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510(k) Data Aggregation
(70 days)
Drill Guide; Drill Bit; Spine & Trauma Navigation
Spine & Trauma Navigation is intended as an intraoperative image-guided localization system to enable open and minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on a patient's preoperative or intraoperative 2D or 3D image data.
Spine & Trauma Navigation enables computer-assisted navigation of medical image data, which can either be acquired preoperatively or intraoperatively by an appropriate image acquisition system. The software offers screw and interbody device planning and navigation with surgical instruments.
The system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, the pelvis, a long bone or vertebra can be identified relative to the acquired image (CT, MR, 3D fluoroscopic image reconstruction or 2D fluoroscopic image) and/or an image databased model of the anatomy.
The Spine & Trauma Navigation is an image quided surgery system for navigated treatments in the fields of spine and trauma surgery, whereas the user may use image data based on CT, MR, 3D fluoroscopic image reconstruction (cone beam CT) or 2D fluoroscopic images. It offers different patient image registration methods and instrument calibrations to allow surgical navigation by using optical tracking technology. To fulfil this purpose, it consists of software, Image Guided Surgery platforms and surgical instruments.
Modified Drill Guides and Drill Bits have been introduced as part of the Subject Device. The Drill Guide instruments are navigated instruments which support the surgeon in guiding drill bits and K-wires during spinal procedures. They consist of a guide tube, a trocar insert (both available in five different diameters), a body with two available handles, an array and a depth control (available in two different sizes for various drilling depths). The Drill Guide Tubes and Drill Guide Trocar Inserts have patient contact. All instruments are delivered unsterile and require end user sterilization.
The Drill Bits are used for drilling of bone. They are made of stainless steel and are delivered non-sterile. They require steam sterilization onsite before use. There are several variants in terms of diameter, length, and presence of a depth stop feature.
The provided text describes the regulatory clearance for the Brainlab AG Drill Guide, Drill Bit, and Spine & Trauma Navigation system. Here's a summary of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature | Acceptance Criteria (Subject Device) | Reported Device Performance |
|---|---|---|
| Navigation Accuracy | Mean Positional Error of the placed instrument's tip ≤ 2 mm | Accuracy testing: Tip position deviation equal to or below 1.7 mm (95th percentile). |
| Mean Angular Error of the placed instrument's axis ≤ 2° | Accuracy testing: Angular deviation equal to or below 1.7° (95th percentile). | |
| Assembly Stability | Withstand unintended loads without losing accuracy or function. | The Drill Guide was able to withstand forces without losing accuracy or function. |
| Lifecycle Assessment | Maintain accuracy and label readability throughout product lifetime. | Accuracy as well as label readability requirements were met. |
| Skiving | Provide a stable hold. | The modified Drill Guide provides a more stable hold with the improved teeth design compared to the predicate Guide Tubes. |
| Handling and Interface | Acceptance criteria met for depth control and array attachment. | Acceptance criteria were met in all cases. |
| Usability | Safe and effective for use in defined scenarios. | The final design was proven safe and effective for use in the defined use scenarios. |
| Mechanical Failure | Strong enough to withstand expected torques and possible bending. | The new worst case drill bit (diameter 2 mm) was tested under different scenarios in order to ensure it is strong enough to withstand the expected torques and possible bending under worst case conditions. |
| Biocompatibility | Compliance with ISO 10993-1:2018. | Was evaluated according to ISO 10993-1:2018 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process." |
| Reprocessing Validation | Compliance with ISO 11737-1:2018, ANSI/AAMI ST98:2022, ISO 15883-5:2021-07. | Was evaluated according to ISO 11737-1:2018, ANSI/AAMI ST98:2022 and ISO 15883-5:2021-07. |
2. Sample Size Used for the Test Set and Data Provenance:
The document doesn't explicitly state sample sizes for all test sets.
- Usability Testing: 15 representative users.
- Other Testing (Accuracy, Assembly Stability, Lifecyle assessment, Skiving, Handling and interface analysis, Mechanical failure testing, Biocompatibility, Reprocessing validation): Sample sizes are not specified in the provided text.
- Data Provenance: Not specified, but generally, these types of performance tests are conducted in a controlled laboratory environment. The document does not mention the country of origin of data or whether it was retrospective or prospective, as clinical data was not required.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided in the document. The performance tests described (e.g., accuracy, mechanical failure) are typically assessed against engineering specifications rather than expert consensus on medical images or diagnoses.
- For usability testing, the 15 "representative users" likely served as the evaluators, but their specific qualifications beyond being "representative" are not detailed.
4. Adjudication Method for the Test Set:
- An adjudication method (like 2+1, 3+1) is not applicable for the reported performance testing, as these are engineering and functional tests.
- For usability testing, the document states "The final design was proven safe and effective," implying an overall assessment rather than a specific multi-reader adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
- No MRMC comparative effectiveness study was done. This device is a navigation system and surgical instruments, not an AI diagnostic or assistive tool that would typically be evaluated in an MRMC study comparing human reader performance with and without AI.
- The document explicitly states: "No clinical testing was required for the subject device."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- The "Spine & Trauma Navigation" system is an image-guided surgery system that inherently involves a human surgeon in the loop. The performance tests (e.g., navigation accuracy) evaluate the system's ability to accurately guide instruments, which is a standalone function of the technology when used by a surgeon. It's not an "algorithm-only" performance in the sense of a fully automated diagnostic or interpretive AI.
7. The Type of Ground Truth Used:
- The ground truth for most of the performance tests (e.g., accuracy, mechanical failure, stability) is based on engineering specifications and metrology (precise measurements against known values).
- For biocompatibility and reprocessing, the ground truth is established by adherence to international standards (ISO 10993-1:2018, ISO 11737-1:2018, ANSI/AAMI ST98:2022, ISO 15883-5:2021-07).
- For usability, the ground truth is the satisfaction of predefined acceptance criteria by the representative users in a simulated scenario.
