variety of heights, widths and lengths. There are six main configurations: ALIF, LLIF, TLIF, T-PLIF, PLIF and CIF. The different configurations allow for multiple surgical technique options. The implants are manufactured from medical grade PEEK (Polyetheretherketone) Superior Polymers Magnolia PEEK (ASTM F2026). The LABYRINTH implants are available in a range of sizes, as well as parallel and lordotic angled implants, to accommodate variations in patients' anatomy. In addition, tantalum beads or pins are embedded in the implants as an option to help allow for radiographic visualization. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates. The LABYRINTH device has a porous structure on the end plate and through the device. This modification seeks clearance for the addition of an ion beam assisted deposition (IBAD) coating made from Grade 2 Commercially Pure Titanium that meets chemical composition requirements of ASTM F67 on previously cleared PEEK devices. The (IBAD) coated PEEK implants will be provided sterile.

The Zavation ALIF System includes a spacer, plate, screws, and anchors. The spacer component is assembled to an interbody plate and implanted anteriorly. The spacer components are available in a variety of materials, depths, widths, and heights. The plate component includes three or four holes for inserting bone screws or anchors. The plate component also includes a lock at each hole. The bone screws are available in a variety of diameters and lengths. The anchors are available in a variety of lengths. The interbody plate components are available in a variety of heights. This modification seeks clearance for the addition of an ion beam assisted deposition (IBAD) coating made from Grade 2 Commercially Pure Titanium that meets chemical composition requirements of ASTM F67 on previously cleared PEEK devices. The (IBAD) coated PEEK implants will be provided non-sterile.

The provided text describes several medical devices: Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, and Zavation ALIF System. The 510(k) summary indicates that this submission is for the addition of an ion beam assisted deposition (IBAD) Titanium coating to previously cleared PEEK devices. The acceptance criteria and the study to prove the device meets these criteria are focused on the coating properties rather than the overall device performance for fusion, as the underlying PEEK devices were previously cleared.

Here's a breakdown of the requested information based on the provided text:

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

Note: The document states "The specifications of the titanium coating are identical to that of the primary predicate device cleared in (K201367)." This implies that the acceptance criteria for these tests would be met if the results are comparable to the predicate device's coating performance. However, specific numerical thresholds for acceptance are not provided in this document. The conclusion states that "substantial equivalence to the cited legally marketed predicate devices" was demonstrated and "any differences between the subject devices and predicate devices do not impact the safety and effectiveness."

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 does not specify the sample size used for the coating property tests (Tensile Bond Strength, Static Shear Strength, Shear Fatigue Strength, Tabor Abrasion Test). It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective).

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 section is not applicable. The study described focuses on bench performance testing of coating properties, not clinical or image-based evaluations requiring expert interpretation.

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

This section is not applicable. The study described focuses on bench performance testing of coating properties, not clinical or image-based evaluations requiring 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 section is not applicable. The document describes a 510(k) submission for an interbody fusion device with a new coating, not an AI-powered diagnostic or assistive technology.

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

This section is not applicable. The document describes a medical device (interbody fusion system), not an algorithm or AI system.

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

For the coating properties tests, the "ground truth" would be the established performance standards or specifications defined by the ASTM standards (ASTM F1147, ASTM F1044, ASTM F1160, and ASTM F1978) and the performance of the predicate device's coating (from K201367).

8. The sample size for the training set

This section is not applicable. The document describes bench testing of a medical device coating, not a machine learning model that requires a training set.

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

This section is not applicable, as there is no training set for the described bench tests.

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When used with the Zavation ZLinkPC System for Posterior-Cervical-Thoracic (Occ-T3)

The Zavation Connector System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radior myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

When used with the Zavation Spinal System for Thoracic, Lumbar, and Sacral Spine Fixation (T1-S2/Illium)

The Zavation Connector System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion as a pedicle screw fixation system (T1-S2/Illium) in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

The Connector System is designed to aid in revision surgeries and extensions of existing hardware constructs from the Occiput to the Ilium. The Connector System includes a variety of non-sterile titanium implants including parallel rod to rod domino connectors, axial connectors with and without attachment rods, bypass connectors, lateral offsets, double tulips (angled and parallel), and Z rods. The implant options allow revisions and extension to be performed without removing existing hardware. The Zavation Connector System is designed to be used with the Zavation Z-Linkpc System for Posterior-Cervical-Thoracic (Occ-T3) and the Zavation Spinal System for Thoracic, Lumbar, and Sacral Spine Fixation (T1-S2/Illium).

The provided text is a 510(k) summary for a medical device called the "Zavation Connector System." It details the device's purpose, description, indications for use, materials, and a comparison to predicate devices, along with performance data.

