Search Results

The InZone IST Detachment System is intended for use with all versions of Stryker Neurovascular embolization devices in the embolization of intracranial aneurysms and other vascular malformations of the neuro and peripheral vasculature.

Stryker Neurovascular's InZone IST Detachment System is a sterile, handheld, single-patient use device designed for use with Stryker Neurovascular embolization devices. The device consists of an enclosure with a detachment button, five LED indicator lamps, a funnel inset at its distal end, and a cable connection port. The device comes pre-loaded with two AAAA (1.5 VDC) batteries.

Stryker Neurovascular's IZDS Connecting Cable is a 180 cm cable intended for use with the InZone IST Detachment System in the detachment of monopolar embolization devices. The cable completes the connection between the InZone IST unit and a patient return electrode (a 20 or 22 gauge uncoated stainless-steel hypodermic needle) inserted subcutaneously at the patient's groin.

N/A

Ask a specific question about this device

The Stryker Robotic Precision System (RPS) Primary TKA Software application, when used with the Stryker Guidance Systems, is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to rigid anatomical structures during orthopedic procedures.

The RPS Primary TKA Software application is indicated for use in total knee arthroplasty (TKA) procedures in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified.

RPS is a total joint bone preparation system to support total knee arthroplasty (TKA) consisting of functionality for intraoperative planning, kinematic analysis, boundary control, and guided resection. The Complete Workflow allows for the placement of Stryker Triathlon CR/PS Total Knee Implants (cemented or cementless), and plans/resects all 6 primary femoral/tibial resections. The Quick-Cut Workflow allows for placement of implants with implant-specific cut guides requiring primary distal femoral and proximal tibial cuts.

A handheld robotic saw is guided via camera visualization in relation to patient anatomy and the surgical plan established intraoperatively. The robotic saw movement is partially controlled by the RPS Console which determines, based on surgical plan and localization data, how the saw actuators need to move within three degrees of freedom (elevation, pitch, roll) to maintain the planned cut plane. The surgeon controls the remaining degrees of freedom.

N/A

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, breast (including mastectomy and lumpectomy) and electrophysiology implant (for implantation, upgrade and revision of Cardiac Implantable Electronic Devices (CIED) and leads) procedures.

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, breast (including mastectomy and lumpectomy) and electrophysiology implant (for implantation, upgrade and revision of Cardiac Implantable Electronic Devices (CIED) and leads) procedures, 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. The 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 unit. A cable with a universal connector attaches the device to an IEC 60601 compliant electrosurgical generator.

N/A

Ask a specific question about this device

The T2 Alpha Humerus Nailing System is indicated for the treatment of humerus fractures. Fractures can include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures.

The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization.

The T2 Humeral Nail is intended to provide temporary stabilization of various types of fractures, malunions, and non-unions of the humerus. The nails are inserted using an open or closed technique and can be static, dynamic, or compression locked. The subject and predicate devices are indicated for use in the humerus. Types of fractures include, but are not limited to, fractures of the humeral shaft, non-unions, malalignments, pathological humeral fractures, and impending pathological fractures.

The T2 Alpha Humerus Nailing System is an intramedullary humerus fracture nailing system consisting of sterile implants (Nails, End Caps, Compression Screw, and Washer) and non-sterile indication-specific instrumentation. The Nails, End Caps, Compression Screw, and Washer are made of titanium alloy as per ASTM F136. The T2 Alpha Humerus Nailing System will be used with the existing Locking Screws and Advanced Locking Screws of the IMN Screws System.

The IMN Screws System includes bone screws (Locking Screws and Advanced Locking Screws) that are inserted through the intramedullary nail to stabilize the nail-bone construct. All screws are sterile and made of titanium alloy (Ti6Al4V ELI) per ASTM F136.

The T2 Humeral Nail System is an intramedullary nailing system that allows antegrade and retrograde humeral nailing. The nails, end caps, compression screw, and washer are provided sterile and made of titanium alloy as per ASTM F136.

The provided FDA 510(k) clearance letter (K251400) does not concern an AI/software device. Instead, it pertains to a physical medical device: the Stryker T2 Alpha Humerus Nailing System, IMN Screws System, and T2 Nailing System, which are intramedullary fixation rods and bone screws used for treating humerus fractures.

Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they relate to AI/software performance metrics (e.g., accuracy, sensitivity, specificity, F1-score, expert consensus, MRMC studies) are not applicable to this submission.

The document discusses non-clinical performance testing for the physical device, focusing on mechanical properties, sterilization, packaging, and biocompatibility, to demonstrate substantial equivalence to previously cleared predicate devices.

Key points from the document regarding "performance":

• Non-Clinical Performance: This section details various engineering and material tests performed on the physical implants, such as dynamic and static bending, torsional stiffness, targeting accuracy, insertion torque, pull-out force, MRI assessment (magnetically induced displacement/torque, RF-induced heating, image artifacts), packaging tests, and biocompatibility evaluation. All these tests are standard for orthopedic implants.
• Clinical Performance: The document explicitly states: "Clinical data were not needed for the subject devices to demonstrate substantial equivalence to the predicate devices." This is a common situation for 510(k) submissions of physical devices where substantial equivalence can be demonstrated through non-clinical testing and comparison to predicates.

Since the request asks for information relevant to AI/software device performance, and this document is for a physical orthopedic device, I cannot extract the requested information (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone performance) because it is not present and not relevant to this specific biological device 510(k) submission.

In summary, there is no AI/software component in this device clearance that would require the types of performance statistics and study methodologies described in the prompt.

Ask a specific question about this device

The Reprocessed HARMONIC 700, 5 mm Diameter Shears with Advanced Hemostasis are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, pediatric, gynecologic, urologic, thoracic procedures, and sealing and transection of lymphatic vessels. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the Advanced Hemostasis hand control button.

The reprocessed HARMONIC 700 with Advanced Hemostasis are designed for soft tissue incisions requiring bleeding control and minimal thermal injury. The instruments serve as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in various procedures, including general, pediatric, gynecologic, urologic, and thoracic surgeries, as well as in the sealing and transection of lymphatic vessels. They enable the coagulation of vessels up to 7 mm in diameter using the Advanced Hemostasis hand control button.

The instruments are available in three (3) shaft lengths: 23cm, 36cm, and 45cm lengths (HAR723, HAR736, and HAR745 respectively). Each shaft length has a diameter of 5 mm. The following features are essential to the control and performance of the device:

• An actuating trigger that closes and releases the clamp arm, securing tissue against the scalpel rod.
• MIN/MAX control buttons that adjust energy levels between minimum and maximum modes on the generator, enabling vessel sealing up to 5 mm.
• An Advanced Hemostasis button that allows the clinician to activate an additional energy mode, enabling vessel sealing up to 7 mm.
• A rotation knob to rotate the shaft 360° unless energy is being delivered.
• A torque wrench, a sterile, single-use component, used to apply the correct amount of torque when attaching the Hand Piece to the device.

The instruments connect to a generator and hand piece, which are essential for the device's functionality but are outside the scope of this submission.
The hand piece is a reusable component that attaches to the device and plugs into the generator, allowing the device to interface with the generator. This component contains the transducer, which converts electrical power to ultrasonic mechanical energy.

The generator is a reusable component that generates the electrical signal. Colored light indicators on the front panel of the generator visually communicate device status information to the user.

This document is a 510(k) premarket notification for reprocessed medical devices, not an AI medical device. Therefore, the questions related to AI device performance, such as MRMC studies, training and test sets, ground truth establishment, and expert adjudication, are not applicable to the content provided.

However, I can extract the acceptance criteria and the study that proves the device meets those criteria from the provided text, focusing on the reprocessed medical device context.

Here's the information based on the provided FDA 510(k) letter for the Reprocessed HARMONIC 700 Shears:

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

The document describes functional performance tests conducted to demonstrate safety and effectiveness. While explicit numerical acceptance criteria values are not provided, the general categories of testing imply the criteria for performance equivalence to the predicate device. The reported performance is that the device meets these criteria and is at least as safe and effective as the predicate.

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

• Sample Size: The document does not specify the exact sample sizes (number of devices or tests) for each bench and laboratory test.
• Data Provenance: The studies were conducted as part of the manufacturer's premarket notification submission to the FDA. They are internal validation studies performed by Stryker Sustainability Solutions. The document does not specify country of origin for the data or whether it was retrospective or prospective, but these studies for 510(k) submissions are typically prospective and specifically designed for the submission.
  • For the preclinical laboratory evaluations, an "animal model" was used.

