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Application of therapeutic ultrasound for:

· Pain.

• · Pain relief, muscle spasms, and joint contractures.
• · Relief of pain, muscle spasms, and joint contractures that may be associated with:
  • o Adhesive capsulitis.
  • o Bursitis with slight calcification,
  • o Myositis,
  • o Soft tissue injuries, and
  • o Shortened tendons due to past injuries and scar tissues.
• · Relief of pain, muscle spasms, and joint contractures resulting from:
  • o Capsular tightness, and
  • o Capsular scarring.
• · Localized increase in blood flow.
• · Increased range of motion of contracted joints using heat and stretch techniques.

The JAS Pulse is a physical medicine ultrasonic diathermy device. The JAS Pulse device consists of a handheld transducer that generates high frequency sound waves. These sound waves penetrate tissue and are used to treat injured or painful areas of the body in order to alleviate symptoms and to stimulate blood flow. The handheld device is intended to be single patient use and is used with ultrasonic gels to facilitate coupling to the patient's skin surface and to enhance ultrasonic penetration.

Components of the JAS Pulse device include the handheld electrical control unit with user interface to select treatment power levels and time intervals. The controller drives the handheld treatment applicator to provide continuous and pulsed 1MHz therapeutic ultrasound. Ultrasonic gels applied to the user's area of pain facilitate ultrasonic coupling and penetration to facilitate the therapeutic ultrasound.

This document is a 510(k) premarket notification for the "JAS Pulse™ Ultrasonic Therapy" device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, much of the requested information (like sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance) is not applicable or present in this type of regulatory submission.

However, based on the provided text, we can extract the acceptance criteria in terms of technical performance and safety standards, and confirm that the device meets these criteria through various non-clinical performance data.

Here's a breakdown of the information that can be extracted, and an explanation of why other requested information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are defined by the technical specifications of the predicate devices and compliance with recognized standards. The "Comparison to Predicates" column effectively serves as the reported device performance relative to these criteria.

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

• Sample Size (Test Set): Not applicable. This submission relies on performance testing against standards and comparison to predicate device specifications, not a clinical test set of patients.
• Data Provenance: Not applicable for clinical data. The performance data is based on laboratory testing of the device against recognized standards and technical comparisons to predicate devices.

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

• Number of Experts: Not applicable. Ground truth from experts (e.g., radiologists) is typically for diagnostic imaging devices, not therapeutic devices like this one that are evaluated based on physical performance and safety metrics.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: 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:

• MRMC Study: No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human interpretation of medical images is involved, often in the context of AI assistance. This device is a therapeutic ultrasound device.
• Effect Size: Not applicable.

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

• Standalone Performance: Not directly applicable in the terms usually associated with AI/diagnostic algorithms. The "standalone" performance for this device refers to its physical output characteristics (acoustic intensity, power, frequency, temperature, etc.) when operated according to its design. This performance was evaluated through laboratory testing against the relevant IEC standards (e.g., IEC 60601-2-5 for ultrasonic physiotherapy equipment).

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

• Type of Ground Truth: The "ground truth" for this device, in a regulatory context focused on substantial equivalence, is defined by the established safety and performance requirements set by international standards (e.g., IEC 60601-1, IEC 60601-2-5, IEC 60601-1-2) and the known technical specifications of legally marketed predicate devices. Laboratory measurements demonstrating compliance with these standards and equivalence to predicate specifications serve as the evidence.

8. The sample size for the training set:

• Sample Size (Training Set): Not applicable. This device is not an AI/machine learning product that requires training data in the traditional sense.

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

• Ground Truth Establishment (Training Set): Not applicable.

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The Unity Ultrasonic System consists of an electrical generator and ultrasonic handpieces. The system is to be used with Unity single patient use absorbable (PLLA) implants intended for use as fasteners (anchors) in the fixation of tissue, ligament, tendon, and bone. The system is indicated in general soft tissue approximation/ligation.