However, the provided text does not contain information about acceptance criteria, clinical studies involving human readers, expert ground truth establishment, sample sizes for training/test sets, or adjudication methods. The "Performance Data" section specifically states: "Static axial and torsional grip were performed according to ASTM F1798 on a worst-case construct. The mechanical test results demonstrated substantial equivalency to the predicate device." This indicates mechanical testing, not clinical performance studies involving human interpretation or AI assistance, which are the focus of your request.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided document in the context of an AI/human reader performance study. The document describes the substantial equivalence of a physical medical implant (a pedicle screw system connector) based on mechanical properties, not an AI or imaging diagnostic device.

If this were a submission for an AI-powered diagnostic device, using the provided template, the description would approximate the following (hypothetical, as the actual data is not in the text):

Hypothetical Description of Acceptance Criteria and Study for an Imaginary AI-Powered Spinal Bone Fracture Detection Device (Not from the provided text)

Based on the provided document, the device in question is the "Zavation Connector System," which is a mechanical implant (thoracolumbosacral pedicle screw system) used to immobilize spinal segments. The provided performance data relates to static axial and torsional grip mechanical testing according to ASTM F1798, demonstrating substantial equivalence to a predicate device in terms of its physical properties and function, not its diagnostic accuracy or the performance of an AI algorithm.

Therefore, the detailed information requested regarding acceptance criteria, study sample sizes, expert ground truth establishment, MRMC studies, and AI performance metrics is not present in the provided 510(k) summary for the Zavation Connector System. This type of information is typically required for diagnostic imaging devices, especially those incorporating AI.

However, to illustrate how such a request would be addressed if the provided document were about an AI-powered diagnostic device, I will provide a hypothetical response demonstrating the structure and type of information that would be present.

Hypothetical Scenario: Acceptance Criteria and Study for an AI-Powered Spinal Bone Fracture Detection Device

Device Name (Hypothetical): SpinalFractureAI Assistant

Indications for Use (Hypothetical): The SpinalFractureAI Assistant is intended as a supplemental tool for radiologists to detect and localize vertebral fractures in thoracic and lumbar spine CT scans in adult patients.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Sizes and Data Provenance:

• Test Set Sample Size: 500 unique CT scans (patients).
• Data Provenance: Retrospective data collected from 3 major hospital systems across the United States (n=300), Germany (n=100), and Japan (n=100).
• Data Type: De-identified thoracic and lumbar spine CT scans.

3. Number of Experts for Ground Truth and Qualifications:

• Number of Experts: 3 independent expert radiologists.
• Qualifications: All were board-certified radiologists with subspecialty training in musculoskeletal radiology, each possessing at least 10 years of experience interpreting spinal CT scans.

4. Adjudication Method for the Test Set:

• Adjudication Method: 2+1 Consensus. Initial reads by two independent expert radiologists. In cases of disagreement on the presence or location of a fracture, a third, senior-level expert radiologist reviewed the case to establish the definitive ground truth.

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

• Yes, an MRMC comparative effectiveness study was performed.
• Effect Size: Human readers (radiologists) demonstrated a 7.2 percentage point improvement in fracture detection sensitivity when assisted by the AI algorithm compared to reading without AI assistance. This was statistically significant (p

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Zavation Navigated Instrument System are indicated for use during the placement of Zavation Spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Zavation Navigated Instruments are reusable and are specifically designed for use with the Medtronic Navigation StealthStation System which are 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 for the anatomy. Use of Zavation Navigated Instrument System is limited to use only with Zavation Spinal System and Zavation Z-Linkec System.

The Zavation Navigation instruments non-sterile, reusable instruments that can be operated manually. These instruments are intended to be used with the Medtronic StealthStation® System to aid in implantation of associated Zavation screw implants. The instruments are manufactured from stainless steel per ASTM F899

The provided text is a 510(k) summary for the Zavation Navigated Instrument System. It outlines the device description, indications for use, materials, and technological characteristics, as well as a list of predicate and reference devices. The "Performance Data" section mentions the types of testing performed but does not provide specific acceptance criteria or detailed results of those tests. It states:

• Accuracy and Precision Testing of Navigation System per ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical System
• Mating Interface Assessments
• CMM Inspection
• Instrument Verification

It also mentions: "Validation testing includes 1:1 accuracy and performance testing of the subject and predicate device in a simulated surgical navigation use environment."

Therefore, based only on the provided text, I cannot answer the questions comprehensively regarding specific acceptance criteria, reported device performance, sample sizes, expert involvement, or adjudication methods, as this detailed information is not present in the provided document.

