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ZPS One-Third Tubular Plates, One-Quarter Tubular Plates, T-Plates, L-Buttress Plates, Cobra Plates, Semi-Tubular Plates, Symphyseal Bridge Plates, Reconstruction Plates, and Contourable Dual Compression Plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures, such as:

• comminuted fractures
• supracondylar fractures
• extra-articular fractures
• fractures in osteopenic bone
• nonunions
• malunions
  Smaller-sized ZPS plates are used for small bones and small fragments of the hands and feet.
  ZPS Calcaneal plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures of the calcaneus. ZPS and Forte Screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process.

The Zimmer Plates and Screws System (ZPS) is a nonlocking, stainless steel plate and screw system. Plate shapes vary to address varying patient bone sizes and injury fragment sizes. Plates incorporate a spherical sliding slope plate hole design to achieve the compression required to treat bone fractures. The plates are used with a variety of screws for temporary fixation to the bone. The ZPS Washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a larger area when used for non-plate, bone fragment, and fracture fixation.

This document is a 510(k) Pre-market Notification for the Zimmer® Plates and Screws System (ZPS) - Non-sterile ZPS Plate Line Extensions, Sterile/Non-sterile ZPS Screws and Washers. It describes the device, its intended use, and a comparison to predicate devices. The document explicitly states that clinical data and conclusions were not needed for these devices.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies (MRMC, standalone) is explicitly stated as not applicable or not needed in this document.

The document primarily focuses on demonstrating substantial equivalence to pre-existing, legally marketed predicate devices through non-clinical performance data.

However, I can extract the non-clinical performance data that serves in place of clinical studies to demonstrate device performance and substantial equivalence.

Here's a breakdown of what the document does provide in relation to performance:

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

The document does not present a formal "acceptance criteria" table in the way one might expect for a clinical study with specific performance metrics (e.g., sensitivity, specificity). Instead, it relies on two primary non-clinical performance tests to demonstrate substantial equivalence to predicate devices. The acceptance criteria are implicitly that the subject device's performance should be "similar" or "substantially equivalent" to the predicate devices.

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

• Sample Size for Test Set: Not specified in terms of number of devices or units tested for the non-clinical tests. The tests were performed on "the plate, screw, and washer material" and "ZPS Plates" for beam bending. This would typically refer to a statistically sufficient sample for engineering tests, but the exact number isn't provided.
• Data Provenance: The tests are non-clinical, likely conducted in a laboratory setting by the manufacturer (Zimmer, Inc.) or a contract research organization. There is no mention of country of origin for this data beyond the manufacturer's location (Warsaw, IN). The data is by nature prospective for the purpose of this submission.
• Retrospective or Prospective: Prospective, as it was conducted specifically for the 510(k) submission.

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

Not applicable. For non-clinical performance tests such as biocompatibility and mechanical testing, "ground truth" is established by adherence to recognized standards (e.g., ISO 10993-1) and objective measurements using calibrated equipment, not by expert consensus.

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

Not applicable. Adjudication methods are typically for subjective assessments (e.g., image interpretation by multiple readers) or complex clinical outcomes. Non-clinical tests follow standardized protocols.

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 (bone plates and screws), not an AI/imaging diagnostic device. Clinical studies (including MRMC) were explicitly stated as "not needed."

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 consensus, pathology, outcomes data, etc)

For the non-clinical tests:

• Biocompatibility: Established by adherence to ISO 10993-1 standards and the specific pass/fail criteria outlined within those standards and Good Laboratory Practices (GLP).
• Mechanical Properties: Established by quantitative measurements of specific mechanical parameters (e.g., stiffness, strength) through standardized engineering test methods (beam bending cross-sectional analysis). "Similar mechanical properties" to the predicate serve as the ground truth for equivalence.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

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ZPS One-Third Tubular Plates, T-Plates and Semi-Tubular plates are indication and stabilization of osteotomies and fractures, such as:

• comminuted fractures
• supracondylar fractures
• extra-articular fractures
• · fractures in osteopenic bone
• nonunions
• malunions
  Smaller-sized ZPS plates are used for small bones and small fragments of the hands and feet.
  ZPS Screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process.

