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The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilum). posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatic patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), deformities or curvatures (i.e., scoliosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis).

When treating patients with Degenerative Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct.

When used with the 3.5 mm/6.0mm parallel connectors. the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5mm Systems. In addition, when used with 3.5 mm/5.0mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5mm Systems. When used with the 5.0 mm/6.0mm parallel connectors, the Synthes Small Stature USS can be linked to the Syn-thes USS 6.0 mm rod systems. When used with the 5.5 mm/6.0mm parallel or extension connectors, Synthes USS 5.5 mm rod systems can be linked to the Synthes USS 6.0 mm rod systems. 5.5 mm/5.5 mm parallel or extension connectors can be used to link all Synthes USS 5.5 mm rod systems to one another. 6.0 mm/6.0mm parallel or extension connectors can be used to link all Synthes USS 6.0 mm rod systems to one another.

Rod-to-rod connectors can be used to link all Synthes USS 5.5 mm rod systems to one another.

When used with the 3.5 mm/6.0mm and 4.0 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 3.5 mm/5.5 mm tapered rods, the Synthes USS 5.5 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm Systems, respectively. When used with the 5.5 mm/6.0mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the Synthes USS 5.5 mm rod systems.

In addition, Synthes USS 6.0 mm rod systems can be interchanged with all USS 6.0 mm rods and transconnectors except Synthes 6.0 mm cobalt-chromium-molybdenum allov rods, which can only be used with USS Monoaxial Dual Core (Single-Opening) Screws. Synthes USS 5.5 mm rod systems can be interchanged with all USS 5.5 mm rods and transconnectors.

The Synthes USS is a comprehensive system of spinal implants and instruments for non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1- S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Currently cleared components of the system include monoaxial and polyaxial pedicle screws, rods, hooks, locking caps, transconnectors, transverse bars, parallel connectors, and extension connectors.

The provided text is a 510(k) summary from the FDA for a medical device called the "USS System," which is a thoracolumbosacral pedicle screw system. This document is a regulatory approval, not a description of a study proving a device meets acceptance criteria for an AI/ML algorithm.

Therefore, I cannot extract the requested information about acceptance criteria, study details, sample sizes, expert ground truth establishment, or MRMC studies because the document describes a mechanical medical device, not a software-based AI system that would typically undergo such validation.

The "Performance Data" section in the document refers to mechanical testing (dynamic compression bending) of the screw and rod, not performance metrics of an AI algorithm.

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The T-PAL Spacer System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the T-PAL Spacer System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device these implants are intended for use with supplemental internal fixation systems.

The T-PAL Titanium Spacer System is indicated for use as an intervertebral body firsion device in skeletally mature patients with degenerative disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Additionally, the T-PAL Titanium Spacer System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. These patients should be skeletally mature and have undergone six mon-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device these implants are intended for use with supplemental internal fixation systems.

The SYNFIX Evolution Spacer 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. DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have had six months of non-operative treatment. Additionally, the SYNFIX Evolution Spacer can be used in patients diagnosed with spinal deformities as an adjunct to fusion with DePuy Synthes Spine supplemental internal fixation products (e.g. pedicle screw system) for use in the lumbar spine in addition to integrated screws. These patients should be skeletally mature and have undergone six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

T-PAL and T-PAL Titanium Spacer System: The T-PAL Spacer is a radiopaque intervertebral body fusion device used in conjunction with supplemental internal fixation to provide structural stability in skeletally mature individuals. The T-PAL Spacer is available in various heights and geometries to best accommodate individual patient pathology and anatomical conditions. The components of this device are manufactured from a radiolucent polymer and titanium alloy.

SYNFIX Evolution System: The SYNFIX Evolution is a combination radiolucent and radiopaque stand-alone anterior lumbar interbody device designed to be inserted within the intervertebral disc space in order to provide structural stability in skeletally mature individuals. The SYNFIX Evolution is available as assembled components in various heights and geometries to suit individual patient pathology and anatomical conditions. The components of this device are manufactured from a radiolucent polymer, titanium alloy, and tantalum.

