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The Titan RC Tack is intended for soft tissue to bone fixation for the following indications:

SHOULDER
Repair of rotator cuff tears
Acromio-clavicular separation
Biceps tenodesis
Deltoid repair

KNEE
Extra-Capsular repairs
Reattachment of medial collateral ligament
Reattachment of lateral collateral ligament
Reattachment of posterior oblique ligament
Joint capsule closure
Patellar ligament and tendon avulsion repairs
Extra-capsular reconstruction
ITB tenodesis

ANKLE
Lateral and medial instability
Achilles tendon reconstruction and repair

The Titan RC Tack is a bioabsorbable implant intended for soft tissue reattachment to host bone in the shoulder, knee, and ankle. The implant consists of three individual components: a tip, sleeve and pin. Upon deployment, the pin is driven into the sleeve expanding the sleeve radially to gain bone fixation. The Titan RC Tack is a sterile, single use device offered in one size, 4.5mm.

Here's an analysis of the provided text regarding the Innovasive Titan RC Tack, focusing on acceptance criteria and the study proving it meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Notes:

• The document explicitly states that the "Bone Model Testing" was conducted to evaluate the "ultimate holding strength at 3, 6, and 12 weeks in-vitro."
• The acceptance criteria themselves (e.g., a specific threshold in Newtons or a percentage of the predicate device's strength) are not provided in this document. The study's conclusion is that the new device's performance is "substantially equivalent" to the predicate, implying that the observed holding strengths met an unstated criterion for equivalence.

2. Sample Size and Data Provenance

• Test Set Sample Size: The document does not specify the sample size used for the bone model testing.
• Data Provenance: The study was "in-vitro" and involved "Bone Model Testing." This suggests a synthetic bone model rather than human or animal tissue. The country of origin of the data is not specified. It is a prospective study as it was conducted for the purpose of the 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth

• This type of device (bone anchor) typically does not involve human expert interpretation for "ground truth" in performance studies of this nature (ultimate holding strength). The ground truth is objective, quantifiable mechanical measurements.
• Therefore, there were no experts establishing ground truth in the traditional sense, as this was a physical performance test, not an image interpretation or clinical diagnosis.

4. Adjudication Method for the Test Set

• No adjudication method like 2+1 or 3+1 was used. This is because the performance data is from objective mechanical testing, not subjective expert assessment or image review. The "adjudication" would be based on the objective measurement and comparison against predefined (but unstated in this document) statistical equivalence thresholds.

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

• No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images. The Titan RC Tack is a surgical implant designed for mechanical fixation, which is evaluated through biomechanical testing, not image interpretation.

6. Standalone Performance Study

• Yes, a standalone performance study was done for the device. The "Bone Model Testing" evaluated the Titan RC Tack's "ultimate holding strength." While directly compared to the predicate device, it generated performance data for the Titan RC Tack itself, allowing for an assessment of its mechanical properties.

7. Type of Ground Truth Used

• The ground truth used was objective mechanical measurement (ultimate holding strength) from "in-vitro" bone model testing. This is a quantifiable physical property, not expert consensus, pathology, or outcomes data in the clinical sense.

8. Sample Size for the Training Set

• This device is not an AI/ML algorithm, so there is no concept of a "training set" in the context of machine learning. The term "training set" is not applicable here.

9. How Ground Truth for the Training Set was Established

• As this is not an AI/ML algorithm, there is no training set and thus no ground truth established for a training set. The "ground truth" for the performance study was the direct, objective measurement of the device's mechanical holding strength in the bone model.

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The 11mm & 12mm Absolute™ Absorbable Interference Screws are intended for fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.

The Absolute™ Absorbable Interference Screw is a biodegradable interference screw intended for interference fit fixation of soft tissue grafts or bone-tendonbone grafts during cruciate ligament reconstruction surgeries of the knee. The device is offered in 11mm and 12mm diameters and 30mm in length.

The provided text describes a 510(k) premarket notification for the Innovasive Absolute™ Absorbable Interference Screw. Here's a breakdown of the acceptance criteria and study information:

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 size used for the test set (e.g., number of screws tested). It mentions "Bone Model Testing," implying in-vitro mechanical testing rather than human subject data. Therefore, data provenance such as "country of origin" or "retrospective/prospective" is not applicable in the traditional sense of clinical studies.

