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510(k) Data Aggregation
(87 days)
Stryker Consolidated Operating Room Equipment (CORE) 2 Console
The Stryker Consolidated Operating Room Equipment (CORE) 2 Console is intended for use in the cutting, drilling, reaming, decorticating, shaping, and smoothing of bone, bone cement and teeth in a variety of surgical procedures, including but not limited to dental, ENT (Ear, Nose, Throat), neuro, spine, and endoscopic applications. The console is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.
The Stryker CORE 2 Console is a modernization of the currently marketed CORE Console. The CORE 2 Console supplies power to a variety of devices, which include small and large bone handpieces, footswitches, and a bone mill. The CORE 2 Console contains a touch screen graphical user interface (GUI), which allows the user to program a number of customized settings related to the connected devices and irrigation.
This FDA 510(k) summary is for the Stryker Consolidated Operating Room Equipment (CORE) 2 Console. It asserts substantial equivalence to a predicate device (Stryker Consolidated Operating Room Equipment (CORE) System, K112593) rather than defining specific acceptance criteria for a novel device and then proving it meets them. Therefore, many of the requested categories related to algorithmic performance and ground truth establishment are "Not Applicable" or "Not Provided" in this document.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a substantial equivalence submission, explicit quantitative acceptance criteria for novel performance metrics are not specified in the document. Instead, the focus is on demonstrating that the device meets established regulatory standards and performs comparably to its predicate.
| Category | Acceptance Criteria (Implied / Stated) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1 | The device complies with the IEC 60601-1 standard for safety. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 | The device complies with the IEC 60601-1-2 standard for EMC. |
| Software Verification & Validation | Adherence to FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Moderate Level of Concern) | Software verification and validation testing was conducted, and documentation was provided as recommended by FDA guidance. |
| Mechanical Performance | Correct functionality of the console as specified, reliability, use life, compatibility with accessories, torque mapping, capacitive touchscreen. | Design verification activities performed to ensure correct functionality: Reliability and Use Life Testing, Compatibility Testing, Performance testing for torque mapping capability and capacitive touchscreen. Results are not quantified but assumed to be acceptable. |
| Human Factors/Usability | Compliance with FDA's "Applying Human Factors and Usability Engineering to Optimize Medical Device Design" and IEC 62366-1 | Human factors analysis and usability testing was performed in accordance with the specified FDA guidance and IEC standard. |
| Biocompatibility | No direct or indirect patient contact (matching predicate) | Not required as the CORE 2 Console is identical to the predicate device in that there are no components with direct or indirect patient contact. |
| Clinical Performance | Not applicable for this device as per the submission. | Not applicable – data from clinical studies was not provided. Clinical studies are not required to demonstrate safety or feasibility. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for any of the performance tests. The document broadly states "Reliability and Use Life Testing," "Compatibility Testing," and "Performance testing for torque mapping capability and capacitive touchscreen" were conducted but does not provide numbers of units tested or duration of tests.
- Data Provenance: Not explicitly stated, but given it's a device manufacturer submitting to the FDA, it is presumed to be internal testing data from the company's facilities. The document does not indicate country of origin of data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable/Not Provided. For a device of this nature (surgical console), "ground truth" usually refers to the accuracy or correctness of an AI algorithm's output relative to established medical fact. As this is not an AI-driven diagnostic or prescriptive device, and the submission is focused on substantial equivalence of hardware/software functionality, this concept of "ground truth" in the context of expert review does not apply directly. The performance tests would be validated against engineering specifications and industry standards by qualified engineers and testers.
4. Adjudication Method for the Test Set
- Not Applicable/Not Provided. Adjudication methods (like 2+1, 3+1 for consensus) are typically used in clinical studies or for evaluating AI diagnostic performance where human expert discrepancy needs resolution. This submission focuses on engineering and regulatory compliance, not clinical diagnostic accuracy requiring expert consensus 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
- No. An MRMC comparative effectiveness study was not conducted as this is not an AI-assisted diagnostic or interpretation device that would involve human "readers" or image interpretation. The device is a surgical console that powers other instruments.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI-driven algorithm with a "standalone" diagnostic or predictive function. The software mentioned "accommodate internal circuitry redesigns" and manages "illumination rings," "GUI workflow," and "transfer saved use-preference profiles." The "software verification and validation testing" would assess the standalone functionality of the software's control over the console's operations, but not in the sense of an "AI algorithm."
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Engineering Specifications and Regulatory Standards. For this device, the "ground truth" for its performance tests would be adherence to documented engineering specifications and compliance with relevant international standards (e.g., IEC 60601-1, IEC 60601-1-2) and the stated indications for use.
8. The Sample Size for the Training Set
- Not Applicable/Not Provided. This device does not use machine learning or AI that requires a "training set" of data in the conventional sense. The "software was rewritten" and verified/validated, but this refers to traditional software development, not AI model training.
9. How the Ground Truth for the Training Set was Established
- Not Applicable/Not Provided. As there is no "training set" for an AI model, this question is not relevant to this submission.