The Unity Ultrasonic System with PLLA Fasteners is designed for the fixation of soft tissue, ligament, tendon, and bone. Absorbable poly-L-lactic acid (PLA) implant materials are ultrasonically welded, staked, and/or joined to secure soft tissue, ligament, tendon, and bone at a repair site. An electrical generator provides ultrasonic energy to the end effector of a handpiece to fix the implant materials together and secure soft tissue, ligament, tendon, and/or bone. Energy applied to the trailing end of the implant portion contacting the handpiece end effector joins this implant portion to the other implant portion in securing soft tissue, ligament, tendon, and bone. Ultrasonic handpieces with end effectors designed to accommodate Unity Implants are product specific and include a force sensor mechanism that allows the surgeon feedback on the amount of load they are applying to the handpiece. Feedback is provided to the surgeon through an audible tone.

The provided document describes a 510(k) premarket notification for the "Unity Ultrasonic System with PLLA Fasteners." The submission is primarily focused on demonstrating substantial equivalence to a predicate device, specifically a modification adding a 40 kHz handpiece to an existing ultrasonic system.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes for the mechanical strength testing or the electrical safety/EMC testing. The description "Implant strengths were statistically equivalent" suggests that a sufficient number of implants were tested to perform statistical analysis, but the exact number is not provided.

The data provenance is not explicitly stated (e.g., country of origin). However, given that it is a FDA 510(k) submission, it is assumed the testing was conducted under appropriate regulatory guidelines. The study appears to be prospective as it involves new design verification testing for the modified device.

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

This type of information is not applicable to this submission. The device is a medical fixation system, and the testing involves mechanical, electrical, and risk evaluations, not interpretation by medical experts to establish a "ground truth" derived from clinical data or images. "Ground truth" in this context refers to the defined objective standards for device performance.

4. Adjudication Method for the Test Set

This is not applicable as the testing involved objective measurements of mechanical strength and electrical safety, not subjective interpretations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret medical images. This submission describes a surgical fixation device.

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 medical device (ultrasonic system and fasteners), not an algorithm or AI system. Therefore, standalone performance in the context of AI is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed was based on:

• Defined engineering specifications and performance targets for mechanical strength. The statistical equivalence to the predicate established the acceptable performance.
• Established industry standards and regulatory requirements for electrical safety (EMC test plan).
• Risk assessment methodology to compare the new 40 kHz handpiece against the predicate, focusing on design, packaging, labeling, and sterilization techniques to ensure no new or increased risks.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical device and does not involve AI or machine learning, which would typically require a training set.

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

This is not applicable as there is no training set for this type of device.

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The Unity Ultrasonic System consists of an electrical generator and ultrasonic handpiece. The system is to be used with existing Unity Alpha single patient use absorbable (PLLA) implants intended for use as fasteners (anchors) in the fixation of tissue, ligament, tendon, and bone. The system is indicated in general soft tissue approximation/ligation.

The Unity Ultrasonic System is designed for the fixation of soft tissue, ligament, tendon, and bone. Absorbable poly-L-laotic acid (PLLA) implant materials are ultrasonically welded, staked, and/or joined to secure soft tissue, ligament, teadon, and bone at a repair site. An olectrical generator provides ultrasonic energy to the end effector of a handpiece to fix the implant materials together and secure soft tissue, ligament, rendon, and/or bone. The system provides a means of sutureless fixation that facilitates overall suture management. Modifications are being made to the electrical generator and ultrasonic handpiece components of the ultrasonic system to improve overall system performance and to enhance user interface features. Additionally, the handpiece is being modified to include a force sensor mechanism that allows the surgeon feedback on the amount of load they are applying to the handpiece. Feedback is provided to the surgeon through an audible tone.

The provided text describes a 510(k) summary for the Bonutti Research, Inc. Unity Ultrasonic System. It details changes made to the system and compares it to predicate devices. However, the document does not provide specific acceptance criteria or the details of a study that proves the device meets such criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity, or specific mechanical thresholds beyond general "mechanical strength testing").

Therefore, I cannot populate the requested table or answer most of the questions fully as the information is not present in the provided text.

Here's what I can extract and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The document states that "Design verification testing identified and conducted as part of the predicate comparison... compared the electrical output of the modified Unity Ultrasonic System electrical generator and ultrasonic handpiece to similar component predicate devices. Mechanical strength testing was also conducted with Unity Alpha predicate devices: for both the modified Unity Ultrasonic System and its predicate ultrasonic systems." However, it does not provide the specific numerical acceptance criteria (e.g., "electrical output must be within X% of predicate") nor the actual measured performance values.

