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Inion CPS™ 1.5 Baby Bioabsorbable Fixation System implants are intended for use in trauma and reconstructive procedures in the craniofacial skeleton (e.g., infant craniofacial surgery, craniosynostosis, congenital malformations, craniotomy flap fixation), mid-face and maxilla.

The Inion CPS™ 1.5/2.0/2.5 Bioabsorbable Fixation System implants are intended for use in trauma and reconstructive procedures and to maintain the relative position of bone grafts or bone graft substitutes in the cranium, including craniotomy flap fixation.

Inion CPS™ and Inion CPS™ Baby implants are bioabsorbable plates, screws and mesh plates made of bioabsorbable co-polymers. Inion CPS™ 1.5/2.0/2.5 System implants are composed of L-lactic acid, D-lactic acid and Trimethylenecarbonate. Inion CPS™ 1.5 Baby System implants are composed of L-lactic acid, D-lactic acid and Poly-Glygolic acid. These polymers have a long history of safe medical use and they degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolised by the body. The implants retain sufficient strength to fulfil their intended function during the healing period of the fracture or osteotomy, and degrade gradually thereafter. Bioresorption of Inion CPS™ implants takes place within 2-4 years, and Inion CPS™ Baby implants within 2-3 years.

The systems consist of fixation plates, meshes and screws offered in different sizes and designed to be used with the Inion CPS™ bone drill bits, bone taps, self-drilling bone taps, countersinks, screw drivers, plate bending pliers and heating device. The instruments are nonsterile and reusable. They are intended to be cleaned and sterilized before initial use and after each use.

The implants are provided sterile by gamma irradiation. They are intended for single use and shall not be re-sterilized or re-used. Implants are non-pyrogenic and fully synthetic.

This FDA 510(k) clearance letter is for bioabsorbable fixation systems, not an AI/ML powered medical device. Therefore, many of the requested fields are not applicable. I will provide information from the document as it relates to the general acceptance criteria and the study that proves the device meets them, while noting when a specific AI/ML related field is not relevant to this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Description: Not directly applicable as this is not an AI/ML device with a specific "test set" in the context of algorithm validation. The "testing" refers to various evaluations:
  • Biocompatibility/Non-pyrogenicity Testing: Representative samples of the subject devices were selected for rabbit pyrogen tests. The exact number of samples or rabbits is not specified but it generally follows standard laboratory protocols. The provenance is likely from laboratory testing.
  • Clinical Evaluation: The clinical evaluation relied on published clinical studies.
    • Inion CPS™ Baby 1.5 Bioabsorbable Fixation System: 11 publications including 240 patients.
    • Inion CPS™ 1.5/2.0/2.5 System: 39 publications including 1755 patients.
  • Data Provenance for Clinical Studies: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective, beyond being "published clinical studies."

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 device is a physical implant, not an AI/ML diagnostic tool that requires experts to establish ground truth for image interpretation or similar tasks. The "ground truth" for its performance is assessed through physical testing (material properties, pyrogenicity) and clinical outcomes reported in published literature.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in AI/ML performance studies, where multiple human experts independently review cases and then resolve disagreements. This concept does not apply to the evaluation of a physical bioabsorbable fixation system.

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. MRMC studies are specific to evaluating human reader performance with and without AI assistance for tasks like medical image interpretation. This device is a physical surgical implant and does not involve "human readers" in this context.

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

Not applicable. This device does not have an algorithm for standalone performance.

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

The "ground truth" (or basis for acceptance) for this device is established through:

• Physical Properties: Material composition, degradation profile, and strength retention are measured against pre-defined specifications.
• Biocompatibility and Non-pyrogenicity: Demonstrated through laboratory testing (e.g., rabbit pyrogen tests) against established biological safety standards (ISO 10993-1, USP chapters).
• Clinical Outcomes Data: Safe and effective use, performance rates, and complication rates are evidenced by published clinical literature and post-market follow-up data.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that requires a training set.

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

Not applicable. This device is not an AI/ML model that requires a training set with established ground truth.

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The Delta Resorbable Fixation System is intended for use in the fixation of bones of the cranial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients.

The self-tapping screws and low profile emergency screws are intended for use in the fixation of bones of the cranial skeleton affected by trauma or for reconstruction, and can be used in pediatric patients older than 29 days and up to two (2) years of age (infants).

