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510(k) Data Aggregation
(19 days)
SPS Small Fragment Set: The Stryker® Plating System, Small Frag Set is indicated for fractures of the metaphysis and/or the diaphysis of the following: One third tubular plate: fibula, metatarsals, metacarpals Fibular plate: fibula Compression plate: radius, ulna, distal tibia, fibula, distal humerus, clavicle Oblique T-plate: distal radius T-plate: distal radius, calcaneus, lateral clavicle Cloverleaf plate: proximal humerus, distal tibia Calcaneal plate: calcaneus Reconstructive plate: humerus, pelvis. Screws are used either to fasten plates or similar devices onto bone, or, as lag screws, to hold together fragments of bone.
SPS Basic Fragment Set: The Basic Fragment Set is intended for use in long bone fracture fixation. Reconstruction plates, wide and narrow straight and waisted compression plates are indicated for fixation of long bone fractures including but not limited: to fractures of the femur, the tibia, the humerus and the pelvis. T-plates, T-buttress plates and L-buttress plates are indicated for fractures at the proximal or distal end of long bones including but not limited to: fractures of the femoral condyles, the tibial plateau, the distal tibia and the proximal humerus.
This Special 510(k) submission is a line extension to address modifications to the Stryker® Plating System (SPS), which includes the SPS Small Fragment Set, the SPS Basic Fragment Set, the SPS Pelvic Set and the Stryker Locked Plating Set. This line extension is to add additional styles of plates based on the plates in the SPS Small Fragment Set and the SPS Basic Fragment Set.
The provided document is a 510(k) summary for the Stryker® Plating System. This type of submission focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving device performance against specific acceptance criteria through a clinical study in the way an AI/ML device submission would.
Therefore, many of the requested points related to acceptance criteria, specific studies, sample sizes, and ground truth establishment (which are common for AI/ML device evaluations) are not applicable or explicitly stated in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|
| Design: The new components are similar in design to the predicate systems. | The additional styles of plates are based on the existing SPS Small Fragment Set and SPS Basic Fragment Set. |
| Intended Use: The new components do not alter the intended use of the predicate systems. | The indications for the subject plates and accessories are the same as their cleared predicates. |
| Performance: The new components perform similarly to the predicate systems. | The document asserts "substantial equivalence... in respect to design, intended use, performance and operational principle as internal fixation components." No specific performance metrics or studies proving this are detailed, as equivalence is often established through design comparison, materials, and (sometimes) mechanical bench testing for orthopedic implants, which are not included here. |
| Operational Principle: The new components function on the same operational principle as the predicate systems. | The document asserts "substantial equivalence... in respect to design, intended use, performance and operational principle as internal fixation components." |
Explanation: For a 510(k) submission, the "acceptance criteria" are typically demonstrating substantial equivalence to a legally marketed predicate device. This means the new device is as safe and effective as the predicate. The "reported device performance" is essentially the claim that the new device meets the equivalence standard in areas like design, intended use, performance, and operational principle. Specific quantitative performance metrics are usually not required for this type of submission unless a significant change that impacts safety or effectiveness is introduced, necessitating new testing.
2. Sample Size Used for the Test Set and the Data Provenance
- Not applicable/Not provided. This document does not describe a clinical study with a "test set" in the context of analytical or clinical performance evaluations for an AI/ML device. The submission is for a physical medical device (bone plates and screws). The "sample size" here refers to the number of new plate styles being added to an existing system.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable/Not provided. This is not relevant for a 510(k) for a bone plating system. Ground truth establishment with experts is a concept often applied to AI/ML clinical evaluations, not for demonstrating substantial equivalence of orthopedic implants.
4. Adjudication Method for the Test Set
- Not applicable/Not provided. This concept is not applicable to this type of device submission.
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/Not provided. This is irrelevant as the device is a physical bone plating system, not an AI/ML diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable/Not provided. This device is a physical implant, not an algorithm.