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

• Sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing is described as "Design verification testing" and "mechanical strength testing," implying laboratory or bench testing rather than clinical data from human subjects.

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

• This question is not applicable as the document describes design verification and mechanical strength testing, not studies requiring expert-established ground truth for performance metrics like those for diagnostic AI systems.

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

• This question is not applicable for the same reason as point 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, an MRMC comparative effectiveness study was not done. The device is a "Fixation Device" (Unity Ultrasonic System) for surgical use, not a diagnostic imaging or AI-assisted interpretation tool. The testing described is related to the device's mechanical and electrical properties.

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

• This question is not applicable as the device is a surgical fixation system, not an algorithm.

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

• For the "mechanical strength testing" and "electrical output comparison," the ground truth would inherently be engineering specifications, physical measurements, and the performance characteristics of the predicate devices. It is not an expert consensus, pathology, or outcomes data in the context of diagnostic performance.

8. The sample size for the training set:

• Not applicable. The document describes device modifications and comparative testing, not the development of a machine learning model requiring a training set.

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

• Not applicable. (See point 8).

In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device through design verification and mechanical testing, specifically for an ultrasonic surgical fixation system. It does not contain the detailed performance metrics, study designs, or ground truth establishment methods typically associated with AI/ML-driven diagnostic devices or clinical comparative effectiveness studies.

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The Unity Beta Anchor System consists of single patient use absorbable (PLLA) implants intended for use as fasteners (anchors) in the fixation of tissue, ligament, tendon, and bone. The system is indicated in general soft tissue approximation/ligation.

The Unity Beta Anchor System is designed for the fixation of tissue, ligament, tendon, and bone. Absorbable poly-L-lactic acid (PLLA) implant materials are ultrasonically joined to secure tissue, ligament, tendon, and bone at a repair site. An electrical generator provides ultrasonic energy to the end effector of a handpiece to weld the two pieces of implant material together and secure tissue, ligament, tendon, and/or bone. The system provides a means of sutureless fixation that facilitates overall, suture management.

The provided text is a 510(k) premarket notification for the Unity Beta Anchor System. This type of document outlines the technical specifications and intended use of a medical device and seeks to demonstrate its substantial equivalence to a legally marketed predicate device.

After reviewing the document, I can say that it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of performance metrics, sample sizes, expert involvement, or statistical analysis typically found in clinical or laboratory performance studies.

Here's why and what information is present:

1. Acceptance Criteria and Reported Device Performance: This information is not explicitly stated in a table format with specific performance metrics (e.g., accuracy, sensitivity, specificity, or mechanical thresholds with acceptance limits). The document mentions "Design verification testing identified and conducted as part of the risk analysis assessment compared the mechanical strengths and failure modes of the Unity Beta Anchor System to predicate devices." However, it does not provide the results, specific acceptance criteria for these comparisons (e.g., "tensile strength must be within X% of the predicate device"), or reported performance values.

2. Sample Size used for the test set and data provenance: Not mentioned.

3. Number of experts used and their qualifications for establishing ground truth: Not applicable, as this is a mechanical fixation device, not one that requires expert interpretation of diagnostic images or data for ground truth.

4. Adjudication method for the test set: Not applicable.

5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This type of study is relevant for diagnostic devices where human readers interpret medical data. This device is a surgical fixation device.

6. Standalone (algorithm only) performance: Not applicable, as this is a mechanical device, not an algorithm.

7. Type of ground truth used: For a mechanical device, "ground truth" would typically refer to validated mechanical testing methods (e.g., ASTM standards for tensile strength, pull-out strength). The document only generally states that "Design verification testing... compared the mechanical strengths and failure modes." Specifics are absent.

8. Sample size for the training set: Not applicable. This document refers to a physical device, not an AI/ML algorithm that requires a training set.

