Search Results

Ask a specific question about this device

The Stryker OptaBlate BVN Intraosseous Nerve Ablation System is intended for the ablation of basivertebral nerves of the L3 through S1 vertebrae for the relief of chronic low back pain of at least six months duration that has not responded to at least six months of conservative care, and is also accompanied by features consistent with Type 1 or Type 2 Modic changes on an MRI such as inflammation, edema, vertebral endplate changes, disruption and fissuring of the endplate, vascularized fibrous tissues within the adjacent marrow, hypointensive signals (Type 1 Modic change), and changes to the vertebral body marrow including replacement of normal bone marrow by fat, and hyperintensive signals (Type 2 Modic change).

The subject device Stryker Optablate® BVN Intraosseous Nerve Ablation System is a bipolar, high frequency electrosurgical system comprising the BVN probe, Microinfuser, syringe, introducer handpiece, introducer conduit, 10 G access cannula with diamond tip stylet, and 10 G bevel tip stylet. The subject device is intended to be used in conjunction with the existing Optablate radiofrequency (RF) generator (K221074), MultiGen2 Splitter Cable (K170242), and Optablate Microinfuser (K221074) to produce lesions by the direct application of radiofrequency currents for the relief of chronic low back pain. The subject generator applies temperature-controlled, radiofrequency (RF) energy into the probe. During lesion creation, targeted tissue is exposed to RF energy using an active probe inserted into a conduit that is within an access cannula. The application of RF energy causes a thermal reaction at the targeted tissue site to ablate the basivertebral nerve. It is indicated for the L3 through S1 vertebrae. When used, the subject OptaBlate BVN probes are connected to the splitter cable, which is connected to the generator, to deliver RF energy to the target tissue. The Optablate Microinfuser is connected to the probe to deliver a small amount of saline to the ablation site. The saline exits the probe between the emitters and helps ensure there is good electrical connection between the emitters and the tissue. The quality of the connection is measured in units called impedance. Impedance goes up if the connection is poor. If the impedance goes to high, the generator will trigger an error and stop the ablation. The Microinfuser slowly introduces saline to prevent impedance rises.

The provided FDA 510(k) clearance letter and summary for the OptaBlate BVN Intraosseous Nerve Ablation System focuses on the **device's safety and effectiveness **through comparison with a predicate device and non-clinical performance testing. It explicitly states "No clinical testing was required to support this submission." This means there was no study proving the device's performance in a clinical setting against acceptance criteria that would typically involve human or AI reader performance metrics, effect sizes, or ground truth established by experts.

Therefore, I cannot fulfill the request for information related to:

• Table of acceptance criteria and reported device performance based on clinical outcomes.
• Sample size for a test set (as no clinical test set was used for effectiveness).
• Number of experts and their qualifications used to establish ground truth.
• Adjudication method for a test set.
• MRMC comparative effectiveness study, effect size of human reader improvement.
• Standalone (algorithm only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for training set (as no AI/machine learning component is described).
• How ground truth for training set was established.

However, I can extract information related to the non-clinical acceptance criteria and proof of mechanism/performance.

Non-Clinical Acceptance Criteria and Device Performance (Summary):

The device's acceptance criteria primarily revolve around its ability to perform its intended function safely and effectively in a technical/mechanical/biological sense, rather than a diagnostic or AI-assisted clinical performance sense.

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: Not applicable in the context of clinical performance; the testing described is non-clinical (e.g., in-vitro biocompatibility tests, mechanical tests of device components, ex vivo tissue models for lesion formation).
• Data Provenance: The data comes from the manufacturer's internal testing (Stryker Instruments) as part of their 510(k) submission. No specific country of origin for test data is mentioned beyond "Stryker Instruments" (headquartered in Portage, MI, USA). The studies are "non-clinical" performance evaluations rather than retrospective or prospective human subject studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not applicable. The ground truth for this device's non-clinical performance is established by engineering specifications, international and national standards (e.g., ISO, IEC, ASTM), and the physical/chemical properties measured via established test methods. No human experts were used to establish "ground truth" in the diagnostic sense for this submission.