The Stryker Resorbable Fixation System (also referred to as Delta System or Stryker Delta Resorbable Fixation System; marketed as DualStart) is a cranio-maxillofacial plating system intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or for reconstruction. The reference device can be used in both adult and pediatric patients but is not intended for use in the mandible and/or full load bearing procedures. It consists of resorbable bone fixation plates, meshes, and screws made of a copolymer of poly lactide and poly glycolide.

Through this submission there is no change to the existing articles within the Delta System. The scope of this submission covers the addition of screws to the Delta System, which are shown as a modification of screws of the reference device to create the addition of self-tapping screws (STS) and low profile emergency screws (LPES). The subject STS and LPES, only, have a limited patient population of pediatric patients older than 29 days and up to two (2) years of age (infants).

The provided text describes the acceptance criteria and supporting studies for the Stryker Resorbable Fixation System (K231208).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the numerical sample size for the test set for the performance bench testing (e.g., number of screws tested for insertion or pull-out). It generically states "Verification and validation testing protocols were constructed to ensure testing captured this specific limited patient population."

• Data Provenance: The studies were conducted by Stryker Leibinger GmbH & Co. KG and are presumed to be internal company studies. The country of origin for the data is not specified, but the company address is in Freiburg, Germany. The studies are prospective in nature, as they are part of a premarket notification for a modified device.

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

For the usability validation, the document mentions "user validation testing" and "human factors and usability engineering," which would typically involve end-users (e.g., surgeons, medical staff). However, the number of experts used and their specific qualifications are not provided in this document.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for the test sets (e.g., 2+1, 3+1, none). The "Passed" results imply direct measurement against established criteria.

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

• No MRMC comparative effectiveness study was done. The device in question is a physical fixation system (screws), not a diagnostic imaging AI, so an MRMC study comparing human readers with and without AI assistance is not applicable. The studies focus on the physical and functional performance of the device and its usability.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not Applicable. This device is a physical medical implant, not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept here.

7. Type of Ground Truth Used

For the performance bench testing:

• The ground truth is established by objective engineering measurements against the performance requirements defined by the ASTM F2502 standard and internal specifications (e.g., successful insertion, specified pull-out strength, acceptable inherent viscosity).

For the usability validation:

• The ground truth is established by user validation through direct observation of task performance (evaluating for use error), assessment of knowledge (knowledge tasks), and subjective feedback (rating questions). This implies that the 'ground truth' for usability is defined by the absence of use errors, successful completion of knowledge tasks, and positive user ratings.

8. Sample Size for the Training Set

• Not applicable. This device is a physical medical device; there is no "training set" in the context of machine learning or AI models. The design and manufacturing processes are validated through traditional engineering methods and testing.

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

• Not applicable. As there is no training set for an AI/algorithm, there is no ground truth established for a training set.

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The Stryker Universal Neuro III System is intended for reconstruction and/or rigid fixation of non loadbearing bony areas subsequent to cramictomy, cramiectomy and cranial fractures in adults and adolescents (age 12 and higher).

The Stryker Universal Neuro III System (UN III) consists of an assortment of different bone plates and screws. The predicate device, the UN III AXS screw, is a part of the overall UN III System, and was cleared in K151387. Here, this special 510(k) is submitted to show the ability to market the UN III AXS screw sterile in two different sterile packaging configurations which are:

1. UN III AXS Screws packed in sterile procedure packs, and
2. UN III AXS Screws packed in a sterile screw cartridge.

This document describes the performance data for the Stryker Universal Neuro III System AXS Screw, specifically regarding the transition to sterile packaging configurations. The focus of the provided text is on demonstrating substantial equivalence to a predicate device, not on validating the performance of an AI algorithm. Therefore, many of the requested categories for AI device studies are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The "acceptance criteria" are often implied as "met" or "proven" in this summary rather than explicitly stated with numerical values, which is common for regulatory submissions demonstrating equivalence to an existing product, especially for changes in manufacturing or packaging.

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

The document does not specify the exact sample sizes used for each individual test (e.g., sterilization validation, packaging tests). Instead, it states that "validations were performed and referenced."

• Data Provenance: The tests were conducted to support the market clearance of a device by Stryker Leibinger GmbH& Co. KG (Germany) for the US market. The nature of these tests (e.g., sterilization, packaging integrity) suggests they are laboratory-based, prospective studies conducted by the manufacturer or a third-party testing facility.

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

Not applicable. This device is not an AI algorithm requiring expert ground truth for its performance. The tests described are engineering and manufacturing validations.