8. The Sample Size for the Training Set:
- This information is not applicable/not provided. The device is an image-guided surgery system and newly modified instruments, not a machine learning or AI model trained on data in the traditional sense that would have a "training set." The development of such physical devices and software systems involves rigorous engineering design, verification, and validation, but not typically a "training set" like that seen in deep learning applications.
9. How the Ground Truth for the Training Set Was Established:
- This information is not applicable, as there is no mention of a "training set" for an AI model.
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(26 days)
7D Surgical System - Drill Guide
The 7D Surgical System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons. The system is also intended to be used as the primary surgical luminaire during image guided surgery. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure can be identified.
The 7D Surgical System is intended for use as a stereotaxic image guided surgical navigation system during spine surgery. The system provides image registration between preoperative scan data and data captured intraoperatively from the 7D Surgical System structured light scanner and/or user selected points. The system provides guidance data by tracking and displaying the position and orientation of wireless optically tracked Spinal Instruments including the 7D Surgical Pedicle Probe and Awl, now including the 7D Surgical Drill Guide, relative to the patient. Position and orientation data of tracked Spinal Instruments are linked to the preoperative scan data using the 7D Surgical System workstation. The system is intended to be used as the primary surgical luminaire for image guided surgery.
The 7D Drill Guide is designed to allow the 7D Spine Module to show real-time interaction of the drill guide with the patient. The 7D Drill Guide is used to extend the initial hole through the cancellous (soft) bone of the vertebra passing the pedicle. The 7D Drill Guide Instrument Set contains several inserts and bits, these can be switched during the procedure. During navigation, the 7D Drill Guide is displayed showing the trajectory of its path, including measurement markings for measuring the depth of the proposed insertion. These measurement markings can be used as a guide to select the appropriate length of the screw for instrumentation.
The provided text describes the 7D Surgical System - Drill Guide and its submission for 510(k) clearance. Here's a breakdown of the acceptance criteria and the study information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from the text, implied from testing) | Reported Device Performance (from the text) |
|---|---|
| Meets design requirement specifications | "Verification successful, all design requirements have been fulfilled." (System Verification) |
| Meets Indications For Use and Customer Requirements | "Validation successful, all user needs met." (System Validation) |
| Risk control measures are effective | "Risk Control requirements are effective and mitigate the associated risks to an acceptable level." (Safety regarding risk analysis) |
| Accuracy specifications are met (per ASTM F2554-10 and Target Registration Error) | "All accuracy specifications have been met for the Drill Guide." (Non-Clinical Accuracy) |
| Performs as safely and effectively as the predicate device | "All non-clinical tests successfully passed demonstrating that the subject device performs as safely and effectively as the predicate device and supporting substantial equivalence." |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Non-Clinical Performance Surgical Simulations Conducted on Phantom Models". This indicates that the testing was performed on non-human models, likely in a laboratory setting. No specific sample size (number of phantom models or tests) is mentioned, nor is the country of origin for the data, but it is implied to be from 7D Surgical Inc. in Canada. The testing is non-clinical, so it's not "retrospective or prospective" in the traditional sense of human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number or qualifications of experts used to establish ground truth for the non-clinical tests. However, it references ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems. This standard likely dictates methods for establishing ground truth, typically involving highly precise measurement instruments and potentially expert calibration. The ground truth for Target Registration Error (TRE) and Absolute Target Error (ATE) involves comparing the system's reported position to a physically measured or otherwise established true position.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method like 2+1 or 3+1. Given that the testing was non-clinical on phantom models, ground truth would likely be established through precise measurements rather than expert consensus requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document states: "A clinical trial was not required to demonstrate safety and effectiveness of the 7D Surgical System." Therefore, there is no discussion of human readers, AI assistance, or effect sizes in this context.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the document describes standalone performance testing for the device. The non-clinical accuracy tests, including those following ASTM F2554-10 and the evaluation of Target Registration Error (TRE) and Absolute Target Error (ATE), are conducted on the device itself (the 7D Surgical System and its Drill Guide) without active human surgical intervention during the measurement of accuracy. The goal is to determine the system's inherent accuracy in positioning and orientation.
7. The Type of Ground Truth Used
The ground truth used for the non-clinical accuracy tests was established through:
- Precise physical measurements: For evaluating absolute accuracy, repeatability, and navigation accuracy according to ASTM F2554-10.
- Comparison to a known true position: For Target Registration Error (TRE) and Absolute Target Error (ATE), which involve comparing the system's reported position to a physically or otherwise established ground truth position on phantom models.
8. The Sample Size for the Training Set
The document does not provide information about a "training set" in the context of machine learning or AI algorithms. The 7D Surgical System is described as a "stereotaxic image guidance system" that uses "optically tracked reflective marker spheres" and "structured light scanner" for registration and tracking. This suggests a traditional computer vision/navigation system rather than one based on deep learning requiring a large training dataset.
9. How the Ground Truth for the Training Set was Established
As no training set (in the machine learning sense) is mentioned or implied, there is no information on how its ground truth would have been established.
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(105 days)
Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill
Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap
The Stryker Navigation System, when used with the SpineMap® 3D software application, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery.
The system is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a rigid anatomical structure such as the pelvis or spine can be identified.
The system assists in the positioning of instruments for procedures on the pelvis and spine, including:
- Screw Placement in the spine, ilium, or pelvis
The OrthoLock Anchoring System is intended to be used as an accessory to the Stryker Orthopedic, Trauma, and Spine Navigation Systems. It is a manual instrument intended to be used in surgery to anchor a patient tracker.
The OrthoLock Anchoring System may be used as part of the Stryker Orthopedic, Trauma, and Spine Navigation Systems, which are indicated for any medical condition in which the use computer assisted surgery may be appropriate. The System can be used for intraoperative guidance where a regid anatomical structure can be identified.
The nGenius Spine Clamp is intended to be used as an accessory to the Stryker Spine Navigation System. The nGenius Spine Clamp is a manual instrument and intended to be used in spine surgery to attach a patient tracker to lumbar or thoracic spinous processes.
