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The Posterior ISOLA Spinal System, when used with pedicle screws, is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). Levels of fixation are for the thoracic, lumbar and sacral spine.

The Posterior ISOLA Spinal System is also indicated for pedicle screw fixation for severe spondylolisthesis (Grades 3 and 4) at L5-S1, in skeletally mature patients, when autogenous bone graft is used, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is attained. Levels of fixation are from L3-S1.

The Posterior ISOLA Spinal System, when not used with pedicle screws, is intended for hook, wire, and/or sacral/iliac screw fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture and previous failed fusion surgery.

The Anterior ISOLA system is intended for use in correcting scoliotic, lordotic or kyphotic spinal deformities by establishing an axially and rotationally rigid fixation bridge parallel to the long axis of the spine. The system is indicated in situations where loss of correction is expected, where severe scoliosis exists or where pelvic obliquity is present.

The Anterior ISOLA system is used for the correction and stabilization of scoliotic curves, for the prevention or recurrence of undesired scoliotic curves, and for the stabilization of weakened trunks. Specific indications include:

1. Collapsing and unstable paralytic deformity.
2. Progressively increasing scoliosis.
3. Decreasing cardio-respiratory function, secondary to spinal or rib deformity or collapse.
4. Inability to maintain sitting balance, necessitating the use of the hands.
5. Increasing pelvic obliquity coincident with back pain or loss of sitting balance.
6. Spinal fractures (acute reduction or late deformity)
7. Degenerative Disc Disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
8. Spinal tumor
9. Previous failed fusion surgery.

Spinal levels for Anterior ISOLA instrumentation are from T5-L4.

The primary purpose of this premarket notification is to add indications to the marketing clearance for the pedicle screws which may be used as a spinal anchor in the ISOLA Spine System. All implant components are manufactured of either ASTM F-138 or F-1314 stainless steel or ASTM F-136 titanium alloy.

The provided documentation describes the ISOLA Spinal System, specifically focusing on the addition of indications for its pedicle screws. However, it does not contain information related to an AI/ML medical device, nor does it conduct a study with acceptance criteria in the manner requested (e.g., performance metrics like sensitivity, specificity, or reader improvement).

Therefore, I cannot provide the requested table and information about acceptance criteria or a study proving the device meets them, as the document details a traditional medical device (spinal system) and not an AI/ML-driven one. The performance data section only states: "Static and fatigue testing shows the constructs of the ISOLA Spinal System to perform consistently with previously cleared components." This indicates mechanical testing, not a clinical study to establish diagnostic or interpretive performance.

The document is a 510(k) summary for a spinal implant system seeking expanded indications for use. It primarily addresses substantial equivalence to existing predicate devices based on material, design, and indications, and mentions static and fatigue testing for mechanical performance, not AI/ML-related performance.

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When labeled for pedicle screw fixation, the TiMX Low Back System is intended for use in Grade 3 and 4 spondylolisthesis at L5-S1, when affixed to the lumbosacral spine, utilizing autologous bone graft, and intended to be removed after solid fusion is attained. Levels of attachment for this indication range from L3 to the sacrum.

When labeled for non-pedicle screw posterior fixation, the TiMX Low Back System is intended for hook, wire and/or sacral/iliac screw fixation from the thoracic spine to the ilium/sacrum. Properly used, the posterior TiMX Low Back System will provide temporary stabilization as an adjunct to spinal bone grafting process. Specific indications are:

1. Idiopathic scoliosis.
2. Neuromuscular scoliosis/ kyphoscoliosis with associated paralysis or spasticity.
3. Scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele.
4. Spinal fractures (acute reduction or late deformity).
5. Degenerative Disc Disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
6. Spondylolisthesis.
7. Neoplastic disease.
8. Previous Failed Fusion.

Levels of attachment for these indications range from T1 to the sacrum. This system is intended for single use.

All components of the TiMX Low Back System are made from implant grade titanium alloy conforming to ASTM F-136 specifications. TiMX pedicle and sacral screws, TiMX washers, TiMX slotted and cross connectors and TiMX Twister connectors are used in conjunction with the Isola System titanium components to comprise a rod based spinal fixation system.

TiMX Pedicle Screws are made from implant grade titanium alloy conforming to ASTM F-136 specifications. The TiMX Pedicle Screw is a variation of the existing titanium alloy pedicle screw previously cleared for the Isola Spinal System under K952236 and is the same screw that was found substantially equivalent for use with plates in K981274.