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 traditional reprocessing medical device submissions. Ground truth in this context is established through engineering specifications, material science, and performance testing against established standards and predicate device performance, not expert consensus on medical images or patient outcomes.

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

Not applicable. Adjudication methods like 2+1 or 3+1 refer to human expert review processes for AI model output or image interpretation, which is not relevant for this type of device submission. Device performance is determined through standardized engineering and biological tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a reprocessed surgical instrument, not an AI-assisted diagnostic or therapeutic device. MRMC studies are specific to evaluating human reader performance with and without AI assistance in diagnostic imaging.

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

Not applicable. This is not an AI algorithm. Its performance is inherent to its physical properties and functionality.

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

The "ground truth" for this device's performance is established by:

• Engineering specifications and design requirements: The device must meet predefined physical, mechanical, and electrical parameters.
• Performance of the original (new) predicate device: The reprocessed device must demonstrate substantial equivalence in performance to the original, legally marketed predicate device.
• Established industry standards: Compliance with standards like ISO 10993-1 (Biocompatibility) and ISO 11135 (EO Sterilization) serves as a ground truth for safety aspects.
• Preclinical (animal) studies: In vivo performance (e.g., thermal spread, hemostasis) in animal models serves as a proxy for clinical performance.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of a reprocessed medical device. The device itself is manufactured and reprocessed, not "trained" like a machine learning model.

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 indications for use of these internal fixation devices include:

• Open and closed femoral fractures
• Pseudoarthrosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures and tumor resections
• Supracondylar fractures, including those with intraarticular extension
• Fractures involving osteopenic and osteoporotic bone
• Fractures distal to a total hip prosthesis
• Periprosthetic fractures
• Nonunions and malunions

The struts of the T2 Alpha Femur Retrograde Nailing System are intended to be used only with the nails of this system; they are not to be used as stand-alone devices.

T2 Alpha Femur Retrograde Nailing System, previously cleared in K203819, consists of sterile implants (intramedullary nails in various diameter and sizes, compression screw and end caps), as well as nonsterile instruments (targeting devices).

The subject of this 510(k) submission is to introduce new devices of the T2 Alpha Femur Retrograde Nailing System. This line extension consists of anatomically pre-contoured struts and interlinking dowels designed to be used in combination with the existing nails of the T2 Alpha Femur Retrograde System for the treatment of complex fractures of the distal femur.

All struts are manufactured from Ti6Al4V ELI (Type II anodization) and are available in different sizes and left/right versions; these will be provided both non-sterile and sterile packaged. Interlinking dowels to the femoral nail are manufactured from CoCr and will be provided sterile packaged.

This appears to be a 510(k) clearance letter for an orthopedic implant, not an AI/Software as a Medical Device (SaMD). The document describes the "T2 Alpha Femur Retrograde Nailing System," which is a physical device used for internal fixation of femoral fractures.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, expert ground truth, MRMC studies, standalone performance, and training/test set provenance does not apply to this clearance document. These criteria are typically evaluated for AI/SaMD products, where algorithmic performance and human-AI interaction are critical.

The provided document details:

• Device Type: Intramedullary fixation rod (physical implant).
• Performance Data: Non-clinical bench testing (fatigue strength, cut-out performance, stiffness, shear-off, pull-out, insertion, static bending, fretting corrosion, targeting accuracy, MR assessment, packaging) and references to clinical evidence from peer-reviewed scientific literature.
• Comparison to Predicate Devices: Focuses on material, manufacturing, intended use, and mechanical performance equivalence.

No mention of AI, algorithms, or software performance evaluation is present.

Ask a specific question about this device

The SPY Laparoscope is intended to be used for gynecological and general procedures that clinicians deem appropriate for the adult or pediatric patient aged one month or older, when the dimensions of the SPY Laparoscope are appropriate for the patient size and anatomy.

The SPY Laparoscope is part of Stryker's rigid endoscope product portfolio. The SPY Laparoscope is an optical instrument used to visualize or image a patient's anatomy during minimally invasive, endoscopic procedures for examination, diagnosis or therapy. The SPY Laparoscope transmits light in both the visible and near-infrared spectrum to illuminate the anatomy, then forms and relays the image of the surgical site to a camera system for image processing and display.