The Zimmer Plates and Screws System (ZPS) is a non-locking, stainless steel plate and screw system. Plate shapes vary to address varying patient bone sizes and injury fragment sizes. Plates incorporate a spherical sliding slope plate hole design to achieve the compression required to treat bone fractures. The plates are used with a variety of screws for temporary fixation to the bone.

The provided document describes the Zimmer Plates and Screws System (ZPS) - Non-Sterile Plates and Screws (K140508). This is a medical device, and the submission focuses on demonstrating its substantial equivalence to predicate devices rather than proving its performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, sample sizes, expert ground truth, adjudication, and reader studies is not explicitly available in this type of regulatory submission.

However, based on the "Performance Data (Nonclinical and/or Clinical)" section, we can infer some aspects of what served as "acceptance criteria" for the non-clinical testing performed.

Here's an attempt to answer your questions based on the provided text:

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

Since this is a non-clinical evaluation for substantial equivalence, the "acceptance criteria" are implied by the comparison to predicate devices and recognized standards.

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

• Sample Size:
  • Biocompatibility: The document states "Biocompatibility testing... was conducted." It does not specify the number of samples or animal subjects used, as is common for a summary of this type.
  • Performance (Plates): The document refers to "four point bend testing and/or the beam bending cross sectional analysis." It does not specify the number of plates tested.
  • Performance (Screws): No new testing was performed for the screws, as they were deemed identical to a previously cleared device.
• Data Provenance: Not specified in the provided text, but non-clinical testing is typically conducted in a laboratory setting. This is not clinical data; it's laboratory performance testing.

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 a bone fixation system (plates and screws), not a diagnostic algorithm or imaging device where "ground truth" would be established by experts. The "ground truth" for non-clinical performance refers to the actual physical properties and behavior of the device under testing conditions.

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

Not applicable. This is not a study requiring expert adjudication of results.

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 or imaging device.

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

Not applicable. This is a physical medical device.

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

For the non-clinical performance data, the "ground truth" would be:

• Biocompatibility: Standardized assay results compared against pass/fail criteria per ISO 10993-1.
• Performance (Plates): Measured mechanical properties (e.g., strength, stiffness) obtained from standardized test methods such as four-point bend testing, compared against predicate device performance.

8. The sample size for the training set

Not applicable. This is not a device employing machine learning or AI that would require a "training set."

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

Not applicable.

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ZPS Plates are indicated for temporary internal fixation of osteotomies and fractures. Smaller-sized ZPS plates are used for small bones and small fragments of the hands and feet. ZPS Calcaneal plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures of the calcaneus. ZPS Screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process.

The Zimmer Plates and Screws System (ZPS) is a non- locking, stainless steel plate and screw system. Plate shapes vary to address varying patient bone sizes and injury fragment sizes. Plates incorporate a spherical sliding slope plate hole design to achieve the compression required to treat bone fractures. The plates are used with ZPS screws for temporary fixation to the bone.

This document is a 510(k) premarket notification for the Zimmer Plates and Screws System (ZPS) - Non-Sterile Plates. It describes the device, its intended use, and substantial equivalence to predicate devices, along with performance data.

Here's a breakdown of the requested information based on the provided text, focusing on the study conducted and its findings:

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)

   • Sample size for the test set: The document states that the "weakest (worst-case) ZPS plate within each of the groups was selected as the representative sample for comparison." This implies a selection of specific plates from different groups for testing, rather than a large numerical sample size. The exact number of representative plates tested is not specified but is implied to be a small, worst-case selection from each group.
   • Data provenance: The performance data is non-clinical. It is based on laboratory testing (mechanical testing) of the device. There is no information about the country of origin of the data or whether it is retrospective or prospective, as it's not 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 question is not applicable to this study. The "ground truth" for this engineering performance study is based on objective mechanical properties (static and fatigue bending moments) and calculations, not expert interpretation of medical images or conditions. The assessment was based on physical property measurements and calculations.