The machine thread portion of the TiMX pedicle screws are available in two thread lengths: Standard (30.0 mm) and No Cut +5 (17.0 mm). The No Cut +5 machine thread requires no cutting. Both the Standard and No Cut +5 thread length TiMX Pedicle screws are available in four cancellous diameters: 5.50 mm, 6.25 mm, 7.00 mm, and 7.75 mm. The larger size pedicle screws, 7.00 mm and 7.75 mm, may also be used in the sacrum. The cancellous portion of the Standard thread length is available in seven lengths that range from 25 mm to 55 mm in five millimeter increments. The cancellous portion of the No Cut +5 thread length is also available in seven lengths that range from 30 mm to 60 mm in five millimeter increments.

TiMX Sacral Screws are made from implant grade titanium alloy conforming to ASTM F-136 specifications. The TiMX Sacral Screw is a variation of the existing titanium alloy sacral screw previously cleared for the Isola Spinal System under K952236 and is the same screw that was found substantially equivalent for use with plates in K981274.

The TiMX Sacral Screw is designed with a larger diameter, 8.5 mm, for placement into the sacrum. TiMX Sacral Screws are available in the No Cut +5 (17.0 mm) machine thread length only. The No Cut +5 machine thread requires no cutting. The cancellous portion is available in four lengths that range from 35 mm to 50 mm in five millimeter increments.

TiMX Washers are manufactured from implant grade titanium alloy conforming to ASTM F-136 specifications. The TiMX Washer design is the same as previously cleared for the TiMX Low Back System under K981274. Washers are available in two styles: flat and tapered. Flat washers come in three sizes, 3 mm, 4.50mm and 5.0 mm. All edges of the washers are rounded. All washers have a chamfered inner hole for placement on the machine threaded portion of the TiMX screws. The tapered washer comes in one size with two different shaped inner holes: one round and the other oblong.

TiMX Connectors are manufactured from implant grade titanium alloy conforming to ASTM F-136 specifications. The Modular Cross Connector utilizes J-hooks which can be positioned anywhere along the construct to provide rod to rod connection. The TiMX Connector designs are a variation of titanium alloy Isola Slotted Connectors and the Modular Cross Connector and J-Hooks previously cleared for the Isola Spinal System under K952236.

The TiMX slotted connector assembly has two parts: a body and a set screw. Slotted connectors provide screw-to-connector-to-rod union. Slotted and offset designs are available in 14 inch diameters to accommodate the rod size. The slotted portion of each connector provides surgical latitude for screw placement. The machine threaded portion of the connector is locked to the screw with the nut. The rod is locked to the connector with the hexlobe set screw. The TiMX slotted connectors are offered in five designs: straight and extended (each with a 90° angle at the rod locking end), angled (with a 45° angle), offset left, and offset right.

TiMX Twister Connector is manufactured from titanium alloy conforming to ASTM F-136 specifications. The TiMX Twister Connector is a variation of the titanium alloy Isola Twister Connector previously cleared for the Isola Spinal System under K965046.

The Twister Connector, like other slotted connectors, provides a stable, strong and durable screw-to-connector-to -rod union. To provide secure fixation to the rod, a patented V-Groove Hollow Ground (VHG) design is used in all connectors. The two piece Twister connector design utilizes the attributes of the one piece connectors. It consists of a slotted transverse member with splines which mate with the splines of the V-Groove body. Together these two pieces create the slotted connector assembly. The spline connection or joint is the medium by which the screw/connector interface can be manipulated and secured. This two piece design allows for intraoperative sagittal alignment in 7º increments.

The AcroMed TiMX Low Back System is a medical device for spinal fixation. The submission provided outlines the mechanical performance testing conducted to demonstrate substantial equivalence to previously cleared devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not explicitly state the sample sizes (number of constructs or components) used for each specific mechanical test. The data provenance is from bench testing conducted by AcroMed Corporation. The document does not specify country of origin for the data, but it is implied to be part of their regulatory submission to the US FDA. The study is a prospective test in the sense that the device was manufactured and then subjected to these specific tests to gather performance data.

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

Not applicable. This submission describes mechanical bench testing of an orthopedic implant, not a diagnostic device requiring expert interpretation of clinical data to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable. The "ground truth" for this type of testing is derived from established engineering principles and ASTM standards for evaluating implant performance, not human expert adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focuses on the mechanical properties of an implant, not its effectiveness in a clinical diagnostic setting involving human readers.

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

Not applicable. This is not an AI/algorithm-based device. The testing described is for the mechanical performance of a physical implant.

7. The Type of Ground Truth Used

The "ground truth" used for this study is based on:

• Engineering specifications and design requirements: The device must meet certain force, torque, and fatigue limits to be considered safe and effective.
• ASTM F-136 specifications: For material conformity (implant grade titanium alloy).
• Comparison to predicate device performance: The performance of the TiMX Low Back System was evaluated against the mechanical properties of the existing titanium alloy Isola Spinal Fixation System and standard titanium VSP pedicle screws, which were already cleared devices. The goal was to demonstrate "equal or superior" mechanical properties or "significant improvement."