4. Adjudication method for the test set

Not applicable. This is not an AI device requiring diagnostic 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 not an AI device.

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

Not applicable. This is not an AI device.

7. The type of ground truth used

Not applicable in the context of an AI device. The "ground truth" for the tests performed relates to established engineering standards, regulatory requirements for sterility, pyrogenicity, biocompatibility, and packaging integrity. For example:

• Sterility: Achieved based on a demonstrated SAL of 1 x 10-6.
• Biocompatibility: Determined through assessment against ISO standards for medical device biocompatibility.
• Packaging Integrity: Evaluated against industry standards for sterile barrier systems (e.g., ASTM, ISO).

8. The sample size for the training set

Not applicable. This is not an AI device that utilizes a training set.

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

Not applicable. This is not an AI device.

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The Stryker Universal Neuro III System is intended for reconstruction and/or rigid fixation of non loadbearing bony areas subsequent to craniectomy and cranial fractures in adults and adolescents (age 12 and higher).

The Stryker Universal Neuro III System (UN III) is intended for reconstruction, stabilization and/or rigid fixation of non load-bearing areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 or higher). The UN III System consists of an implant module for the respective anatomical and indicated areas with each containing various screw, and plate versions and shapes. This special 510(k) is being submitted due to dimensional modifications to the screw and screwdriver blade. There have been no modifications to the plates, meshes, or other accessory devices.

This document is a 510(k) premarket notification for the Stryker Universal Neuro III System: UN III AXS Screw and UN III AXS Screwdriver Blade. It focuses on demonstrating substantial equivalence to a predicate device following dimensional modifications. It is therefore a submission for a medical device and not for an AI/ML powered device. Hence, most of the questions relating to AI/ML powered devices are not relevant for this submission, and the information is not present in the document.

Here's the breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "The subject device met all pre-defined acceptance criteria." However, the specific quantitative acceptance criteria for each test are not explicitly detailed. Instead, only the types of tests performed are listed.

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

This is not applicable as this is a medical device submission, not an AI/ML device. The document details bench testing, not a dataset for an algorithm.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This is not applicable as this is a medical device submission, not an AI/ML device. Ground truth as typically defined for AI/ML models is not relevant here.

4. Adjudication Method

This is not applicable as this is a medical device submission, not an AI/ML device.

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

No MRMC study was done, as this is a medical device submission and not an AI/ML powered medical device.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical medical device (screws and screwdriver blades), not an algorithm.

7. Type of Ground Truth Used

Not applicable. The performance was assessed through physical bench tests. For these tests, the "ground truth" would be the engineering specifications and performance standards that the device is designed to meet.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML powered device, so there is no "training set."

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

Not applicable. There is no training set for this type of medical device submission.

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The RAPIDSORB Injectable Polymer System (IPS) is intended for use in non-load bearing fracture repair and reconstructive procedures of the craniofacial skeleton (excluding the upper and lower jaw) in pediatric and adult populations. RAPIDSORB IPS fasteners are designed to be used for the fixation of RAPIDSORB plates, and sheets.

In addition, RAPIDSORB IPS implants and instruments may be used with RAPIDSORB meshes and sheets in non-load bearing applications for maintaining the relative position of, and/or containing, bony fragments, bone grafts (autograft or allograft), or bone graft substitutes in craniofacial reconstruction (excluding the upper and lower jaw).

DePuy Synthes RAPIDSORB IPS Injectable Polymer System consists of a sterile resorbable polymer, 85:15 Poly (L-lactide co-glycolide) and a battery powered delivery device. The polymer can be extruded from the delivery device into a predrilled pilot hole at the surgical site.

The polymer is presented as a rod in a sterile package (cartridge) that fits into the delivery device. The device then briefly heats the polymer at the implant site beyond the glass transition temperature of the polymer, allowing the polymer to be extruded in a controlled manner in a preselected length from the device through a plate, mesh, or sheet and into a predrilled hole at the site of the defect. The extruded polymer fills the predrilled hole. Retention is attained through friction and interdigitation with the surrounding bone.

The delivery device consists of three principal components: 1) a Power Drive Unit, which is nonsterile and reusable, and which fits into and is enclosed by 2) a disposable, sterile, single-use, rigid plastic shell and cap, and 3) a sterile, single-use, battery pack that attaches to the shell and serves as the power source. The delivery device is comfortably shaped and balanced to fit the left or right hand of the surgeon.