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

   • This question is not applicable to this study. Adjudication methods are typically used in clinical studies for interpretation of medical data by multiple experts. For this engineering study, the "adjudication" is inherent in the objective measurements and calculations of mechanical properties.

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

   • No. A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study is a non-clinical, mechanical performance evaluation of a medical device (plates and screws). There is no AI component or human-in-the-loop performance involved.

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 study focuses on the mechanical performance of a physical device.

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

   • The "ground truth" for this study is based on objective mechanical measurements and calculations of static and fatigue bending strength/moments. Specifically, it involves:
     • Beam bending cross-sectional analysis.
     • Calculations of static and fatigue bending moments.
     • Comparison to mechanical properties of predicate devices.

8. The sample size for the training set

   • This question is not applicable to this study. There is no "training set" as this is not a machine learning or AI study. The study involves direct mechanical testing and calculation on physical device samples.

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

   • This question is not applicable as there is no training set or AI component. The "ground truth" for the performance evaluation was established through engineering principles, standardized testing (ISO 10993-1 for biocompatibility), and calculation methods.

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The sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System are intended for use on non-load bearing fixation, including cranial bone fixation and brow fixation and the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implant

The Bioplate® Titanium Fixation System includes a variety of plate configurations for different anatomical applications. Unalloyed commercially pure Grade 1, Grade 2 and Grade 4 titanium and titanium allov plates, and titanium allov screws of varying diameters and lengths are included for fixation of the plates to the craniomaxillofacial bony tissues. These materials have been implanted safely for many years. The predicate device had been approved under K022033.

The bone plates will be manufactured of unalloyed, commercially pure titanium and titanium 6A1-4V Eli alloy. The materials adhere to the American Society of Testing and Materials (A.S.T.M.) F67 Standards and the American Society of Testing and Materials ( A.S.T.M.) F136 Standard.. The screw will be manufactured of a titanium 6A1-4V Eli alloy that meets the American Society of Testing and Materials (A.S.T.M.) F136 Standard.

The plate and screw fit configurations are sterilized by gamma radiation sterilization, using VD Max dose setting method. Successful completion of sterilization validation and packaging validation studies provides a high level of assurance that sterility of the device has been achieved and can be maintained.

The provided text is a 510(k) summary for a medical device (Modified Sterile Plate & Screw Kit Configurations for use with the Bioplate® Titanium Fixation System) and primarily focuses on establishing substantial equivalence to predicate devices, rather than presenting a performance study with specific acceptance criteria as would typically be seen for a new or novel device.

Therefore, the document does not contain the information requested regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (e.g., pathology, outcomes).
8. Sample size for the training set.
9. How ground truth for the training set was established.

Instead, the document states:

• Comparison of the device's technological characteristics with those of the predicate devices: "All the technical characteristics of the sterile plate and screw kit configurations for use Bioplate® Titanium Fixation System are substantially equivalent to the corresponding characteristics of the predicate devices, and any minor differences raise no new issues of safety and efficacy."
• The materials used have been implanted safely for many years.
• Sterilization validation and packaging validation studies were successfully completed, providing a high level of assurance of sterility.

The "acceptance criteria" in this context are effectively demonstrating that the device is substantially equivalent to legally marketed predicate devices, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. The study proving this involves comparing the new device's specifications (materials, sterilization method, intended use) against those of established predicate devices.

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The sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System are intended for use in non-load bearing fixation, including, but not limited to cranial bone fixation and brow fixation, and the treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

The sterile plate and screw kit configurations for use with the Bioplate® Titanium Fixation System includes a variety of plate confiqurations for different anatomical applications. Titanium alloy screws of varying lengths are included for fixation of the plates to the craniomaxillofacial bony tissue. Titanium alloy screws of varying lengths are included for fixation of the plates to the craniomaxillofacial bony tissue.