The nGenius Spine Clamp may be used as part of the Stryker Spine Navigation, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The Navigated Drill Guide Set is intended to be used as an accessory to the Stryker Spine Navigation System. The Navigated Drill Guide Set consists of manual instruments that are intended to be used in spine surgery by providing guidance during drilling.
The Navigated Drill Guide Set may be used as part of the Stryker System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The Navigated Xia 3 Awl Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Xia 3 Awl Taps may be used as part of the Stryker Spine Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The System can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The Navigated Xia 3 Awl Taps are intended for use with the Rotation Adaptor and associated trackers to facilitate the placement of screws of the Stryker Spine Xia 3, Xia 4.5, MANTIS Redux, and ES2 Spinal Fixation Systems using the Stryker Spine Navigation System.
The Navigated Xia 3 Serrato Taps are intended to be used as accessories to the Stryker Spine Navigation System. They are manual surgical instruments used to facilitate placement of Stryker Spine implants.
The Navigated Xia 3 Serrato Taps may be used as part of the Stryker System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The Navigated Xia 3 Serrato Taps are intended for exclusive use with the Rotational Navigation Adapter and associated trackers to facilitate the placement of the Stryker Spine Xia 3 System - Serrato using the Stryker Spine Navigation System.
The Stryker Navigation System with the SpineMap® 3D 3.1 software application is intended for use as an image guided surgery system to enable open or percutaneous computer assisted spinal surgery. It assists the surgeon in positioning of instrumentation during spinal surgeries. The system provides intraoperative guidance to the surgeon using wireless optical tracking technology and displaying the position of navigated surgical instruments relative to medical images such as CT images.
The Stryker Navigation System with SpineMap 3D 3.1 software is comprised of a platform, SpineMap 3D software, navigated instruments (e.g. patient/instrument trackers, pointers), and accessories. The system uses wireless optical tracking technology to display the intraoperative location of navigated surgical instruments relative to medical images, such as a CT image. The platform consists of a computer, camera, monitor and IO (input/output) Tablet. The SpineMap 3D 3.1 software is dedicated for spinal procedures as defined in the Indications for Use. Required navigated instruments include instruments such as a patient tracker, an instrument tracker, and pointers. An instrument battery also required when a battery powered navigated instrument or calibration device is used.
The SpineMap 3D 3.1 software application is a required part of the Stryker Navigation System. It is installed by a Stryker representative on the platform. The SpineMap 3D 3.1 software application is used on a platform and interfaces with Stryker navigated instruments and accessories. It is compatible with the Nav3i Platform family, which includes the NAV3i, NAV3, and NavSuite3.
SpineMap 3D 3.1 is an interactive software application that provides the functions necessary to conduct the indicated spinal procedures. The software application implements methods for planning, patient registration, and instrument navigation. It also guides the user through the preoperative and intraoperative workflow process.
The SpineMap 3D 3.1 Software Application provides new features including improved patient registration with non-Hounsfield calibrated imaging devices, updated screw database that includes new Stryker Spine spinal implant screws, an updated Coordinate Engine to improve the visibility of the nGenius Universal Tracker when used on the Rotational Navigation Adapter, implements an Automatic Intraoperative Mask (AIM) Registration fallback workflow to allow the surgeon to identify LEDs when the automatic LED detection for AIM registration fails due to poor image quality or when using non-Hounsfield calibrated systems, implements a new indirect vector calibration workflow to calibrate the new Navigated Drill Guides, and implements new cybersecurity measures.
The nGenius Spine Clamps are manual surgical instruments that are intended to be used in spine surgery to attach a patient tracker to the lumbar or thoracic spinous processes to enable surgical navigation. They are intended to be accessories to the Stryker Spine Navigation System. The nGenius Spine Clamps are available in two different sizes (i.e., short and long). They can be used in open or percutaneous procedures. The nGenius Spine Clamps are compatible with the nGenius Universal Tracker and the Spine Tracker.
The OrthoLock is a manual surgical instrument intended to be used to anchor a patient tracker. It is an anchoring system that is used to anchor a patient tracker during computer assisted orthopedic, trauma, and spinal surgeries. It can be used with the Stryker Orthopedic, Trauma, and Spine Navigation Systems.
The OrthoLock anchoring system is intended to be used with the Stryker Navigation Pins and OrthoLock Ex-Pins. It can be tightened or loosened with the screwdriver or Universal Joint Screwdriver.
The OrthoLock Indications for Use are being updated as part of this Traditional 510(k) to allow them to be used during spinal surgical procedures.
The Navigated Drill Guide Set consists of short and long Navigated Drill Guides, short and long Navigated Drill Guide Calibrators, short and long Navigated Drill Bits, a Navigated Drill Bit Stop, and a Navigated Drill Guide Set Container (class 1 exempt). The instruments of the Navigated Drill Guide Set are intended to be used with the Stryker Navigation System with the SpineMap 3D 3.1 software application.
The Navigated Drill Guides are manual instruments that are intended to provide guidance during drilling. They can be used in open or percutaneous procedures. The Navigated Drill Guides can be used as accessories to the Stryker Spine Navigation System. The Navigated Drill Guides can be navigated using the nGenius Universal Tracker as an instrument tracker.
The Navigated Drill Guides are available in two sizes (i.e., short and long). The Navigated Short Drill Guide is intended for use with the Navigated Short Drill Bits and in spine surgical procedures on the cervical, thoracic, and lumbar spine. The Long Navigated Drill Guide is intended for use with the Long Navigated Drill Bits and in spine surgical procedures on the cervical, thoracic and lumbar spine.
The Navigated Drill Guides can be calibrated using the Navigated Drill Guide Calibrators. Calibration of the Navigated Drill Guides has been incorporated into the SpineMap 3D 3.1 software application workflow. The Navigated Drill Guides can also be calibrated using the Vector Calibration Device (VCD) or the Point Calibration Device (PCD).