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

Not applicable. The ground truth for this type of device (mechanical performance) is established through physical measurement and engineering principles, not expert medical opinion.

4. Adjudication Method for the Test Set

Not applicable. This is a mechanical performance study, not one requiring expert human adjudication.

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 document describes a medical device (an interference screw), not an AI-powered diagnostic or assistive technology.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used was physical measurement in a bone model for ultimate holding strength, insertion force, and stripping force.

8. The Sample Size for the Training Set

Not applicable. This is a mechanical performance study of a physical device, and the concept of a "training set" is not relevant.

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

Not applicable, as there is no training set mentioned or implied for this type of device testing.

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The RC Multi-Suture Anchor is intended for soft tissue to bone fixation for the following indications: SHOULDER Repair of rotator cuff tears Acromio-clavicular separation Biceps tenodesis Deltoid repair KNEE Extra-Capsular repairs Reattachment of medial collateral ligament Reattachment of lateral collateral ligament Reattachment of posterior oblique ligament Joint capsule closure Patellar ligament and tendon avulsion repairs Extra-capsular reconstruction ITB tenodesis ANKLE Lateral and medial instability Achilles tendon reconstruction and repair

The RC Multi-Suture Anchor is intended for fixation of soft tissue to bone in the shoulder, knee, and ankle. The device consists of a three-piece polymer implant assembled onto a delivery shaft. The implant is delivered manually using a delivery handle. The RC Multi-Suture Anchor is a sterile, single use device offered in one size, 4.5mm.

This document describes the performance data for the RC Multi-Suture Anchor, which is a bone anchor device. The study is a comparison of the RC Multi-Suture Anchor to a predicate device, the ROC EZ Suture Bone Fastener, to demonstrate substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

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

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "Bone Model Testing" and compares the "ultimate holding strength" of the proposed device to the predicate device, implying a quantitative test, but the number of samples or tests performed is not provided.
• Data Provenance: Not explicitly stated. The study appears to be a laboratory-based performance test rather than involving patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• This information is not applicable to the type of study conducted. The ground truth for device performance in this context is the measured "ultimate holding strength" in a bone model, not expert interpretation of clinical data.

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

• This information is not applicable. The study involves direct physical measurement of device performance, not expert adjudication of subjective outcomes.

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 (MRMC) comparative effectiveness study was not done. This study focuses on the mechanical performance of a medical device, not on the effectiveness of human readers with or without AI assistance.

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

• This information is not applicable. The device is a physical bone anchor, not an algorithm. The study assesses the standalone performance of the physical device.

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

• The ground truth used is the measured ultimate holding strength of the devices in a bone model. This is a direct physical measurement of performance.

8. The sample size for the training set

• This information is not applicable. There is no mention of a "training set" as this is a physical device performance study, not an AI/machine learning study.

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

• This information is not applicable, as there is no training set involved in this type of device performance study.

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The proposed RC Tack is intended for soft tissue reattachment to host bone for the following indications: SHOULDER Repair of rotator cuff tears Acromio-clavicular separation Biceps tenodesis Deltoid repair KNEE Extra-Capsular repairs Reattachment of medial collateral ligament Reattachment of lateral collateral ligament Reattachment of posterior oblique ligament Joint capsule closure Patellar ligament and tendon avulsion repairs Extra-capsular reconstruction ITB tenodesis ANKLE Lateral and medial instability Achilles tendon reconstruction and repair

The RC Tack is a polymmer implant intended for soft tissue reattachment to host bone in the shoulder, knee, and ankle. The implant consists of three components: a tip, sleeve, and pin. Upon deployment, the pin is driven into the sleeve expanding the sleeve radially to gain bone fixation. The RC Tack is a sterile single use device offered in one size, 4.5mm.

The provided document is a 510(k) Summary for a medical device (RC Tack Bone Anchor). It describes the device, its intended use, and comparison to predicate devices, and reports performance data in support of substantial equivalence. However, this document does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a specific study proving the device meets that criteria with the requested level of detail (e.g., sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance details).

This 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device, as opposed to providing a detailed performance study with explicit acceptance criteria from an AI/algorithm perspective. There is no mention of an algorithm or AI in this document.

Despite this, I will extract and infer information where possible based on the provided text, and clearly state where information is not available.

