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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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Neuro Plating System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure.

The Neuro Plating System is comprised of plates and screws. The range of plate sizes is from 0.3mm to 0.6mm thick. It is made of commercially pure titanium of Gr 1, 2 and 3 (ASTM F67) and in 3 colors (silver, blue and gold) by anodizing. The range of screw diameter is from 0.8mm to 1.95mm in lengths of 3.0 to 6.0mm. It is made of Ti-6Al-4V ELI titanium alloy (ASTM F136) and in 3 colors (silver, green and gold) by anodizing.

Neuro Plating System consists of plates and screws to provide fixation and aid in the alignment and stabilization of fractures in reconstructive processes. The plate is placed on the fractured bone and the screw is inserted into the bone through a plate hole to fix. If necessary, the plate may be bent or cut to meet the anatomical needs of patient.

The Neuro Plating System has two types of sterilization method; Neuro Plating System is non-sterile state packed in PE bag which must be sterilized before use and Neuro Plating System - Sterile Kit is provide sterile state with gamma sterilization packed in Tyvek and PET. Both are single use only.

The provided text is a 510(k) Pre-Market Notification for the Neuro Plating System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study.

Therefore, much of the requested information about acceptance criteria, study design, sample sizes, expert involvement, and ground truth is not directly available or applicable in the context of this 510(k) summary. This document primarily relies on non-clinical (mechanical and sterilization) testing to show equivalence.

However, I can extract information related to non-clinical testing and the comparison to predicate devices, which serves as the "proof" for substantial equivalence in this regulatory context.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission based on substantial equivalence, there isn't a table of specific clinical "acceptance criteria" with numerical targets and reported clinical device performance. Instead, the "acceptance criteria" are implied by the performance of the predicate device, and the "reported device performance" refers to the non-clinical tests conducted on the subject device to show it is equivalent.

• Comparable bending strength
• Comparable torsion strength
• Comparable axial pullout strength | Non-clinical tests performed:
• 4 Point Bending Test
• Torsion Test & Axial Pullout Strength Test
  Rationale for equivalence: "The subject device's titanium grade is the same as the predicate device's, but the subject device is thicker than the predicate device. Therefore, the performance testing of the subject device is expected to be substantially equivalent to the predicate device." (This implies the subject device met or exceeded the predicate's performance in these tests, although specific numerical results are not provided in this summary.) |
  | Sterilization Efficacy:
• Achieves sterility for pre-sterilized kits
• Compatibility with steam sterilization for non-sterile components | Non-clinical tests performed:
• Packaging Process Validation Test (only Neuro Plating System - Sterile Kit)
• Gamma Sterilization Validation (only Neuro Plating System - Sterile Kit)
  Rationale for equivalence: "Validation of sterilization parameters... of the subject device are supported by sterilization validation... as provided in the primary predicate K190811." |
  | Biocompatibility:
• Biocompatible materials and design, similar to predicate | Rationale for equivalence: "...biocompatibility of the subject device are supported by... biocompatibility testing as provided in the primary predicate K190811." |
  | Shelf Life:
• Maintained functionality and sterility over intended shelf life (for pre-sterilized kits) | Non-clinical tests performed:
• Shelf life (only Neuro Plating System - Sterile Kit) |

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

• Sample Size for Test Set: Not specified in the provided summary. For mechanical tests, this would typically involve a specific number of samples for each test (e.g., n=5 or n=10 per test), but the exact numbers are not present.
• Data Provenance: Not specified, but implied to be from laboratory testing conducted on device samples. Country of origin for testing is not stated. The data is "non-clinical" (bench testing), not patient data, so "retrospective or prospective" is not applicable.

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

This information is not applicable as the submission relies on non-clinical, laboratory bench testing (mechanical and sterilization) rather than clinical data requiring expert review or ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable as the submission relies on non-clinical, laboratory bench testing. Adjudication methods are typically relevant for clinical studies where subjective assessments or multiple interpretations of patient data might occur.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic imaging aids or AI assistance where human readers interpret cases. The Neuro Plating System is a surgical implant, not a diagnostic tool.

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

• No, a standalone (algorithm only) performance study was not done. This concept applies to AI/software as a medical device. The Neuro Plating System is a physical implant.

7. The Type of Ground Truth Used

• Not applicable in the sense of clinical ground truth (e.g., pathology, outcomes data). For the non-clinical tests, the "ground truth" would be the engineering specifications and established acceptable performance limits (often derived from the predicate device or relevant ASTM standards). For example, a "ground truth" for the 4-point bending test would be a minimum bending force or deformation standard that the device must meet, typically aligned with or surpassing the predicate's performance.