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(48 days)
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
The Stryker Consolidated Operating Room Equipment (CORE) System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone, bone cement, teeth and other related tissue in a variety of surgical procedures, including but not limited to Dental, ENT, Neuro and Endoscopic. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.
The device description of the Stryker System includes drills, shavers, shields, guards, motors, attachments, saws, wire drivers, collets, console, irrigation pump, cords, footswitch, handswitch, clips, tubing, cutting accessories, and sterilization cases. The scope of this modification is limited to the console of the system.
This document is a 510(k) summary for the Stryker Consolidated Operating Room Equipment (CORE) System. It describes the device, its intended use, and states that it is substantially equivalent to previously cleared devices.
Based on the provided text, there is no information about acceptance criteria or a study proving the device meets acceptance criteria. This type of information is typically found in performance testing sections of a 510(k) submission, which evaluates quantifiable metrics like accuracy, precision, or other performance characteristics of the device.
The provided document is limited to:
- Device identification: Trade Name, Common Name, Classification Names, Equivalent predicate devices, Device Description, Intended Use, Technological Comparison.
- Regulatory correspondence: A letter from the FDA confirming substantial equivalence and outlining general controls.
- Indications for Use Statement: Detailing the surgical procedures and materials the device is intended for.
Therefore, I cannot provide the requested information:
- A table of acceptance criteria and the reported device performance: Not present.
- Sample size used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method for the test set: Not present.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not present.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present.
- The type of ground truth used: Not present.
- The sample size for the training set: Not present.
- How the ground truth for the training set was established: Not present.
The document focuses on demonstrating substantial equivalence to predicate devices, implying that its safety and effectiveness are established by comparison to existing, legally marketed devices with similar technological characteristics and intended uses, rather than through a new, standalone performance study with detailed acceptance criteria as one might see for novel AI/software devices.
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(23 days)
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)
The Stryker Consolidated Operating Room Equipment (CORE) System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone, bone cement and other bone related tissue in a variety of surgical procedures, including but not limited to ENT. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.
The device description of the Stryker System includes drills, shavers, shields, guards, motors, attachments, saws, wire drivers, collets, console, irrigation pump, cords, footswitch, handswitch, clips, tubing, cutting accessories, and sterilization cases. The scope of this modification is limited to the console of the system.
This is a 510(k) premarket notification for the Stryker Consolidated Operating Room Equipment (CORE) System, specifically the console. It doesn't contain information about AI/ML models or clinical studies to establish performance metrics as would typically be found for AI-driven diagnostic devices. This submission is for a traditional medical device (a surgical console) and demonstrates substantial equivalence to previously cleared devices. Therefore, many of the requested categories related to AI/ML performance and studies are not applicable.
Here's an analysis of the provided text based on your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on demonstrating "substantial equivalence" to existing, legally marketed predicate devices. This is achieved by showing that the new device has similar intended use and technological characteristics, and does not raise new questions of safety or effectiveness. The document itself is the comparison table demonstrating this equivalence.
| Acceptance Criteria | Reported Device Performance (as demonstrated by substantial equivalence) |
|---|---|
| Intended Use: Device is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone, bone cement and other bone related tissue in various surgical procedures (including ENT), and placement/cutting of screws, metal, wires, pins, and other fixation devices. | Equivalent: The Stryker CORE ENT System Console's intended use is identical to previously cleared predicate devices (e.g., Stryker CORE Console K032303, Stryker TPS Plus K032117) for cutting, drilling, reaming, decorticating, and smoothing of bone, bone cement, and other bone-related tissue, including placement or cutting of screws, metals, wires, pins, and other fixation devices. |
| Technological Characteristics: Similar outer profile, handpiece connectors, footswitch connectors, adjustable operating parameters, system status display, software (microprocessor), non-volatile memory, power sources, power output, wireless tag technology, window jog capability, enhanced serial interface, and auxiliary control as legally marketed predicate devices. | Equivalent: The "TABLE 1-COMPARISON" explicitly demonstrates that the Stryker CORE ENT System Console has identical or substantially similar technological characteristics across all listed elements (Outer Profile, Handpiece Connector, Footswitch Connector, Adjustable Operating Parameters, System Status Display, Software, Non-volatile Memory, Power Source, Power Output, Wireless Tag Technology, Window Jog Capability, Enhanced Serial Interface, Auxiliary Control) when compared to its predicate devices like the Stryker CORE Console (K032303) and Stryker TPS Plus (K032117). Variations are noted for some predicates (e.g., power output difference with TPS Dental, lack of wireless tag/window jog/serial interface on some TPS systems), but the subject device aligns with at least one or more predicates that possess these features. |
| Safety and Effectiveness: Does not raise new questions of safety or effectiveness. | Implied: The FDA's letter states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices..." This determination implicitly confirms that the FDA found no new questions of safety or effectiveness for the device. |
2. Sample size used for the test set and the data provenance
Not applicable. This is not an AI/ML device that uses a test set of data for performance evaluation. The "test" for this device is demonstrating substantial equivalence through a comparative analysis of its design and technical specifications against predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no "ground truth" establishment from experts for a test set in a 510(k) submission for a non-AI surgical console. The "ground truth" here is the established safety and effectiveness of the predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set or adjudication process for performance evaluation in this 510(k) 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. This is not an AI-assisted device, and no MRMC studies were conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a hardware device (surgical console) and does not deploy an algorithm for standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. As described above, the "ground truth" concept is not directly applicable in the context of this traditional medical device 510(k) submission. The basis for approval is the demonstrated substantial equivalence to established predicate devices whose safety and effectiveness have already been determined.