This document is a 510(k) premarket notification for the T-PAL Spacer System, T-PAL Titanium Spacer System, and SYNFIX Evolution System. It primarily focuses on demonstrating substantial equivalence to predicate devices and does NOT contain information about acceptance criteria and a study proving device performance against those criteria.

Therefore, I cannot provide the requested information based on the provided text. The document states:

"No additional testing was required as there were no changes to the technological characteristics of the subject devices."

This indicates that the submission relies on the established safety and effectiveness of the predicate devices and existing literature, rather than new performance studies with specific acceptance criteria.

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The DePuy Synthes T-PAL Ti Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the T-PAL Spacers should be packed with autogenous bone graft (i.e. autograft).

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 nonoperative treatment.

The T-PAL Spacers are intended to be used with DePuy Synthes supplemental fixation.

The DePuy Synthes T-PAL Ti Spacer is an interbody fusion device used in conjunction with supplemental fixation to provide structural stability in skeletally mature individuals following total or partial discectomy. Previously, only T-PAL Spacers manufactured from PEEK (With TAN marker pins) material were available. The subject T-PAL Ti spacers will be manufactured entirely of TAN per ASTM F1295. The T-PAL Ti Spacer is available in two footprints and a range of heights and is angulated 5° to accommodate the lordotic curve (except for the smallest height of each footprint, which does not have a lordotic angle). Pyramidal teeth that assist in stabilization of the construct are located on the inferior and superior surfaces of the spacers. These teeth are oriented along a contour that follows the curve of the implant to assist in implantation. A bullet-nose design also facilitates self-distraction and ease of insertion. The open architecture of the devices allows them to be packed with autogenous bone graft material, i.e. autograft.

This document is a 510(k) premarket notification decision letter from the FDA regarding the DePuy Synthes T-PAL Ti Spacer. It is not a study demonstrating acceptance criteria or device performance in the context of an AI/algorithm-driven medical device.

Therefore, I cannot provide the requested information, such as:

• A table of acceptance criteria and the reported device performance: This document does not contain performance metrics that would be applicable to an AI device. The "performance data" mentioned (Section H) refers to a Finite Element Analysis of the physical implant, not an AI algorithm's performance.
• Sample size for the test set and data provenance: No such data is presented.
• Number of experts and qualifications for ground truth: Not applicable to this type of device submission.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not conducted as this is a physical implant, not an AI device.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used: Not applicable.
• Sample size for the training set: No training data for an algorithm is mentioned.
• How the ground truth for the training set was established: Not applicable.

Summary of what the document does provide:

The document concerns the regulatory clearance (510(k)) of a new version of an existing intervertebral body fusion device, the DePuy Synthes T-PAL Ti Spacer. The key aspects are:

• Device: DePuy Synthes T-PAL Ti Spacer (an intervertebral body fusion device).
• Changes from predicate: The main changes are a material change (from PEEK to Ti-6Al-7Nb (TAN) ASTM F-1295 titanium alloy), a sterilization modality change, and a minor design modification.
• Intended Use: For patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, requiring interbody fusion with supplemental fixation. The spacers must be packed with autogenous bone graft. DDD is defined by back pain of discogenic origin, confirmed by history and radiographic studies, in skeletally mature patients who have had six months of non-operative treatment.
• Predicate Device: Synthes T-PAL Spacer (K100089) and Patriot Signature® Ti Spacer (K122097).
• Demonstration of Equivalence: The submission asserts that the new device is substantially equivalent to the predicate devices because the intended use, performance, and technology remain "identical" despite the material and minor design changes.
• Performance Data (for the physical implant): A Finite Element Analysis (FEA) simulating static/dynamic axial compression and compression shear was performed to demonstrate that the proposed modifications do not introduce a "new worst case" regarding the physical implant's mechanical performance. This is not performance data for an AI algorithm.
• Conclusion: The FDA determined substantial equivalence based on the unchanged intended use and similar technological characteristics, with FEA and post-market data supporting that the changes do not raise new questions of safety and effectiveness.

