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510(k) Data Aggregation
(170 days)
The Stryker RF electrodes and cannulae, in combination with the Stryker RF Generator/Multigen, are intended for coagulation of soft tissues in orthopedic, spinal, and neurosurgical applications. These products are also used for selective denervation and tissue destruction procedures which may be performed on the lumbar, thoracic, and cervical regions of the peripheral nerves, and nerve roots for the relief of pain. Examples include, but are not limited to, Facette Denervation, Trigeminus Neuralgia, Peripheral Neuralgia and Rhizotomy.
The Stryker Cannulae will be used in conjunction with the Stryker RF Generator/MultiGen, cables and electrodes to create radiofrequency lesions in nerve tissue. The generator applies temperature-controlled, radio frequency (RF) energy into targeted nerve tissue via an electrode probe. This energy destroys the nerve tissue's ability to conduct electrical signals. Pain relief is achieved by creating defined lesions on pain-conducting nerve fibers or tissue.
This document describes the Stryker® Venom™ Electrodes and Cannulae, a medical device used for radiofrequency (RF) lesion creation in nerve tissue for pain relief.
The acceptance criteria for this device are primarily established through substantial equivalence to predicate devices and non-clinical bench testing.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (as per non-clinical testing) |
|---|---|---|
| Substantial Equivalence | Device materials: Same as predicate devices for electrodes (Nitinol) and cannulae (Stainless Steel). | Met: Stryker Venom™ Electrodes and Cannulae are manufactured from the same materials as the predicate devices (Stryker® Monopolar Electrodes and Cannulae, K032406, and Cosman RF Cannula, K060799). The document explicitly states: "There are no changes to the material content." |
| Functional Equivalence | Intended Use: Coagulation of soft tissues in orthopedic, spinal, and neurosurgical applications; selective denervation and tissue destruction for pain relief (lumbar, thoracic, cervical peripheral nerves/nerve roots). | Met: The Intended Use/Indications for use for Stryker® Venom™ Electrodes and Cannulae are identical to the predicate devices. The document states the device "will be used in conjunction with the Stryker RF Generator/MultiGen, cables and electrodes to create radiofrequency lesions in nerve tissue" and for specific pain relief procedures, which aligns with the predicates. |
| Lesion Size: Should not introduce new issues of safety and effectiveness, implying comparable or acceptable lesion characteristics relative to the intended use and predicate devices, despite a different electrode gauge. | Met (with nuance): Bench testing was performed to compare lesion sizes. It was determined that "the lesion sizes created were smallest for the 18 gauge Venom™ cannula standard deployment followed by the Venom™ cannula using the Venom deployment. The largest lesion was created by the 16 gauge Cosman cannula and electrode." The document concludes that the "difference is size does not change the intended use of the device and does not introduce any new issues of safety and effectiveness." (This implies the created lesions are within an acceptable range for the intended clinical effect). | |
| Safety and Effectiveness | Mechanical Durability: Device must withstand simulated use conditions. | Met: "Testing which was conducted included simulated use, mechanical durability and cleaning." No specific performance metrics or thresholds are provided, but the statement indicates testing was performed and the device meets "specification and performance characteristics as identified in Stryker's internal design control procedures." |
| Cleaning: Device must be cleanable. | Met: "Testing which was conducted included simulated use, mechanical durability and cleaning." (Same as above) | |
| Biocompatibility: Device materials must be biocompatible according to FDA guidelines (ISO-10993 Biological Evaluation of Medical Devices Part -1). | Met: "Biocompatibility testing of the Stryker® Venom™ confirmed that the device meets the applicable requirements of the FDA Blue Book Memorandum G95-1 entitled Use of International Standards ISO-10993 Biological Evaluation of Medical Devices Part -1: Evaluation and Testing and are biocompatible." | |
| Design Feature Impact | Side Port Impact: The additional side port on the Venom™ Cannula should not change the intended use or introduce new issues of safety and effectiveness, but aid in diffusion of anesthesia and create comparable lesion size to larger gauge cannulas/electrodes. | Met: The document states the side port "does not change the intended use of the device and does not introduce any new issues of safety and effectiveness. It allows for diffusion of anesthesia closer to the lesion site and, in conjunction with the electrode, helps to create a lesion size comparable to more invasive, larger gauge cannula and electrodes." |
| Overall Conclusion | The device must be substantially equivalent to legally marketed predicate devices and "not raise any new concerns of safety and effectiveness." | Met: "Based on device comparison information and non-clinical bench testing, the Stryker® Venom™ Electrodes and Cannulae are substantially equivalent to legally marketed predicate devices and do not raise any new concerns of safety and effectiveness." |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not explicitly stated as numerical values for the "bench testing" of lesion sizes. The description mentions testing "the 18G Venom™ Cannula using standard electrode deployment and Venom electrode deployment, and the Cosman 16G RF Cannula used with the 27 gauge electrode and Cosman generator." This suggests a comparative test across different configurations, but the number of actual tests or samples per configuration is not provided.