The Navigated Drill Guide Calibrators are manual instruments that are intended to be used to calibrate the Navigated Drill Guides when used with the SpineMap 3D 3.1 software in combination with the Point Calibration Device or Vector Calibration Device. The Navigated Drill Guide Calibrators come in short and long lengths and are intended to be used with the corresponding Navigated Drill Guide. They are not intended to be used for calibrating the Navigated Drill Guides when they are not being used with Navigation.
The Navigated Drill Guide Calibrator cannot be navigated.
The Navigated Drill Bits are manual instruments that are intended to drill holes of a specified diameter. They drill non-threaded holes. They are designed for use with the Navigated Drill Bit Stop. While the design is based on the Xia CT Drill Bits, they are not designed to be used exclusively with any Stryker Spine Implant System.
The short and long Navigated Drill bits come in a variety of sizes. They must be used with a handle and are designed to be used with Stryker Spine's Short Quick Release Handle (class 1, exempt) and Quick Release Handles (class 1, exempt) which have previously been released to market as Class 1, exempt devices.
The Navigated Drill Bits are single-use only. They will be provided non-sterile, but will need to be sterilized prior to use.
The Navigated Drill Bits cannot be navigated and can be used during non-navigated spine surgical procedures.
The Navigated Drill Bit Stop is a manual instrument that is intended for use with the short and long Navigated Drill Bits. The Navigated Drill Bit Stop allows the drilling depth of the Navigated Drill Bits to be controlled by pre-setting the drill depth. The Navigated Drill Bit Stop cannot be navigated.
The Navigated Xia 3 Awl Taps are manual surgical instruments intended to facilitate placement of Stryker Spine implants. They are a combination of an awl and a tap. The Awl Taps have an awl tip that includes a range of tap diameter sizes with thread designs that are only compatible with bone screws from Stryker Spine's Xia 3, Xia 4.5 (not including Xia Bone CT), ES2, MANTIS, and MANTIS Redux implant systems.
The Navigated Xia 3 Awl Taps are intended as accessories to the Stryker Spine Navigation System. The Awl Taps are designed for use with the Rotational Navigation Adaptor when used for navigated spinal procedures. The Navigated Xia 3 Awl Taps can be used with the Navigated Xia 3 Round Ratchet Handle, Navigated Xia 3 Ratchet T-Handle, and the Navigated Mantis Short Ratchet T-Handle, which have previously received market clearance via letter to file for both navigated and non-navigated spine surgical procedures.
The Serrato Navigated Taps are manual surgical instruments intended to facilitate placement of Stryker Spine's Xia 3 - Serrato screw implants. They have a dual-lead thread geometry and come in a variety of diameter sizes. The thread profile is designed to match that of the Serrato screw implants which is critical in achieving a rigid bone fixation. The Xia 3 Serrato Navigated Taps have a color-anodized titanium ring that corresponds to a specific diameter size for each tap.
The Navigated Xia 3 Serrato Taps are intended as accessories to the Stryker Spine Navigation System. They are designed for use with the Rotational Navigation Adaptor when being used for navigated spinal procedures. The Navigated Xia 3 Serrato Taps are designed to be used with a Modular Handle (Class 1, exempt) if used for non-navigated surgical procedures.
Here's a breakdown of the acceptance criteria and the study information for the Stryker Navigation System with SpineMap 3D software application and its accessories, based on the provided FDA 510(k) document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Target Performance) | Reported Device Performance |
|---|---|
| Mean accuracy of 2 mm for positional displacement and 2° for trajectory angle displacement within the working space. | Mean Positional Displacement: 1.07 mm |
| Mean Trajectory Angle Displacement: 0.61 degrees | |
| 95th percentile of the point displacement ≤ 3 mm and ≤ 3° for angular axis displacement within the registration zone. | The document provides 99th percentile, which is stricter: |
| 99th Percentile Positional Displacement: 2.70 mm | |
| 99th Percentile Trajectory Angle Displacement: 1.07 degrees | |
| Effectiveness of all risk controls determined in the device risk analysis. | Verified and all requirements met. No new issues of safety or effectiveness were raised. |
| Compliance with design specifications for all components. | Verified and all requirements met. No new issues of safety or effectiveness were raised. |
| Software verification and validation (IEC 62304 and FDA guidance on general principles of software validation). | All requirements met. No new issues of safety or effectiveness were raised. |
| Biocompatibility of all patient contact materials (ISO 10993-1:2009 and FDA draft guidance on the use of ISO 10993-1). | Verified. No new issues of safety or effectiveness were raised. |
| Electrical Safety (ANSI/AAMI ES60601-1:2005/ (R)2012, AND C1:2009 AND A2:2010(R)2012). | Conformance verified. |
| Electromagnetic Compatibility (IEC 60601-1-2: 2007 +AC: 2010, CISPR 11 Group 1, Class B, and compatibility with RFID). | Conformance verified and additional testing for RFID compatibility confirmed. |
| Functionality of devices after simulated shipping conditions. | Verified. No new issues of safety or effectiveness were raised. |
| Sterility assurance level (SAL) of 10-6 or greater after processing for reusable devices (steam sterilization). | All requirements met. No new issues of safety or effectiveness were raised. |
| User needs and intended use requirements (validated with intended users in cadaver labs or simulated use tests). | All requirements met and no new issues of safety or effectiveness were raised. |
2. Sample Size for Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set in numerical terms (e.g., number of cadavers, number of subjects). However, it mentions that the "subject devices were validated with intended users in cadaver labs or simulated use tests." This indicates that the testing was conducted in a laboratory or simulated environment, likely using anatomical models or cadavers.
The data provenance is retrospective/simulated/laboratory-based, as "No clinical testing was performed" (page 20). The country of origin of the data is not specified, but the applicant, Stryker Leibinger GmbH & Co. KG, is located in Freiburg, Germany.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. It mentions validation "with intended users," implying surgeons or similar medical professionals, but lacks detail.