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for the mechanical performance testing of an orthopedic implant. The tests described are direct evaluations of the device's physical properties.

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

Not applicable, as there is no training set in this context.

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The ISOLA Spinal System, when used with pedicle screws, is intended for use in grade 3 or 4 spondylolisthesis at L5-S1 utilizing autologous bone graft, when affixed to the lumbosacral spine, and intended to be removed after solid fusion is attained.

The ISOLA Spinal System, when not used with pedicle screws, is intended for hook, wire, and/or sacraViliac screw fixation from T1 to the illium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, lordosis and kyphosis), tumor, fracture and previous failed fusion.

As a whole, the ISOLA Spinal System is intended for T1-sacral fixation. Screw fixation is from L3-S1.

The purpose of the premarket notification is to add a pediatric PRC (Plate-Rod Combination) and downsized hooks to the components intended for use with AcroMed's ISOLA Spine System. All implant components are manufactured of either ASTM F-138 or F-1314 stainless steel or ASTM F-136 titanium alloy.

The provided text describes a 510(k) premarket notification for the "PEDIATRIC PRC for use with the ISOLA Spine System." This document is not a clinical study report but rather a regulatory submission for device clearance. Therefore, it does not contain the typical structure of a study that establishes acceptance criteria and then proves the device meets them through clinical data.

Instead, the performance data section states: "Static and fatigue testing were conducted to characterize the performance of the devices." This implies mechanical or laboratory testing, which is common for implantable devices to ensure their structural integrity and durability. The acceptance criteria for such tests would be internal to the manufacturer's design specifications for strength, fatigue life, and other mechanical properties, and would be compared against validated methods or industry standards for similar devices.

The document then focuses on establishing "Substantial Equivalence" to previously cleared devices (K920392, K952236, and K962984) based on material, design, and intended use. This is a regulatory pathway for devices that are similar in technology and indications to existing legally marketed devices, rather than a demonstration of clinical efficacy and safety through new clinical studies.

Therefore, many of the requested points cannot be answered from the provided text, as it doesn't describe a clinical study with human subjects, ground truth establishment, or expert adjudication.

Here's a breakdown of what can be inferred or directly stated from the text regarding acceptance criteria and performance, with explanations for what cannot be answered:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document does not provide specific numerical acceptance limits for static and fatigue testing. It simply states that testing was conducted to "characterize" performance and that the device is "substantially equivalent" to predicate devices, implying that its performance is acceptable within the context of those predicates.

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

• Sample Size (Test Set): Not applicable for a clinical test set from this document. The "tests" mentioned are mechanical static and fatigue tests. The sample size for these mechanical tests is not specified.
• Data Provenance: Not applicable for a clinical test set. The mechanical testing was likely conducted by the manufacturer (AcroMed Corporation).

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

• Not applicable as this is not a clinical study requiring ground truth established by medical experts. The "ground truth" for mechanical testing would be engineering specifications and industry standards.

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

• Not applicable as this is not a clinical study involving human readers or interpretation of medical data. Adjudication methods are relevant for subjective assessments, which are not described here.

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

• No. This is a 510(k) submission for a spinal implant, not an AI-powered diagnostic or assistive device. Therefore, MRMC studies and AI assistance are not relevant.

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

• No. This is a 510(k) submission for a physical medical device (spinal implant), not an algorithm or software.

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

• For the mechanical performance, the "ground truth" would be established by engineering principles, industry standards (e.g., ASTM standards for biomechanical testing of spinal implants), and the performance characteristics of the predicate devices. It is not clinical "ground truth" like pathology or outcomes data.
• The "truth" for substantial equivalence is based on comparing the new device's design, materials, manufacturing, indications for use, and performance to a legally marketed predicate device.

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

• Not applicable. (See #8)

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The Titanium MX Plate Based Low Back System is intended for use in Grade 3 and 4 spondylolisthesis at L5-S1, when affixed to the lumbosacral spine, utilizing autologous bone graft, and intended to be removed after solid fusion is attained. Levels of attachment for this indication range from L3 to the sacrum.

The TiMX Plate Based Low Back System is a variation of the existing titanium alloy VSP Spinal System previously cleared under K944736. The TiMX Plate Based Low Back System is a construct that consists of pedicle and sacral screws, spine plates, nuts, washers and a transverse connector. This modified system provides increased pedicle screw strength, increased construct fatigue performance, increased construct stiffness, improved geometry and lower profile than its predecessor, the titanium alloy VSP Spinal System.

The document describes a medical device called the "TiMX Plate Based Low Back System" and its substantial equivalence to a previously cleared device. It is a 510(k) premarket notification, which assesses substantial equivalence to a predicate device rather than establishing new acceptance criteria and conducting studies to prove the device meets those criteria from scratch.