In essence, this document is a regulatory approval letter for a medical implant, not a study of an AI device's performance against acceptance criteria.

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These Systems are intended for the following:

Hooks, Plate/Rods, Plates, Rods and Screws

When intended to provide stabilization as an adjunct to fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, plates, rod, hook and screw (3.2 mm cortex) components of the Synthes CerviFix, Axon; OC Fusion and Synapse Systems are indicated for skeletally mature patients using allograft and/or autograft for the following:

• Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with . degeneration of the disc as confirmed by patient history and radiographic studies)
• . Spondylolisthesis
• Spinal stenosis .
• Fracture/dislocation .
• Atlantoaxial fracture with instability .
• Occipitocervical dislocation .
• Revision of previous cervical spine surgery .
• Tumor .

When used to treat these cervical and occipitocervical conditions, screws are limited to occipital fixation only.

Hooks and Rods

The rod and hook components are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Rods, Clamps, Screws, Nuts, Variable Axis Screws, Locking Screws and Transverse Bars

The rods, clamps, screws, nuts, variable axis screws, locking screws and transverse bars are intended to promote fusion following reduction of fracture/dislocation or trauma in the upper thoracic spine (TI-T3).

The use of these screws (3.5 mm. 4.0 mm and 4.5 mm cancellous and 3.5 mm and 4.2 mm cortex) is limited to placement in T1-T3 in treating thoracic conditions only. They are not intended to be placed in or treat conditions involving the cervical spine.

The Synthes CerviFix, Axon, and Synapse Systems can also be linked to the Synthes Universal Spinal System using the 3.5 mm/6.0 mm and 4.0 mm/6.0 mm paralle1 connectors from that system and via the CerviFix tapered rods using lamina hooks, transverse process hooks, pedicle hooks; 4.2 mm screws, and the 5.0 mm/6.0 mm parallel connector.

Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic (T4-T12), or lumbar spine.

The Synapse System is a hook and pedicle screw spinal system which is designed to provide spinal fixation to allow for stabilization of spinal segments in skeletally mature patients as an adjunct to fusion. The Synapse System is composed of multiple components to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Axon System and Cervifix System also included in the indications for use statement are additional hook and pedicle screw spinal systems. These systems consist of anchors including bone screws, pedicle screws and hooks: interconnection mechanisms including locking screws, set screws, parallel rod connectors, clamps, transverse bars, rod collars and nuts; longitudinal members including rods and rod/plates; and transverse connectors including transconnectors. These system components are implanted using class I surgical instruments.

This document describes a 510(k) premarket notification for the Synapse System, specifically focusing on proposed curved rods. It is a submission intended to demonstrate substantial equivalence to previously cleared devices, rather than a study proving performance against acceptance criteria for a novel device.

Therefore, many of the requested categories for a study proving device performance are not applicable (N/A) in this context, as this submission primarily relies on a "rationale" comparing the new components to existing ones, rather than new performance testing.

Here's an analysis based on the provided text, addressing your questions:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: N/A. No new test set involving patient data or specimens was described. The submission relies on a "rationale" for equivalence to predicate devices.
• Data Provenance: N/A. No new data from a test set (e.g., country of origin, retrospective/prospective) is presented. The "performance data" section explicitly states "A rationale is provided in place of performance testing."

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

• N/A. As no new test set data requiring ground truth establishment was presented, this is not applicable.

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

• N/A. No test set requiring expert adjudication was described.

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

• N/A. This device is a spinal fixation orthosis (physical implant system), not an AI-assisted diagnostic or treatment planning tool. Therefore, MRMC studies and AI effect sizes are not relevant to this submission.

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

• N/A. This is a physical implant, not an algorithm or software device.