The document primarily focuses on establishing "substantial equivalence" based on similar technological characteristics and types of performance testing, rather than reporting the quantitative results of those tests against specific acceptance criteria.

Therefore, I must state that the requested information (acceptance criteria, specific performance data, sample sizes, expert details, etc.) is NOT available in the provided text.

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The Zavation ALIF System is a stand-alone anterior interbody fusion device indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S 1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The interior of the spacer component of the Zavation ALIF System is to be filled with autogenous bone graft material.

The Zavation ALIF System spacer and plate assembly are an integrated for stand-alone use when used with screws. When used with anchors only the recessed plate may be used, and the assembly is intended for use with additional supplemental fixation that has been cleared by the FDA for use in the lumbar spine.

Hyperlordotic interbody devices (>20 dogrees) must be used with supplemental fixation (c.g. posterior fixation) that has been cleared by the FDA for the use in the lumbar spine.

The Zavation ALIF System includes a spacer, plate, screws, and anchors. The spacer component is assembled to an interbody plate and implanted anteriorly. The spacer components are available in a variety of materials, depths, widths, and heights. The plate component includes three or four holes for inserting bone screws or anchors. The plate component also includes a lock at each hole. The bone screws are available in a variety of diameters and lengths. The anchors are available in a variety of lengths. The interbody plate components are available in a variety of heights.

The provided text does not contain information about acceptance criteria and the study that proves a device meets them in the context of an AI-powered medical device. Instead, it is a 510(k) premarket notification summary for the Zavation ALIF System, which is an intervertebral body fusion device (a physical implant) and not an AI device.

Therefore, I cannot extract the requested information like expert qualifications, adjudication methods, MRMC studies, or training/test set details, as these are specific to the evaluation of AI/ML-based medical devices.

The document discusses the mechanical performance of the physical implant against ASTM standards, but not the performance of an AI algorithm. If you have a document describing an AI device's performance study, please provide it.

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Uni-FuZe-C Bone Strip is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Uni-FuZe-C Bone Strip resorbs and is replaced with bone during process.

Zavation Medical's Uni-FuZe-C Bone Strip is a bioactive osteoconductive, resorbable, biocompatible bone graft substitute in strip form. The product is composed of a matrix of purified bovine collagen per ASTM F2212, beta tricalcium phosphate (Beta-TCP per ASTM F1088), and Bioglass 45S5 per ASTM F1538.

The provided text describes the 510(k) summary for Zavation Uni-FuZe-C Bone Strip (K221726) and focuses on demonstrating its substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting on a study directly proving the device meets those criteria in a typical AI/software context.

However, based on the information provided, we can infer performance criteria related to the device's biological and physical characteristics and how they were evaluated.

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

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The Zavation Spinal System is a pedicle screw system 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal turnor, and failed previous fusion (pseudarthrosis).

The Zavation Spinal 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 having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

The Zavation Spinal System when used as anterior thoracic/lumbar screw fixation systems, is 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 (pseudarthrosis).

The Zavation Spinal System Fenestrated Screws are intended to be used with saline and radiopaque dye.

The Zavation Spinal System is comprised of polyaxial pedicle screws, rods, and cross connectors. The Zavation Spinal System can be used for single or multiple level fixations. The standard pedicle screws have various options in lengths and diameters as well as a sterile packaged Hydroxyapatite (HA) coated option. The rods are available in straight and pre-lordosed (curved) configurations. The system has variable length cross connectors.

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

The provided document is a 510(k) summary for the Zavation Spinal System, which is a medical device. It does not describe any acceptance criteria or studies related to device performance in a clinical or diagnostic context (e.g., accuracy, sensitivity, specificity) involving AI, imaging, or human readers.

Instead, the document focuses on regulatory approval based on substantial equivalence to predicate devices, primarily through mechanical testing of the implant's physical properties.

Therefore, most of the requested information cannot be extracted from this document as it pertains to different types of device validation.

Here's what can be extracted and a clear statement regarding what cannot:

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

This document describes mechanical testing for the Zavation Spinal System. The "acceptance criteria" can be inferred as meeting or exceeding the performance of predicate devices according to established ASTM standards.

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

• Sample size for test set: Not explicitly stated in terms of number of devices or constructs tested for the mechanical evaluation.
• Data provenance: Not applicable in the context of mechanical testing of physical implants. The testing was conducted in a lab setting.

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 mechanical testing of an orthopedic implant, not a diagnostic device requiring expert interpretation for ground truth.

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

Not applicable. This is mechanical testing, not a study involving human adjudication of results.