Therefore, the information you're requesting regarding "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of typical AI/software device evaluation (e.g., sensitivity, specificity, F1-score) is not directly applicable to this type of medical device submission.

Instead, the document details performance data in comparison to its predicate device to demonstrate substantial equivalence.

Here's how to frame the information based on the provided text, focusing on the equivalence study presented:

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

Since this is a 510(k) demonstrating substantial equivalence, the "acceptance criteria" are implied to be that the new device (TiMX) is "generally superior or equivalent" to the predicate device (standard titanium VSP system) in terms of its mechanical performance.

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: Not specified in terms of distinct units or number of tests conducted, but refers to "a full battery of testing" on "both the TiMX and standard titanium VSP systems." This implies testing on physical prototypes of the components and systems.
• Data Provenance: Not specified, but given it's a 510(k) submission in the US, the testing would typically be performed by the manufacturer or a certified lab, likely in the US, for regulatory submission to the FDA. The study is prospective in the sense that the testing was performed on the new device designs to gather data for the submission.

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. The "ground truth" here is objective mechanical engineering measurements (e.g., torque, bending force, fatigue cycles) from physical testing, not expert interpretation of medical data. Therefore, no human experts as described are involved in establishing ground truth for mechanical testing.

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

Not applicable, as this is objective mechanical testing. The results would be quantitative measurements, not subjective 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:

Not applicable. This document describes a physical medical implant (spinal system), 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 software. It is a physical device.

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

The "ground truth" for the performance claims is objective mechanical engineering measurements obtained from physical laboratory testing (e.g., static compression bending, static torsion, dynamic compression bending, torque to failure, endurance limit) comparing the new device components and system to the predicate device components and system.

8. The sample size for the training set:

Not applicable. This is a physical device, not a machine learning algorithm that requires a training set. The "training" in manufacturing comes from design iterations and engineering experience.

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

Not applicable, as there is no training set in the context of an AI/ML algorithm for this device.

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The University AM Plate™ Anterior System is intended for lateral screw fixation to the T9-L4 levels of the spine, and is not suitable for attachment to the sacrum. Specific indications are fracture, tumor, previous failed fusion and pseudoarthrosis, and degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).

The University AM Plate™ Anterior System Plates are fabricated from ASTM F-136 implant grade titanium alloy. The plates have a contoured low profile to match the curvature of the lateral aspect of the thoracolumbar vertebral bodies. The slot pattern allows a wide range of screws and bolt placement, while the spherical countersinks allow up to 15 degrees of screw angulation. The University AM Plate™ Anterior System plates are either rectangular or distally tapered, and come in a variety of lengths. Distally tapered plates are used at the L4 level to allow the common iliac vessels to cross without undue pressure. The University AM Plate™ Anterior System Bolts and Screws are fabricated from ASTM F-136 implant grade titanium alloy. Bolts are 7.0mm in diameter and screws are 6.25mm in diameter. Bolts and screws are available in 5mm length increments. When inserted, the tip of each bolt or screw should extend one thread through the opposite cortex of the vertebra to increase holding power. The University AM Plate™ Anterior System Drill Guide is designed to allow precise drilling of the vertebral bodies and to act as a sizing template for the plates.

Here's an analysis of the provided text regarding the acceptance criteria and study for the AcroMed UniversityAM Plate™ Anterior System:

It's important to note that the provided document is a 510(k) summary for a medical device and not a detailed clinical study report. Therefore, it focuses on demonstrating "substantial equivalence" to existing devices rather than presenting a novel clinical trial with the detailed performance metrics you've requested.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation:
The document does not specify quantitative acceptance criteria (e.g., minimum load strength in Newtons, cycles to failure). Instead, the performance is benchmarked against "previously cleared components" via "substantial equivalence." This is typical for a 510(k) submission where the device is considered similar enough to existing, legally marketed devices that new, extensive clinical trials are not required.

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

• Sample Size: Not specified. The document mentions "Static and fatigue testing," which typically involves multiple test samples, but the exact number isn't reported.
• Data Provenance: The document does not provide details on data provenance (e.g., country of origin, retrospective/prospective). It describes laboratory-based mechanical testing, not human or patient data.

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

This information is not applicable to this document. "Ground truth" for mechanical testing is established by engineering parameters and measurements (e.g., load cells, displacement sensors) and adherence to ASTM standards, not by expert medical review.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus in clinical data review, not for mechanical testing.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes mechanical testing of the device itself, not a study evaluating human readers' performance with or without AI assistance.

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

This information is not applicable. The device is a surgical implant (anterior spinal plate system), not a software algorithm that would have "standalone" performance in the context often used for AI/diagnostic devices.

7. The Type of Ground Truth Used

The ground truth for the "PERFORMANCE DATA" section is based on engineering measurements and material science standards (ASTM F-136 specifications) related to the mechanical properties of the plate and screw system under static and fatigue loading.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical implant, not an AI model that requires a "training set."

