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OC JuggerKnot® Soft Anchor are intended for use in soft tissue to bone fixation for the following indications:

The OC JuggerKnot® Soft Anchor is comprised of a suture sleeve structure and working suture. Non-absorbable braided ultra-high molecular weight polyethylene (UHMWPE) sutures are spliced through a non-absorbable braided polyester suture anchor sleeve. Up to three non- absorbable round and flat braided UHMWPE working sutures can be added inside the suture anchor sleeve. The UHMWPE sutures are available undyed (white), blue, black or with or without a stainless steel needle attached. Available Suture sizes are standard according to USP requirements (dependent on suture type). The hydroxyapatite and bioceramic particles are embedded in the surface of the suture anchor material.

Suture supplied meet United States Pharmacopeia (USP) requirements for nonabsorbable suture except for diameter. Suture dyes are FDA approved. The inserter is comprised of a metallic shaft with a self-punching tip and an overmolded handle. The device is sterilized by ethylene oxide gas, and is provided sterile for single use. OC JuqgerKnot® Soft Anchors are available in common sizes and lengths with or without pre-attached 302 stainless steel needles and will be sold sterile for single use with no components or accessories. The device is intended for use in a hospital/clinic/surgical setting.

The provided text describes a medical device, the "OC JuggerKnot® Soft Anchor," and its FDA 510(k) submission for substantial equivalence. However, the document does not contain the specific acceptance criteria, reported device performance metrics in a table, or details of a study that proves the device meets specific performance criteria in the format the user requested.

Instead, the document primarily focuses on establishing substantial equivalence to a predicate device (K232411 – Riverpoint Medical JuggerKnot® Soft Anchor with OC Coating) and a reference device (K231128 – Riverpoint Medical JuggerKnot® Soft Anchor).

Based on the information provided, here's what can be extracted and what is missing:

Missing Information:

• A table of specific numerical acceptance criteria and reported device performance.
• Sample size used for the test set and data provenance.
• Number of experts and their qualifications for establishing ground truth.
• Adjudication method for the test set.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Detailed results of a standalone (algorithm only) performance study.
• Specific ground truth type (e.g., pathology, outcomes data) for non-mechanical tests.
• Sample size for the training set.
• How the ground truth for the training set was established.

Information that can be inferred or directly stated from the document regarding the study and performance:

The document mentions non-clinical mechanical testing and usability engineering validation.

Study Description (Inferred and direct quotes):

The device underwent non-clinical mechanical testing and usability engineering validation.

• Non-clinical Mechanical Testing:

  • Purpose: To verify the fixation strength of the OC JuggerKnot® Soft Anchor with self-punching inserter.
  • Types of tests: Insertion, cyclic, and pullout testing.
  • Comparison: Compared to the predicate device and other currently marketed soft anchor devices with self-punching inserters.
  • Conclusion: "Results of performance testing for the OC JuggerKnot® Soft Anchor device with self-punching inserter concluded that the device performed comparably to the predicate device and to other currently marketed soft anchor devices with self-punching inserters in insertion, cyclic and pullout testing and the validations performed demonstrated that the OC JuggerKnot® Soft Anchor with selfpunching inserter met all requirements for its intended use."

• Usability Engineering Validation:

  • Purpose: Performed per EN62366: 2015- Medical devices - Application of usability engineering to medical devices.
  • Methodology: Involved "simulated use in a cadaveric models."

• Other Testing Mentioned:

  • Endotoxin/pyrogenicity testing per ANSI/AAMI ST72:2019, USP , USP and USP .
  • Suture testing per USP performance requirements for needle attachment and tensile strength.

Regarding your specific questions:

1. A table of acceptance criteria and the reported device performance:
   Not explicitly provided in the document. The document states that "the device performed comparably to the predicate device and to other currently marketed soft anchor devices with self-punching inserters in insertion, cyclic and pullout testing" and "met all requirements for its intended use," but specific numerical criteria and corresponding performance values are absent.