The provided FDA 510(k) clearance letter for the SPY Laparoscope primarily details bench testing and compliance with various recognized standards to demonstrate substantial equivalence to a predicate device. It explicitly states that "The subject device does not require clinical studies to support the determination of substantial equivalence."

Therefore, the information you've requested regarding acceptance criteria and study proving performance, particularly related to human-in-the-loop performance, multi-reader multi-case studies, and the specifics of clinical ground truth establishment, is not available in this document. The clearance is based on a demonstration of equivalent technical performance and safety through non-clinical testing.

Here's how we can address your request based on the provided text, focusing on the available information:

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing)

Since no clinical study data is presented, the "acceptance criteria" here refers to meeting the performance specifications and standards compared to the predicate device, primarily through bench testing.

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

Information Not Available (Due to Reliance on Non-Clinical Testing)

The following points cannot be addressed from the provided document because the 510(k) clearance was based on non-clinical testing for substantial equivalence, not on clinical performance studies involving human subjects or AI:

2. Sample size used for the test set and the data provenance: Not applicable in the context of clinical data. The "test set" here refers to the physical units of the SPY Laparoscope and reference devices used in the various bench tests. Data provenance is internal lab testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for bench testing is derived from metrology and engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an endoscope, not an AI-driven image analysis tool. The document explicitly states "The subject device does not require clinical studies to support the determination of substantial equivalence."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a hardware device; no AI algorithm is mentioned or evaluated in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For non-clinical tests, "ground truth" is defined by established engineering and optical standards, and measurements. For example, FOV measurements are compared against an acceptable range, not a clinical diagnosis.
8. The sample size for the training set: Not applicable. This is not an AI or machine learning device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary: The FDA clearance for the SPY Laparoscope, as described in this 510(k) summary, is based entirely on a demonstration of non-clinical substantial equivalence to a predicate device. This includes demonstrating equivalent optical performance, electrical safety, biocompatibility, reprocessing efficacy, and overall risk management. Clinical studies or studies involving human-in-the-loop performance, AI, or advanced diagnostic accuracy metrics were not part of this clearance process.

Ask a specific question about this device

The SPY Cystoscopes/Hysteroscopes are intended to provide visualization in general urological and gynecological surgery through the minimally invasive approach, by utilizing natural orifices to access the surgical site.

The SPY Cystoscope/Hysteroscope is part of Stryker's rigid endoscope product portfolio. The SPY Cystoscope/Hysteroscope is an optical instrument used to visualize or image a patient's anatomy during minimally invasive, endoscopic procedures for examination, diagnosis or therapy. The SPY Cystoscope/Hysteroscope transmits light in the visible spectrum to illuminate the anatomy, then forms and relays the image of the surgical site to a camera system for image processing and display.

Based on the provided FDA 510(k) clearance letter for the SPY Cystoscope/Hysteroscope (K252012), here's a description of the acceptance criteria and the study that proves the device meets them:

Important Note: The provided document is a 510(k) clearance letter, which summarizes the information submitted by the manufacturer. It does not contain the full details of the testing performed. Therefore, some of the requested information (especially regarding specific test methodologies, exact sample sizes for training/test sets, expert qualifications, and ground truth establishment details) is not explicitly stated in this summary. I will highlight what is present and what is inferred based on standard regulatory practices for this type of device.

Study Proving Device Meets Acceptance Criteria

The study performed to demonstrate the device meets acceptance criteria was a non-clinical performance and safety evaluation, primarily involving bench testing. This approach is common for optical, non-diagnostic devices like endoscopes, where functionality can be objectively measured. The submission explicitly states, "The subject device does not require clinical studies to support the determination of substantial equivalence."

1. Table of Acceptance Criteria and Reported Device Performance

The letter outlines the types of non-clinical tests performed, implying these are the areas for which performance criteria were established. While the letter doesn't provide specific numerical acceptance thresholds or the exact measured values, it states that the testing "demonstrates the device conforms with design input requirements, user needs and intended uses."

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

• Sample Size: The document does not specify the exact sample sizes (e.g., number of devices tested) for the non-clinical bench tests. For most bench testing, typically a representative sample or a statistically significant number of production units are tested to ensure consistency and meet specifications.
• Data Provenance: This was non-clinical bench testing, not human data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" do not directly apply to the primary performance testing.