Enclosing the Power Drive Unit thus assures sterile delivery of the polymer at the implant site. The brevity of the increase in the temperature of the polymer combined with the controlled, minimized volume of polymer implanted prevents tissue injury or necrosis at the implant site.

The given text describes the DePuy Synthes RAPIDSORB Injectable Polymer System (IPS) and the studies performed to demonstrate its substantial equivalence to predicate devices. However, the document does NOT include a table of acceptance criteria for specific performance metrics nor does it directly list "reported device performance" against such criteria. Instead, it summarizes the conclusions of various nonclinical, in vitro, and animal studies.

Here's an attempt to extract the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance values. The "Conclusion" sections for each test type indicate whether the device "Passed" or met a comparative standard (e.g., "identical to the cleared polymers," "significantly greater," "superior," "comparable").

2. Sample Sizes and Data Provenance

• Test Set Sample Sizes:
  • Biocompatibility (Guinea Pig, Intra-cutaneous Reactivity, Acute Systemic Injection): Guinea pigs (number not specified, but stated as "Guinea pigs were injected...", "Test animals were topically patched...", implying multiple). Rabbits (three male NZW rabbits). Mice (number not specified, but "Mice were treated...").
  • In Vitro Axial Pullout Test: "two different IPS fasteners lengths" compared to "a 1.5 x 3mm (length) Direct Drive Lactosorb Screw." (Specific number of samples per group not specified).
  • In Vitro Shear Testing: IPS fastener compared to predicate Lactosorb Fastener. (Specific number of samples per group not specified).
  • Immature Ovine Model Animal Test: Number of animals used for the study is not specified, but the study was conducted in an "immature ovine model."
• Data Provenance: The studies are nonclinical (in vitro bench tests, animal tests, and laboratory tests) and are likely prospective studies conducted specifically for this 510(k) submission. The country of origin for the data is not specified, but the submitting company is based in West Chester, Pennsylvania, USA.

3. Number of Experts and Qualifications

This document does not describe the use of human experts to establish ground truth for a test set in the context of diagnostic accuracy. The studies described are engineering, material science, and animal studies, not interpretive diagnostic studies.

4. Adjudication Method

Not applicable for the types of studies described (nonclinical, in vitro, and animal studies).

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

No. The document describes the evaluation of a medical device (a polymer system for craniofacial repair), not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.

6. Standalone (Algorithm Only) Performance Study

No. This device is a polymer system, not an algorithm or AI.

7. Type of Ground Truth Used

The ground truth or reference standard for these studies is based on:

• Standard biological responses (e.g., absence of toxicity, sensitization, irritation for biocompatibility tests).
• Quantitative mechanical measurements (e.g., Newtons for pullout strength, peak load for shear strength).
• Histopathological evaluation of bone and soft tissues in animal models for biocompatibility and healing.
• Chemical identity comparison for controlled extraction studies.
• Compliance with electrical safety standards.

8. Sample Size for the Training Set

Not applicable. This is a medical device, not an AI model requiring a training set.

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

Not applicable. This is a medical device, not an AI model.

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The MEDPOR Fixation System - Cranial is intended for use in cranial surgery to fixate MEDPOR cranial implants to the surrounding cranial skeleton.

The MEDPOR Fixation System - Cranial is a plate and screw system to be used in Cranial Surgery. The components that comprise the system are composed of titanium plates. titanium alloy bone screws, titanium alloy implant screws, and surgical stainless steel instruments for the installation of the plates and screws. The plates are manufactured of grade 4 titanium and adhere to the American Society of Testing Materials (A.S.T.M.) F67 Standard. The bone and implant screws are manufactured of 6-4 ELI titanium that meets the ASTM F136 standard. The implant screws are designed to be used with MEDPOR polyethylene implants manufactured by Porex Surgical under K832283. K922489. K952677, K040364 and K083621. The screws and plates have been color anodized for ease of use by a surgeon. The blue anodized side of the plate corresponds to the blue anodized bone screw and the magenta anodized side of the plate corresponds to the magenta anodized implant screw. The MEDPOR Fixation System -- Cranial is sterilized by ethylene oxide sterilization. The instruments and unused components can be resterilized via steam sterilization.