4. Adjudication Method for the Test Set:

• Not applicable. This concept applies primarily to clinical studies where human or AI interpretations are adjudicated. For non-clinical testing, results are typically binary (pass/fail) based on pre-defined quantitative or qualitative acceptance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No. The submission explicitly states, "No clinical testing was required to support this submission." Therefore, no MRMC study to compare human reader performance with or without AI assistance was conducted or reported.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not applicable. This device is an ablation system, not a diagnostic algorithm. Its performance is related to its mechanical, electrical, and biological safety and its ability to create a lesion, not to interpret medical images or data.

7. The Type of Ground Truth Used:

• For Biocompatibility: Established by standardized biological response measurements against control samples, as per ISO 10993 series.
• For Electrical Safety/EMC: Established by conformance to specified IEC standards for medical electrical equipment.
• For Mechanical and Functional Testing: Established by engineering specifications and measurements in controlled laboratory settings (e.g., ex vivo tissue models for lesion size) and validated against ASTM standards where applicable. This is not "expert consensus, pathology, or outcomes data" in the clinical sense.

8. The Sample Size for the Training Set:

• Not applicable. This device does not involve an AI/machine learning component that would require a "training set."

9. How the Ground Truth for the Training Set Was Established:

• Not applicable, as no training set was relevant for this device submission.

Ask a specific question about this device

The intended use of the OptaBlate Radiofrequency (RF) Generator System is as follows:

• Palliative treatment in spinal procedures by ablation of metastatic malignant lesions in a vertebral body.
• Coagulation and ablation of tissue in bone during surgical procedures including palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standards therapy.
• Ablation of benign bone tumors such as osteoid osteoma.

The device description of the OptaBlate Radiofrequency (RF) Generator System remains consistent with that of the previously cleared K221074, with no modifications other than the incorporation of the OptaBlate Curve 10mm, 15mm, and 20mm Probe Single Kits.

The OptaBlate Curve Probe Kits provide flexible probes with microinfusers that are used with OmniCurve 10G Fracture Kits, the OptaBlate RF Generator and the Splitter Cable. Together they enable a unipedicular approach for bone tumor ablation. The access tools from the OmniCurve Kits create a curved, unipedicular pathway to the bone tumor. Based on tumor size, a flexible probe size is selected and inserted into the curved pathway. Then with the microinfuser (which reduces impedance events), the OptaBlate RF Generator and the Splitter Cable, the bone tumor is ablated.

This document is a 510(k) clearance letter for the OptaBlate Radiofrequency (RF) Generator System. It's a medical device, not an AI/ML product. Therefore, the information requested to describe the acceptance criteria and study proving the device meets them, particularly regarding AI-specific criteria, is not present in this document.

The document discusses the substantial equivalence of the new device (including OptaBlate Curve 10mm, 15mm, and 20mm Probe Single Kits) to a previously cleared predicate device. The testing described focuses on non-clinical aspects typical for electrosurgical devices, rather than AI/ML performance.

Here's how the provided information relates to your request:

• No AI-specific acceptance criteria or performance study is described. This is a clearance for an RF generator and associated probes, not an AI/ML-driven diagnostic or treatment planning system.
• The "Performance Testing" section refers to design verification testing to confirm performance as intended and safety/effectiveness in accordance with FDA Guidance for Electrosurgical Devices, not a clinical study to demonstrate performance against a specific clinical endpoint using AI.
• "Summary of Clinical Testing: Clinical testing was not required for this Special 510(k)." This explicitly states that no clinical trial data was submitted to support this particular 510(k) given its "Special 510(k)" nature, indicating minor modifications to an already cleared device.

Therefore, I cannot populate the table or answer the specific questions related to AI/ML device performance validation based on the provided text. The document focuses on regulatory compliance through substantial equivalence to a predicate device for an electrosurgical system, not on proving AI efficacy.

Ask a specific question about this device

The Sonopet iQ Ultrasonic Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated Organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery, and Thoracoscopic surgery.

CONTRAINDICATION: This ultrasonic surgical aspirator device is not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids.