Here's an analysis based on the provided text:

Device: RC Tack Bone Anchor

Intended Use: Soft tissue reattachment to host bone in the shoulder, knee, and ankle for specific indications (listed in the document).

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document describes a "Bone Model Testing" study that compares the RC Tack's ultimate holding strength. The acceptance criteria are implicitly tied to demonstrating performance "substantially equivalent" to or better than the predicate devices.

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

• Sample Size for Test Set: Not specified. The document only mentions "Bone Model Testing" was performed.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified. It is likely laboratory-based biomechanical testing.

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

• Not Applicable. This device is a mechanical implant, and the assessment of "holding strength" in a bone model test does not typically involve expert clinical review to establish ground truth in the way an AI diagnostic algorithm might. The ground truth (holding strength) would be measured directly using biomechanical testing equipment.

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

• Not Applicable. Adjudication methods are typically relevant for clinical studies or evaluations where subjective assessments (e.g., image interpretation) are made by multiple observers. For a biomechanical test of holding strength, the result is an objective measurement, not subject to adjudication in this manner.

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 document pre-dates and does not involve AI. The device is a mechanical bone anchor, not an AI-assisted diagnostic or therapeutic tool.

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

• Not Applicable. This document does not describe an algorithm or AI.

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

• Type of Ground Truth: The ground truth for the performance test ("ultimate holding strength") was based on direct biomechanical measurement in a bone model.

8. The sample size for the training set

• Not Applicable. This document does not describe an AI/algorithm, so there is no training set in that context. The "training set" concept is not relevant for this type of mechanical device submission.

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

• Not Applicable. As there is no training set in the context of AI/algorithms, this question is not applicable.

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The Bio-Interference Screw is intended for fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee.

The Bio-Interference Screw is a biodegradable interference screw intended for interference fit fixation of soft tissue grafts or bone-tendon-bone grafts during cruciate ligament reconstruction surgeries of the knee. The device is offered in varying diameters and lengths.

The provided text describes the 510(k) premarket notification for the Innovasive Bio-Interference Screw. Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided information:

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

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

The document does not explicitly state the sample size used for the bone model testing or the data provenance (e.g., country of origin, retrospective or prospective). It only mentions "Bone Model Testing."

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 study involves mechanical testing on a bone model, not expert assessment of images or data that would require "ground truth" established by experts in the typical sense for medical imaging algorithms.

4. Adjudication method for the test set

This information is not applicable and not provided. The study involves mechanical testing, not a process that would typically require adjudication.

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

An MRMC comparative effectiveness study was not done. This document describes a medical device (an interference screw) and its mechanical performance, not an AI algorithm for diagnosis or interpretation that would typically involve human readers.

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 implant, not a standalone algorithm.

7. The type of ground truth used

The "ground truth" in this context is the mechanical performance of the predicate device (Arthrex Bio-Interference Screw). The Innovasive Bio-Interference Screw's performance was compared directly to this established device. This is a form of functional equivalence based on established device performance.

8. The sample size for the training set

This information is not applicable and not provided. The device is not an AI algorithm that would have a "training set."

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

This information is not applicable and not provided, as there is no "training set" for this type of medical device.

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The Sutureless Anchor is intended for soft tissue to bone fixation for reattachment of the glenoid labrum and/or inferior glenohumeral ligament in patients with primary or recurrent anterior dislocation or subluxation of the shoulder.

The Sutureless Anchor is a biodegradable bone anchor intended for soft tissue to bone fixation in the repair of shoulder injuries. The device is offered in one size, 7.0mm. The Sutureless Anchor implant consists of three components: a sleeve, pin and washer. Upon deployment, the pin is driven through the center of the washer into the sleeve, expanding the sleeve radially to gain bone fixation. Simultaneously, a shearing mechanism releases the implant from the deployment shaft. The washer, fastened to the implant by the pin head, remains above the bone surface, tacking the soft tissue to the bone.

The provided text describes specific performance data for the "Sutureless Anchor" device, focusing on its ultimate holding strength compared to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not explicitly state the sample size used for the Bone Model Testing. It refers to "the ultimate holding strength" and "holding strength mean," implying multiple tests were performed, but the number of samples is not given.
• Data Provenance: The testing was "in-vitro," meaning it was conducted in a controlled laboratory environment, not on live subjects. The country of origin of the data is not specified but given the submitter's address (Marlborough, MA, USA), it can be inferred the testing was likely conducted in the USA or supervised by the US-based company. The data is retrospective in relation to the submission date as it was performed to support the 510(k) application.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

• This information is not provided in the text. The study described is a mechanical performance test (bone model testing), not one requiring expert human interpretation. The "ground truth" here is the measured holding strength, a quantitative metric.

