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510(k) Data Aggregation
(87 days)
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.
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(86 days)
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
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Ultimate Tensile Strength (UTS) | Statistically equivalent or higher UTS compared to predicate devices immediately after insertion, after cyclic loading, and after accelerated degradation at multiple time points through the anticipated duration of healing. | This demonstrates the device's mechanical strength and durability over time, comparable to or better than existing approved devices. |
| Insertion Performance | Successful insertion confirmed under worst-case conditions. | This indicates the device can be reliably implanted in challenging scenarios. |
| Bacterial Endotoxin Levels | Passing results below the required limits. | This confirms the device meets sterility and biocompatibility requirements. |
| Design, Intended Use, Indications for Use, Implantation Technique (in comparison to Primary Predicate K233893) | Identical | This establishes direct equivalence in fundamental aspects to the primary predicate. |
| Intended Use, Indications for Use, Raw Material for Implantation, General Anchor System Design Features (in comparison to Secondary Predicate K203495) | Identical (for intended use, indications for use, raw material for implantation); Equivalent (for general anchor system design features) | This establishes equivalence to the secondary predicate in key areas, despite some differences. |
| Overall Safety and Effectiveness | Raises no new questions of safety or effectiveness and is substantially equivalent to the predicate devices. | This is the overarching conclusion required for 510(k) clearance. |
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.
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(48 days)
Stryker AlphaVent PEEK Suture Anchor (K231093)
The AlphaVent Knotless SP PEEK 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 PEEK Anchors (herein referred to as the subject device(s)) are bone anchors with a screw-in mechanism. The subject device system is comprised of a poly-ether-etherketone (PEEK) eyelet and anchor body, pre-assembled onto a disposable stainless-steel inserter, which enables insertion of the anchor into bone via self-punching or after creation of a pilot hole. The devices are single use, provided sterile, and are packaged in sterile barrier systems (SBS). The AlphaVent Knotless SP PEEK Anchors are sterilized via Ethylene Oxide to a Sterility Assurance Level of 106. The devices are intended to be used in a professional healthcare facility.
This document is a 510(k) summary for the AlphaVent Knotless SP PEEK Anchor, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance in the way typically seen for a diagnostic or AI-driven device.
Therefore, many of the requested categories for describing acceptance criteria and a study proving device performance are not applicable or cannot be extracted from this type of regulatory submission. This document highlights benchtop testing for product safety and equivalence, not clinical performance against ground truth.
Here's an attempt to answer the questions based only on the provided text, indicating when information is not present:
Acceptance Criteria and Device Performance Study (Based on 510(k) Summary)
This 510(k) summary focuses on demonstrating substantial equivalence of the AlphaVent Knotless SP PEEK Anchor to a legally marketed predicate device (Arthrex SwiveLock Anchor, K203495) and a reference device (Stryker AlphaVent PEEK Suture Anchor, K231093). The "study" described is a series of non-clinical benchtop tests, a biological risk assessment, and bacterial endotoxin testing, designed to show the new device performs at least as safely and effectively as the predicate.
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Ultimate Tensile Strength (UTS) | Equivalent or higher UTS as compared to predicate devices | Demonstrated equivalent or higher UTS as compared to the predicate devices | Non-clinical benchtop testing. No specific numerical values provided for criteria or performance; reported comparatively. |
| Insertion Testing | Successful insertion | Successful insertion | Non-clinical benchtop testing. No specific metrics provided. |
| Biological Risk Assessment | Met requirements of ISO10993-1 | Met requirements of ISO10993-1 | |
| Bacterial Endotoxin Testing (LAL test) | ).** The performance is measured against these objective criteria rather than subjective human interpretation or clinical outcomes data presented in this document. |
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. (See point 8).
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(53 days)
The Knotilus+ PEEK 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+ PEEK Knotless Anchors (herein referred to as the subject device(s)) are bone anchors with a push-in mechanism. The subject device system is comprised of a poly-ether-etherketone (PEEK) eyelet and anchor, 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).
The provided text is a 510(k) premarket notification clearance letter for the Stryker Endoscopy Knotilus+ PEEK Knotless Anchor. It details the device's intended use, regulatory classification, and a summary of performance testing and conclusions regarding its substantial equivalence to predicate devices. However, the document does not contain the kind of detailed information typically found in a study report for an AI/software device, such as specific acceptance criteria for performance metrics, detailed sample sizes for training or test sets, data provenance, expert qualifications, adjudication methods, or MRMC study results.
The device in question, the Knotilus+ PEEK Knotless Anchor, is a physical medical device (a bone anchor) and not an AI or software-driven device. Therefore, the questions related to AI/software performance criteria, ground truth, expert adjudication, and MRMC studies are not applicable to this submission.
Here's a breakdown of the information that can be extracted relevant to the device and its testing, and why other requested information is not present:
1. Table of acceptance criteria and the reported device performance
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Ultimate Tensile Strength (UTS) | Sufficiently strong for soft-tissue to bone fixation, comparable to or exceeding predicate devices. | "The proposed devices demonstrated higher pull-out strength as compared to the predicate devices." (Quantitative values not provided in this summary) |
| Insertion Performance | Successful insertion into bone after creation of a pilot hole. | "Successful insertion." |
| Bacterial Endotoxin | Below required limits. | "Passing results below the required limits." |
| Safety and Effectiveness | No new issues of safety and effectiveness identified. | "No new issues of safety and effectiveness were identified." |
| Substantial Equivalence | Demonstrates equivalence to predicate devices in terms of intended use, indications for use, raw materials, general anchor system design, and operational principle. | Concluded that the device is "substantially equivalent to the predicate devices, and will perform as safely and effectively within the intended use." |
Study that proves the device meets the acceptance criteria:
The document states: "Non-clinical benchtop testing was performed to evaluate the performance characteristics of the Knotilus+ PEEK Knotless Anchor, including ultimate tensile strength (UTS) and insertion testing." It also mentions "Bacterial endotoxin testing was performed on the Knotilus+ PEEK Knotless Anchor".
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. These details are typically found in a full test report, which is not part of this clearance letter. Given this is a physical device, "data provenance" like country of origin for clinical data or retrospective/prospective studies is generally not applicable to bench testing, which uses manufactured device samples.
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 is not applicable as this is a physical medical device, not an AI/software device requiring "ground truth" established by human experts in the context usually meant for AI. The performance testing (tensile strength, insertion, endotoxin) are objective measurements performed in a laboratory setting according to engineering and bioload testing standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a physical medical device. Adjudication methods are relevant for subjective assessments, often in clinical trials or AI performance evaluations, not for objective benchtop engineering 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. MRMC studies are used to evaluate diagnostic imaging systems or AI software performance in clinical settings. This device is a surgical implant, and no such study type would be relevant to its clearance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For physical benchtop testing, the "ground truth" is typically the quantitative measurement obtained through calibrated testing equipment using established engineering and material science methodologies. For example, the "ground truth" for ultimate tensile strength is the physical force recorded by the testing machine at the point of failure.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical device, not an AI model requiring a training set and associated ground truth establishment.
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