This document is a 510(k) premarket notification for the MEDPOR® Fixation System - Cranial. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting detailed acceptance criteria and a study to prove device performance against those criteria. In the context of a 510(k) submission for a device like plates and screws, the "acceptance criteria" are generally related to demonstrating that the new device is as safe and effective as existing legally marketed devices (predicate devices) and that any differences do not raise new questions of safety or effectiveness.

Therefore, the requested information elements (1-9) which typically relate to performance studies for novel or significantly modified devices, are not explicitly provided in this 510(k) summary. A 510(k) does not usually include a formal "study" with stated acceptance criteria and device performance results in the same way a PMA or de novo submission might. Instead, it relies on comparisons to predicate devices and adherence to established material standards and manufacturing practices.

Here's a breakdown of what can be extracted and what is not applicable or stated:

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

• Acceptance Criteria: Not explicitly stated as pass/fail criteria from a specific performance study in this 510(k) summary. The acceptance criteria for a 510(k) is generally the demonstration of "substantial equivalence" to predicate devices, meaning the new device has "similar technological characteristics" and "same intended use."
• Reported Device Performance: No specific performance metrics (e.g., tensile strength, fatigue life, etc.) are reported with numerical values in this summary. The submission implies that the material and design choices (titanium, specific alloys) meet established standards (ASTM F67, ASTM F136), which are themselves forms of performance criteria.

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

• Not applicable as no specific device performance testing study with a "test set" and "data provenance" is detailed in this 510(k) summary. The comparison is primarily against the characteristics of predicate devices.

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

• Not applicable as there is no "test set" ground truth established by experts in the context of this 510(k) summary. Substantial equivalence is assessed by regulatory reviewers based on design, materials, and intended use.

4. Adjudication method for the test set

• Not applicable for the same reasons as #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 device for surgical fixation, not an AI or imaging diagnostic device.

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

• Not applicable. This is a medical device for surgical fixation, not an algorithm.

7. The type of ground truth used

• The "ground truth" for a 510(k) submission for this type of device is the evidence that the device's technological characteristics (materials, design, sterilization) and intended use are substantially equivalent to legally marketed predicate devices, which are themselves considered safe and effective. The reference to conformity with ASTM standards (F67 and F136) serves as a form of "ground truth" for material properties.

8. The sample size for the training set

• Not applicable as there is no "training set" in the context of this 510(k) submission. Design and manufacturing are based on established engineering principles and material standards.

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

• Not applicable for the same reasons as #8.

Summary based on the provided document:

The provided document is a 510(k) Summary. For devices like the MEDPOR® Fixation System - Cranial, the "acceptance criteria" are intrinsically linked to demonstrating substantial equivalence to predicate devices already on the market. The "study" proving this largely involves a comparison of technological characteristics (materials, design, indications for use, sterilization) and adherence to recognized standards.

Table of Acceptance Criteria (Implied by Substantial Equivalence) and Reported Features:

Explanation of Study (Substantial Equivalence Demonstration):

The "study" in this context is the detailed comparison provided in the "Substantial Equivalence" section and the comparative table on page 2 of the document. This comparison directly addresses how the MEDPOR Fixation System - Cranial aligns with the identified predicate devices:

• Comparison of Intended Use: The document argues that the intended use of the MEDPOR system (fixating cranial implants to the cranial skeleton) is comparable to the broad craniofacial, cranial, and reconstructive procedures of the predicate devices.
• Comparison of Materials: The use of specific titanium grades (CP 4 Titanium for plates, 6-4 ELI Titanium Alloy for screws) is stated to meet ASTM standards F67 and F136, respectively. The document highlights that titanium has a "long history of use in surgical implantable products" and that these materials are consistent with most predicate devices (Predicate Device #1 is an exception, being bioabsorbable).
• Comparison of Technological Characteristics: The document states that the "technological characteristics of the design are substantially equivalent to the predicate devices and any slight differences do not raise new issues of safety and effectiveness." This includes design as a plate and screw system, dedicated instrumentation, and sterilization methods.

Missing/Not Applicable Information:

• Sample Size for Test Set/Training Set: Not applicable for a 510(k) based on substantial equivalence comparison of device characteristics.
• Data Provenance: Not applicable.
• Experts/Ground Truth for Test/Training set: Not applicable in the sense of clinical study experts. The "ground truth" hinges on the established safety and effectiveness of the predicate devices and conformity to recognized standards.
• Adjudication Method: Not applicable.
• MRMC or Standalone AI Study: Not applicable as this is not an AI/diagnostic device.

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