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

Summary of what is in the document:

• Device Name: Unity Beta Anchor System
• Manufacturer: Bonutti Research, Inc.
• Contact Information: Patrick Balsmann, MBA, MS, RAC
• Date Prepared: September 29, 2008
• Common Name: Fixation Device
• Classification Name: Fastener, Fixation, Biodegradable, Soft Tissue.
• Device Description: Absorbable poly-L-lactic acid (PLLA) implants ultrasonically joined for the fixation of tissue, ligament, tendon, and bone. It uses an electrical generator to provide ultrasonic energy to weld the implant materials.
• Indications for Use: Fixation of tissue, ligament, tendon, and bone as fasteners (anchors), indicated in general soft tissue approximation/ligation.
• Predicate Device(s): Existing Bonutti Research, Inc., fixation products and various other suture anchors determined to be substantially equivalent.
• Predicate Comparison: "Design verification testing identified and conducted as part of the risk analysis assessment compared the mechanical strengths and failure modes of the Unity Beta Anchor System to predicate devices." (No specific results or acceptance criteria provided)
• Regulatory Information:
  • 510(k) Number: K082906
  • Regulation Number: 21 CFR 888.3040
  • Regulation Name: Smooth or threaded metallic bone fixation fastener (Note: The product is PLLA, not metallic, but falls under this classification for regulatory purposes).
  • Regulatory Class: Class II

In conclusion, the document serves as a regulatory submission demonstrating substantial equivalence based on design and intended use, and general mechanical comparison to predicate devices, but it does not provide the detailed performance study results and acceptance criteria as outlined in your request.

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The Unity Alpha PLLA System consists of single patient use absorbable (PLLA) implants intended for use as fasteners (anchors) in the fixation of tissue, ligament, tendon, and bone. The system is indicated in general soft tissue approximation/ligation.

The Unity Alpha PLLA System is designed for the fixation of tissue, ligament, tendon. and bone. Absorbable poly-1.-lactic acid (PLLA) implant materials are ultrasonically welded to secure tissue, ligament, tendon, and bone at a repair site. An electrical generator provides ultrasonic energy to the end effector of a handpiece to weld the two pieces of implant material together and secure tissue, ligament, tendon. and/or bone. The system provides a means of sutureless fixation that facilitates overall suture management.

The provided text describes the Unity Alpha PLLA System (medical device) and its 510(k) submission. It does not include detailed information regarding acceptance criteria, specific performance metrics, sample sizes for testing/training sets, expert qualifications, or adjudication methods for a study. The document primarily focuses on establishing substantial equivalence to a predicate device.

However, based on the text, here's what can be extracted and what cannot be answered:

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

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

• Sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing appears to be internal design verification.

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)

• Not applicable/Not specified. The "ground truth" for this device appears to be comparison against predicate devices' mechanical properties, not expert-adjudicated clinical outcomes.

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

• Not applicable/Not specified.

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. This is a medical device for fixation of tissue, ligament, tendon, and bone, not an AI or imaging diagnostic device requiring an MRMC study.

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

• Not applicable. This device is not an algorithm. Performance is likely assessed through mechanical testing.

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

• The "ground truth" or reference standard for comparison was the mechanical strengths and failure modes of predicate devices. This suggests a comparative engineering/mechanical testing approach.

8. The sample size for the training set

• Not applicable/Not specified. There is no mention of a "training set" in the context of this device's approval process, as it is not an AI or machine learning product.

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

• Not applicable/Not specified.

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The TranSet™ System are fixation devices indicated in bone, tissue, ligament, and tendon repair. The system allows for dynamic stabilization and linear fixation of bone, tissue, ligament, and tendon fragments in surgical procedures. The system can also be used as fixation posts for distributing suture tension over areas of bone, tissue, ligament, and tendon repair. The compression and holding together of bone, tissue, ligament, and tendon fragments of the system further promotes healing at the repair site. The system consists of single patient use metallic crimping devices that secure the following flexible materials running across a repair site:

• Up to USP Size No. 2 Suture,
• Up to USP Size No. 2 High Tensile Suture,
• Metallic Cable, and
• Metallic Wire.