The Sonopet iQ Ultrasonic Aspirator System is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. It allows the selective resection of target tissue while preserving vessels, ducts, and other delicate structures. The system consists of a console which provides control and power functions, a surgical handpiece to provide ultrasonic energy (25kHz), sixteen (16) titanium tips with irrigation sleeves, and an Irrigation Suction Cassette.

Modifications to the device console software allow for inter-device communications with compatible Stryker devices, and the implementation of Stryker's proprietary communications protocol 'DCM' (Device Communication Module) to support these communications.

RISE (Reimagining Integrated Surgical Experience) is an optional software functionality that allows for ethernet-based communication between compatible Stryker devices (i.e., Connected OR Hub, SDC4K Information Management System (SDC4K), and CORE 2 consoles) and utilizes the DCM communications protocol.

The RISE functionality is built into the Sonopet iQ console software but can only be accessed via a Stryker-provided activation license.

RISE provides for an integrated OR (Operating Room) solution to healthcare facilities that simplifies workflows and reduces OR clutter. In a RISE configuration, adjustment of the Sonopet iQ power, suction, irrigation, and pulse control settings can now be made directly on the Connected OR Hub / SDC4K GUI, thereby allowing the user to input commands via a single console.

RISE functionality also features optional foot pedal assignment, which provides users the opportunity to use a single foot pedal to control multiple handpieces.

The Sonopet iQ Ultrasonic Aspirator System (K243930) is substantially equivalent to its predicate device (K213824). The key difference between the two devices is the addition of an optional 'RISE' software functionality in the subject device, which enables inter-device communication and allows for adjustment of Sonopet iQ settings via compatible Stryker devices like the Connected OR Hub and SDC4K.

Here is a summary of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in terms of patient data. The non-clinical testing conducted involved:

• Software and wireless technology testing
• EMC and Electrical Safety testing
• Bench testing
• Simulated use testing
• Human factors testing

These tests are performed on the device itself and its software, not on patient data. Therefore, there is no mention of country of origin or retrospective/prospective nature of data for a "test set" in the context of this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. As described above, the testing involved engineering and system performance evaluations, not diagnostic interpretation or clinical outcomes requiring expert ground truth establishment for a test set.

4. Adjudication Method for the Test Set

Not applicable. The testing did not involve adjudication of clinical cases or data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. The device is an ultrasonic aspirator system, and the changes involve software for control and communication, not an AI-driven image analysis or diagnostic aid that would typically warrant such a study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The regulatory filing focuses on the safety and effectiveness of the device as a whole, including the software's functionality. While the software components were tested, the concept of "standalone" performance typically applies to diagnostic algorithms. For a surgical device with control software, the software's functionality is inherently part of the "human-in-the-loop" (surgeon operating the device) performance, as it controls the device's actions based on user input.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing was established by:

• Compliance with recognized standards (e.g., for EMC, electrical safety, software, human factors).
• Adherence to internal protocols for bench and simulated use testing, which would define acceptable functional performance parameters.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML model in the typical sense that requires a "training set" of data for learning. The software modifications are functional enhancements (inter-device communication) rather than algorithms that learn from data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set was used.

Ask a specific question about this device

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 orthopedic, 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 CORE 2 Console is also indicated as an accessory to the Stryker Spine Guidance Software for stereotactic surgical procedures on the spine in adult and pediatric (adolescent) patients.

The CORE 2 Console is a non-sterile, 120V AC-powered, reusable device that is intended for use outside of the sterile environment during surgery. The console supplies 40V DC power to a range of motors for use in a variety of surgical procedures as described in its labeling. It also provides a means for irrigation through an integrated irrigation pump. The console has three motor ports, two footswitch ports, and one irrigation cassette port. CORE 2 receives identification and configuration information from connected devices including Stryker handpieces, footswitches, cutting attachments with RFID, and irrigation cassettes. The console allows further device configuration through its graphical user interface (GUI).