7. The Type of Ground Truth Used
- Not applicable/Not provided. The concept of "ground truth" as typically discussed in AI/ML device evaluations (e.g., pathology, outcomes data, expert consensus) does not apply directly here. For a bone plating system, the "truth" is established through design specifications, material properties, biocompatibility, and mechanical testing (though the details of such testing are not in this summary). Substantial equivalence is the primary "truth" being established in this document.
8. The Sample Size for the Training Set
- Not applicable/Not provided. This device is not an AI/ML system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable/Not provided. This device is not an AI/ML system that requires a "training set" or corresponding ground truth.
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(18 days)
SPS Small Fragment Set The Stryker Plating System, Small Frag Set is indicated for fractures of the metaphysis and/or the diaphysis of the following: One third tubular plate: fibula, metatarsals, metacarpals Compression plate: radius, ulna, distal tibia, fibula, distal humerus, clavicle Oblique T-plate: distal radius T-plate: distal radius, calcaneus, lateral clavicle Cloverleaf plate: proximal humerus, distal tibia Calcaneal plate: calcaneus Reconstructive plate: humerus, pelvis Screws are used either to fasten plates or similar devices onto bone, or, as lag screws, to hold together fragments of bone. SPS Basic Fragment Set The Basic Fragment Set is intended for use in long bone fracture fixation, Reconstruction plates, wide and narrow straight and waisted compression plates are indicated for fixation of long bone fractures including but not limited: to fractures of the femur, the tibia, the humerus and the pelvis. T-plates, T-buttress plates and L-buttress plates are indicated for fractures at the proximal or distal end of long bones including but not limited to: fractures of the femoral condyles, the tibial plateau, the distal tibia and the proximal humerus.
This Special 510(k) submission is a line extension to address modifications to the Stryker® Plating System (SPS), which includes the SPS Small Fragment Set, the SPS Basic Fragment Set, the SPS Pelvic Set and the Stryker Locked Plating Set. This line extension is to add additional styles of monoaxial plates based on the SPS Small Fragment Set and the SPS Basic Fragment Set.
This document describes a Special 510(k) submission for a line extension to the Stryker® Plating System. It focuses on the substantial equivalence of the new components to existing predicate devices, rather than a study proving device performance against acceptance criteria in the traditional sense of a clinical or analytical performance study for a novel device.
Therefore, many of the requested elements for a performance study (like sample size, ground truth, expert adjudication, MRMC studies, standalone performance, and training set information) are not applicable in this context. The acceptance criteria here are about demonstrating that the modified device maintains the same safety and effectiveness as its already-cleared predicates.
Here's a breakdown based on the provided text, addressing the applicable points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance (Stated Equivalence) |
|---|---|
| Intended Use: The modifications to the device must not alter the intended use of the predicate systems. | "The modifications do not alter the intended use of the predicate systems as cleared in their respective premarket notifications. The indications for use for the subject plates are provided below... The subject plates and subject accessories have the same indications as cleared their predicates." |
| Indications for Use: The new components must have the same indications for use as their predicates. | The document explicitly lists the indications for use for the SPS Small Fragment Set and SPS Basic Fragment Set, and states: "The subject plates and subject accessories have the same indications as cleared their predicates." This is further reiterated in the FDA's "Indications for Use" enclosure. |
| Substantial Equivalence (Design, Performance, Operational Principle): The new components must be substantially equivalent to their predicates in design, performance, and operational principle as internal fixation components to ensure safety and effectiveness. | "These additional monoaxial components are substantially equivalent to their predicate systems from the Stryker® Plating System in respect to design, intended use, performance and operational principle as internal fixation components." The FDA's 510(k) clearance itself is a determination that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This implies the FDA concurred with the applicant's assessment that the design, performance (presumably mechanical testing, biocompatibility, etc., as per similar predicate devices, though not detailed in this summary), and operational principles are equivalent. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is not a study with a test set of data in the traditional sense of evaluating an algorithm's performance on a dataset. The "test" here refers to the comparisons made to predicate devices for substantial equivalence. The data provenance would be the design and manufacturing specifications of the new components compared against those of the predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. Ground truth, in the context of device performance, usually refers to a definitive diagnosis or reference standard. Here, the "ground truth" for substantial equivalence is the FDA's regulatory framework and the established safety and effectiveness profiles of the predicate devices.