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

• N/A. No new ground truth establishment was described, as the submission focused on comparing the new components to established predicate devices based on design, materials, and existing performance data (implied from the predicates).

8. The sample size for the training set

• N/A. No training set for an algorithm was involved; this is a physical medical device.

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

• N/A. No training set or associated ground truth was established for this submission.

Summary of the Submission's Approach:

The K133698 submission for the Synapse System (specifically, proposed curved rods) is a substantial equivalence (SE) submission. This means the applicant demonstrated that the new device components (curved rods) are as safe and effective as a legally marketed predicate device.

Instead of conducting new performance studies, the manufacturer provided a "rationale" arguing that:

• The materials (Ti-6A1-7Nb (TAN)) are identical to those used in previously cleared components.
• The technological characteristics (design, intended use, indications for use) of the proposed curved rods are the same or similar to predicate devices (Synapse System, Sierra™ System, Altius™ OCT System).

This approach is common in 510(k) submissions where modifications to existing devices are minor and do not raise new questions of safety or effectiveness. The FDA's clearance (as indicated in the letter dated January 16, 2014) confirms their agreement that the device is substantially equivalent to predicates.

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The Synthes MultiLoc Humeral Nailing System is indicated for fractures of the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures, proximal humeral fractures with diaphyseal extension, diaphyseal fractures of the humeral shaft, and impending pathologic humeral fractures.

The Synthes MultiLoc Humeral Nailing System consists of metallic rods and accessories which are intended for implantation in the medullary canal of the humerus for fracture fixation. The system features intramedullary nail devices, as well as bone screws and end cap accessories. The nails are cannulated, offered in 7.0mm, 8.5mm, and 10mm diameters, and are available in 180mm -315mm in overall length. The nails additionally feature a polymer inlay in the proximal end to enhance the stability of the 4.5mm MultiLoc locking screws. Cleared 4.5mm MultiLoc Screws, used to facilitate the proximal locking of the nail construct, can be interlocked with cleared Synthes 3.5mm Locking Screws to enhance the stability of the construct.

The provided text describes a medical device, the Synthes MultiLoc Humeral Nailing System, seeking FDA clearance via a 510(k) pathway. This pathway establishes substantial equivalence to a predicate device, rather than proving meeting specific acceptance criteria through a clinical study with performance metrics in the way a novel medical AI/ML device would.

Therefore, many of the requested categories are not applicable to the information provided for this type of device submission. The existing information focuses on bench testing to demonstrate mechanical equivalence to predicate devices, rather than human performance metrics.

Here's an analysis based on the provided text, indicating where information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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 human data. The testing was in vitro bench testing. The number of samples for each type of mechanical test (static/dynamic bending, torsional, eccentric dynamic fatigue) is not provided.
• Data Provenance: The testing was "in vitro bench testing" performed according to ASTM F 1264-03. This implies lab-based mechanical testing, rather than data from a specific country or retrospective/prospective clinical studies on human subjects.

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

• Not Applicable. This device relies on mechanical testing against a standard and comparison to predicate devices, not on expert-established ground truth from clinical cases.

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

• Not Applicable. See point 3.

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 implant, not an AI/ML diagnostic or assistive device that would involve human readers.

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

• Not Applicable. See point 5.

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

• The "ground truth" for this submission is established through mechanical properties standards (ASTM F 1264-03) and demonstrating equivalence to the mechanical performance of legally marketed predicate devices.

8. The sample size for the training set

• Not Applicable. This device does not involve a "training set" in the context of AI/ML or statistical learning.

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

• Not Applicable. See point 8.

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Norian Drillable Inject and Norian Drillable Fast Set Putty are intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. Norian Drillable Inject and Norian Drillable Fast Set Putty can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure. Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process. Norian Drillable Inject and Norian Drillable Fast Set Putty are intended to be placed into bony voids either before or after final fixation.