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

• This information is not applicable to the described study. The study is a quantitative mechanical test measuring ultimate holding strength, which does not involve human adjudication for ground truth.

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 information is not provided and is not applicable. The provided document describes a pre-market notification for a medical device (Sutureless Anchor) and its mechanical performance testing. It does not involve AI, human readers, or image interpretation.

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

• This information is not provided and is not applicable. The device is a mechanical anchor; there is no algorithm involved in its function or performance testing as described.

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

• The ground truth for the test set was based on quantitative measurement of ultimate holding strength in a bone model.

8. The sample size for the training set:

• This information is not provided and is not applicable. The device is a mechanical implant, not an AI-driven system 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 training set for a mechanical implant.

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The intended use of the Intratunnel Tibial Fixation Fastener is for fixation of soft tissue grafts during cruciate ligament reconstruction surgeries of the knee.

The Innovasive Intratunnel Tibial Fixation Fastener consists of two components, an Expansion Sheath, and Expansion Screw. Also included with the system is the instrumentation to place the devices and establish the tunnel. The device functions by establishing the tibia-femoral tunnel and placing the Expansion Sheath into the tibial tunnel. This is followed by screwing an Expansion Screw into the Sheath, expanding the Sheath which compresses the graft against the tunnel and creating fixation.

The provided text describes a 510(k) premarket notification for a medical device called the Innovasive Devices Intratunnel Tibial Fixation Fastener. The information focuses on the device's description, intended use, comparison to a predicate device, and the type of performance data submitted.

However, the document does not contain specific acceptance criteria values or detailed results of the study that proves the device meets those criteria. It only states that "Bench Testing: Comparison of the static holding strength of the Intratunnel Tibial Fixation Fastener compared to the predicate device in a porcine model" was provided as performance data.

Therefore, many of the requested fields cannot be filled.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

2. Sample size 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: Porcine model (animal study). No country of origin is mentioned for the data collection. It's a bench test (laboratory, not human clinical data).

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. This was a bench test involving static holding strength in a porcine model, not a study requiring expert interpretation of medical images or diagnoses.

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

• Not Applicable. As above, this was a bench test and did not involve expert adjudication.

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 not relevant to a mechanical fixation device in a porcine model.

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

• Not Applicable. This is a mechanical device, not an AI or algorithmic system. The bench testing performed is essentially a "standalone" evaluation of the device's physical properties.

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

• The "ground truth" for this type of bench testing would be the measured static holding strength of the device and the predicate device in the porcine model. This is an objective measurement based on physical testing.

8. The sample size for the training set

• Not Applicable. This is not a machine learning device; therefore, there is no "training set."

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

• Not Applicable. As above, no training set was used.

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The Tibial Fastener is intended for use in the fixation of ligament and tendon grafts in cruciate ligament reconstruction surgeries of the knee.

Innovasive's proposed Tibial Fastener utilizes a central pin placed inside an outer sleeve. The central pin is threaded its entire length, resembling a "screw". The pin is cannulated in a hex shape to fit a Hex Driver for insertion into the outer sleeve. The pin is designed to lock into the central ID of the outer sleeve. The outer sleeve has a threaded central ID to accept the pin component, and an angled plate designed to lay flush against the tibia and prevent the device from pulling through the tibial tunnel. The angled plate will be offered in three angles: 40°, 45°, and 50° to accommodate varying tibial tunnel angles. The outer sleeve is manually placed in the tibial tunnel, and the graft passed through the sleeve's central ID. A Sizer is used to determine the appropriate pin diameter and length by insertion into the sleeve between the graft strands. The pin is than inserted into the central ID, and locks into the sleeve. Any excess graft ends may be removed. The proposed Tibial Fastener outer sleeve and central pin will be offered in various sizes to accommodate varying graft and tibial tunnel sizes.