The TranSet™ System intended use is in the dynamic stabilization and linear fixation of bone, tissue, ligament, and tendon fragments in surgical procedures. The system consists of a cannulated drill, a lead button or anchor, a flexible material that runs across a repair site, a metallic crimp, and a manual hand held crimping instrument. The flexible material is tensioned and secured with a metallic crimp by the manual hand held instrument allowing a compressive load to be applied across the repair site. This compression and holding together of the bone, tissue, ligament, and tendon fragments further promotes healing at the repair site. Lead buttons or anchors with a corresponding flexible material are provided sterile for single patient use. Cannulated drills for delivery of the implant materials are single patient use. The reusable crimping instrument and a sterilization tray for autoclaving complete the system.

The provided document describes a Special 510(k) submission for a modification to the TranSet™ System, a fixation device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through design verification testing.

Therefore, the study described is a predicate comparison study focusing on mechanical strength and failure modes, rather than an AI or clinical performance study. Many of the requested details about acceptance criteria for AI devices, and the characteristics of a clinical study, are not applicable in this context.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation of the "Implied" Criteria: The document directly states that "Design verification testing identified and conducted as part of the predicate comparison compared the mechanical strengths and failure modes of the modified TranSet™ System to predicate devices." The positive outcome ("Results demonstrated that the modified TranSet™ System is statistically equivalent to predicate devices") implies these were the critical acceptance criteria for this specific 510(k) submission.

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

• Sample Size: The document does not specify the sample size for the design verification testing. It only states that "Design verification testing identified and conducted as part of the predicate comparison compared the mechanical strengths and failure modes..."
• Data Provenance: This was retrospective data in the sense that the testing was performed on the modified device and compared against existing predicate devices. The country of origin for the data is not explicitly stated, but given the company (Bonutti Research, Inc.) is based in Illinois, USA, it's reasonable to assume the testing and data generation occurred in the USA.

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

• Not Applicable. This was a mechanical engineering design verification study, not a clinical study requiring expert ground truth for interpretation of medical images or patient outcomes. The "ground truth" would be objective measurements of mechanical properties.

4. Adjudication Method for the Test Set

• Not Applicable. As above, this was a mechanical engineering study. Adjudication methods like 2+1 or 3+1 are used for human interpretation of medical data, which is not relevant here.

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

• No. The document does not mention any MRMC study. This is a 510(k) for a mechanical fixation device, not an AI-assisted diagnostic tool.

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

• Not Applicable. This is not an AI algorithm. The device itself (TranSet™ System) is the "standalone" component being evaluated for its mechanical properties.

7. Type of Ground Truth Used

• The ground truth in this context was objective mechanical measurements (e.g., tensile strength, displacement at failure, etc.) obtained through design verification testing. These are empirical measurements, not expert consensus, pathology, or outcomes data in the medical sense.

8. Sample Size for the Training Set

• Not Applicable. This product is a mechanical medical device, not an AI model that requires a "training set."

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

• Not Applicable. As this is not an AI model, there is no training set or ground truth in that context.

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The Multitak 6.0 mm Absorbable Anchor System consists of a single use absorbable anchor implant and is intended for use as a load bearing or non-load bearing suture anchor in the attachment of soft tissue to bone in various arthroscopic and open surgical procedures.

The Multitak 6.0 mm Absorbable Anchor System is indicated for use in securing soft tissue to bone in such applications as the following:

Shoulder:
Bankart lesion repairs
Acromio-clavicular repairs
Deltoid repairs
Rotator cuff tear repairs
Biceps tenodesis
SLAP lesion repairs

Elbow, Wrist, & Hand:
Scapholunate ligament reconstruction
Ulnar collateral ligament reconstruction
Radial collateral ligament reconstruction
Biceps tendon reattachment

Knee:
Extra-capsular repairs
Medial collateral ligament repair
Lateral collateral ligament repair
Posterior oblique ligament repair
Illiotibial band tenodesis
Patellar tendon repair
VMO advancement
Joint capsule closure

Foot & Ankle:
Medial instability repair/reconstruction
Lateral instability repair/reconstruction
Achilles instability repair/reconstruction
Midfoot reconstruction
Hallux valgus reconstruction

Pelvis
Bladder neck suspension procedures

The Multitak 6.0 mm Absorbable Anchor System consists of a single use absorbable suture anchor implant and is intended for use as a load bearing or non-load bearing suture anchor in the attachment of soft tissue to bone in various arthroscopic and open surgical procedures. The 6.0 mm absorbable suture anchor implant is provided sterile and once passed with suture is inserted into a predrilled bone soft tissue repair site (i.e., rotator cuff repairs) with the use of disposable and reusable introduction devices. The threaded design of the suture anchor implant allows it to be screwed into the bone tissue repair site engaging cancellous bone and acts as an anchor in securing soft tissue to bone.