- Data provenance: Prospective, as it was specifically conducted bench testing for this submission. The origin is Stryker Instruments (Kalamazoo, MI, USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Experts: Not applicable. The ground truth for bench testing (e.g., lesion size measurement, mechanical durability, biocompatibility) is typically established through objective measurements and validated laboratory protocols, not expert consensus in the clinical sense.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication method: Not applicable. The "test set" here refers to non-clinical bench testing, which doesn't involve subjective interpretations that would require 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:
- MRMC Study: No. This is a medical device (electrodes and cannulae) for surgical procedures, not an AI-assisted diagnostic or therapeutic system involving human readers interpreting data.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Study: Not applicable. This device is an instrument used during a surgical procedure by a human operator, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth Type: For the non-clinical testing, the "ground truth" was based on objective physical and biological measurements (e.g., lesion dimensions as measured in a bench setting, adherence to material specifications, biological response to materials, mechanical properties).
8. The sample size for the training set:
- Training set sample size: Not applicable. This device does not use machine learning or AI models that require a "training set."
9. How the ground truth for the training set was established:
- Training set ground truth establishment: Not applicable, as there is no training set for this type of device.
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(44 days)
The Stryker® iVAS Inflatable Vertebral Augmentation System (system) is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal Polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.
The Stryker® iVAS balloon catheter is a bone tamp with an inflatable component (balloon) at the distal end. The balloon is inflated to create a void within the vertebral body.
This document, K113477, is a 510(k) summary for the Stryker® iVAS Balloon Catheter, seeking clearance for a modification to a previously cleared device. As such, the study described is primarily focused on demonstrating substantial equivalence to predicate devices through functional and biocompatibility testing, rather than a clinical trial with acceptance criteria for disease detection or diagnostic accuracy.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria for each test or detailed performance metrics in a table format as might be seen for a diagnostic device. Instead, it makes a general statement of compliance and equivalence.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Functional Testing (e.g., Insertion and Retraction Force, Force to Puncture, Burst, Simulated Use) | Meets specified performance characteristics and is substantially equivalent to predicate devices. (Implies meeting established engineering specifications for safety and effectiveness, and performing comparably to the predicate devices). | "The Stryker® iVAS balloon catheter meets the specification and performance characteristics and are substantially equivalent to the predicate devices. The testing which was conducted included functional testing, such as insertion and retraction force, force to puncture, burst and simulated use." |
| Biocompatibility | Meets applicable requirements of FDA Blue Book Memorandum G95-1 and ISO-10993 Part -1. (Implies no unacceptable biological reactions and safe for contact with the body). | "Biocompatibility testing of the Stryker® iVAS balloon catheter confirmed that the device meets the applicable requirements of the FDA Blue Book Memorandum G95-1 entitled Use of International Standards ISO-10993 Biological Evaluation of Medical Devices Part -1: Evaluation and Testing and are biocompatible." |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for any of the tests (functional or biocompatibility). It also does not discuss data provenance in terms of country of origin or whether it was retrospective or prospective, as these are typically not relevant for benchtop and biocompatibility testing for medical device clearance of this nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to the type of testing described. The document pertains to engineering performance and biocompatibility of a medical device, not a diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method for the test set
Not applicable. This is not a study requiring adjudication of expert interpretations.
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 clearance for a physical catheter, not an AI or imaging diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an algorithm or AI device.
7. The type of ground truth used
For functional testing, the "ground truth" would be established engineering specifications, safety standards, and performance benchmarks derived from the predicate devices. For biocompatibility, the ground truth is defined by the requirements of the FDA Blue Book Memorandum G95-1 and ISO-10993.
8. The sample size for the training set
Not applicable, as this is a physical medical device and not an AI/machine learning model that undergoes training.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a physical medical device.
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(136 days)
The Stryker® iVAS Inflatable Vertebral Augmentation System (system) is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used. with cleared spinal Polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation procedures, such as kyphoplasty.
The Stryker® IVAS balloon catheter is a bone tamp with an inflatable component (balloon) at the distal end. The balloon is inflated to create a void within the vertebral body.