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

This information is not applicable for the same reason as point 8.

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The Kaneda Anterior Spinal System is intended for use in:

1. Idiopathic scoliosis.
2. Degenerative Disc Disease defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.
3. Scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele.
4. Neuromuscular scoliosis/kyphoscoliosis
5. Spinal fractures (acute reduction or late deformity).
6. Revision surgery.
7. Tumor.
   In addition, the Kaneda Anterior Scoliosis System can also be used for the correction and stabilization of scoliotic curves, for the prevention or recurrence of undesired scoliotic curves, and for the stabilization of weakened trunks. Indications for these scoliotic uses include:
8. Collapsing and unstable paralytic deformity.
9. Progressively increasing scoliosis.
10. Decreasing cardio-respiratory function, secondary to spinal or rib deformity or collapse.
11. Inability to maintain sitting balance, necessitating the use of hands.
12. Increasing pelvic obliguity coincident with back pain or loss of sitting balance.
    The intended levels for treatment with the Kaneda Anterior Scoliosis System. are T4 to L4.

The Kaneda Anterior Scoliosis System is a construct that consists of two spinal staples, KASS blunt tip open and closed screws, standard Isola open and closed screws and 3/16 inch diameter Isola spinal rods.

KASS Spinal Staple:
The KASS spinal staple is made from ASTM F-138 implant grade stainless steel. The KASS spinal staple is available in a single or two-hole design.
The single hole KASS spinal staple is intended to be utilized in the thoracic spine, specifically when the anatomy of the spine restricts the use of a two-holed spinal staple. The single hole KASS spinal staple contains a centered single machined hole designed to accommodate a 6.25mm open or closed screw. The single hole KASS spinal staple is contoured in two planes. This design provides a more suitable fit when utilized in the thoracic spine. The single hole KASS spinal staple is available in one size.
The two-hole KASS spinal staple contains two machined holes placed diagonally across from one another. Both holes are designed to accommodate a 6.25mm open or closed screw. The two-hole KASS spinal staple is contoured in one plane which compliments the vertebral anatomy. The two-hole KASS spinal staple is etched with a ";" or "@" indicating the correct alignment of the spinal staples within a construct. In addition, a directional arrow (->) with the word "APEX" is etched on the twoholed KASS spinal staple. These etchings aid in the correct positioning of the two-hole spinal staple to ensure that the shortest spinal rod is posteriorly positioned in the construct. The two-hole KASS spinal staple is available in small, medium and large sizes.
Both the single and two-holed spinal staple are etched with an "A" for anterior placement and a "P" for posterior placement to the vertebral anatomy. All spinal staples are designed with four tetraspikes on the underneath side of the staple.

Spinal Screws:
The KASS and Isola standard screws are made from ASTM F-138 implant grade stainless steel. The KASS and Isola standard screws have a cancellous diameter of 6.25mm and connect to a 3/16 (4.75mm) diameter Isola spinal rod. The spinal screws are available in two designs. A standard Isola open and closed design and a KASS open and closed screw containing a blunt tip at the end of the cancellous portion of the screw. The KASS screw is intended for bi-cortical purchase of the vertebral body.
The closed KASS and standard Isola screws are designed to thread the spinal rod through the closed screw head. The open KASS and standard Isola screws are designed with a removable cap which allows the rod to be placed into the open screw head. The cap is re-applied to the head of the open screw capturing the spinal rod. Both the open and closed design KASS and standard Isola screws utilize a Isola set screw that tightens the spinal rod into the KASS screw.
The 6.25mm diameter KASS open and closed screws are available in twelve lengths which range from 25mm to 60mm in varying millimeter increments. The 6.25mm diameter standard Isola open and closed KASS screws are available in eleven lengths which range from 20mm to 70mm in 5 millimeter increments.

Spinal Rod:
The Isola spinal rod is made from ASTM F-138 implant grade stainless steel. The spinal rod is 3/16 inch (4.75mm) diameter and has a smooth surface. The spinal rod is cut to the required length needed for the KASS construct. The spinal rod is available in a 18 and 24mm length.

The provided text describes a medical device, the Kaneda Anterior Spinal System (KASS), and its regulatory clearance. However, it does not contain information about acceptance criteria, device performance from a clinical study, sample sizes, expert ground truth establishment, or any comparative effectiveness studies.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving clinical efficacy through detailed performance studies.

Therefore, I cannot fulfill the request to provide the acceptance criteria and study that proves the device meets the criteria because the necessary information is not present in the provided text. The "Performance Data" section only lists "Non-Clinical: Mechanical characterization" and types of mechanical tests, not clinical performance metrics.