2. Sample size used for the test set and the data provenance:
   Not explicitly stated for the mechanical testing or usability studies. For the usability study, it mentions "cadaveric models" but not the number. Data provenance (e.g., country of origin, retrospective/prospective) is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Not applicable or not stated as this is a physical medical device, not an AI/software system requiring expert consensus for ground truth on disease detection. The "ground truth" for mechanical testing would be the physical outcome measurements.

4. Adjudication method for the test set:
   Not applicable or not stated.

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 physical surgical anchor, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. This is a physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   For mechanical testing, the ground truth would be physical measurements of fixation strength (e.g., load at failure, displacement) under controlled conditions. For usability, it would involve evaluation of user interaction and safety in a simulated environment.

8. The sample size for the training set:
   Not applicable as this is a physical device.

9. How the ground truth for the training set was established:
   Not applicable.

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JuggerKnot Soft Anchor OC are intended for use in soft tissue to bone fixation for the following indications: Knee MPFL Knee Patellar tendon repair Knee MCL Knee Quadriceps tendon repair Hip Acetabular labral repair Hip Proximal hamstring repair Hip Hip Labral reconstruction Foot and Ankle Achilles tendon repair Foot and Ankle Medial/lateral repair and reconstruction Foot and Ankle Plantar plate repair Foot and Ankle Mid- and forefoot repair Foot and Ankle Metatarsal ligament/tendon repair or reconstruction Shoulder Rotator Cuff Shoulder Shoulder Instability Shoulder Biceps Tenodesis Elbow Lateral epicondylitis repair Elbow Biceps tendon reattachment

The JuggerKnot Soft Anchor OC is identical to the previously cleared JuggerKnot Soft Anchor OC except for the presence of a bioceramics embedded in the anchor portion of the device. The JuggerKnot Soft Anchor OC is comprised of a suture sleeve structure and working suture. Nonabsorbable braided ultra-high molecular weight polyethylene (UHMWPE) sutures are spliced through a suture anchor sleeve comprised of non-absorbable braided polyester. Up to two nonabsorbable round or flat braided UHMWPE working sutures can be added inside the suture anchor sleeve. The UHMWPE sutures are available undyed (white) and black. The hydroxyapatite and bioceramic particles are embedded in the surface of the suture anchor material. Sutures supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. Suture dyes are FDA approved. The inserter is comprised of a metallic shaft with over molded handle. The device is sterilized by ethylene oxide gas and is provided sterile for single use. The JuggerKnot Soft Anchor OC are available in common sizes and lengths and will be sold sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.

The provided text describes a medical device, the JuggerKnot Soft Anchor OC, and its clearance under a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a full clinical trial to prove efficacy and safety from scratch.

Therefore, the specific information requested about acceptance criteria and a study proving the device meets those criteria (especially in terms of diagnostic performance, human reader improvement with AI assistance, standalone algorithm performance, and ground truth establishment for training and test sets) is not applicable in the context of this 510(k) submission.

The document focuses on non-clinical performance testing and substantial equivalence to a predicate device, as opposed to a diagnostic device for which such performance metrics would be relevant.

Here's a breakdown based on the information provided and what is implied by a 510(k) submission for this type of device:

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

   • Acceptance Criteria: For this device (a bone fixation fastener), acceptance criteria are primarily related to mechanical performance, biocompatibility, sterilization, and material properties, demonstrating it is as safe and effective as the predicate.
   • Reported Device Performance:
     • Mechanical Testing: "performed comparably to the predicate device in insertion, cyclic and pullout testing."
     • Sterilization: "sterilization adoption validation"
     • Biocompatibility: "biocompatibility testing per ISO10993- 1:2018"
     • Stability: "stability testing on the product packaging per ISO 11607-1:2006"
     • Usability Engineering: "usability engineering validation with simulated use in a cadaveric models performed per EN62366: 2015"
     • Endotoxin/Pyrogenicity: "Endotoxin/pyrogenicity testing was performed per ANSI/AAMI ST72:2019, USP , USP and USP ."