This 510(k) summary for the Stryker® IVAS Balloon Catheter (K093419) does not contain information about acceptance criteria or a study proving the device meets those criteria.
The document is a submission for substantial equivalence to a predicate device (Kyphx Xpander Inflatable Bone Tamps, K041454). The core of the argument is that the Stryker® IVAS balloon catheter is "equivalent in intended use, technological characteristics, safety, and effectiveness" to the predicate, and does not "raise any new safety and efficacy concerns."
Therefore, I cannot populate the table or answer the questions based on the provided text. The document focuses on establishing equivalence rather than presenting an independent performance study with defined acceptance criteria.
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(177 days)
The Stryker AntiMic Catheter Kit is intended to provide continuous or intermittent delivery of medication (such as local anesthetics) to or around surgical wound sites for preoperative, perioperative, and postoperative pain management. The Stryker AntiMic Catheter Kit is contraindicated for the epidural space and in neonatal populations.
The Stryker AntiMic Catheter Kit contains an anti-microbial agent which may destroy or inhibit the growth of microorganisms on both the inner and outer surfaces of the catheter. The antimicrobial agent is intended to reduce the possibility that the catheter may become microbially compromised. The antimicrobial agent is not intended to be used as a treatment for existing infections.
The Stryker AntiMic catheter is intended to be used with the Stryker Pain Pump Systems. Catheters are available in the following sizes: Standard; and 2.5", 5.0", and 10" Extended Fenestration. The Standard catheter has a closed tip with three holes arranged radially along the lateral surface at the distal end of the device. The Extended Fenestration catheters have a closed tip with multiple holes arranged radially along the lateral surface at the distal end of the device.
The catheter contains an antimicrobial agent that is intended to inhibit the growth of microorganisms and reduce the possibility of the catheter becoming microbially compromised.
The provided 510(k) summary for the Stryker AntiMic Catheter Kit does not contain the detailed information necessary to complete the requested table and study information.
This document focuses on establishing substantial equivalence to predicate devices rather than presenting performance data from a specific study against predefined acceptance criteria. Clinical trial or performance data, sample sizes, expert qualifications, and ground truth methodologies are typically found in more comprehensive study reports or regulatory submissions, which are not part of this 510(k) summary.
Therefore, I cannot provide the requested information from the given text.
Explanation of limitations based on the provided document:
- No acceptance criteria or reported device performance: The document declares substantial equivalence based on similar intended use and technological characteristics to predicate devices. It does not define specific acceptance criteria (e.g., a certain percentage reduction in infection, a specific tensile strength) or provide numerical performance data for the Stryker AntiMic Catheter.
- No sample sizes, data provenance, expert information, adjudication methods, or MRMC studies: These details are relevant for studies specifically designed to demonstrate safety and effectiveness or to compare performance, which are not presented in this 510(k) summary. The summary simply states that "performance characteristics" are similar to predicate devices, implying that any underlying data would have been part of the predicate device's approvals or internal testing by Stryker, but no such data is included here.
- No standalone algorithm performance or ground truth type: This device is a physical medical catheter, not an AI or algorithmic device. Therefore, the concepts of "standalone algorithm performance," "training set," and "ground truth" (in the context of clinical decision-making or diagnostic AI) do not apply to this submission.
- No training set information: As it's not an AI/algorithm-based device, there is no training set mentioned.
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(36 days)
The Stryker Steri-Shield Flyte Toga, Pullover; Stryker Steri-Shield Flyte Toga, Zippered; Stryker Steri-Shield Flyte Toga with Peel-away Lens, Zippered; and Stryker Steri-Shield Flyte Togas with UV Lens, Zippered are components of a personal protection system and are intended to protect the patient, health care personnel and operating room personnel against contamination, exposure of infectious bodily fluids, the transfer of microorganisms and particulate material.
The scope of this Special 510k material modification is limited to material changes to the gown. The toga has a hood and gown section. The hood covers the user's head. A lens is attached to the front of the hood. The gown of the toga covers the user's front, back and arms. The Stryker Steri-Shield Flyte Togas are tested to meet applicable AAMI PB70:2003 standards. The AAMI standard does not cover apparel for the head, face, and eyes. Therefore, the hoods and lens (components of the togas) are exempt from classification under the AAMI PB70:2003 standard.