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The M-2 Anterior Plate System is intended for use in:

1. Degenerative Disc Disease defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.
2. Pseudoarthrosis
3. Spondylolysis
4. Spondylolisthesis
5. Burst fractures/ trauma
6. Tumor
7. Anterior fusion following failed posterior operations
8. Unsuccessful previous anterior surgery
9. Lordotic deformities of the spine
   The intended levels for treatment with the M-2 Anterior Plate System are T3 to L3. In order to treat levels T3 to L3, plate attachment is from T2 to L4. The M-2 Plate System is intended to treat one motion segment per construct.

The M-2 Anterior Plate System is a construct which consists of one M-2 plate attached to the vertebral body by either four M-2 screws or by two M-2 screws and two M-2 bolts. Surgeon preference dictates which type of implant construct is utilized. The components of the M-2 Anterior Plate System have been designed with anatomic limitations in mind.
M-2 PLATES: The M-2 plate is made from ASTM F-136 implant grade titanium alloy. The plate is contoured in two planes to provide a more suitable fit of the thoracic, thoracolumbar and lumbar segments of the spine. Each plate has two sets of nested slots on each end of the M-2 plate. Larger sized M-2 plates contain an additional nested slot centered in the middle of the M-2 plate for graft fixation. Each nested slot allows 15 degrees angulation of a M-2 screw. The letters A and P are etched on the M-2 plate to identify the anterior and posterior portions of the M-2 plate. On the underside beneath the posterior nested slots is a machined groove designed to prevent rotation of the M-2 bolt. M-2 plates are available in six sizes that range from 40mm to 90mm in ten millimeter increments.
M-2 SCREWS: The M-2 screw is made from ASTM F-136 implant grade titanium alloy. The M-2 screw has a cancellous diameter of 4.75mm. The M-2 screw is capable of 15 degrees angulation within each nested slot of the M-2 plate. A M-2 screw may be used in all nested slots of the M-2 plate. The 4.75mm diameter M-2 screws are available in seven lengths which range from 25mm to 55mm in five millimeter increments.
M-2 BOLTS: The M-2 bolt and spherical nut are made from ASTM F-136 implant grade titanium alloy. The M-2 bolt is composed of two parts: a long cancellous section with an integral fixed lower nut and a machine threaded section above the integral nut. A spherical nut secures the M-2 bolt to the M-2 plate. M-2 bolts have a threaded cancellous of 5.50mm. The integral nut portion of the M-2 bolt connects into the machined groove beneath the posterior nested slots of the M-2 plate. A bolt may be used only in the inferior and superior posterior nested slots of the M-2 plate. The M-2 bolts are available in seven lengths that range from 25mm to 55mm in five millimeter increments.

The provided text describes a 510(k) summary for a medical device, the M-2 Anterior Plate System, and its regulatory approval. It does not contain information about acceptance criteria for an AI/ML powered device, nor does it describe a study proving such a device meets acceptance criteria.

The document pertains to a traditional medical device (spinal implant) and its non-clinical performance data (mechanical testing). Therefore, I cannot generate a response based on your request, as it specifically asks for information related to AI/ML acceptance criteria and studies which are not present in the provided text.

Here's why the provided text is not suitable for your request:

• Device Type: The M-2 Anterior Plate System is a physical surgical implant (plates, screws, bolts), not an AI/ML powered device.
• Performance Data: The performance data described is "Non-Clinical: Static compression bending and torsion... Dynamic bending compression testing," which are mechanical tests for structural integrity of the hardware. This is entirely different from the performance metrics (e.g., sensitivity, specificity, accuracy) and study types (e.g., MRMC, standalone) associated with AI/ML algorithms.
• Regulatory Pathway: The document is a 510(k) summary for substantial equivalence to a predicate device, a pathway for traditional medical devices. It does not mention any AI/ML specific regulatory considerations or guidance.
• Lack of AI/ML Specific Information: There's no mention of algorithms, training sets, test sets, ground truth establishment by experts, adjudication methods, or any other terminology relevant to evaluating AI/ML performance.

If you have a document about an AI/ML powered device, please provide that, and I would be happy to help.

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The Kaneda SR Anterior Spinal System is intended for anterolateral screw fixation to the T10-L3 levels of the spine, with all metal at least 1 cm. from a major vessel. Specific indications are degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), deformities (scoliosis, kyphosis, lordosis), tumor, fracture and revision of previous surgery. The Kaneda system is used in conjunction with the Isola Spine System. Specifically, the 1) Isola ¼" Rods 2) Isola Open Caps and 3) the Isola Set Screws are interchangeable parts.