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

   • Test Set (for mechanical and other non-clinical tests): Not explicitly stated numbers for each test, but standard engineering and biological testing samples would have been used.
   • Data Provenance: The tests were likely conducted in laboratories or facilities chosen by the manufacturer, Riverpoint Medical, LLC, which is based in Portland, Oregon, USA. The studies are prospective in the sense that they were conducted for the purpose of this submission.
   • Animal Study: "An animal study was performed to evaluate the biological safety and in vivo performance associated with the JuggerKnot Soft Anchor OC." No specific animal numbers are provided.

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 the device is a medical implant (bone fixation fastener), not a diagnostic device requiring expert interpretation of images or other medical data for ground truth. Ground truth for this device relates to physical and biological properties.

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

   • This is not applicable for the reasons stated above. Adjudication methods are typically for diagnostic interpretations.

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 is not applicable. The device is an implantable fastener, not an AI-assisted diagnostic tool.

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

   • This is not applicable. The device is a physical implant, not an algorithm.

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

   • For the non-clinical tests, the "ground truth" is based on established engineering standards, material science properties, and biological safety parameters. For the animal study, the "ground truth" would be the observed biological response to the implant in vivo.

8. The sample size for the training set:

   • This is not applicable. This is a physical device submission; there is no "training set" in the context of machine learning or AI.

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

   • This is not applicable for the reason stated above.

Ask a specific question about this device

JuggerKnot® Soft Anchors are intended for soft tissue to bone fixation for the following indications: Knee MPFL Knee Patellar tendon repair Knee MCL Knee Quadriceps tendon repair Foot and Ankle Achilles tendon repair Foot and Ankle Medial/lateral repair and reconstruction Foot and Ankle Plantar plate repair Foot and Ankle Mid- and forefoot repair Foot and Ankle Metatarsal ligament/tendon repair or reconstruction Shoulder Rotator Cuff Shoulder Shoulder Instability Shoulder Biceps Tenodesis Elbow Lateral epicondylitis repair Elbow Biceps tendon reattachment

The JuggerKnot® Soft Anchor is comprised of a suture sleeve structure and working suture. Non-absorbable braided ultra-high molecular weight polyethylene (UHMWPE) sutures are spliced through a non-absorbable braided polyester suture anchor sleeve. Up to three nonabsorbable round and flat braided UHMWPE working sutures can be added inside the suture anchor sleeve. The UHMWPE sutures are available undyed (white), blue, black or with or without a stainless steel needle attached. Available Suture sizes are standard according to USP requirements (dependent on suture type). Suture supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. Suture dyes are FDA approved. The inserter is comprised of a metallic shaft with a self-punching tip and an overmolded handle. The device is sterilized by ethylene oxide gas, and is provided sterile for single use. JuggerKnot® Soft Anchors are available in common sizes and lengths with or without pre-attached 302 stainless steel needles and will be sold sterile for single use with no components or accessories. The device is intended for use in a hospital/clinic/surgical setting.

The provided text is a 510(k) summary for a medical device (JuggerKnot® Soft Anchor) that has received FDA clearance. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the manner of an AI/ML algorithm or diagnostic test.

Therefore, the information required to populate the fields related to AI/ML device performance (like "acceptance criteria table," "sample size for the test set," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "training set sample size," and "ground truth for training set") is not present in the provided document.

The document describes non-clinical mechanical testing and usability engineering validation, but these are not the types of studies that would generate the performance metrics typically requested for an AI/ML or diagnostic device's acceptance criteria table.