Stryker Steri-Shield Flyte Toga, Pullover: The Stryker Steri-Shield Flyte Toga, Pullover is intended to be worn over any Stryker Flyte Helmet. The Stryker Steri-Shield Flyte Pullover togas provide Level 4 and Level 1 barrier protection for the critical zones as set froth in the accompanying drafted IFUs (Attachment 8 and as classified under the AAMI (Association for the Advancement of Medical Instrumentation) guidelines for barrier performance. This garment was tested for resistance to bacteriophage Phi-X174 in accordance with ASTM F1671:2003 per the AAMI Barrier Classification System and demonstrate a passing result with an AQL of 4% under Procedure A. Level 1 zones resist liquid penetration per AATCC (American Association of Textile Chemist and Colorist) 42:2000 with an AQL (acceptable quality level) of 4%. Level 4 critical zones resist liquid and viral penetration. The Stryker Steri-Shield Flyte Toga Zippered garment was tested for resistance to bacteriophage Phi-X174 in accordance with ASTM (American Society for Testing and Materials) F1671:2003 with an AQL of 4% under Procedure A. The barrier material for the Stryker Steri-Shield Flyte Toga Pullover is constructed of layers of polypropylene or polyester non-woven fabric and copolymer polyester film. The Stryker Steri-Shield Flyte Toga, Pullover will be available in a variety of sizes ranging from Small/Medium thru 3X-Large sizes.
Stryker Steri-Shield Flyte Toga, Zippered: Stryker Steri-Shield Flyte Toga with Peel-away Lens, Zippered; Stryker Steri-Shield Flyte Toga with UV Lens, Zippered. The Stryker Steri-Shield Flyte Toga, Zippered; Stryker Steri-Shield Flyte Toga with Peel-away Lens, Zippered; and Stryker Steri-Shield Flyte Togas with UV Lens. Zippered are intended to be worn over any Stryker Flyte Helmet. The Stryker Steri-Shield Flyte Togas provide protection as specified by the AAMI (Association for the Advancement of Medical Instrumentation) Barrier Classification System. Level 1 zones resist liquid penetration per AATCC (American Association of Textile Chemist and Colorist) 42:2000 with an AQL (acceptable quality level) of 4%. Level 4 critical zones resist liquid and viral penetration. The Stryker Steri-Shield Flyte Toga Zippered garment was tested for resistance to bacteriophage Phi-X174 in accordance with ASTM (American Society for Testing and Materials) F1671:2003 with an AQL of 4% under Procedure A. The Level 4 barrier material is constructed of layers of polypropylene or polyester non-woven fabric and copolymer polyester film. The Level 1 material on the back of the zippered togas is constructed of 35 gram SMMS polypropylene. The Stryker Steri-Shield Flyte Toga. Zippered will be available in a variety of sizes ranging from Small/Medium thru 3X-Large sizes.
The provided text describes a 510(k) submission for Stryker Steri-Shield Flyte Togas, which are surgical gowns. The focus of the submission is on material changes to existing products and demonstrating substantial equivalence to predicate devices, rather than a study on a new device's performance against specific acceptance criteria in a clinical setting.
Therefore, many of the requested categories for AI/medical device studies (e.g., sample size for test set, number of experts for ground truth, MRMC study, stand-alone performance) are not applicable to this document as it's not a clinical trial of an AI-powered diagnostic or therapeutic device.
However, I can extract information related to the performance standards and testing mentioned for the Steri-Shield Flyte Togas.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| AAMI PB70:2003 standards (General) | The Stryker Steri-Shield Flyte Togas are tested to meet applicable AAMI PB70:2003 standards. (Note: The AAMI standard does not cover apparel for the head, face, and eyes; therefore, hoods and lenses are exempt). |
| AAMI Barrier Classification System - Level 1 (liquid penetration) | Level 1 zones resist liquid penetration per AATCC 42:2000 with an AQL (acceptable quality level) of 4%. The barrier material for the Pullover and the Level 1 material on the back of the zippered togas are constructed of 35 gram SMMS polypropylene. |
| AAMI Barrier Classification System - Level 4 (liquid and viral penetration) | Level 4 critical zones resist liquid and viral penetration. Tested for resistance to bacteriophage Phi-X174 in accordance with ASTM F1671:2003 with an AQL of 4% under Procedure A. The Level 4 barrier material for both Pullover and Zippered versions is constructed of layers of polypropylene or polyester non-woven fabric and copolymer polyester film. |
2. Sample size used for the test set and the data provenance
Not applicable. This document describes performance testing against material standards, not a clinical study with a "test set" of patient data. The AQL (Acceptable Quality Level) of 4% for certain tests refers to a sampling plan for manufacturing quality control, not a clinical test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for AI/medical device studies (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for these tests are the established and recognized testing methodologies and standards (AAMI, AATCC, ASTM).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a clinical test set is relevant to this 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
Not applicable. This is not an AI-powered device or a cognitive aid for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm. The device's "standalone" performance is its ability to meet the defined material barrier standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" or reference standards used are established industry and regulatory standards for material performance:
- AAMI PB70:2003 (Association for the Advancement of Medical Instrumentation)
- AATCC 42:2000 (American Association of Textile Chemist and Colorist) for liquid penetration
- ASTM F1671:2003 (American Society for Testing and Materials) for resistance to viral penetration (bacteriophage Phi-X174).