4. Adjudication Method for the Test Set
Not applicable. There's no specific adjudication method described for a "test set" as this is a regulatory submission demonstrating substantial equivalence, not a performance trial. The FDA's review process itself serves as the "adjudication" for the substantial equivalence claim.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is performed to evaluate the diagnostic accuracy of a medical imaging device with and without AI assistance across multiple readers and cases. This document is for a bone plating system, not an imaging device, and its purpose is to demonstrate substantial equivalence, not comparative effectiveness of human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is a physical medical device (bone plating system), not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" implicitly used for this submission is the established regulatory compliance and performance of the predicate devices. The new components are asserted to be equivalent to these cleared devices, meaning they meet the same safety and effectiveness standards already accepted by the FDA for the predicates.
8. The Sample Size for the Training Set
Not applicable. This is not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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(30 days)
The Periarticular Plates are intended for use in long bone fracture fixation.
The 3.5mm and 4.5mm Periarticular Plate components are intended for use in long bone fracture fixation.
The 3.5mm and 4.5mm proximal tibial Periarticular Plates are indicated for fixation of long bone fractures, including, but not limited to, fractures of the tibia. The 4.5mm distal femur Periaticular Plates are indicated for fixation of long bone fractures, including, but not limited to, fractures of the femur.
This Special 510(k) submission is intended to address a line extension to the predicate SPS Small Fragment Set and SPS Basic Fragment Set which are both part of the Stryker Plating System. Both the SPS Small Fragment Set and SPS Basic Fragment Set consist of plates and screws for the fixation of fractures of the cortical and metaphyseal areas of long bones as well as fractures of the pelvis. There is no change in intended use for the modified device when compared to the previously cleared devices. The line extension involves offering a new Periarticular Plate version for the fixation of fractures of the cortical and metaphyseal regions of long bones. Howmedica Osteonics intends to add the new components to the current product line, thereby offering additional design options for the surgeon. The Periarticular Plates will be available in stainless steel (316L).
The provided document describes a Special 510(k) Premarket Notification for a line extension to the Stryker Plating System, specifically involving 3.5mm and 4.5mm Periarticular Plates. This submission is for a medical device (bone plates) and not an AI/ML powered medical device. Therefore, many of the typical acceptance criteria and study components related to AI/ML performance (like sample sizes for test and training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable here.
However, I can extract information related to the device's functional equivalence based on the provided text.
Acceptance Criteria and Device Performance
| Acceptance Criterion | Reported Device Performance (or Mechanism for Demonstrating Equivalence) |
|---|---|
| Intended Use | The Periarticular Plates are intended for use in long bone fracture fixation. This matches the intended use of the predicate SPS Small Fragment Set and SPS Basic Fragment Set. |
| Materials | The Periarticular Plates will be available in stainless steel (316L), which aligns with common materials used in bone plating systems and likely matches the predicate devices. |
| Design | Similarities in design to other currently marketed plating systems, specifically the predicate SPS Small Fragment Set and SPS Basic Fragment Set. |
| Mechanical Properties | FEA (Finite Element Analysis) demonstrates comparable mechanical properties of the subject Periarticular Plates and the predicate SPS Basic Fragment Set. |
| Regulatory Classification | Class II, consistent with Single/Multiple Component Metallic Bone Fixation Appliances and Accessories (21 CFR §888.3030) and Smooth or Threaded Metallic Bone Fixation Fastener (21 CFR §888.3040). |
Study Information (as applicable to a physical medical device submission)
- Sample size used for the test set and the data provenance: Not applicable. This submission is for a physical device, and the "study" primarily consists of engineering analyses (FEA) and comparison to predicate devices, not data from a patient test set in the traditional sense.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's mechanical properties is typically established through engineering standards, material testing, and computational modeling, not by expert consensus on clinical data.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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-powered device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML-powered device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the mechanical properties, the "ground truth" would be established by engineering principles, accepted material standards, and results from a validated Finite Element Analysis (FEA) model. The comparison is against the mechanical properties of a predicate device.