Here's a breakdown of what is available and what is not:

Information Present in the Document (relevant to general device clearance, but not AI/ML specific):

• Device Name: JuggerKnot® Soft Anchor
• Intended Use/Indications for Use: Detailed list of soft tissue to bone fixation indications (e.g., Knee MPFL, Shoulder Rotator Cuff).
• Predicate Device: K203740 – Riverpoint JuggerKnot® Soft Anchor.
• Performance Data (General):
  • Sutures meet USP requirements (except diameter).
  • UMHWPE sutures tested for needle attachment and tensile strength per USP.
  • Followed FDA Guidance documents for "Bone Anchors" and "Surgical Sutures."
  • Biocompatibility, sterilization method, packaging, material stability are the same as the predicate.
  • Non-clinical performance testing:
    • Usability engineering validation with simulated use in cadaveric models per EN62366:2015.
    • Endotoxin/pyrogenicity testing per ANSI/AAMI ST72:2019, USP , USP , USP .
    • Mechanical testing (insertion, cyclic, and pullout testing) comparing to predicate and other marketed soft anchor devices.
• Conclusion: Device performed comparably to the predicate and met all requirements for its intended use, demonstrating substantial equivalence.

Information NOT Present in the Document (required for the requested AI/ML acceptance criteria study description):

1. A table of acceptance criteria and the reported device performance: This document does not present performance in terms of sensitivity, specificity, accuracy, or similar metrics typically seen for AI/ML or diagnostic devices. Instead, it discusses mechanical performance relative to a predicate.
2. Sample sized used for the test set and the data provenance: No "test set" in the context of an AI/ML algorithm is mentioned. The mechanical testing implicitly used a "test set" of anchors, but the size and provenance are not detailed, nor is it the type of test set requested (e.g., patient data).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no diagnostic ground truth being established.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This is not an AI-assisted diagnostic device.
6. Standalone performance: While the device has "standalone performance" as a mechanical anchor, this isn't relevant to "algorithm only without human-in-the-loop performance."
7. The type of ground truth used: Not applicable in the AI/ML context. Ground truth for a mechanical device is its physical performance characteristics.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes the clearance of a mechanical medical device (a surgical anchor) based on its substantial equivalence to an existing predicate. It does not pertain to an AI/ML algorithm or a diagnostic device, and therefore, the requested information regarding AI/ML acceptance criteria and study details cannot be extracted from this text.

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JuggerKnot® Soft Anchors are intended for use in soft tissue to bone fixation for the following indications:
Knee MPFL
Knee Patellar tendon repair
Knee MCL
Knee Quadriceps tendon repair
Hip Acetabular labral repair
Hip Proximal hamstring repair
Hip Hip Labral reconstruction
Foot and Ankle Achilles tendon repair
Foot and Ankle Medial/lateral repair and reconstruction
Foot and Ankle Plantar plate repair
Foot and Ankle Mid- and forefoot repair
Foot and Ankle Metatarsal ligament/tendon repair or reconstruction
Shoulder Rotator Cuff
Shoulder Shoulder Instability
Shoulder Biceps Tenodesis
Elbow Lateral epicondylitis repair
Elbow Biceps tendon reattachment

The JuggerKnot® Soft Anchor is comprised of a suture sleeve structure and working suture. Non-absorbable braided ultra-high molecular weight polyethylene (UHMWPE) sutures are spliced through a non-absorbable braided polyester suture anchor sleeve. Up to three nonabsorbable round and flat braided UHMWPE working sutures can be added inside the suture anchor sleeve. The UHMWPE sutures are available undyed (white), blue, black or with or without a stainless steel needle attached. Available Suture sizes are standard according to USP requirements (dependent on suture type).
Suture supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. Suture dyes are FDA approved. The inserter is comprised of metallic shaft with overmolded handle. The device is sterilized by ethylene oxide gas, and is provided sterile for single use. JuggerKnot® Soft Anchors are available in common sizes and lengths with or without pre-attached 302 stainless steel needles and will be sold sterile for single use with no components or accessories. The device is intended for use in a hospital/clinic/surgical setting.

The provided document describes the JuggerKnot® Soft Anchor device and its substantial equivalence to a predicate device (K150768 – Zimmer Biomet JuggerKnot® Soft Anchor). This document is a 510(k) summary, which focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. It addresses performance testing but not in the format of a clinical study with detailed acceptance criteria, sample sizes, expert involvement, or comparative effectiveness studies of human readers with and without AI.