The primary modules that comprise CORE 2 are its power supply, central processing unit, motor controller, irrigation pump controller, RFID module, liquid crystal display (LCD) screen and speaker, touchscreen, USB interface, and an Ethernet interface. The CORE 2 is responsible for the integration of these modules and control of the console's software receives identification and configuration from connected devices. This information is monitored and processed based on current system configurations, and can be used to activate handpiece motors, change motor speed, and activate or deactivate irrigation, among other functions.

The device modifications in scope of this premarket notification consist of updates to the CORE 2 software to allow for its use within a RISE (Reimagining Integrated Surgical Experience) ecosystem. RISE is an optional software functionality that allows for Ethernet-based communication between compatible Stryker devices (i.e., Connected OR Hub, SDC4K Information Management System, and Sonopet iQ consoles) and utilizes the DCM (Device Communication Module) protocol.

RISE provides for an integrated OR (Operating Room) solution to healthcare facilities to simplify workflows and reduce OR clutter. In a RISE configuration, adjustment of CORE 2 power, irrigation, and handpiece settings can be made directly on a Connected OR Hub / SDC4K GUI, thereby allowing the user to input commands via a single console. RISE functionality also allows for the activation of the subject device output via a remotely connected foot pedal. The functional output tasks that the software performs are the same as that of the predicate device.

The provided text describes a 510(k) premarket notification for a medical device called the Consolidated Operating Room Equipment (CORE) 2 Console. However, the document does not contain specific acceptance criteria, reported device performance data, or details about a study that proves the device meets specific performance criteria in the way that would typically be presented with quantitative metrics (e.g., sensitivity, specificity, accuracy, precision).

The submission focuses on demonstrating substantial equivalence to a predicate device (CORE 2 Console, K241171) following a software modification. The core argument for safety and effectiveness relies on the fact that the "functional output tasks that the software performs are the same as that of the predicate device" and that "no changes made to the intended use, indications for use, design, materials, or fundamental scientific technology."

Instead of explicit acceptance criteria and corresponding performance metrics, the document outlines the types of testing performed to support the substantial equivalence claim:

• Software and wireless technology testing per FDA guidance documents and recognized standards
• EMC and Electrical Safety testing per FDA recognized standards
• Bench testing per various internal protocols
• Simulated use testing per various internal protocols
• Human factors testing per FDA guidance documents and recognized standards

The "Conclusions Drawn from Testing Performed" states: "Results of performance testing demonstrate that the functionality, integrity, and safety and effectiveness of the subject device is sufficient for its intended use. Verification test results for the CORE 2 Console confirm that the differences in technology raise no new issues of safety or effectiveness when compared to the predicate device."

Therefore, based on the provided text, it is not possible to fill out the requested table or answer most of the detailed questions about acceptance criteria and quantitative study results. The submission is a regulatory document asserting substantial equivalence through comparison to a predicate, rather than a detailed report of a performance study against specific acceptance metrics.

Here's what can be extracted/inferred from the document given the constraints:

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

   • Cannot be provided as specific quantitative acceptance criteria and reported performance metrics are not detailed in the document. The general acceptance criterion is that the device "demonstrate that the modifications to the subject device are as safe and effective as the predicate" and "raise no new issues of safety or effectiveness."

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

   • Not specified. The document mentions "bench testing," "simulated use testing," and "human factors testing," but does not provide details on the number of samples, test cases, or data provenance (e.g., country of origin, retrospective/prospective).
   • The testing described (Software and wireless technology testing, EMC and Electrical Safety testing, Bench testing, Simulated use testing, Human factors testing) are typically conducted in a controlled lab or simulated environment rather than with patient data.

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

   • Not specified. Given the nature of the device (surgical console, not a diagnostic AI system), "ground truth" in the clinical sense established by experts is not described as part of the testing. The ground truth for engineering and performance testing would typically be engineering specifications and functional requirements.

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

   • Not applicable/Not specified. This pertains to clinical studies often involving human interpretation and consensus, which is not described 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:

   • No, an MRMC study was not done. This type of study is relevant for diagnostic AI systems with human-in-the-loop components. The CORE 2 Console is a surgical instrument console with software modifications for integration into an operating room ecosystem, not a diagnostic imaging AI.