8. The sample size for the training set
Not applicable. There is no concept of a "training set" for this type of device and testing.
9. How the ground truth for the training set was established
Not applicable.
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(24 days)
The Stryker T4 Hytrel Toga is a component of a personal protection system that is intended to provide a barrier between the operating environment and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
The Stryker T4 Hytrel Toga is a single use sterile product that covers the user to minimize potentially hazardous contact between the user and patient.
This document is a 510(k) summary for the Stryker T4 Hytrel Toga, a surgical gown. The FDA's letter of substantial equivalence confirms its marketing authorization.
Based on the provided text, a detailed description of acceptance criteria and a study proving the device meets that criteria cannot be fully generated. This document primarily focuses on establishing substantial equivalence to previously marketed devices rather than presenting specific performance study results against defined acceptance criteria.
Here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "The Stryker T4 Hytrel Toga is substantially equivalent to (SE) devices in commercial distribution. The Stryker T4 Hytrel Togas have the same intended use, similar patient contact materials, same operating principles and physical specifications as compared to predicate devices. There are no new safety or efficacy concerns."
This indicates that the "acceptance criteria" appear to be based on equivalence to predicate devices, rather than specific numerical performance metrics for the new device itself. The document does not provide quantitative acceptance criteria or reported device performance data in a table format.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Same intended use as predicate devices | Meets intended use (as deemed substantially equivalent) |
| Similar patient contact materials as predicate devices | Has similar materials (as deemed substantially equivalent) |
| Same operating principles as predicate devices | Has same operating principles (as deemed substantially equivalent) |
| Similar physical specifications as predicate devices | Has similar physical specifications (as deemed substantially equivalent) |
| No new safety concerns compared to predicate devices | No new safety concerns (as deemed substantially equivalent) |
| No new efficacy concerns compared to predicate devices | No new efficacy concerns (as deemed substantially equivalent) |
| Provides a barrier against contamination/exposure to infectious body fluids and harmful microorganisms (Intended Use) | (Implicitly meets this through substantial equivalence) |
Missing Information: Specific quantifiable performance metrics (e.g., barrier effectiveness ratings, material strength, fluid repellency, etc.) that would typically be associated with acceptance criteria for a surgical gown are not provided.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not mentioned.
- Data Provenance: Not mentioned. It's likely that any testing, if conducted beyond comparing specifications to predicate devices, would have been done by or for Stryker Instruments. The document does not specify if data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Number of Experts: Not applicable or not mentioned. This type of submission relies on comparing specifications and intended use to predicate devices, not on expert consensus for "ground truth" in clinical scenarios.
- Qualifications of Experts: Not applicable or not mentioned.
4. Adjudication Method:
- Adjudication Method: Not applicable or not mentioned for a study of the new device's performance. The "adjudication" in this context is the FDA's review and determination of substantial equivalence.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was it done?: No. An MRMC study is not relevant for a surgical gown, which is a physical barrier product, not an imaging or diagnostic device requiring human reader interpretation.
- Effect Size of Human Readers with/without AI: Not applicable.
6. Standalone (Algorithm Only) Performance Study:
- Was it done?: No. This device is not an algorithm or AI-driven system.
7. Type of Ground Truth Used:
- The "ground truth" for this submission is the established performance, safety, and specifications of the predicate devices (K040764, K011755, K944393). The new device is deemed substantially equivalent based on its comparison to these existing devices. There isn't a "ground truth" derived from patient outcomes or pathology for this type of device submission as described.
8. Sample Size for the Training Set:
- Sample Size: Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- How Established: Not applicable. This is not an AI/ML device.
In summary, this 510(k) submission for the Stryker T4 Hytrel Toga focuses on demonstrating substantial equivalence to already legally marketed predicate devices, rather than providing detailed performance study results of the new device against specific, quantifiable acceptance criteria. The FDA's acceptance is based on this finding of substantial equivalence, meaning the new device is considered as safe and effective as the predicates without requiring new clinical trials or extensive performance studies with specific acceptance metrics.
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