4. Adjudication Method
The document does not specify any adjudication method for the test set results (e.g., 2+1, 3+1, none).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document states that "No clinical testing was performed" (page 20), which would typically be a prerequisite for such a study involving human readers. Therefore, no effect size of human readers improving with AI vs. without AI assistance is provided.
6. Standalone (Algorithm Only) Performance
The main accuracy claims (positional and angular displacement) are presented as standalone performance metrics for the navigation system itself, specifically "tracking in the workspace" and "within the registration zone," without direct human intervention as part of the measured accuracy. The system's performance is inherently about the algorithm's ability to accurately track instruments.
7. Type of Ground Truth Used
The ground truth for the accuracy measurements was established using physical measurements related to positional and angular displacement within a controlled environment (working space/registration zone). This would typically involve highly precise measurement devices to establish the true position/angle against which the system's output is compared. For user needs and intended use, the ground truth would be the satisfaction of requirements/successful completion of tasks in simulated environments or cadaver labs.
8. Sample Size for the Training Set
The document does not provide a sample size for a training set. This is a navigation system and associated instruments, not a machine learning model that typically undergoes a distinct training phase with a labeled dataset for image recognition or similar tasks. The "software verification and validation testing" (page 19) would involve testing against predefined specifications and requirements, rather than training data in the AI sense.
9. How the Ground Truth for the Training Set Was Established
As there isn't a traditional "training set" in the context of an AI/ML model for this device, the concept of establishing ground truth for a training set does not apply directly. The software development process would involve various stages of testing and validation against defined functional and performance requirements, but not typically a labeled training dataset like in machine learning.
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(41 days)
Q-FIX SUTURE ANCHOR, 1.8MM; Q-FIX SUTURE ANCHOR, 2.8MM; DRILL, DRILL GUIDE AND OBTURATOR, 1.8MM & 2.8MM
The Q-Fix Suture Anchor is intended to be used for soft tissue to bone fixation for:
Shoulder: Bankart lesion repair; SLAP lesion repair; acromio-clavicular repair; capsular shift/capsulolabral reconstruction; deltoid repair; rotator cuff tear repair; biceps tenodesis
Foot & Ankle: Medial/Lateral repair and reconstruction; midfoot and forefoot repair; Hallux valgus reconstruction; Metatarsal ligament/tendon repair or reconstruction; Achilles tendon repair
Elbow: Ulnar or radial collateral ligament reconstruction; lateral epicondylitis repair; biceps tendon reattachment
Knee: Extra-capsular repair: medial collateral ligament (MCL), lateral collateral ligament (LCL) and posterior oblique ligament; Iliotibial band tenodesis (IBT); patellar tendon repair; vastus medialis obliquus advancement (VMO); joint capsule closure
Hand & Wrist: Collateral ligament repair; Scapholunate ligament reconstruction; Tendon transfers in phalanx; Volar plate reconstruction
Hip: Acetabular labral repair
The purpose of this subnission is to seek clearance for modifications and additions to the accessory instrumentation used with the previously cleared Q-Fix Suture Anchor System (K132513). There are no changes to the previously cleared indications for use, materials, design, technology, method of anchor insertion and or tissue attachment.
The Q-Fix Suture Anchor System (Q-Fix) is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures.
The Q-Fix consists of two primary parts: a bone anchor inserter, which is preloaded with the anchor. The anchor inserter is a disposable tool.
The entire product is packaged in a tray with a Tyvek® Iid, and the finished product is sterilized by ethylene oxide. Both the anchor and inserter are designed for single use only.
The O-Fix Suture Anchor System consists of the bone anchor and associated instruments for implanting the bone anchor.
The Q-Fix™ Suture Anchor System is a medical device designed for soft tissue to bone fixation. The device underwent mechanical testing to demonstrate its safety and effectiveness.
1. Acceptance Criteria and Reported Device Performance:
The acceptance criteria are not explicitly quantifiable performance metrics in the provided text, but rather a demonstration of substantial equivalence to the predicate device and adherence to design, performance, and safety specifications based on mechanical testing.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meets design, performance, and safety specifications | "The test results demonstrate that the Q-Fix meets its design, performance, and safety specifications." |
| Performs as intended | "Based on the test results, the proposed device performs as intended..." |
| Mechanical properties are substantially equivalent to the predicate device (ArthroCare Q-Fix™ Suture Anchor: K132513) | "...mechanical properties are substantially equivalent to the predicate devices when used in accordance with labeling." Also, "All testing demonstrates that the Q-Fix performs as intended and has acceptable mechanical properties..." |
| Testing performed in accordance with FDA Guidance Document, Testing Bone Anchors, April 1996 | "Mechanical testing was performed in accordance with the requirements of the FDA Guidance Document, Testing Bone Anchor Devices, April 1996." |
2. Sample Size and Data Provenance for Test Set:
- Sample Size: Not explicitly stated. The text mentions "Bench testing was performed on both the proposed and predicate devices," implying multiple units were tested, but the exact number is not provided.
- Data Provenance: The testing was "in vitro," involving insertion of anchors into a "simulated human bone substrate." This indicates the data is from laboratory bench testing, rather than from human or animal subjects. The origin (country) is not specified beyond "ArthroCare Corporation" which is located in Austin, Texas, USA. The testing is prospective as it was conducted specifically for this submission.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. This device is a mechanical implant, and its performance was assessed through bench testing, not through expert interpretation of data or images. Therefore, clinical experts were not required to establish ground truth for the device's mechanical performance.
4. Adjudication Method:
Not applicable, as no expert adjudication was involved for this type of mechanical bench testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data. The Q-Fix™ Suture Anchor System is a surgical implant, and its performance is evaluated mechanically rather than through human interpretation.
6. Standalone (Algorithm Only) Performance:
Not applicable. The Q-Fix™ Suture Anchor System is a medical implant, not an AI algorithm. Its performance is inherent to its physical design and mechanical properties, not an algorithm.
7. Type of Ground Truth Used:
The ground truth for evaluating the device's performance was established through mechanical testing against predefined specifications and comparison to the predicate device. This involved "static and cyclic fatigue testing" in a "simulated human bone substrate."