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

   • Not applicable/Not explicitly detailed as such. While the software itself was tested, it's not a standalone diagnostic algorithm that would typically be evaluated without human interaction. Its performance is tied to its function as a controller for surgical tools. The testing described (software, EMC, bench, simulated use, human factors) would cover the "standalone" functional behavior of the software and hardware components.

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

   • Inferred: The ground truth for the various engineering and performance tests (software, EMC, bench, simulated use) would likely be engineering specifications, functional requirements, and recognized industry standards. For "human factors testing," the ground truth relates to usability and safety heuristics / guidelines. Clinical ground truth like pathology or outcomes data is not mentioned as being used for this specific submission's testing.

8. The sample size for the training set:

   • Not applicable/Not specified. This device is not described as an AI/ML device that requires a "training set" in the context of machine learning model development. This is a traditional software and hardware update submission.

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

   • Not applicable. See point 8.

Ask a specific question about this device

The iBur™ Hubs and Cutting Accessories are intended to be used with the Stryker Consolidated Operating Room Equipment (CORE®) Console and electric and pneumatic motors. When used with these motors, the iBur™ Hubs and Cutting Accessories are intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/Otorhinolaryngology; and Endoscopic applications.

Specific applications include Craniectomy, Laminotomy/Laminectomy, Minimally Invasive Surgery (MIS) Spine, Expanded Endonasal Approach (EEA)/ Anterior Skull Base/ Endoscopic/ Transnasal/ Transphenoidal, and Orthopedic Spine.

These devices are also usable in the preparation for the placement of screws, metal, wires, pins, and other fixation devices.

iBur™ Cutting Accessories are prescription medical devices that are designed to provide an interface between a cutting accessory and a high speed motor. When used with a motor and a cutting accessory, the iBur™ Hubs are intended to cut, drill, ream, decorticate, shape, dissect, shave and smooth bone in a variety of surgical procedures including the following specialty areas: Neuro, Spine, ENT, Endoscopic. Cutting accessories are single use, sterile devices which have a mount or notch machined at their proximal end and a head with a sharp cutting edge at their distal end. The iBur™ Cutting Accessories are designed to fit the corresponding iBur™ Hubs. The cutting accessories when used with a high speed drill and iBur™ Hubs are intended to cut, drill, ream, decorticate, shape, dissect, shave and smooth bone in a variety of surgical procedures.

This document is a 510(k) premarket notification for a medical device, the Stryker iBur™ Hubs and Cutting Accessories. It outlines the modifications to an existing device, compares it to a legally marketed predicate device (K210377), and provides performance data to demonstrate substantial equivalence.

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 provide a specific table of acceptance criteria with corresponding numerical performance metrics for the iBur™ device. Instead, it makes a general statement about meeting acceptance criteria and demonstrating sufficiency for intended use.

However, it does indicate the types of performance tests conducted and their qualitative outcomes:

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

The document does not explicitly state the sample size used for the test set or the data provenance. It mentions "performance testing was conducted on the proposed devices" but does not specify the number of devices or units tested.

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 to this document. The device is a surgical cutting accessory, not an AI/diagnostic device that requires expert-established ground truth from a test set. The validation focuses on the device's physical performance characteristics.

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

This information is not applicable. Adjudication methods are typically used for establishing ground truth in diagnostic studies, which is not the nature of this 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

This information is not applicable. The device is a surgical tool, not an AI system.

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

This information is not applicable. The device is a surgical cutting accessory, not an AI algorithm.

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

This information is not explicitly stated in terms of "ground truth" as it would be for an AI or diagnostic device. For this type of device (surgical cutting accessory), the "ground truth" for performance is established through engineering and material science testing, ensuring the device meets predefined technical specifications for cutting efficacy, safety (e.g., temperature), and structural integrity. This is indicated by the mention of "all acceptance criteria were met for the performance testing."

8. The sample size for the training set

This information is not applicable. The device is a physical product, not an AI model that requires a training set.

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

This information is not applicable. The device is a physical product, not an AI model.