The provided text is a 510(k) summary for the Innovasive Tibial Fastener, a medical device. It describes the device, its intended use, and a performance study. Here's an analysis of the acceptance criteria and the study, based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document does not explicitly state numerical acceptance criteria (e.g., "The holding strength must be greater than X Newtons"). Instead, the acceptance criterion for the performance study is implicitly based on demonstrating "substantial equivalence" in ultimate holding strength to already cleared predicate devices.

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

• Sample Size: Not explicitly stated. The text mentions "human cadaver," indicating the type of test material but not the number of cadavers or individual tests performed.
• Data Provenance: The data was obtained from testing on "human cadaver." This suggests a preclinical, laboratory-based study rather than data collected from live patients. The country of origin is not specified but given the submitter's address (Marlborough, MA, USA) and the FDA submission, it's highly likely to be the USA. The study would be considered prospective in the sense that the testing was designed and executed specifically for this 510(k) submission.

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

• Not Applicable. This type of information (experts, ground truth, adjudication) is relevant for studies involving diagnostic imaging or subjective assessments. The performance study described is a mechanical-biological test measuring ultimate holding strength. The "ground truth" in this context is the physically measured holding strength, not an expert's interpretation.

4. Adjudication Method for the Test Set

• Not Applicable. See explanation above. Adjudication is not relevant for a mechanical holding strength test.

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

• No. An MRMC study is used to assess the effectiveness of diagnostic tools or interpretations, often comparing human readers with and without AI assistance. The study described here is a mechanical test of device strength, not a diagnostic or interpretative study.

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

• Not Applicable. This typically refers to AI/algorithm performance. The device is a mechanical fastener, not an algorithm. The "performance" being evaluated is the physical holding strength of the device itself.

7. The Type of Ground Truth Used

• Direct Mechanical Measurement. The "ground truth" for this study is the ultimate holding strength directly measured in the mechanical tests performed on human cadaver material. It's an objective physical property rather than an expert consensus, pathology, or outcomes data interpretation.

8. The Sample Size for the Training Set

• Not Applicable. The device is a mechanical fastener, not an AI or machine learning model. Therefore, there is no "training set" in the context of algorithm development.

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

• Not Applicable. See explanation above.

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The intended use of the Meniscal Dart is intended for use in the arthroscopic fixation of longitudinal, vertical meniscus lesions (bucket handle lesions) in the vascularized area of the meniscus (red-red and red-white areas).

The Meniscal Dart is a device fabricated from L-PLA which is intended for meniscal repair. The device consists of a molded device with a back tab and barbs along its length. The device is inserted into the meniscus with the aid of an inserter instrument. Additional instruments include calibration instruments to measure the depth of the tear. The Meniscal Dart is provided in 3 sizes, 10, 11 and 13mm.

The provided document describes the Innovasive Meniscal Dart, a bioabsorbable orthopedic fixation device. The 510(k) summary focuses on establishing substantial equivalence to a predicate device, the Biofix Arrow, rather than presenting a performance study with defined acceptance criteria and specific outcomes like sensitivity, specificity, or accuracy.

Therefore, many of the requested categories (e.g., specific acceptance criteria, sample sizes for test sets/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth methodologies) are not available in the provided text, as these are typically part of a comprehensive performance study. The document primarily reports on bench and animal testing comparing the device to a predicate.

Here's an analysis of the available information:

Acceptance Criteria and Device Performance

Study that Proves Device Meets Acceptance Criteria:

The document refers to two types of testing:

1. Bench Testing: This involved in vitro comparison of the Meniscal Dart's fatigue strength against a predicate device (Biofix Arrow). It also assessed the device's performance under constant load, weight loss, and intrinsic viscosity. The implicit acceptance criterion for fatigue strength would be non-inferiority or equivalence to the predicate device. For the other parameters, the "assessment" implies that the results were within acceptable ranges, though specific numerical criteria are not provided.
2. Animal Testing: This testing aimed to demonstrate the efficacy and confirm the adequate function of the Innovasive Meniscal Dart for its intended use. The implicit acceptance criteria here would be the successful repair of meniscal tears in an animal model, demonstrating the device's ability to hold the repair and that it functions as intended without adverse events that would preclude its use.

