Search Results

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.

Ask a specific question about this device

Dental
The self-tapping screws and low profile emergency screws are intended for use in the fixation of bones of the maxillofacial and midfacial 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 self-tapping screws and low profile emergency screws are designed to be compatible with the components (plates, meshes) of the Delta Resorbable Fixation System K213777.

The subject devices, the Delta System self-tapping screw (STS) and low profile emergency screw (LPES), are intended for use in the fixation of bones of the maxillofacial and midfacial skeleton, affected by trauma or for reconstruction. The subject device can be used in pediatric patients older than 29 days and up to two (2) years of age (infants), but is not intended for use in the mandible and/or full load bearing procedures.

The scope of this submission covers the addition of the subject device screws to the previously cleared Delta System. Through this submission there is no change to the existing articles within the Delta System. The subject device screws are designed to be compatible with the existing components of the Delta System (plates, meshes), which have been previously cleared through K213777. Compared to the original Delta System, the subject STS and LPES have a limited patient population of pediatric patients older than 29 days and up to two (2) years of age (infants).

The document provided is a 510(k) summary for a medical device called the "Stryker Resorbable Fixation System". This summary outlines the device, its intended use, and comparative information to a predicate device to demonstrate substantial equivalence to a legally marketed device.

However, the provided text does not contain information about an AI/ML device or a study to prove that a device meets acceptance criteria related to AI/ML performance. The document focuses on regulatory approval for an orthopaedic fixation system, specifically resorbable screws, based on traditional engineering performance testing (e.g., mechanical tests, material properties) and comparison to a predicate device.

Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria, study details, sample sizes, expert involvement, or MRMC studies, as these concepts are not applicable to the content of the provided document.

The document discusses "acceptance criteria" in the context of:

• Regulatory Acceptance: The FDA's determination of substantial equivalence.
• Performance Testing: Bench test "acceptance criteria" are implied by the "Passed" results for tests like Insertion, Shear, and Pull-out, and "Passed" for Inherent Viscosity. These are mechanical and material property tests, not AI/ML performance metrics.
• User Validation Testing: A validation study was done to confirm usability, comprehension of Instructions for Use, and that user needs are met, concluding a "passing result." This relates to human factors and usability, not AI/ML performance.

In summary, the provided text does not contain the information needed to answer the prompt's specific questions about AI/ML device acceptance criteria and proving device performance related to AI/ML.

Ask a specific question about this device

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

Neuro: 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 Stryker Resorbable Fixation System 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 system 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.

The provided text describes a 510(k) premarket notification for the Stryker Resorbable Fixation System. This submission focuses on design modifications related to the sterilization process and packaging, not on validating the core performance of a new device or an AI/ML algorithm. Therefore, the information needed to answer the prompt, particularly regarding acceptance criteria and studies proving the device meets those criteria in the context of an AI/ML device, is not present in the provided document.

The document states:

• "Performance bench testing was not required as a basis for substantial equivalence."
• "Animal testing was not required as a basis for substantial equivalence."
• "Clinical testing was not required as a basis for substantial equivalence."

The "studies" mentioned are limited to:

• Sterilization Validation: Product Adoption and Sterility, EO Residual, Endotoxin Testing. These confirm the new sterilization process achieves sterility and meets safety limits for ETO residuals and endotoxins.
• Summative Usability Validation of Packaging: A study to confirm correct aseptic transfer despite a packaging change.

Since the prompt specifically asks about acceptance criteria and studies for a device (implying a functional, potentially AI/ML, device performance) and the document indicates these types of performance tests were not required for this particular 510(k) submission (which focused on demonstrating substantial equivalence for manufacturing/packaging changes), I cannot fill out the requested table or answer the questions as they pertain to the performance validation of an AI/ML device.

However, I can extract the information provided about the limited validation studies that were performed for the changes described in the document:

1. Table of acceptance criteria and the reported device performance (for the changes evaluated):

Regarding the other questions, the document does not contain the required information as it is not an AI/ML device validation study:

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

   • Packaging Usability: Sample size of 19 representative users.
   • Data Provenance: Not specified, but generally, usability studies are prospective.
   • For sterilization tests, "product adoption" would involve a specific number of units, but this detail is not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for sterility is laboratory measurement against standards. For packaging usability, "correct performance" by representative users serves as the "ground truth."

4. Adjudication method for the test set: Not applicable. For usability, direct observation of performance. For biochemical tests, measurement against established limits.

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/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

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

   • Sterilization: Laboratory measurements and standardized biological indicators (implicit in ISO standards).
   • Packaging Usability: Observational performance of users against defined correct steps.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Ask a specific question about this device

The Stryker Resorbable Fixation System is intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or for reconstruction. The system can be used in both adult and pediatric patients but is not intended for use in the mandible and/or full load bearing procedures.

The Stryker Delta Resorbable Fixation System is a cranio-maxillofacial plating system, intended for use in the fixation of bones of the craniofacial and midfacial skeleton affected by trauma or reconstruction. The system can be used in both adult and pediatric patients but is not intended for use in 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. The copolymer degrades and resorbs in vivo by hydrolysis into lactic and glycolic acid which are metabolized in the body to water (H₂O) and carbon dioxide (CO₂). The Delta Resorbable Fixation System is color coded and currently offered in two diameters, 1.7 mm and 2.2 mm with an emergency screw option of 2.6 mm. As the resorbable bone fixation plates and other devices already cleared in the earlier submission have not been modified, they are not described in this Special 510(k).

This submission is a Special 510(k) for modifications to an already cleared device, the Stryker Leibinger Resorbable Fixation System (K993061). The document states that the Stryker Resorbable Fixation System has the same intended use, indications for use, material, and fundamental scientific technology as the previously cleared predicate device.

Therefore, the acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to its predicate device (K993061) regarding the proposed modifications. The study proving this involves a comparison of the modified features to the predicate, focusing on whether these changes introduce new questions of safety or efficacy.

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

1. A table of acceptance criteria and the 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)

The provided text does not contain information about a specific test set, its sample size, or data provenance for performance evaluation of the modified device. For a Special 510(k) where modifications are minor and substantial equivalence is being claimed, often the testing involves engineering analysis, bench testing, and comparison to existing predicate data rather than new clinical trials with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the given document. As mentioned above, a traditional "test set" for ground truth establishment may not be applicable for this type of Special 510(k) submission.

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

This information is not provided in the given document.

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

This is not applicable to this device. The Stryker Resorbable Fixation System is a physical medical device (implants and screws), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance would not be relevant.

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

This is not applicable to this device. As a physical medical device, there is no "algorithm only" performance to evaluate.

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

Given the nature of a Special 510(k) for minor modifications to a physical device, the "ground truth" for demonstrating acceptance would primarily be engineering and material specifications, biomechanical testing results (if conducted), and a comparison to the predicate device's established safety and performance profile. The document does not explicitly detail what specific tests were performed, but the clearance implies that the modifications were deemed to not negatively impact safety or effectiveness.

8. The sample size for the training set

This information is not provided and is not applicable to this type of device and submission. There is no concept of a "training set" for a physical medical device like this.

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

This information is not provided and is not applicable to this type of device and submission.

Ask a specific question about this device