In summary, the provided document is a 510(k) premarket notification for a modified medical device. It focuses on demonstrating that the device's modifications do not alter its fundamental scientific technology or intended use and that its performance remains substantially equivalent to a predicate device through non-clinical performance testing. The questions regarding AI, expert ground truth, and training data are not relevant to this type of device submission.

Ask a specific question about this device

The Stryker System 9 Sterile Battery Container is a reusable rigid sterilization container intended to allow for sterilization, by hospitals, surgery centers, and healthcare facilities, of the enclosed, compatible Stryker Sterile Battery Packs and maintain sterility of the enclosed device until used. The container is validated for use with compatible battery packs in low temperature hydrogen peroxide sterilization cycles.

The Stryker System 9 Sterile Battery Container is a rigid, reusable device intended to enclose compatible Stryker sterile battery packs for hydrogen peroxide sterilization. The container consists of a stainless-steel perforated lid with a stainless-steel filter retention plate and a plastic (Radel®) base. The Sterile Battery container utilizes single use polypropylene filters and indicator cards. The container base is designed to exclusively fit onto the Stryker sterile battery charger to allow the sterile battery pack to charge while maintaining a sterile barrier. The Stryker System 9 Sterile Battery Container encompasses one distinct configuration in two sizes, small and large.

The provided text describes a 510(k) premarket notification for a medical device (Stryker System 9 Sterile Battery Container). This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving absolute safety and effectiveness through extensive clinical trials for novel devices.

Therefore, the study described is a non-clinical performance testing suite designed to show that the device performs as intended and is as safe and effective as its predicate, particularly in the context of sterilization efficacy and maintenance of sterility. It is not a clinical study involving human patients or complex AI algorithms requiring MRMC studies, expert consensus on images, or detailed ground truth establishment in a diagnostic context.

Here's an analysis based on the provided document, fulfilling the requested information where applicable. Many questions regarding AI/diagnostic device studies (like sample size for test sets, number of experts, adjudication methods, MRMC studies, training set details) are not applicable to this type of device and submission, as it's a physical sterilization container, not a diagnostic imaging AI.

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

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

The document does not specify the exact sample sizes (e.g., number of containers tested, number of sterilization cycles performed) for each non-clinical test. It generally states that "A suite of non-clinical testing was performed."

• Data Provenance: The data comes from the manufacturer's (Stryker Instruments) internal testing as part of their premarket notification. The country of origin of the data is implied to be the USA, given the manufacturer's address in Michigan. These were prospective tests specifically conducted for this submission.

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

This question is not applicable to the non-clinical performance testing of a sterilization container. "Ground truth" in the context of diagnostic devices (e.g., AI for medical imaging) involves expert interpretation or pathological confirmation. For this device, the "truth" is established by adherence to validated sterilization standards and measurable outcomes (e.g., sterility, absence of toxic residuals, successful cleaning). The expertise would lie with the engineers and microbiologists performing and validating these standard-driven tests, not a panel of clinical experts interpreting data for diagnostic purposes.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for establishing ground truth from multiple human readers for diagnostic AI, to resolve disagreements. Here, validation is against objective, measurable criteria defined by established standards.

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. MRMC studies are specific to evaluating diagnostic AI systems, comparing human performance with and without AI assistance. This device is a physical sterile battery container, not an AI or diagnostic tool.

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

Not applicable. This concept applies to AI algorithms. The "performance" of this device is its physical and chemical properties and its ability to maintain sterility, which are evaluated through direct testing, not an algorithm.

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

The "ground truth" for this device's performance is adherence to established international and national standards for sterilization, cleaning, biocompatibility, and human factors. This includes:

• Microbiological testing for sterility (e.g., confirming no microbial growth after sterilization cycles).
• Chemical analysis for residuals.
• Physical measurements and observations for cleaning effectiveness and structural integrity after simulated use.
• Usability testing according to human factors standards.

This is not a diagnostic device where pathology or expert consensus on images would define the ground truth.

8. The sample size for the training set

Not applicable. This device is a physical product, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

The PhotonBlade 3 is a monopolar radiofrequency (RF) device coupled with illumination that is indicated for cutting and coagulation of soft tissue during general, plastic and reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, gynecologic, orthopaedic, arthroscopic, spinal, neurological, and breast procedures (including mastectomy and lumpectomy).