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 document does not describe a clinical study of diagnostic or AI-assisted performance, nor does it mention AI.

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

Not applicable. This document does not describe the performance of an algorithm.

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

Not applicable. For mechanical testing, the "ground truth" is adherence to established engineering standards (ASTM) and performance comparable to a predicate device.

8. The sample size for the training set:

Not applicable. This document does not describe a machine learning algorithm or a training set.

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

Not applicable. This document does not describe a machine learning algorithm or a training set.

In summary: The provided FDA 510(k) summary focuses on the mechanical and material properties of an orthopedic implant (Zavation Spinal System) to demonstrate substantial equivalence to existing predicate devices. It does not contain any information related to studies involving AI, diagnostic accuracy, human readers, clinical endpoints, or ground truth establishment in a clinical context.

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The VariSync Plate is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis.

The VariSync Spacer is an interbody fusion device intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) at one level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The VariSync Spacer is to be filled with autograft or allogenic bone graft comprised of cancellous and/or corticancellous bone graft in skeletally mature patients. These devices are intended to be used with supplemental fixation such as the Zavation VariSync Plate, Zavation Midline Plate, Zavation EZ Plate, or Zavation Cervical Plate Systems. When used with the VariSync Plate, the assembly takes on the indications of the VariSync Spacer, with the VariSync Plate acting as the supplemental fixation.

The VariSync Plate is an anterior, cervical fixation device available in various heights and widths to fit the anatomical needs of a wide variety of patients. The plates are made from titanium alloy, as specified in ASTM F136. The Screws for use with the VariSync Plates are manufactured from titanium alloy, as specified in ASTM F136.

VariSync Spacers are anterior cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The spacers are available in various heights and footprints to fit the anatomical needs of a wide variety of patients. These devices are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. The VariSync Spacers are manufactured from radiolucent PEEK polymer, with tantalum markers, as specified in ASTM F2026 and F560.

The provided document is a 510(k) premarket notification for the Zavation VariSync Plate System & VariSync Spacer System. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and performance study results like those expected for novel device approval or AI-based software.

Therefore, many of the requested details, such as specific acceptance criteria in numerical terms, sample sizes for test sets (as these are not clinical studies for efficacy in the same way), number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone performance details, training set information, or how ground truth was established for training sets, are not applicable to this type of submission.

Instead, the document highlights mechanical testing to show that the new device performs similarly to existing, legally marketed predicate devices.

Here's an breakdown of the information that is available in the provided text:

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

The document does not present a table of specific numerical acceptance criteria (e.g., "Accuracy > 90%"). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through mechanical testing. The reported performance is that the "mechanical test results demonstrated that the Zavation VariSync Plate System and The VariSync Spacer System is substantially equivalent to the predicate devices."

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

• Sample Size: Not explicitly stated as a "test set" in the context of clinical or AI studies. For mechanical testing, the "sample size" would refer to the number of devices or constructs tested. This detail is not provided in the summary.
• Data Provenance: The mechanical testing was performed in accordance with recognized ASTM standards (F2077, F2267, F1717). The location or specific laboratory where these tests were conducted is not mentioned. This is not a human data provenance (e.g., country of origin, retrospective/prospective) but rather a lab-based, engineering testing provenance.

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

• Not applicable. Ground truth in this context refers to the physical properties and performance characteristics determined by standardized mechanical tests, not expert medical opinion on a dataset.

4. Adjudication method for the test set:

• Not applicable. The "ground truth" for mechanical testing is derived from the results of the standardized tests themselves, not through expert 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:

• Not applicable. This is a medical device for spinal fusion, not an AI software device that assists human readers.

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

• Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

• Mechanical Performance Data: The "ground truth" is established by the results of standardized mechanical tests (ASTM F2077, ASTM F2267, ASTM F1717) designed to assess the strength, stability, and other physical properties of intervertebral body fusion devices and spinal implant constructs.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of AI or machine learning for this type of device submission. The device's design is based on engineering principles and similarity to predicate devices.

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

• Not applicable. As there's no training set, there's no ground truth for it.

In summary:

The provided document describes a traditional 510(k) submission for a physical medical device (spinal implantation system). The "study" mentioned is mechanical testing performed according to ASTM standards. The purpose of this testing is to demonstrate that the various components of the Zavation VariSync Plate System and VariSync Spacer System perform mechanically in a way that is substantially equivalent to legally marketed predicate devices, thereby establishing their safety and effectiveness for their intended use. This is a crucial distinction from AI/Software as a Medical Device (SaMD) clearances which would typically involve the types of detailed data analysis and ground truth assessment you've inquired about.

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