The bone plates will be manufactured of unalloved, commercially pure titanium and titanium 6AI-4V ELI allov. The materials adhere to the American Society of Testing and Materials (A.S.T.M) F67 Standards and The American Society for Testing and materials (A.S.T.M.) F136 Standard. The screws will be manufactured of a titanium 6Al-4V ELI alloy that meets The American Society for Testing and materials (A.S.T.M.) F136 Standard.

The plate and screw kit confiqurations are sterilized using gamma radiation sterilization methods. Successful completion of sterilization validation and packaging validation studies provides a high level of assurance that sterility of the devices has been achieved and can be maintained.

This submission K022033 does not contain a study that describes acceptance criteria for device performance in the manner typically seen for software or AI/ML devices. This is a 510(k) premarket notification for a Class II medical device, specifically Sterile Plate & Screw Kit Configurations for use with the Bioplate® Titanium Fixation System.

For devices like bone plates and screws, the "acceptance criteria" and "study" proving they meet those criteria are typically focused on substantial equivalence to predicate devices and adherence to established material and sterilization standards, rather than performance metrics like sensitivity, specificity, or accuracy.

Here's a breakdown based on the provided document, addressing the requested points where applicable, and noting where the information is not present or not relevant to this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

• Plates: Unalloyed, commercially pure titanium and titanium 6Al-4V ELI alloy, adhering to ASTM F67 and ASTM F136 Standards.
• Screws: Titanium 6Al-4V ELI alloy, meeting ASTM F136 Standard. |
  | Sterilization Efficacy: |
• Successfully completed sterilization validation studies proving sterility has been achieved.
• Successfully completed packaging validation studies proving sterility can be maintained. |
  | Intended Use Equivalence: |
• Intended for use in non-load bearing fixation, cranial bone fixation, brow fixation, and treatment of fractures and reconstructive procedures of the craniomaxillofacial skeleton.
• Matches the indications for use of predicate devices: Bioplate, Inc., Wurzburg, Synthes, TiMesh, and KLS-Martin.
• Intended for single use only. |
  | Technological Characteristics Equivalence: |
• Same indications for use as predicate devices.
• All technical characteristics are "substantially equivalent" to predicate devices.
• "Minor differences raise no new issues of safety and efficacy." |
  | Manufacturing Quality System: |
• Implicitly meets Good Manufacturing Practice (GMP) requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820), as mandated by FDA for all medical devices. (Mentioned in FDA letter as a general requirement, not a specific claim from the submitter). |
  | Safety and Efficacy (Overall Substantial Equivalence): |
• Found substantially equivalent by FDA to legally marketed predicate devices, allowing it to proceed to market. The FDA letter states: "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies." |

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

This information is not applicable and not provided in the document. This type of device (bone plates and screws) does not typically involve a "test set" in the context of diagnostic or AI/ML performance evaluation studies. The "testing" refers to material and sterilization validation, which are engineering and manufacturing tests, not clinical performance tests 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 applicable and not provided. "Ground truth" for this device is established by adherence to engineering standards (ASTM), manufacturing specifications, and successful physical/chemical testing for material properties and sterility. It doesn't involve expert medical interpretation in the way an AI diagnostic device would.

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

This information is not applicable and not provided. Adjudication methods are relevant for disputes in expert-labeled datasets, which is not the case here.

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

This information is not applicable and not provided. MRMC studies are used for evaluating diagnostic performance, often involving human readers and AI/ML systems. This is not a diagnostic device; it's a surgical implant.

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

This information is not applicable and not provided. This device does not involve an algorithm.

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

The "ground truth" for this device is effectively established by:

• Adherence to Material Standards: ASTM F67 and ASTM F136 specifications define the "truth" for material composition and properties.
• Validation of Manufacturing Processes: Successful completion of sterilization validation and packaging validation studies (likely per ISO standards or similar) serves as "ground truth" for sterility.
• Substantial Equivalence: The ultimate "ground truth" for marketing approval is that the device is substantially equivalent to predicate devices already on the market, meaning it performs as intended and introduces no new safety or efficacy concerns.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" in the context of an AI/ML algorithm for this device.

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

This information is not applicable and not provided. There is no "training set" or "ground truth" establishment in the AI/ML sense for this device.

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