8. The Sample Size for the Training Set

• Not applicable. The Neuro Plating System is a physical medical device, not an AI/machine learning algorithm that requires a "training set."

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

• Not applicable. As above, there is no "training set" for this device.

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The NeuroVention Cranial Fixation System is intended for use as a burr hole cover and/or skull bone fixation following craniotomy, cranioplasty, or craniectomy surgery.

The NeuroVention Cranial Fixation System is a series of burr hole covers and plates with various configurations to facilitate surgeon selection of the implant he/she determines to be most appropriate for the patient and the surgical circumstances. Each is provided non-sterile single use and is made of titanium as per ASTM F67, titanium alloy (Ti-6AI4V ELI) implantable components that comply with ASTM F136 or PEEK per ASTM F2026. Class I exempt instrumentation is available for delivery and removal: Screwdriver Adapter (handle), Torx Drivers, Forceps. Additionally, a Class II Drill bit is included to create pilot holes for the screws.

This document, K192162, describes a 510(k) premarket notification for the "NeuroVention Cranial Fixation System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials. Therefore, the information provided primarily relates to mechanical performance and material biocompatibility.

Here's an analysis of the provided text in relation to your request about acceptance criteria and study proving device meets them:

Key Takeaway: This document does not describe a clinical study or an AI/algorithm-driven device. It is for a physical medical device (cranial fixation system) and relies on mechanical testing and material equivalence to demonstrate substantial equivalence to a predicate device.

Therefore, many of your requested points regarding AI/algorithm performance, human readers, ground truth establishment for training/test sets, and expert consensus are not applicable to this specific submission.

However, I can extract the relevant information from the document that addresses mechanical performance, which serves as the "study" for this type of device.

Acceptance Criteria and Reported Device Performance (Mechanical Testing)

The document primarily relies on mechanical testing to demonstrate substantial equivalence. The acceptance criteria for these tests are implicitly that the "Subject device [is] equivalent or better than the predicate devices" and that "All testing met or exceeded the requirements as established by the test protocols and applicable standards."

Here's a table summarizing the "acceptance criteria" (implied through performance comparison to predicates and standards) and the reported performance for the mechanical tests:

Addressing Other Requested Information (and why some are not applicable):

1. Sample sized 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 number of physical test articles for each mechanical test. This is common for 510(k) mechanical testing summaries, where the focus is on meeting standards rather than statistical clinical significance as in a clinical trial.
   • Data Provenance: Not applicable as this is mechanical/biocompatibility testing, not clinical data from patients. The testing would have been conducted by the manufacturer or a contracted testing lab.

2. 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 "ground truth" for this device is established by engineering principles, mechanical test standards (e.g., ASTM F543-13), and material specifications (e.g., ASTM F67, F136, F2026). No clinical experts (like radiologists) are involved in establishing ground truth for mechanical performance.

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

   • Not Applicable. Adjudication methods are relevant for subjective assessments, primarily in clinical data interpretation (e.g., reading medical images). Mechanical testing results are objective measurements against defined standards.

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

   • Not Applicable. This is a physical cranial fixation system, not an AI or imaging system. No human reader studies (MRMC) would be relevant here.

5. 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.

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

   • Ground Truth: For mechanical testing, the "ground truth" is defined by widely accepted engineering test standards (e.g., ASTM standards) and the specifications of the predicate device. For biocompatibility, it's defined by the material's conformity to established standards (e.g., ASTM F67-13, ASTM F136, ASTM F2026) and its history of safe use as an implantable material.

7. The sample size for the training set:

   • Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

   • Not Applicable. There is no "training set" as this is not an AI/machine learning device.

In summary, the provided document is a 510(k) clearance for a traditional physical medical device. The "study" proving it meets "acceptance criteria" consists of mechanical performance testing (as outlined in the table above) and biocompatibility assessments, which demonstrated substantial equivalence to a legally marketed predicate device (Stryker Universal Neuro 3 System). The concept of AI performance metrics, expert reviews, and large human data sets is outside the scope of this type of device and submission.

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The Optimus Neuro Plating System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedures.

The Neuro Plating System is comprised of plates and screws. The range of plate sizes is from 0.3mm to 0.6mm thick. It is made of commercially pure titanium of Gr 1, 2 and 3 (ASTM F67) and comes in 3 anodized colors (silver, blue and gold). The screws range in diameter from 0.8mm to 1.95mm and in lengths of 3.0mm to 6.0mm. They are made of Ti- 6Al-4V ELI titanium alloy (ASTM F136) and come in 3 anodized colors (silver, green and gold).