The components of the Kaneda SR Anterior Spinal System consist of spinal plates, anterior vertebral body screws, transverse rod couplers and rods. This system can also be used in conjunction with some components of the Isola Spine System. Specifically, 1) the Isola ¼" rods 2) the Isola Open Caps and 3) the Isola Set Screws. The contoured spiked plates are designed to help the construct anchors resist axial forces and serve as a guide for placement of the screws. The plates are available in three sizes (small, medium and large) and are designed as pairs with specific caudal and rostral components. The screws serve to anchor the vertebral bodies to the longitudinal rods. The screws are available in open and closed formats designed to fit the 1/4" rod in cancellous lengths of 35 mm to 60 mm. The Kaneda Anterior Spinal System utilizes the 1/4" diameter rod, available in 18" lengths or in precut lengths from 45 mm to 150 mm.

The provided text pertains to the 510(k) summary for the AcroMed Kaneda SR Anterior Spinal System, a medical device. This document describes the device, its intended use, and its substantial equivalence to previously cleared devices. It also includes the FDA's clearance letter with specific conditions.

However, the provided text does not contain information regarding detailed acceptance criteria for device performance, nor does it describe a specific study (like a clinical trial or performance study with metrics such as sensitivity, specificity, or F1 score) that proves the device meets such criteria.

The "PERFORMANCE DATA" section states: "Static and fatigue testing show the Kaneda SR Anterior Spinal System to perform consistently with previously cleared components." This is a very high-level statement and does not provide:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for a test set or data provenance. The testing mentioned is mechanical ("static and fatigue").
3. Number of experts used to establish ground truth or their qualifications. This is not applicable to mechanical testing of physical implants.
4. Adjudication method. Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study. Not applicable, as this is a physical medical device (spinal implant), not an AI/software device that assists human readers.
6. Standalone performance. The device is a physical implant; its "performance" is mechanical strength and durability, not an algorithm's output.
7. Type of ground truth used. For mechanical testing, this would typically be engineering specifications and standards, not expert consensus or pathology in a clinical sense.
8. Sample size for the training set. Not applicable for mechanical testing.
9. How ground truth for the training set was established. Not applicable for mechanical testing.

Conclusion based on the provided text:

The provided document (K971248 510(k) Summary) states that "Static and fatigue testing show the Kaneda SR Anterior Spinal System to perform consistently with previously cleared components." This implies that the device met certain mechanical performance standards, which are usually defined by industry standards (e.g., ASTM) or internal specifications of the manufacturer, and these standards would constitute the "acceptance criteria" for such a physical implant. However, the exact numerical acceptance criteria, the specific test results, the sample sizes of the tested components, or the detailed methodology of these tests are not disclosed in the provided 510(k) summary. These details would typically be found in the full 510(k) submission, not the summary intended for public release.

Therefore, I cannot populate the requested table or answer the specific questions related to clinical performance, expert ground truth, or AI/software evaluation, as the provided text only refers to mechanical testing for a physical spinal implant.

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The AcroMed Anterior Cervical Stabilization System is intended for anterior cervical intervertebral body fixation. This system is indicated for patients in which stability is desired following anterior cervical fusion for the indications listed below. The intended levels for treatment range from C2 to T1.

Indications include symptomatic cervical spondylosis, trauma (including fracture), post-traumatic kyphosis or lordosis, tumor, degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), re-operation for failed fusion, or instability following surgery for the above indications.

The AcroMed Anterior Cervical Stabilization System, in its fully assembled form, consists of two laterally placed rods joined by platforms which lie on the anterior vertebral surface. The system is anchored to the vertebrae with screws. The implant provides supplemental stability to the cervical spine following anterior cervical fusion. Depending upon the implant configuration, it may serve as either a fixed (load-bearing) or unfixed (load-sharing) construct.

The following types of components are available in the system: Rods, Platforms, Screws and Cross Connectors. All components are manufactured from implant grade Titanium alloy which conforms to ASTM F136 specifications. Assemblies are also available for convenience of the surgeon. These are pre-assembled partial constructs consisting of one Platform, one Cross Connector, two Rods and two Locking Screws.

An instrument set is available specifically designed for use with the AcroMed Anterior Cervical Stabilization System.

The provided text describes a medical device, the AcroMed Anterior Cervical Stabilization System, and its 510(k) submission for market clearance. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, or any of the detailed study parameters requested.

The document states: "PERFORMANCE DATA: Non-Clinical: Static bending compression and torsion were performed on the system to characterize its mechanical properties. Additionally, testing was also performed to characterize fatigue life. Finally, quasi-static range-of-motion studies were performed in axial compression/tension and torsion to characterize the system's displacement during loading."

This section only broadly mentions the types of non-clinical mechanical tests conducted. It does not provide any specific criteria for these tests, the actual results obtained, or any details about how these results demonstrate that the device meets some predefined acceptance criteria. It also does not discuss any clinical studies.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or any of the other detailed study parameters, as this information is not present in the provided text.