The PhotonBlade 3 Smoke Evacuation device is a monopolar RF device coupled with illumination that is indicated for cutting and coagulation of soft tissue during general, plastic and reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, gynecologic, orthopaedic, arthroscopic, spinal, neurological, and breast procedures (including mastectomy and lumpectomy), and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

The PhotonBlade 3 (Model No: 0730-101-000) and PhotonBlade 3 Smoke Evacuation (Model No: 0730-102-000) devices are sterile, single use, electrosurgical devices have a monopolar electrode at the distal end, which delivers radiofrequency (RF) energy for cutting and coagulation of tissue. The electrode is located at the distal end of a rotatable and extendable shaft. The devices have integrated LED-based illumination. In addition, the PhotonBlade 3 Smoke Evacuation features integrated smoke evacuation tubing for removal of smoke generated by electrosurgery when connected to a smoke evacuation universal connector attaches the device to an IEC 60601 compliant electrosurgical generator.

The provided text is a 510(k) Summary for the Stryker Instruments PhotonBlade 3 and PhotonBlade 3 Smoke Evacuation devices. It discusses the regulatory clearance process and comparison to predicate devices, but does not contain the detailed information required to answer your specific questions regarding acceptance criteria and a study proving the device meets those criteria.

While it mentions "pre-defined acceptance criteria for the above tests were met" in the "Performance Testing" section, it does not explicitly state what those acceptance criteria were for each test, nor does it provide a detailed study design or results from such a study.

Therefore, I cannot extract the information requested. The document primarily focuses on establishing "substantial equivalence" to a predicate device based on similar indications for use and technological characteristics, and by referencing compliance with various standards and general performance testing without providing the specific details of a study that directly proves the device meets predefined acceptance criteria for its performance metrics.

To specifically address your questions, the following would need to be present in the document:

1. A table of acceptance criteria and reported device performance: This would require a table explicitly listing criteria (e.g., "minimum lumen output 50 lumens") and the actual measured performance (e.g., "Device A measured 65 lumens").
2. Sample size and data provenance for the test set: The document vaguely mentions "simulated use life testing," "coag verification test," etc., but no sample sizes or origin of data (e.g., animal, human, in vitro, country).
3. Number and qualifications of experts for ground truth: This type of information is usually relevant for studies involving subjective assessment (e.g., image interpretation). For a device like an electrosurgical unit, ground truth often comes from objective measurements or established physical/biological parameters. The document does not provide this.
4. Adjudication method for the test set: Not applicable based on the type of device and testing described.
5. MRMC comparative effectiveness study: Not conducted or mentioned. This type of study is typically for diagnostic aids involving human interpretation.
6. Standalone performance: The described "performance testing" implies standalone testing of the device's physical and electrical characteristics, but the specific metrics and study details are missing.
7. Type of ground truth used: Ground truth would be based on objective measurements against established engineering, physical, and biological standards (e.g., thermal spread in porcine tissue). The document describes what was tested but not the specific "ground truth" values used for comparison or how they were established.
8. Sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
9. How ground truth for the training set was established: Not applicable.

The closest the document comes to providing performance data related to "acceptance criteria" is under "Performance Testing," which states: "All pre-defined acceptance criteria for the above tests were met. Results from the the subject devices perform as intended and support a determination of substantial equivalence to the predicate." However, it fails to specify what those acceptance criteria were or the actual results that met them.

Ask a specific question about this device

The Stryker Steri-Shield 8 disposables, including all hood and toga models, are components of the Stryker Steri-Shield 8 Personal Protection System and are intended to protect the patient, healthcare personnel, and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganism and particulate material. The Stryker Steri-Shield 8 disposables are sterile, disposable, single-use only devices.

The Stryker Steri-Shield 8 Surgical Protective Equipment consist of Stryker Steri-Shield 8 Surgical Hoods and Steri-Shield 8 Surgical Togas.