The Neuro Plating System consists of plates and screws to provide fixation and aid in the alignment and stabilization of fractures in the reconstructive process. The plate is placed on the fractured bone and the screw is inserted into the bone through a plate hole to achieve fixation. If necessary, the plate may be bent or cut to meet the anatomical needs of the patient.

The Neuro Plating System has two types of sterilization methods: 1.) the Neuro Plating System is non-sterile state packed in a PE bag which must be sterilized before use; and 2.) the Neuro Plating System - Sterile Kit is provided sterile using gamma sterilization packed in Tyvek and PET. Both are single use only.

The provided text describes the regulatory clearance of a medical device, the Optimus Neuro Plating System, and details its substantial equivalence to predicate devices. It does not present a study proving the device meets specific acceptance criteria in terms of AI or algorithm performance.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to regulatory acceptance for market clearance based on substantial equivalence to existing devices, rather than performance metrics for an AI-powered system or diagnostic accuracy study.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone algorithm performance) are not applicable to this type of submission.

Here's how the provided information relates to your request:

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

The document doesn't present "acceptance criteria" in the sense of performance metrics for an AI system. Instead, it presents a comparison table demonstrating the "substantial equivalence" of the modified device to its predicate devices across various attributes. The "performance" here refers to the device proving it is as safe and effective as the predicate, not a quantifiable clinical outcome or AI accuracy.

Table: Comparison of Modified Device to Predicate Devices for Substantial Equivalence

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

• Test Set Description: The "test set" in this context refers to the samples of the physical device that underwent non-clinical laboratory testing (e.g., mechanical strength, sterilization validation).
• Sample Size: The document does not specify the exact number of units used for each test (e.g., how many plates/screws for the 4-point bending test). It only states that "The following tests were performed on the modified devices."
• Data Provenance: The tests were performed by Osteonic Co., Ltd. (the manufacturer) in South Korea. The data would be internally generated "non-clinical tests." The provenance typically refers to the source of the clinical data (e.g., patient records), which is not relevant here as this is a device clearance based on engineering and material testing. The tests are prospective as they were conducted for this 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):

• Not applicable. This submission is for a physical medical implant, not an AI or diagnostic imaging device that requires interpretation by medical experts to establish ground truth for performance evaluation. The "ground truth" for the device's characteristics (e.g., material strength, sterility) is established by standardized engineering tests and established quality control methods, not expert consensus on medical images.

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

• Not applicable. This refers to a method used to resolve discrepancies in expert interpretations (e.g., for image annotations or diagnoses), which is not relevant to the non-clinical engineering and material tests performed for this device.

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 type of study performed for diagnostic AI tools to evaluate their impact on human interpretation. This submission is for a physical neuro plating system.

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

• Not applicable. This describes the performance evaluation of an AI algorithm in isolation. The Optimus Neuro Plating System is a physical implant, not an algorithm.

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

• For the physical device, the "ground truth" for demonstrating substantial equivalence is based on:
  • Engineering specifications and standards: ASTM F67, ASTM F136, ISO 10993.
  • Validated test methods: 4 Point Bending Test, Torsion Test, Axial Pullout Strength Test, Packaging Process Validation Test, Gamma Sterilization Validation, Shelf life, MR safety tests.
  • Comparison to predicate device performance data in these established physical and biological safety metrics.

8. The sample size for the training set:

• Not applicable. This is relevant for AI/ML models. This document describes a physical medical device.

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

• Not applicable. Relevant for AI/ML models.

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The Sterile NS System is intended for use in selective trauma of the cranial surgery and reconstructive procedures.

The Sterile NS System consists of bone plates in a variety of shapes and sizes, bone screws to secure the plates, and accessories to assist in the operational procedures. The Sterile NS System is made of pure titanium (ASTM F67) and titanium Alloy (ASTM F136). It is intended for use in selective trauma of cranial skeleton, cranial surgery and reconstructive procedures.

The provided text describes a 510(k) premarket notification for a medical device called the "Sterile NS System." This notification seeks to demonstrate substantial equivalence to previously cleared predicate devices. The information provided heavily emphasizes the comparison to predicate devices rather than a standalone study with defined acceptance criteria and performance metrics for the novel device itself.

Based on the provided text, the following information can be extracted and interpreted regarding the "acceptance criteria" and "study."