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The Easy Rod is a variation of the Vincer ISOLA rod of the ISOLA Spine System. This rod offers the suggeon casier contourability and casior in-site bending compared with crising V inch disneter ISOLA System consists of two subsystems: The Posterior ISOLA system and the Anarior 1501:4 System. The Easy Rod is intended to be used with the Posterior ISOLAsystem at this time.

The ISQLA implants, when used with pedicte scews, are in Grade 3 or 4 spondylolisthesis at LS-S1 utilizing and logous bone graft, having the device to the lumbar and secral spinc and intended to be removed after solid fusion is amained.

When not used with redicle screws, the ISOLA System is intended for hook, wire, and or sacrabilias screw fixation from the T1 to the ilium/secum. The non pedicle screw indications are spondylolistesis, degate (defined as discogence back pain with degencration of the disc confirmed by history and radios), deformines (scolinsis, lordosis and kyphosis), buttor, forture and previous failed surgery.

As a whole, the Posterior ISOLA spinal system is intended for T !- secral fixation. Pedicle secon fixation is from 13-S1.

The Anterior ISOLA system is intended for use in correcing schiol deformities by establishing an scially and routionally rigid firstion bridge parallel to the soinc. The Anterior system is indicated in sincations where loss of correction is expected, where scollosis cass or where pelvic obliquity is present. Spinal levels for anterior instrumentation ac from TS-L4.

Properly used, the Posterior and Anterior ISOLA Systems will provide temporary stabilization as an adjunct to spinal bone grafing processes. Specific indications are:

1. Idiopathic scoliosis.
2. Neuromuscular scoliosis kyphoscoliosis with associated paralysis or spacisticity.
3. Scollosis with deficient posterior elements such as that resulting from laminectomy or myelomeningoosle.
4. Spinal fractures (acute reduction or late deformity).
5. Degenerative disc disease (defined as discognic back pain with deperation of the discover and radiographic studies).
6. Neoplastic discase.
7. Revision surgery.

The Anterior ISOLA system is also used for the correction and stabilization of schiotic curves, for the prevence of undesired scoliotic curves, and for the stabilization of weskened trunks. Indications for these include:

1. Collapsing and unstable paralytic deformity.
2. Progressively increasing scoliosis.
3. Decreasing cardio-respiratory function, secondary to spinst or rib deformity or collapse.
4. Inability to maintain sitting balance, necessitating the use of the hands.
5. Increasing pelvic obliquity coincident with beck pain or loss of sitting balance.

The stainless steel Easy Rod is offered in 1/4 inch (6.35 mm) outer diameter and 18" (457 mm) in length. Generally, two rods are required in the construct and are cut to the appropriate length during the surgical procedure. The Easy Rod is a variation of rods previously cleared for the ISOLA Spinal System under K884163 and K944737.

The provided text describes the 510(k) summary for the AcroMed Easy Rod, a component of the ISOLA Spinal System. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed performance data from a clinical study. Therefore, the information requested about acceptance criteria, device performance, and study methodology is largely not present in this regulatory filing as it would be for a clinical trial.

However, I can extract the relevant information that is available and note what is missing.

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

Missing Information:

• Specific quantitative acceptance criteria (e.g., minimum fatigue cycles, specific load limits).
• Detailed quantitative performance data for the Easy Rod (e.g., actual fatigue cycles achieved, load-to-failure values). The statement simply asserts consistency, not concrete numbers against criteria.

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 specified. The performance data section refers to "static and fatigue testing" which indicates mechanical testing, not a clinical test set with patient data.
• Data Provenance: Not applicable in the context of clinical data. This refers to mechanical testing conducted by the manufacturer, AcroMed Corporation, based in Cleveland, OH, USA.

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. The "performance data" refers to mechanical testing, not clinical studies requiring expert ground truth establishment.

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

• Not applicable. This pertains to clinical studies, not mechanical testing.

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

• No. This is a medical device (spinal rod) and not an AI/imaging diagnostic device. Therefore, MRMC studies are not relevant.

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

• Not applicable. This is a physical medical device, not an algorithm or AI system.

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

• Not applicable. For mechanical testing, the "ground truth" would be established by engineering standards and validated testing protocols.

8. The sample size for the training set

• Not applicable. No training set is mentioned as this device is not an AI/machine learning system.

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

• Not applicable. No training set is mentioned.

Summary of the Study:

The "study" described in the 510(k) summary is a series of mechanical static and fatigue tests. The purpose of these tests was to demonstrate substantial equivalence of the AcroMed Easy Rod to legally marketed predicate devices. The key finding was that the Easy Rod's performance was consistent with previously cleared components, specifically AcroMed's 1/2 inch diameter ISOLA rod (K944737) and the historical Harrington System. This is a common approach for spinal fixation device 510(k) clearances, where mechanical performance equivalence is used to establish safety and effectiveness without requiring new clinical trials, given the predicate device's established clinical history.

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