Norian Drillable Inject and Norian Drillable Fast Set Putty are moldable, biocompatible bone void fillers with added reinforcing fibers. Norian Drillable Inject and Norian Drillable Fast Set Putty are intended to be placed into bony voids or defects of the extremities or pelvis either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during or after the setting process. When fully cured. the composition formed closely approximates the mineral phase of bone.

The product is available in two delivery forms. Norian Drillable Inject is an injectable paste that is mixed with an automatic mixer, and Norian Drillable Fast Set Putty is manually mixed with a cup and spatula.

Norian Drillable Inject is provided in a sterile pouch (the "Rotary Pouch"). The Rotary Pouch is constructed of a clear-film outer pouch and a foil laminate inner pouch with an attached delivery syringe. The Rotary Pouch contains sterile powder with fibers and is designed with an injection port for the purpose of adding the mixing solution to the pouch. The mixing solution is contained in the Solution Syringe, which is packaged separately.

The Rotary Pouch is designed to be placed in a reusable mixer (the “Rotary Mixer”) where the two components are mixed together to form a smooth, viscous paste. The paste remains injectable for approximately 5 minutes at 18°-23°C / 64°-73°F. At body temperature (37°C / 98.6°F), Norian Drillable Inject begins to harden after 2 minutes and sets in approximately 10 minutes. Norian Drillable Inject is slowly resorbed over a period of years and replaced with bone during the healing process.

Norian Drillable Fast Set Putty is supplied in two containers. The mixing cup holds sterile powder with fibers and the Solution Syringe holds sterile solution. When the powder and solution are mixed together with the provided cup and spatula, the resultant putty material can be manipulated for two minutes at 18°-23°C / 64°-73°F.

At body temperature (37°C / 98.6°F), Norian Drillable Fast Set Putty begins to harden after 2 minutes and sets in approximately 3 to 6 minutes. Norian Drillable Fast Set Putty is slowly resorbed over a period of years and replaced with bone during the healing process.

The provided text describes the Norian Drillable™ Inject and Norian Drillable™ Fast Set Putty, which are bone void fillers. The document is a 510(k) summary submitted to the FDA for market clearance. While it details the device and its intended use, it does not contain information about acceptance criteria or a specific study proving the device meets acceptance criteria regarding performance metrics such as sensitivity, specificity, accuracy, or any statistical measures.

The document states that "Documentation is provided that demonstrates that Norian Drillable is substantially equivalent to other legally marketed devices." This implies that the device achieved market clearance based on its substantial equivalence to predicate devices (Norian SRS Bone Void Filler and Norian SRS Fast Set Putty, K073303), rather than through a study designed to establish specific performance acceptance criteria for the new device itself.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor can I provide information on sample size, ground truth establishment, expert adjudication, or comparative effectiveness studies, as these types of data are not present in the provided text for this specific device.

The FDA's 510(k) clearance process often relies on demonstrating substantial equivalence to a predicate device, meaning that the new device is as safe and effective as a legally marketed device, even if it has different technological characteristics. This process typically doesn't require a new clinical trial or performance study with defined acceptance criteria for the new device if its equivalence can be successfully demonstrated.

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Norian Reinforced and Norian Reinforced Fast Set Putty are indicated for repairing or filling cranial defects and craniotomy cuts with a surface area no larger than 25 cm '. Norian Reinforced and Norian Reinforced Fast Set Putty are also indicated for the restoration or augmentation of bony contours of the cranial skeleton (including frontoorbital areas) such as burr hole voids and other cranial defects.

Norian Reinforced and Norian Reinforced Fast Set Putty (FSP) are moldable, biocompatible bone cements with added reinforcing fibers. Norian Reinforced and Norian Reinforced FSP are intended for filling craniofacial defects in the restoration or augmentation of bony contours of the craniofacial skeleton. The material resists cracking during the setting process. When fully cured, the composition formed closely approximates the mineral phase of bone.