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

• Not Applicable: Since this device is an optical instrument for visualization (not an AI/diagnostic algorithm interpreting images), and the testing was non-clinical bench testing, "experts" in the sense of clinical reviewers establishing ground truth for a test set (e.g., radiologists reading images) were not involved in the direct performance evaluation of the device's optical properties. The "ground truth" for these tests would be the established engineering and optical performance specifications.

4. Adjudication Method for the Test Set

• Not Applicable: Given that the performance evaluation was based on objective, quantitative bench testing (e.g., measuring MTF, FOV, transmission), there was no need for human adjudication of test results in the way one would adjudicate case labels for diagnostic AI. The results are based on instrumental measurements compared against specifications.

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

• No: The document explicitly states: "The subject device does not require clinical studies to support the determination of substantial equivalence." An MRMC study is a clinical study involving human readers. Therefore, no MRMC study was performed or required for this 510(k) clearance.
• Effect Size: Not applicable as no MRMC study was conducted.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Not Applicable: This device is a physical optical instrument (cystoscope/hysteroscope), not an AI algorithm. Therefore, the concept of "standalone algorithm performance" does not apply. Its performance is its ability to transmit light and form an image according to specifications, which was evaluated via bench testing.

7. The Type of Ground Truth Used

• Engineering/Optical Specifications: The ground truth for this device's performance evaluation was established through pre-defined engineering and optical specifications (design input requirements) that the device must meet (e.g., a specific MTF value, a defined FOV range, acceptable levels of distortion, etc.). These specifications are typically derived from industry standards, predicate device performance, and user needs.

8. The Sample Size for the Training Set

• Not Applicable: This is a hardware device; thus, it does not have a "training set" in the context of machine learning. The design and manufacturing processes are refined through engineering, prototyping, and iterative testing, not through training on data.

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

• Not Applicable: As there is no "training set," this question is not relevant for this device. Ground truth for hardware development is established through engineering design principles, materials science, and manufacturing tolerances.

Summary of Approach:

The clearance for the SPY Cystoscope/Hysteroscope relied on a "Comparison to Predicate" approach, underpinned by extensive non-clinical bench testing to demonstrate that the new device's different technological characteristics (specifically smaller outer diameter and increased field-of-view) "do not raise different questions of safety or effectiveness" compared to the predicate devices. The safety and effectiveness were established by confirming the device met its design specifications for various optical and mechanical parameters.

Ask a specific question about this device

The Knotilus+ Biocomposite Knotless Anchor is intended to be used for soft-tissue to bone fixation in the shoulder, foot and ankle, knee, hand and wrist, elbow, and hip in skeletally mature pediatric and adult patients. It is indicated for use in the following procedures:

2.4x11.3mm, 2.9x12.5mm, and 2.9x15.5mm:

• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift, or Capsulolabral Reconstruction
• Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament and Tendon Repair
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
• Hand and Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair
• Hip: Acetabular Labral Repair

2.4x8.9mm:

• Hip: Acetabular Labral Repair

The Knotilus+ Biocomposite Knotless Anchors are hard-body, push-in, knotless bone anchors. The subject device is comprised of a poly-ether-ether-ketone (PEEK) eyelet and poly-L-lactide ("PLLA") and beta-tricalcium phosphate ("β-TCP") anchor body, pre-assembled onto a disposable stainless-steel inserter, which enables insertion of the anchor into bone after creation of a pilot hole. The devices are single use, provided sterile, and are packaged in sterile barrier systems (SBS).

It appears there has been a misunderstanding. The FDA 510(k) clearance letter you provided is for a Knotilus+ Biocomposite Knotless Anchor, which is a medical device used for soft-tissue to bone fixation. This is a physical, implantable device, not a software or AI-driven diagnostic tool.

The questions you've asked (about acceptance criteria, test set sample sizes, data provenance, expert ground truth, MRMC studies, standalone algorithm performance, training set details, etc.) are highly relevant to the validation of Artificial Intelligence (AI) or machine learning (ML) medical devices, particularly those performing image analysis or diagnostic functions.

Since the provided document describes a physical bone anchor device, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they relate to AI/ML performance metrics (like sensitivity, specificity, AUC, etc., derived from test sets and human expert evaluations) does not apply.