8. The sample size for the training set
Not applicable. There is no AI/ML model for which a training set would be used.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML model or training set.
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(175 days)
STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM
The Stryker Consolidated Operating Room Equipment (CORE) System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and bone cement in a variety of surgical procedures, including but not limited to Neuro and Endoscopic. It is also usable in the placement or cutting of screws, metal, wires, pins, and other fixation devices.
The endoscopic applications with CORE include use with the SE5 Small Joint Shaver in the wrist for any need for morselization of tissue within the joint. Cutters will be used to debride synovitis, articular cartilage flaps, or torn ligaments when surgeons deem resection appropriate. Burs are indicated for management of osseous lesions such as eburnated articular surfaces or osteophytes.
The device description of the Stryker System includes drills, shavers, shields, guards, motors, attachments, saws, wire drivers, collets, console, irrigation pump, cords, footswitch, handswitch, clips, tubing, cutting accessories, and sterilization cases.
The scope of this modification is limited to the console of the system.
The provided text is a 510(k) summary for the Stryker Consolidated Operating Room Equipment (CORE) System. This document focuses on establishing substantial equivalence to previously cleared predicate devices, rather than an independent study proving the device meets specific acceptance criteria in terms of performance metrics like accuracy, sensitivity, or specificity.
Therefore, many of the requested details about acceptance criteria and study design are not present in this type of regulatory submission. The 510(k) process primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, not necessarily on new clinical performance studies with predefined acceptance criteria.
However, I can extract information related to the device description and the comparison to predicate devices, which implicitly serves as the "study" for a 510(k) application in the sense of demonstrating equivalence.
Here's a breakdown of the information that can be extracted and an explanation of why other requested information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Safety and Effectiveness Equivalence to Predicate Devices | The Stryker Consolidated Operating Room Equipment (CORE) System is deemed substantially equivalent to the following legally marketed predicate devices: |
- Stryker TPS (Dental-K943540, ENT-K943569, Neuro- 943541)
- TPS Hermes (K991696)
- Stryker Navigation System (K012380)
- Dyonics (K771218)
The technological characteristics of the CORE Console are stated to be the same as previously cleared predicate devices. This implies that the performance characteristics (e.g., power output, rotational speed, torque, vibration, material compatibility of cutting accessories, sterilization compatibility) meet or exceed those of the predicate devices. |
Explanation: In a 510(k) submission, the primary "acceptance criterion" is often demonstrating substantial equivalence to a predicate device. This means the new device is as safe and effective as the predicate device(s). The "reported device performance" is essentially that its technological characteristics are the same as or comparable to the cleared predicates for the stated intended uses. Specific quantitative performance metrics (e.g., "95% accuracy in tissue identification") are typically not required or provided unless the device has novel technology or a different intended use compared to its predicates, which would necessitate a more rigorous performance study.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary. A 510(k) for a system like the CORE Console, which is a surgical tool based on established technology, generally relies on engineering testing, performance bench testing, and comparisons to predicate devices rather than a "test set" of patient data as you might see for an AI/diagnostic device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided and is not applicable in the context of this 510(k) submission. The "ground truth" for a mechanical surgical system like this would be established through engineering specifications, material science, and clinical experience with the predicate devices, not typically by expert consensus on a test set of data.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable.
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 provided and is not applicable. The Stryker CORE System is a surgical tool, not an AI-assisted diagnostic or interpretative device that would involve human "readers."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided and is not applicable. The CORE System is a human-operated surgical console, not an "algorithm only" device.
7. The Type of Ground Truth Used
The "ground truth" for a device of this nature is implicitly established through:
- Engineering specifications and standards: The console and its accessories are designed to meet certain power outputs, safety features, ergonomic requirements, and material compatibility.
- Performance of predicate devices: The functionality and safety profile of the predicate devices (Stryker TPS, TPS Hermes, Stryker Navigation System, Dyonics) serve as the benchmark or "ground truth" for what is considered safe and effective for the stated intended uses.
- Clinical experience and literature: The acceptance of the intended uses (cutting, drilling, reaming, etc., in neuro and endoscopic procedures) is based on established surgical practices and the proven utility of similar devices.
8. The Sample Size for the Training Set
This information is not provided and is not applicable. This device is not an AI/machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not provided and is not applicable. This device is not an AI/machine learning model.
In summary:
The provided document is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to previously cleared devices. It does not present a clinical performance study with specific acceptance criteria, sample sizes, expert ground truth establishment, or AI-related metrics (like MRMC or standalone algorithm performance). The "study" in this context is the comparison of technical characteristics and intended use to the predicate devices to argue for substantial equivalence.
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