I am sorry, but the provided text does not contain the detailed information necessary to complete the table and answer all the questions regarding acceptance criteria and a study proving device performance. The document is a 510(k) summary for the Bonutti Research Multitak 6.0 mm Absorbable Anchor System, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study report with specific acceptance criteria and performance metrics.

Here's what I can extract and what is missing:

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

Missing Information: Specific numerical acceptance thresholds (e.g., minimum tensile strength, push-out strength, failure load) are not provided. The "statistically equivalent" statement is a qualitative summary of the performance rather than a detailed quantitative metric.

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

Missing Information: The document does not specify the sample size for the test set used in the performance testing. It also does not mention the country of origin of the data or whether the data was retrospective or prospective.

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

Missing Information: This information is not relevant to the type of performance testing described (mechanical testing of a medical device) and is therefore not present in the document. Ground truth for mechanical device performance is typically established through direct physical measurement, not expert consensus.

4. Adjudication method for the test set

Missing Information: Adjudication methods (like 2+1, 3+1) are typically used for studies involving human interpretation (e.g., medical imaging reviews). For mechanical performance testing of a device, formal adjudication by experts is not applicable.

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

Missing Information: This is not applicable. The device is a physical absorbable anchor system, not an AI or imaging diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI assistance would not have been conducted.

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

Missing Information: This is not applicable given the nature of the device as a physical surgical implant.

7. The type of ground truth used

• Type of Ground Truth: Direct mechanical measurements of the Multitak 6.0 mm Absorbable Anchor System and the predicate devices. This involves testing parameters such as mechanical strengths and failure modes.

8. The sample size for the training set

Missing Information: This device is a physical implant, not a machine learning algorithm. Therefore, there is no "training set" in the context of an AI model.

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

Missing Information: As above, this concept does not apply to the testing of this physical medical device.

Summary of available information:

The 510(k) summary states that "Performance testing comparing the mechanical strengths and failure modes of the Multitak 6.0 mm Absorbable Anchor System suture anchor implants to predicate devices demonstrated that the anchors are statistically equivalent." This is the core claim regarding device performance meeting acceptance criteria (i.e., equivalence to a legally marketed predicate device). However, it lacks the specific quantitative details of the tests, sample sizes, and detailed performance figures that would typically be found in a full study report.

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The TranSet™ Fracture Fixation System is indicated as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated. It may also be used as an adjunct to external and intramedullary fixation systems involving fixation plates and rods, with fracture braces and casting, and with bone graft substitutes. The system is also indicated in ligament and tendon repair and reconstruction associated with fractures and soft tissue reattachment including ligament/tendon avulsions and meniscal repairs. The system consists of both absorbable and titanium fixation buttons used with up to USP Size No. 5-braided suture and are not intended for reuse. The system may also be used with the Unity Ultrasonic Fixation seat for tissue approximation and ligation when using USP Size No. 2-0 through 2-braided suture. Custom manual surgical instrumentation for button insertion and a sterilization tray complete the TranSet™ Fracture Fixation System.

The TranSet™ Fracture Fixation System is not indicated for use in intra-articular sites.