For a physical device like a bone anchor, "acceptance criteria" would typically relate to:

• Mechanical properties: E.g., Ultimate Tensile Strength (UTS), pull-out strength, fatigue life, torsional strength.
• Biocompatibility: Absence of adverse tissue reactions.
• Sterility: Ensuring the device is free from microorganisms.
• Dimensional accuracy: Conforming to design specifications.
• Material properties: Chemical composition, degradation rates (for biocomposite materials).

The document states that "Non-clinical benchtop testing was performed to evaluate the performance characteristics of the Knotilus+ Biocomposite Knotless Anchor, including ultimate tensile strength (UTS), UTS after Cyclic Loading, UTS after Degradation, and insertion testing." It also mentions "Bacterial endotoxin testing." These are the types of studies that prove this device meets its performance and safety acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions related to AI/ML device validation based on the provided document because it describes a different class of medical device.

If you have a document related to an AI/ML medical device, please provide that, and I will be happy to answer your questions accordingly.

Ask a specific question about this device

The Stryker AlphaVent™ Knotless SP Biocomposite Anchor is intended to be used for soft-tissue to bone fixation in the shoulder, foot and ankle, knee, hand and wrist, elbow, and hip in skeletally mature pediatric and adult patients. It is indicated for use in the following procedures:

• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair
• Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair, Secondary or Adjunct Fixation for ACL/PCL Reconstruction or Repair, Meniscal Root Repair, MPFL Repair/Reconstruction
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Reconstruction, Lateral Epicondylitis Repair
• Hip: Capsular Repair, Acetabular Labral Repair, Gluteus Medius Repair, Proximal Hamstring Repair

The AlphaVent Knotless SP Biocomposite Anchors (herein referred to as the subject device(s)) are bone anchors with a screw-in mechanism. The subject device is comprised of a poly-ether-ether-ketone (PEEK) eyelet and a biocomposite (Poly-L-lactic Acid (PLLA)/beta-tricalcium phosphate (β-TCP)) anchor body, pre-assembled onto a disposable stainless-steel inserter, which enables insertion of the anchor into bone either via a self-punching mechanism or after creation of a pilot hole. The devices are single use, provided sterile, and are packaged in sterile barrier systems (SBS).

This FDA 510(k) clearance letter is for a medical device (Stryker AlphaVent™ Knotless SP Biocomposite Anchor), not an AI/ML medical device. Therefore, a significant portion of the requested information (items 2-5, 7-9) is not applicable as these relate specifically to studies conducted for AI/ML performance evaluation.

However, I can extract and present the relevant information regarding acceptance criteria and performance testing for this physical medical device.

Acceptance Criteria and Study for Stryker AlphaVent™ Knotless SP Biocomposite Anchor

Based on the provided FDA 510(k) summary, the device is a physical implant, and its performance is evaluated through non-clinical benchtop testing. The acceptance criteria are implicitly defined by demonstrating equivalence or superiority to predicate devices in key performance areas.

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 the exact sample sizes used for the non-clinical benchtop testing (e.g., number of anchors tested for UTS or insertion). The testing is described as "non-clinical benchtop testing," which implies laboratory-based experiments rather than human or animal studies. Therefore, provenance such as country of origin or retrospective/prospective is not applicable in the same way it would be for clinical data.

3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This device is a physical implant, and its performance is assessed through objective, quantitative, non-clinical benchtop tests, not through expert interpretation of data or images.

4. Adjudication Method for the Test Set
Not applicable. The performance is determined by objective physical measurements and comparisons, not through adjudication by experts.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
Not applicable. This is not an AI/ML device that assists human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.

7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through objective physical measurements and laboratory standards. For example:

• Ultimate Tensile Strength (UTS): Measured in a lab using force-testing equipment against established engineering standards and comparison with predicate device performance.
• Insertion Performance: Evaluated against defined mechanical parameters and successful deployment in simulated "worst-case" conditions.
• Bacterial Endotoxin Testing: Measured against predefined regulatory limits for endotoxin levels (e.g., ISO or USP standards).

8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of an AI/ML algorithm for this physical device.

9. How the Ground Truth for the Training Set was Established
Not applicable. There is no "training set" for an AI/ML algorithm.

Ask a specific question about this device