- The sample size for the training set: Not applicable. This involves a physical device and engineering analysis, not a machine learning model.
- How the ground truth for the training set was established: Not applicable.
Summary of the Study (Demonstration of Substantial Equivalence):
The "study" in this context is a demonstration of substantial equivalence to existing legally marketed predicate devices, as required for a 510(k) submission.
- Methodology: The submission relies on Finite Element Analysis (FEA) to compare the mechanical properties of the proposed Periarticular Plates with those of the predicate SPS Basic Fragment Set.
- Basis for Equivalence: Equivalency is based on similarities in:
- Intended Use: "long bone fracture fixation" remains unchanged from the predicate devices.
- Materials: Use of 316L stainless steel.
- Design: Comparison to other currently marketed plating systems, specifically the predicate SPS Basic Fragment Set.
- Conclusion: The FEA analysis "demonstrates the comparable mechanical properties" of the new plates and the predicate, supporting the claim of substantial equivalence. This allows the new components to be added to the product line as a "line extension."
In essence, for this type of medical device submission, the "study" is an engineering validation and comparative analysis to a predicate device, rather than a clinical trial or performance study involving patient data or AI algorithms.
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(51 days)
The Basic Fragment Set is intended for use in long bone fracture fixation.
Reconstruction plates, wide and narrow straight and waisted compression-plates are indicated for fixation of long bone fractures including but not limited to:
- Fractures of the femur .
- Fractures of the tibia .
- Fractures of the humerus .
- Fractures of the pelvis .
T-Plates, T-buttress Plates and L-buttress-Plates are indicated for fractures at the proximal or distal end of long bones including but not limited to:
- Fractures of the femoral condyles .
- Fractures of the tibial plateau .
- Fractures of the distal tibia .
- Fractures of the proximal-humerus ●
The Basic Fragment Set is part of the Stryker Plating System. The Basic Fragment Set is consists of plates and screws for the fixation of fractures of the cortical and metaphyseal area of long bones as well as fractures of the pelvis. The implant set is available either in stainless steel (316L) or titanium alloy (Ti6Al4V).
This document is a 510(k) summary for the Stryker Plating System Basic Fragment Set, submitted to the FDA in 2001. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics is not available in the provided text.
Here is a breakdown of the requested information based on the provided text:
-
Table of acceptance criteria and the reported device performance
- Not Applicable. The document is a 510(k) summary demonstrating substantial equivalence, not a performance study with defined acceptance criteria and reported device performance metrics in the way these terms are typically used for diagnostic or AI devices. The substantial equivalence is based on similarities in intended use, materials, and design to other currently marketed plating systems.
-
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No test set or data provenance is mentioned as this is not a clinical performance study. The substantial equivalence analysis does not involve a "test set" in this context.
-
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. Ground truth establishment by experts is not relevant to this 510(k) submission, which focuses on substantial equivalence based on design and materials.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication method is described.
-
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 hardware device (bone plate system), not an AI or diagnostic device that would undergo an MRMC study.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware device, so a standalone algorithm performance study is not relevant.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. Ground truth, in the context of clinical studies for AI or diagnostic devices, is not a concept applied to this type of device submission.
-
The sample size for the training set
- Not Applicable. There is no "training set" as this is not a device employing machine learning or AI.
-
How the ground truth for the training set was established
- Not Applicable. As no training set exists, ground truth establishment for it is not applicable.
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