The TranSet™ Fracture Fixation System intended use is in the stabilization and linear fixation of bone or tissue fragments in orthopedic fractures and in ligament and tendon repair and reconstruction. The system consists of both absorbable and titanium cylindrical buttons manufactured from poly-L-lactic acid or titanium alloy. The buttons are provided sterile packaged with or without braided suture and are intended for single-patient use. Buttons are applied to the outer bone cortex and with suture running across the fracture site allows for stabilization and linear fixation of the bone or tissue fragments. This allows the bone or tissue fragments to be compressed and held together to promote healing. The cylindrical design of the buttons also allows them to be used as fixation devices in orthopedic ligament and tendon repair and reconstruction. The buttons are placed outside the cortical bone or though a soft tissue repair site and act as fixation posts by distributing suture tension over larger areas to promote healing and eliminate any suture tearing or pulling through the tissue. The absorbable buttons degrade over time and eliminate the need for any surgical removal. Removal of the titanium buttons is based upon surgeon preference. Reusable manual surgical instrumentation for insertion of the buttons and a sterilization tray for autoclaving complete the system.

This document, a 510(k) summary for the TranSet™ Fracture Fixation System, focuses on demonstrating substantial equivalence to predicate devices based on intended use and material similarity, as well as mechanical strength testing. It does not contain information typically found in a study proving a device meets specific acceptance criteria related to clinical performance or algorithm-driven accuracy.

Therefore, many of the requested categories cannot be filled from the provided text.

Here is the information that can be extracted or reasonably inferred, along with notations for what is not present:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Sample Size: Not specified for the mechanical performance testing.
   • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). It is physical performance testing, not clinical data from patients.

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

   • Not Applicable. This was mechanical performance testing, not a clinical study involving expert assessment of patient outcomes or images. The "ground truth" would be the measured physical properties of the materials.

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

   • Not Applicable. This was mechanical performance testing, not a clinical study requiring human adjudication of results.

4. 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. This document describes a medical device (fracture fixation system), not an AI or imaging diagnostic device. Therefore, an MRMC study is not relevant.

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

   • No. This is not an algorithm or AI device.

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

   • Laboratory Measured Physical Properties: The "ground truth" for the performance testing would be the objectively measured mechanical properties (e.g., tensile strength, bending strength, failure load) of the devices under controlled laboratory conditions.

7. The sample size for the training set:

   • Not Applicable. This is not an AI or machine learning study, so there is no "training set."

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

   • Not Applicable. No training set was used.

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The intended use of the Multitak Suture Snap System is in general soft tissue approximation and/or ligation. The system is indicated in securing soft tissue in arthroscopic and open surgical procedures where USP Size No. 2-0 through Size 2 nonabsorbable suture is used.

The Multitak Suture Snap System is designed for approximating and securing soft tissue in arthroscopic and open surgical procedures. The resorbable poly-L securing our assue in tasonically welded to secure suture at the wound repair site and takes the place of tying arthroscopic and open surgical repair knots. The system consists of a generator that provides ultrasonic energy to a handpiece. The energy applied to the handpiece is used to ultrasonically weld a resorbable crimp and secure suture during general tissue wound repair. The resorbable poly-L-lactic acid crimp is gradually degraded into lactic acid and excreted as carbon dioxide and water.

The provided text does not contain detailed acceptance criteria for the Multitak Suture Snap System, nor does it describe a comprehensive study with specific performance metrics against those criteria. Instead, it refers to "performance testing comparing the mechanical strengths" and "an in vitro degradation study" that demonstrated "no statistical difference in suture secured with the resorbable crimp and knotted suture" to establish substantial equivalence to a predicate device.

However, based on the information available, here's an attempt to structure an answer, highlighting what is present and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for either the "bench testing" or the "in vitro degradation study."
• Data Provenance: The studies were "bench testing" and "in vitro degradation study," implying laboratory-based testing rather than studies involving human or animal subjects. No country of origin is specified for the data itself, but the manufacturer (Bonutti Research, Inc.) is based in Illinois, USA. The studies are by nature prospective as they were conducted to evaluate the device prior to market clearance.

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

This information is not provided in the document. The studies described are mechanical and degradation tests, which typically rely on quantitative measurements rather than expert human interpretation for "ground truth."

4. Adjudication Method for the Test Set

This information is not applicable as the described studies are mechanical and degradation tests, not studies requiring human adjudication of qualitative outcomes.

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

No, an MRMC comparative effectiveness study was not done. The studies described are bench tests and in vitro degradation studies, not clinical studies involving human readers or comparative effectiveness with human operators.