The Stryker Steri-Shield 8 Surgical Hood is a single piece device that covers the user's head, neck, and shoulder region and is intended to be worn with commercially available sterile surgical gowns. The Steri-Shield 8 Hoods are available with Standard (NPA), Peel Away (PA) and Anti-Reflective (AR) face shield options.

The Stryker Steri-Shield 8 Surgical Togas are a single piece device that covers the user's head, neck, arms, torso, and upper legs region. The Stryker Steri-Shield 8 Surgical Togas is offered in three configurations: Steri-Shield 8 Pullover Togas, Steri-Shield 8 Zippered Togas, and Steri-Shield 8 Tie Back Togas.

The Stryker Steri-Shield 8 Surgical Hoods and Togas is a medical device intended to protect the patient, healthcare personnel, and operating room personnel against contamination, exposure to infectious bodily fluids, and the transfer of microorganisms and particulate material. The device is sterile, disposable, and for single-use only.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

Ask a specific question about this device

The intended use is to facilitate the placement of the pedicle screws using the power technique (cordless). When the attachment is attached, the Stryker Power Tools provide power to rotate the screwdrivers for the insertion of pedicle screws.

Pedicle screws from select Stryker Spine implant systems may be implemented in the non-cervical spine using powered instrumentation.

The Stryker POWEReam Xia/Serrato is an attachment used with a Stryker battery powered handpiece that drives accessories to achieve their intended function. The design reduces the speed and increases the torque output from the handpiece by a ratio of 5:1.

This document describes a 510(k) premarket notification for a medical device called POWEReam Xia/Serrato, which is an attachment used with a Stryker battery-powered handpiece to facilitate the placement of pedicle screws. The submission seeks to demonstrate substantial equivalence to a predicate device, the Stryker POWEReam ¼” Drive (K233300).

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document states that "All pre-defined acceptance criteria for the above tests have been met." However, it does not explicitly list the specific acceptance criteria or provide detailed performance data in a table format. It only broadly states that the device performs as intended.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the test set for any of the non-clinical tests (Performance Design Verification, Human Factors, Simulated Use Design Validation). It also does not provide information about the data provenance (e.g., country of origin of the data, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since this is a non-clinical submission for a mechanical instrument, the concept of "experts" establishing ground truth in the same way it would be for diagnostic AI is not directly applicable. The "ground truth" for the non-clinical tests would have been established by engineering specifications, validated test methods, and potentially a team of engineers or quality assurance personnel. The document does not specify the number of individuals involved in establishing these engineering "truths" or their specific qualifications (e.g., "mechanical engineer with 15 years of experience in medical device design").

4. Adjudication Method for the Test Set

As this is a non-clinical device focused on mechanical performance and usability, traditional adjudication methods like 2+1 or 3+1 (common in AI diagnostic studies) are not mentioned or typically used. The "adjudication" of test results would likely involve review and approval by qualified engineers and quality personnel based on established test protocols and acceptance criteria. No specific adjudication method is detailed in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. The document explicitly states: "Clinical testing was not required for this Traditional 510(k)." MRMC studies are typically clinical studies designed to compare diagnostic performance, especially with AI assistance. This device is a surgical instrument attachment, not a diagnostic tool.

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

This question is not applicable to the device described. The POWEReam Xia/Serrato is a mechanical attachment for a surgical power tool, not an algorithm, and it inherently requires human-in-the-loop operation. "Standalone performance" in the context of an algorithm does not apply here. The non-clinical tests (Performance Design Verification, Human Factors, Simulated Use Design Validation) assessed the device's functional performance and usability.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" would be established by:

• Engineering Specifications: The design parameters, torque outputs, speed reductions, and material properties defined during the device's development.
• Validated Test Methods: Standardized procedures and instruments used to measure the device's performance against its specifications.
• Regulatory Standards: Adherence to relevant industry and regulatory standards for medical devices.

It does not involve expert consensus, pathology, or outcomes data in the manner of diagnostic devices.

8. The Sample Size for the Training Set

This question is not applicable. The POWEReam Xia/Serrato is a mechanical medical device, not an AI/ML algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set was Established

This question is not applicable as there is no training set for a mechanical device.

Ask a specific question about this device