Therefore, much of the requested information regarding detailed acceptance criteria, a specific study proving device meets criteria, sample sizes for test/training sets, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, and standalone performance for an AI/algorithm-based device is not applicable to this submission, as the JuggerKnot® Soft Anchor is a physical medical device (a soft anchor for tissue fixation), not an AI/software device.

However, I can extract information related to the performance data provided for the physical device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of specific quantitative acceptance criteria or detailed reported performance values for mechanical testing. Instead, it states that the device "performed comparably to the predicate device and to other currently marketed soft anchor devices."

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

• Sample Size: Not explicitly stated for mechanical or bench testing. Performance testing normally involves a defined number of units, but "sample size" in the context of an AI device's test set (e.g., number of images or cases) is not relevant here.
• Data Provenance: The usability engineering validation involved "simulated use in a cadaveric models." This implies the data originates from cadaveric human tissue. It is not specified if these cadavers are from a particular country or origin.
• Retrospective or Prospective: Not applicable in the context of this type of device testing.

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

• Experts: Not applicable for mechanical bench testing or biocompatibility where ground truth is established by objective measurements against established standards.
• Qualifications: For usability testing ("simulated use in a cadaveric models"), it is implied that qualified surgeons or medical professionals would perform the simulated use, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

• Not applicable as this is not an AI/algorithm-based diagnostic device requiring expert adjudication of results. Ground truth for most tests (e.g., tensile strength, sterilization) is determined by quantitative measurements against standards.

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

• No. This is a physical medical device, not an AI/diagnostic software. MRMC studies are not relevant.

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

• No. This is a physical medical device. "Standalone performance" in the context of an algorithm is not relevant.

7. The Type of Ground Truth Used

• For Mechanical Properties (Insertion, Cyclic, Pullout): Comparative performance against a legally marketed predicate device (K150768 JuggerKnot® Soft Anchor) and "other currently marketed soft anchor devices." The criteria for comparability would be defined by the mechanical testing protocols.
• For Material and Biological Properties: Conformance to established international standards (e.g., USP, ISO 10993-1, ISO 11607-1, EN62366, ANSI/AAMI ST72).

8. The Sample Size for the Training Set

• Not applicable. This device does not use a "training set" in the context of machine learning or AI.

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

• Not applicable. This device does not use a "training set" in the context of machine learning or AI.

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The JuggerKnot Soft Anchors are intended for soft tissue to bone fixation for the following indications:

Shoulder: Bankart lesion repair, SLAP lesion repair, Acromio-clavicular repair, Capsular shift/capsulolabral reconstruction. Deltoid repair, Rotator cuff tear repair, Biceps tenodesis, Pectoralis major repair

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, Iliotibial band tenodesis, Patellar tendon repair, VMO advancement, Joint capsule closure, Medial Patellofemoral Ligament (MPFL) repair or reconstruction, Quadriceps tendon repair

Hand and Wrist: Collateral ligament repair, Scapholunate ligament reconstruction, Tendon transfers in phalanx, Volar plate reconstruction

Hip: Acetabular labral repair, Proximal hamstring repair

The JuggerKnot Self-Punching Soft Anchors are intended for soft tissue to bone fixation for the following indications:

Shoulder: Rotator cuff tear repair

Foot and Ankle: Achilles tendon repair

The JuggerKnot Soft Anchors consists of a coreless sleeve structure and suture. The anchors are intended for use in soft tissue fixation by bunching against bone when deployed.

The provided text is a 510(k) premarket notification for the "JuggerKnot Soft Anchors" and "JuggerKnot Self-Punching Soft Anchor" for soft tissue to bone fixation. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a study with defined performance metrics.

Therefore, much of the requested information (like a table of acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC study results, and detailed ground truth methodology) is not available in the provided document. The document describes a comparison to a predicate device, not a standalone performance study against pre-defined acceptance criteria.