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative "acceptance criteria" in the traditional sense, such as specific thresholds for sensitivity, specificity, or accuracy for a diagnostic algorithm. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices. The performance is assessed through non-clinical tests to verify compliance with design specifications and standards.

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

The document states: "No clinical studies were considered necessary and performed." Therefore, there is no test set in the sense of patient data. The "test set" refers to the physical devices that underwent non-clinical testing. The sample size for these non-clinical tests (e.g., how many plates or screws were dimensionally tested) is not specified in the provided text. The data provenance is also not specified beyond the manufacturer being in Korea.

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 medical implant, not an AI/diagnostic software, and no human ground truth establishment (e.g., by clinicians or radiologists) is described or relevant for the substantial equivalence claim.

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

Not applicable. As this is not a diagnostic device involving human interpretation, adjudication methods are not relevant.

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-assisted diagnostic device.

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

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

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

For the non-clinical tests, the "ground truth" would be the engineering specifications and established standards (e.g., ASTM F67, ASTM F136). The tests (e.g., "Dimension test") verify that the manufactured devices conform to these pre-defined specifications.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning 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 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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Optimus Neuro System is intended for use in selective trauma of the cranial skeleton, cranial surgery and reconstructive procedure.

The Optimus Neuro System is comprised of plates and screws. The range of plate sizes is from 0.3mm to 0.6mm thick. It is made of commercially pure titanium of Gr 1, 2 and 3 (ASTM F67) and in 3 colors (silver, blue and gold) by anodizing. The range of screw diameter is from 0.8mm to 1.8mm in lengths of 3.0 to 6.0mm. It is made of Ti-6AI-4V ELI titanium alloy (ASTM F136) and in 3 colors (silver, greenand gold) by anodizing. The plate and screw are a single use only, non-sterile product and they must be sterilized by the user before use. Each component is individually packed in a PE bag. Optimus NEURO System consists of plates and screws to provide fixation and aid in the alignment and stabilization of fractures in reconstructive processes. The placed on the fractured bone and the screw is inserted into the bone through a plate hole to fix. If necessary, the plate may be bent or cut to meet the anatomical needs of patient.

The provided text describes the "Optimus Neuro System," a medical device for cranial surgery and reconstructive procedures. However, the document primarily focuses on demonstrating substantial equivalence to predicate devices through bench testing (mechanical, sterilization, cleaning, and packaging validation), rather than a clinical study involving human or animal subjects that would typically involve acceptance criteria for diagnostic or clinical performance.

Therefore, the information required to directly answer some of your questions, particularly those related to a study proving diagnostic or clinical performance (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details), is not present in this document. This is common for devices like cranioplasty plates and screws, where substantial equivalence is often established through material testing, mechanical performance, and comparisons to existing devices with a long history of safe and effective use.

Here's a breakdown of what can be answered based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not specified. The document refers to "worst case test articles" for mechanical testing, implying a limited number of samples were tested for each specified test type. These are bench tests on physical devices, not a clinical study on patient data.
• Data Provenance: Not applicable in the context of a clinical test set. The tests described are laboratory/bench tests on manufactured devices, not patient data.

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

• Not applicable. The ground truth for bench testing is established by technical specifications and validated test methods, not expert clinical consensus.

4. Adjudication method for the test set

• Not applicable. This is not a clinical study with image interpretation or similar expert-dependent outcomes.

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

• Not applicable. This device is a mechanical implant (plates and screws), not an AI-powered diagnostic or assistive tool for human readers.

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

• Not applicable. This device is a mechanical implant, not an algorithm. Performance relates to its physical and material properties.

7. The type of ground truth used

• For the bench tests, the ground truth or reference standard is based on pre-set criteria, technical specifications, and recognized standards (e.g., ASTM F67, ASTM F136 for materials, and established parameters for sterilization, bioburden, and packaging integrity).

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 algorithms.

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

• Not applicable. As above, this is a mechanical device, not an AI model.

Summary of Study Type:

The "study" described in the provided text is a set of non-clinical bench tests and validation activities, typical for demonstrating the safety and performance of medical implants like cranioplasty plates and screws. These tests are designed to confirm material properties, mechanical strength, sterility, cleanliness, and packaging integrity, which are crucial for the intended use of such a device in surgery. The objective is to demonstrate substantial equivalence to already legally marketed predicate devices, primarily through engineering and material science evaluations, rather than clinical efficacy studies on patient outcomes or diagnostic accuracy.

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