8. Sample Size for Training Set:
Not applicable. As a medical implant, there is no "training set" in the context of machine learning or AI. The design and manufacturing process would involve internal testing and validation, but not a training set as understood in AI/ML.
9. How Ground Truth for Training Set was Established:
Not applicable, as there is no training set. The "ground truth" for the device's design and manufacturing would be based on engineering principles, material science, and regulatory standards.
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(38 days)
Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM AND 2.8MM /BONE PUNCH,2.8MM
The Q-Fix Suture Anchor is intended to be used for soft tissue to bone fixation for:
Shoulder: Bankart lesion repair; SLAP lesion repair; acromio-clavicular repair; capsular shift/capsulolabral reconstruction; deltoid repair; rotator cuff tear repair; biceps tenodesis
Foot & Ankle: Medial/Lateral repair and reconstruction; midfoot and forefoot repair; Hallux valgus reconstruction; Metatarsal ligament/tendon repair or reconstruction; Achilles tendon repair
Elbow: Ulnar or radial collateral ligament reconstruction; lateral epicondylitis repair; biceps tendon reattachment
Knee: Extra-capsular repair: medial collateral ligament (MCL), lateral collateral ligament (LCL) and posterior oblique ligament; Iliotibial band tenodesis (IBT); patellar tendon repair; vastus medialis obliquus advancement (VMO); joint capsule closure
Hand & Wrist: Collateral ligament repair; Scapholunate ligament reconstruction; Tendon transfers in phalanx; Volar plate reconstruction
Hip: Acetabular labral repair
The Q-Fix Suture Anchor System (Q-Fix) is a bone anchor with inserter handle designed for use in arthroscopic and orthopedic procedures.
The Q-Fix consists of two primary parts: a bone anchor inserter, which is preloaded with the anchor. The anchor inserter is a disposable tool.
The entire product is packaged in a tray with a Tyvek® lid, and the finished product is sterilized by ethylene oxide. Both the anchor and inserter are designed for single use only.
The Q-Fix Suture Anchor System consists of the bone anchor and associated instruments for implanting the bone anchor.
Here's an analysis of the provided text regarding the ArthroCare Q-Fix Suture Anchor System, focusing on acceptance criteria and the supporting study:
Acceptance Criteria and Device Performance
The document does not explicitly state quantitative-only acceptance criteria in a dedicated table format. Instead, it describes acceptance based on the device performing as intended and its mechanical properties being "substantially equivalent" to a predicate device. The "Comparison of Technological Characteristics" table serves as a form of acceptance criteria by showing that the proposed device is largely identical or very similar to the predicate device.
Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (based on Predicate Device K122336) | Reported Device Performance (Proposed Device ArthroCare Q-Fix) |
|---|---|---|
| Intended Use | Fixation of soft tissue to bone | Same |
| Delivery Method | Arthroscopic and Limited Access | Same |
| How Supplied | Packaged in pouch, Sterile (EtO), Single Use | Packaged in thermoform tray with Tyvek® lid, Sterile (EtO), Single Use (minor packaging difference) |
| Suture Material | No. 2 UHMWPE Suture | Same |
| Anchor Material | Braided Polyester | Same |
| Inserter Handle Materials | Medical Grade Plastics and Surgical Grade Stainless Steels | Same |
| Method of Anchor Insertion | Inserted into a predrilled hole | Same |
| Bone Locking Mechanism | Expandable Compression Fit | Same |
| Suture Locking Mechanism | Manually tied suture knot | Same |
| # of Suture Legs | Two (1.8mm) & Four (2.8mm) | Same |
| Sizes Offered | 1.8mm & 2.8mm | Same |
| Deployed Length | 15mm for 1.8mm anchor, 20mm for 2.8mm anchor | Same |
| Bone Hole Size | 2.1mm (0.083") for 1.8mm anchor, 3.1mm (0.121") for 2.8mm anchor | 2.2mm (0.085") for 1.8mm anchor, 3.1mm (0.123") for 2.8mm anchor (minor dimensional difference) |
| Accessory Instruments | Drill, Drill Guide, Obturator | Same (with additional listed instruments: Bone Punch, Knot Pusher, FirstPass* Suture Punch) |
| Overall Performance | Adherence to "design, performance, and safety specifications" and "substantially equivalent" to predicate based on FDA Guidance Document, Testing Bone Anchors, April 1996. | "meets its design, performance, and safety specifications" and "mechanical properties are substantially equivalent to the predicate devices." |
Study Information
-
Sample Size used for the test set and data provenance:
- The document states: "Bench testing was performed on both the proposed and predicate devices in accordance with the FDA Guidance Document, Testing Bone Anchors, April 1996."
- It mentions "insertion of the anchors into a simulated human bone substrate followed by both static and cyclic fatigue testing."
- Sample Size: The exact sample size (number of anchors tested) for the bench testing is not specified in the provided text.
- Data Provenance: The data is from in vitro bench testing using a "simulated human bone substrate." There is no mention of country of origin as it's not human data. The study is inherently prospective in its design as laboratory testing.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- There is no mention of human experts being used to establish ground truth for this mechanical/bench test. The "ground truth" here is objective mechanical performance measured against predefined standards or comparison to a predicate device.
-
Adjudication method for the test set:
- No adjudication method (like 2+1, 3+1, none) is applicable or mentioned, as this involves mechanical testing, not expert review of subjective data.
-
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 done. This device is a mechanical medical implant (suture anchor), not an AI diagnostic or assistance system. Therefore, the concept of "human readers improve with AI" is not applicable.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone algorithm-only performance study was not done. As mentioned, this is a mechanical device, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" used for this submission is based on objective mechanical test results (static and cyclic fatigue testing) against established FDA guidance for bone anchors, and direct comparison of technological characteristics to a legally marketed predicate device to establish substantial equivalence.
-
The sample size for the training set:
- This is not an AI/machine learning device, so there is no training set in the traditional sense.