Here's an attempt to answer the questions based only on the provided text, highlighting what is not available due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the provided document. The document describes a comparison to a predicate device, not performance against pre-defined acceptance criteria. The performance data is stated as:

"The test results indicate that the JuggerKnot Soft Anchors achieved statistically equivalent or greater pullout strength to the predicate device and would be functional within their intended use."

The acceptance criterion, by inference, was demonstrating "statistically equivalent or greater pullout strength" compared to the predicate.

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

The document mentions "non-clinical laboratory testing was performed to verify the fixation strength... as compared to the predicate JuggerKnot Soft Anchors (K110145)". However, the sample size for this test set is not specified. The data provenance is also not specified, though it is a non-clinical laboratory test, implying it was conducted as part of the device development and testing process.

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

This information is not applicable/not provided as the "test set" described is a mechanical pullout strength test, not an evaluation by human experts requiring ground truth establishment in the traditional sense of clinical or image-based studies.

4. Adjudication method for the test set

This information is not applicable/not provided for the same reasons as #3.

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

No, a multi-reader multi-case comparative effectiveness study was not conducted or reported. This document pertains to a medical device for soft tissue fixation, not an AI-assisted diagnostic tool.

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

This refers to an "algorithm-only" performance, which is a concept for AI/software devices. The JuggerKnot Soft Anchors are physical medical devices. The performance testing was a standalone mechanical test of the physical device's pullout strength, compared to a predicate device.

7. The type of ground truth used

The "ground truth" for the mechanical pullout strength test was the measured pullout strength values obtained during the laboratory testing. This is a direct measurement of a physical property, not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not applicable/not provided. The device is a physical medical device, not an AI algorithm that requires a "training set" in the context of machine learning.

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

This information is not applicable/not provided for the same reasons as #8.

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The JuggerKnot™ Soft Anchor is intended to be used for soft tissue to bone fixation with indications for use in: Shoulder, Foot and Ankle, Elbow, Knee, Hand and Wrist, Hip.

The JuggerKnot™ Soft Anchors consist of a coreless sleeve structure and suture. The anchors are intended for use in soft tissue fixation by bunching against bone when deployed.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the JuggerKnot™ Soft Anchors:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of "Acceptance Criteria (Implicit)": The document doesn't explicitly state quantitative acceptance criteria (e.g., "must meet 90% of predicate device strength"). Instead, the acceptance criterion for the non-clinical testing is implied to be "equivalent fixation strength" when compared to the specified predicate devices.

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

• Sample Size: Not explicitly stated. The document refers to "mechanical pullout testing" and "test results" but does not provide details on the number of samples tested.
• Data Provenance: The testing was "Non-clinical laboratory testing" performed by Biomet Sports Medicine. The country of origin is not specified, but the company's address is in Warsaw, Indiana, USA, suggesting the testing likely occurred in the US or under US guidance. The data is entirely retrospective as it was conducted before the 510(k) submission.

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

• Number of Experts: Not applicable. The ground truth for this device's performance was established via "mechanical pullout testing," not expert opinion on diagnostic images or clinical outcomes.
• Qualifications of Experts: Not applicable for mechanical testing. The expertise would lie with engineers or technicians performing and analyzing the mechanical tests.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. As the testing was mechanical pullout testing, the "ground truth" was derived directly from the physical measurements and not through an adjudication process involving human reviewers.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study Done: No. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." The evaluation was based solely on non-clinical mechanical testing comparisons to predicate devices.
• Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study Done: Yes, in a sense. The non-clinical mechanical testing represents a "standalone" evaluation of the device's physical performance without human intervention in its efficacy measurement. The device itself is a physical implant, not an algorithm. The "performance" being evaluated is its structural integrity and fixation strength.

7. Type of Ground Truth Used

• Ground Truth Type: Objective physical measurements from "mechanical pullout testing." The "truth" in this context is the quantitative force required to pull out the anchors, measured under controlled laboratory conditions, which formed the basis for comparison to predicate devices.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a physical medical device, not an AI/ML algorithm. There is no concept of a "training set" in the context of its development and validation for regulatory submission.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this device.

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