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

This question is not applicable to the Multitak Suture Snap System, as it is a mechanical device (a surgical tool and resorbable crimp) and not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the bench testing, the ground truth would be quantitative measurements of mechanical strength (e.g., tensile strength, knot security) derived from standardized testing methods. For the in vitro degradation study, the ground truth would similarly be quantitative measurements of degradation products or material properties over time. These are objective measurements rather than subjective expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not provided and is likely not applicable in the context of this device. The Multitak Suture Snap System is a mechanical device, not a machine learning model that requires a "training set."

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

This information is not provided and is not applicable as there is no mention of a training set for an AI or machine learning model.

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The Multitak Splinter 3.0 mm Resorbable Anchor System consists of a single use bone soft tissue resorbable anchor implant and is intended for use as a load bearing or non-load bearing suture anchor in the attachment of soft tissue to bone in various arthroscopic and open orthopedic procedures.

The Multitak Splinter 3.0 mm Resorbable Anchors are indicated for use in the following orthopedic soft tissue to bone fixation applications:

• Shoulder: Bankart lesion repairs Acromio-clavicular repairs · Deltoid repairs Rotator cuff tear repairs Biceps tenodesis
• Elbow: Ulnar or radial collateral ligament reconstruction
• Knee: Extra-capsular repairs Medial collateral ligament repair Lateral collateral ligament repair Posterior oblique ligament repair Illiotibial band tenodesis Patellar tendon repair VMO advancement Joint capsule closure
• Foot/Ankle: Medial/Lateral repairs/reconstructions Achilles tendon repairs

The Multitak Splinter 3.0 mm Resorbable Anchors are cylindrical suture anchors with a conical tip on one end. The resorbable anchors are injection molded from a poly-L-lactic acid resin and have two transverse suture holes. The resorbable implant comes threaded with up to USP Size No. 2 polyester suture preloaded on the tip of a single use disposable introduction device. The resorbable implant and suture is delivered into a predrilled bone site. The suture ends are pulled to engage cancellous bone and to toggle and lock the anchor in bony tissue. A curved needle attached to the suture end is used to secure soft tissue to bone.

The provided text describes a 510(k) premarket notification for the "Multitak Splinter 3.0 mm Resorbable Anchor." This document focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness through clinical trials with specific acceptance criteria in the manner one might find for a new diagnostic device or drug.

Therefore, the information requested regarding acceptance criteria, study details, expert involvement, and ground truth establishment, which are typical for diagnostic device performance studies, does not directly apply in the same way to this 510(k) submission.

However, I can extract information related to the device's performance based on the predicate comparison:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified in the provided text. The term "performance testing" implies a laboratory-based study rather than a clinical one with human subjects.
• Data Provenance: Not explicitly stated, but given it's a 510(k) submission, the testing would have been conducted by the manufacturer, Bonutti Research, Inc. It's likely a retrospective comparison to existing data or concurrent in-house testing against predicate devices.

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

• Not applicable in this context. The "ground truth" here is based on defined engineering standards for mechanical strength and failure modes, rather than expert interpretation of a diagnostic output.

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

• Not applicable. This method is used for establishing ground truth in diagnostic studies, which is not the type of study described here.

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

• Not applicable. This device is a medical implant (suture anchor), not a diagnostic AI device requiring human reader improvement studies.

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

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

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

• The "ground truth" for the performance claims would be defined engineering specifications and measured mechanical properties (e.g., tensile strength, pull-out strength, torque to failure) for both the Multitak Splinter and the predicate devices. The claim of "statistically equivalent" suggests quantitative comparisons.

8. The sample size for the training set

• Not applicable. This refers to machine learning models, which is not relevant to this device.

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

• Not applicable. This refers to machine learning models, which is not relevant to this device.

Summary based on the provided text:

The provided document describes a predicate comparison study for a medical implant device. The "study" involves performance testing focused on the mechanical strengths and failure modes of the Multitak Splinter 3.0 mm Resorbable Anchor. The primary finding is that the device is statistically equivalent to its predicate devices in these aspects. The "acceptance criteria" were implicitly met by demonstrating this statistical equivalence in the relevant mechanical properties. No clinical trial data, expert review, or AI-related information as typically requested was part of this 510(k) summary.

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