-
How the ground truth for the training set was established:
- Not applicable as there is no training set.
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(248 days)
ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS
The Smith & Nephew, Inc. SUTUREFIX Ultra Suture Anchor is intended for the secure fixation of soft tissue to bone for the following indications:
Hip
Hip capsule repair (Acetabular labrum repair/reconstruction)
Shoulder
Capsular stabilization (Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions), Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis
Foot and Ankle
Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repair/reconstructions, Bunionectomy
Elbow, Wrist, and Hand
Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair
Knee
Extra-capsular repairs (Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament), Patellar realignment and tendon repairs (Vastus medialis obliquous advancement), Illiotibial band tenodesis
The Smith & Nephew SUTUREFIX Ultra Suture Anchor is intended to provide secure . fixation of soft tissue to bone. The device consists of a soft suture anchor with an attached non-absorbable suture(s) preassembled onto an insertion device. The SUTUREFIX Ultra Suture Anchors are available pre-loaded with either one #2 suture or with two #1 sutures. This device is provided sterile, for single use only.
Here’s a breakdown of the acceptance criteria and study information for the SUTUREFIX Ultra Suture Anchor, based on the provided text:
Important Note: The provided text is a 510(k) premarket notification summary. This type of submission generally focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical efficacy studies against acceptance criteria like you'd find for novel therapies or AI-driven diagnostic tools. Therefore, much of the requested information (especially regarding AI, human readers, sample sizes for training/test sets, and expert details for ground truth) is not applicable or not present in this document. The document primarily discusses mechanical performance data.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Insertion Strength Met | Met performance specifications for insertion strength |
| Pull-out Strength Met | Met performance specifications for pull-out strength |
| Substantial Equivalence to Predicate Devices | Considered substantially equivalent to currently marketed predicate devices, raising no new issues of safety and efficacy. |
Explanation: The document states, "Performance data demonstrates that the SUTUREFIX Ultra Suture Anchor has met performance specifications for insertion strength and pull-out strength and therefore, is considered substantially equivalent to the currently marketed predicate devices." This implies that the 'acceptance criteria' were the successful demonstration of adequate insertion and pull-out strength, and the ultimate acceptance criterion was deemed 'substantially equivalent' to the predicate devices.
Study Details
-
Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to "Performance data" but does not quantify the number of devices or tests performed.
- Data Provenance: Not specified, but generally, such biomechanical testing would be conducted in a laboratory setting (e.g., in-vitro or ex-vivo testing). No information on country of origin for the data is provided, nor whether it was retrospective or prospective in a clinical sense.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a mechanical device like a suture anchor, ground truth is typically established through direct physical measurement and engineering standards, not through "expert consensus" in the medical diagnostic sense. There are no "experts" establishing a diagnostic ground truth.
-
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 studies where human interpretation of medical images or data is involved to establish a consensus ground truth. This is a biomechanical performance study, not an interpretative one.
-
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 device is a surgical implant, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study, AI assistance, or human reader improvement data is relevant or provided.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm or AI.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Biomechanical Performance Metrics: Ground truth for this device would be based on empirically measured physical properties, such as the force required for insertion and the force required to pull out the anchor from a test material (e.g., bone surrogate or cadaveric bone). This is determined by engineering and biomechanical testing standards.
-
The sample size for the training set:
- Not Applicable. This is not an AI/ML device that requires a "training set."
-
How the ground truth for the training set was established:
- Not Applicable. As above, no training set for an AI/ML model.
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(160 days)
Q-FIX SUTURE ANCHOR, 1.8MM Q-FIX ACCESS TOOLS (DRILL GUIDE W/OBTURATOR, DRILL BIT) 1.8MM
The Eleven Blade Solutions, Inc. Q-Fix™ Suture Anchor System is intended for soft tissue to bone fixation for:
Shoulder
Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction, Deltoid repair, Rotator cuff repair, Biceps tenodesis
Foot and Ankle
Medial/lateral repair and reconstruction, Mid and forefoot repair, Hallux valgus reconstruction, Metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair
Elbow
Ulnar or radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment
Knee
Extra-capsular repair: MCL, LCL, and posterior oblique ligament, Illiotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure
Hand and Wrist
Collateral ligament repair, Sacpholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction
Hip
Acetabular labral repair
The Q-Fix™ Suture Anchor is an all-suture anchor device designed for soft tissue to bone fixation by expanding against bone when deployed. Made of a polyester sleeve-type structure with one or more strands of UHMWPE suture threaded through it, the anchor is provided preloaded on a disposable inserter. The inserter is used to deploy the anchor into the bone, with the suture remaining slideable within the anchor to facilitate attachment of the soft tissue. The one-time use anchor is provided sterile, preloaded on the inserter. Additional accessory instruments, including a drill bit and drill guide with obturator are single use devices provided sterile for use during the orthopedic procedure.
The Q-Fix™ Suture Anchor System is a medical device designed for soft tissue to bone fixation. The provided document is a 510(k) summary, which indicates that the device is seeking substantial equivalence to already marketed predicate devices. This type of submission focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving absolute safety and efficacy through extensive clinical trials. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the demonstration of substantial equivalence through bench testing compared to predicate devices.
Here's an analysis 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" in a table format with corresponding "reported device performance" values for the Q-Fix™ Suture Anchor System. Instead, it states that bench studies were conducted to evaluate performance characteristics and demonstrate equivalence to predicate devices. The implicit acceptance criterion is that the Q-Fix™ Suture Anchor System's performance characteristics are "equivalent to the predicate devices and thus provide equivalent fixation strength within their intended use."