The product is available in two delivery forms. Norian Reinforced is an injectable paste that is mixed with an automatic mixer, and Norian Reinforced Fast Set Putty is manually mixed with a cup and spatula.

Norian Reinforced is provided in a sterile pouch ("Rotary Pouch"). The Rotary Pouch is constructed of a clear-film outer pouch and a foil laminate inner pouch with an attached delivery syringe. The Rotary Pouch contains sterile powderpurpose of adding the mixing solution to the pouch. The mixing solution is contained in the Solution Syringe that is

The Rotary Pouch is designed to be placed in an automatic reusable mixer outside the sterile field where the two components are mixed together to form a smooth, viscous paste. The paste remains injectable for approximately 5 minutes at 18°-23°C / 64°-73°F. At body temperature (37°C / 98.6°F), Norian Reinforced begins to harden after 2 minutes and sets in approximately 10 minutes.

Norian Reinforced is slowly resorbed over a period of years and replaced with bone during the healing process.

Norian Reinforced Fast Set Putty is supplied in two containers. The mixing cup holds sterile powder with fibers and the solution syringe holds sterile solution. When the powder and solution are mixed together with the provided cup and spatula, the resultant putty material can be manipulated for two minutes at 18°-23°C / 64°-73°F.

At body temperature (37°C / 98.6°F), Norian Reinforced Fast Set Putty begins to harden after 2 minutes and sets in approximately 3 to 6 minutes. Norian Reinforced Fast Set Putty is slowly resorbed over a period of years and replaced with bone during the healing process.

Here's an analysis based on the provided 510(k) summary for Norian Reinforced and Norian Reinforced Fast Set Putty:

Key Takeaway: This 510(k) summary is for a medical device (bone cement), not an AI/ML powered device. Therefore, many of the requested sections related to AI/ML specific evaluation criteria (e.g., sample sizes for test and training sets, expert ground truth, MRMC studies, standalone performance) are not applicable to this document. The "study" here refers to a comparative non-clinical study against predicate devices, focusing on material properties and biocompatibility.

Acceptance Criteria and Study Details (Non-AI/ML Medical Device)

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a bone cement, the "acceptance criteria" are related to its physical properties, biocompatibility, and intended use as compared to predicate devices. The document doesn't provide specific quantitative tables for acceptance criteria and performance values in the way one would for an AI model. Instead, it states that the device meets the requirements through comparative testing.

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

• Sample Size: Not specified in the provided summary. This would refer to the number of material samples tested for mechanical, in-vitro, and biocompatibility assessments.
• Data Provenance: Not specified, but generally, such tests are conducted in laboratories following specific standards (e.g., ISO, ASTM). The data would be from controlled laboratory experiments, not patient data.

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

• Not Applicable. This is a medical device (bone cement) undergoing non-clinical testing for material properties and biocompatibility, not an AI/ML system requiring expert-based ground truth on medical images or diagnoses.

4. Adjudication Method for the Test Set

• Not Applicable. As above, this doesn't involve subjective human interpretation or diagnostic agreement typical of AI/ML evaluation. Performance is based on objective measurements against established material standards and comparisons to predicate devices.

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

• No. This is a bone cement, not an imaging AI diagnostic aid. MRMC studies are not relevant for this type of device.

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

• Not Applicable. This is a physical medical device (bone cement), not an algorithm.

7. The Type of Ground Truth Used

• Objective Material Science and Biocompatibility Standards: The "ground truth" for this device's performance is based on established scientific and engineering principles for material properties (e.g., strength, setting time), chemical composition, and biological response as defined by recognized standards (e.g., ISO 10993 for biocompatibility). The comparison point is often the performance of the predicate device.

8. The Sample Size for the Training Set

• Not Applicable. This is a medical device, not an AI/ML model that requires a training set. The device formulation and manufacturing process are developed through R&D and engineering, not machine learning training.

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

• Not Applicable. As with point 8, there is no "training set" in the context of an AI/ML model for this type of device.

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