The performance characteristics evaluated were:
| Performance Characteristic | Reported Device Performance (Implicit Acceptance) |
|---|---|
| Anchor Pull-out Strength | Equivalent to predicate devices |
| Cyclic Displacement | Equivalent to predicate devices |
| Device Insertion Testing | Equivalent to predicate devices |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "bench studies" for Anchor Pull-out Strength, Cyclic Displacement, and Device Insertion Testing. However, it does not specify the sample sizes used for these tests. It also does not provide information on the country of origin of the data or whether the studies were retrospective or prospective, as these are bench tests and not human or animal studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable in the context of this 510(k) summary. The "ground truth" for bench testing of a suture anchor system is typically based on established engineering and biomechanical standards, not on expert clinical consensus. The assessments are objective measurements of physical properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods are typically used in clinical studies or image interpretation studies where expert consensus is needed. For bench testing of physical properties, measurements are objective and do not require expert adjudication in the same way.
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 question is not applicable. An MRMC comparative effectiveness study is used for evaluating diagnostic aids or imaging devices where human interpretation is involved. The Q-Fix™ Suture Anchor System is a surgical implant, and its performance is evaluated through biomechanical bench testing.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. The Q-Fix™ Suture Anchor System is a physical medical device, not an algorithm or AI system. Its performance is inherent to its physical properties and design.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the bench studies, the "ground truth" for assessing device performance is based on objective biomechanical measurements against established engineering and material science principles, and comparison to the performance characteristics of the predicate devices. It is not based on expert consensus, pathology, or outcomes data, as these are typically relevant for clinical studies.
8. The sample size for the training set
This question is not applicable. This device is a physical medical implant, not an AI or machine learning algorithm. Therefore, there is no "training set."
9. How the ground truth for the training set was established
This question is not applicable, as there is no "training set" for this type of device.
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(62 days)
SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL
GUIDE MODEL OM-75
The SpeedFix Suture Implant with inserter is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:
Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction
Foot: Hallux valgus reconstruction
Elbow: Tennis elbow repair, biceps tendon attachment
Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions
The SpeedFix Suture System is a bone anchor system with inserter handle designed for specific indications in arthroscopic and orthopedic procedures.
The provided text describes a 510(k) summary for the ArthroCare Corporation SpeedFix Suture System, not a study involving acceptance criteria and device performance in the context of AI or a reader study.
The document states that a "side-by-side comparison bench testing was performed on the proposed and predicate device per the US FDA Guidance Document for Testing Bone Anchors." However, it does not provide details of the acceptance criteria, the specific test results, sample sizes, or the other information requested in the prompt (e.g., data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets).
Therefore, based only on the provided text, I cannot complete the requested information. The document focuses on demonstrating substantial equivalence to a predicate device (SpeedFix Suture Implant cleared under K101437) rather than presenting a detailed performance study against defined acceptance criteria in the manner described by the prompt.
The document explicitly states: "The differences between the SpeedFix and the predicate device do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the materials are well characterized and have been used in predicate devices with similar indications. The proposed device, as designed, is as safe and effective as predicate devices." This indicates a reliance on the predicate device's established safety and effectiveness, supported by bench testing, rather than a de novo performance study against explicit internal acceptance criteria.
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(70 days)
DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC)
The Drill Guide Attachment of the Sodem High Speed System allows to make holes in adjustable depth and operate with drills and cutters in different applications and surgeries.
This attachment is intended for use in Neurology (spine and craniotomy), General Plastic surgery (median sternotomy) and Orthopedic (revision implant surgery, extremity: hand, foot ... ) applications.
The Drill Guide Attachment PN 3105 DG is used with different elements of the Sodem High Speed System (Pneumatic).
The Sodem High Speed System is a modular pneumatically powered high speed instrument system consisting of a hand piece, adapters and accessories/attachments (spindles, burs ... ) and especially Drill Guide Attachment used to make holes in the bone with an adjustable depth.
The Sodem High Speed System (Pneumatic) is a complete system including:
- a High Speed motor, .
- . a foot pedal,
- dedicated hoses to connect the motor and the foot pedal, -
- adapters (angled adapter)
- Drill Guide Attachment PN 3105 DG (other attachments/spindles already submitted exist as angled attachments, straight attachments standard and tapered, craniotomes)
- drills, burs and cutters -
The Sodem High Speed System (Pneumatic) for use in Neurology applications is the same product as the Sodem High Speed System (Pneumatic) already submitted for Neurology, Orthopedic and General plastic surgery (K954717, K954080, K955174) and currently submitted for ENT and Dental surgery. The difference is the addition of a new attachment PN 3105 DG : Drill Guide Attachment.
The provided text is a 510(k) premarket notification for a medical device, the "Drill Guide Attachment (PN 3105 DG) of the Sodem High Speed System (Pneumatic)." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study demonstrating the device meets specific acceptance criteria through a clinical trial or performance study with detailed metrics.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, ground truth, and comparative effectiveness studies is not present in this document. The 510(k) process relies on demonstrating that the new device is as safe and effective as a predicate device, primarily through comparison of intended use, technological characteristics, and materials.
Here's a breakdown of why each specific point cannot be addressed from the provided text:
- A table of acceptance criteria and the reported device performance: This document does not establish specific performance acceptance criteria for the Drill Guide Attachment in the way a clinical trial would. Its performance is implicitly deemed acceptable if it is substantially equivalent to the predicate device.
- Sample sized used for the test set and the data provenance: No test set or associated data provenance (country of origin, retrospective/prospective) is mentioned, as this is not a clinical study report.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no "test set" and thus no ground truth established by experts within this document. The FDA reviews the submission for substantial equivalence.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as there is no test set or adjudication process described.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is a surgical drill attachment, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant or included.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for a physical surgical instrument.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): No "ground truth" as typically defined in diagnostic studies is used here. The basis for acceptance is substantial equivalence to a predicate device in terms of intended use, materials, and technological characteristics.
- The sample size for the training set: Not applicable, as this is not a machine learning or AI device that requires a training set.
- How the ground truth for the training set was established: Not applicable, as there is no training set mentioned or required for this type of device submission.
In summary, the provided document demonstrates substantial equivalence, not performance against specific acceptance criteria through empirical study results. The "study" in this context is the FDA's review of the comparison between the new device and predicate devices.
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