Detailed Information Not Available in the Provided Text:

• Sample sizes used for the test set and the data provenance: Not specified.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this was not a human observer study.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this type of study was not mentioned.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
• The type of ground truth used:
  • Bench Testing: Engineering measurements and comparisons to a predicate device's measured performance.
  • Animal Testing: Histopathological and gross pathological examinations, clinical observations of repair success in an animal model.
• The sample size for the training set: Not applicable, as this is not an AI/algorithm.
• How the ground truth for the training set was established: Not applicable.

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The 3.5mm Metal ROC XS Suture Bone Fasteners are intended for the reattachment of soft tissue to bone for the following indications: SHOULDER Bankart repair Repair of rotator cuff tears Capsular instability Slap lesion repair Acromio-clavicular separation Capsule shift/capsulolabral reconstruction Biceps tenodesis Deltoid repair KNEE Extra-capsular repairs Reattachment of medial collateral ligament Reattachment of lateral collateral ligament Reattachment of posterior oblique ligament Joint capsule closure Patellar ligament and tendon avulsion repair Extra-capsular reconstruction ITB tenodesis ANKLE Lateral and medial instability Achilles tendon reconstruction and repair Mid-foot reconstructions FOOT Hallux valgus reconstruction ELBOW Tennis elbow repair Biceps tendon reattachment Medial and lateral repairs BLADDER NECK SUSPENSION Bladder neck suspension for female urinary incontinence due to urethral hypermobility

The 3.5mm Metal ROC XS suture bone fastener implant tip portion consists of a shear pin, crown and anvil. The crown and anvil are fitted onto the shear pin component such that the crown component is located below the anvil on the shear pin. As the crown is pulled up during the device deployment, the anvil forces it open. The anvil is tapered such that it will fit into the crown component as the deployment action progresses. As the crown is forced open by the anvil, the crown expands to make contact with the surrounding bone. This expanding crown results in the final fixation properties of the device. Once the anvil is completely seated inside the crown, the shearing pin shears from the fastener assembly resulting in the device being fixated into the bone hole. In addition to the Fastener, a stainless steel drill guide is available to establish the proper hole in the bone for the Fastener along with a deployment handle and hole finder. All of the instrumentation except the Fastener will be offered as reusable devices and can be autoclaved in the sterilization tray provided for this purpose. The 3.5mm Metal ROC XS will be available as a sterile, single use device. Both sutured and sutureless versions will be marketed.

The provided text is a 510(k) summary for a medical device called the "Innovasive 3.5mm Metal ROC XS Suture Bone Fastener". This document describes the device, its intended use, and its comparison to predicate devices for substantial equivalence. It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics in the way that would typically be described for software or AI-based devices.

The 510(k) notification process is about demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against pre-defined acceptance criteria through a specific study with statistical power.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, and expert evaluation is not available in the provided document, as it pertains to a different type of regulatory submission and device.

However, I can extract the following relevant information:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not available in the provided document. The 510(k) process for this device focuses on demonstrating substantial equivalence to predicate devices, not on meeting specific, quantifiable acceptance criteria regarding performance like sensitivity or specificity.

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

This information is not available as there is no described performance study in the provided text. The submission is for a physical medical device (bone fastener), not an AI or software product that would typically have a test set of data.

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

This information is not available as there is no described study involving ground truth experts in the provided text.

4. Adjudication method for the test set:

This information is not available as there is no described performance study or adjudication process in the provided text.

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 information is not available. The device is a physical bone fastener, not an AI or imaging diagnostic tool. Therefore, an MRMC study is not applicable.

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

This information is not available. The device is a physical bone fastener, not an algorithm.

7. The type of ground truth used:

This information is not available. There is no ground truth concept applied in this 510(k) submission for a physical medical device.

8. The sample size for the training set:

This information is not available as there is no training set mentioned or applicable for this type of device submission.

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

This information is not available as there is no training set or ground truth concept mentioned or applicable for this type of device submission.

Summary of Available Information from the Provided Text:

The provided text focuses on the following aspects for the Innovasive 3.5mm Metal ROC XS Suture Bone Fastener:

• Device Description: A 3.5mm metal suture bone fastener with a shear pin, crown, and anvil, designed to expand and fixate into bone upon deployment. It's made of stainless steel.
• Intended Use: Reattachment of soft tissue to bone for various indications in the shoulder, knee, ankle, foot, elbow, and bladder neck suspension.
• Predicate Devices: Innovasive Devices 3.5mm ROC XS Suture Bone Fastener (plastic) and Innovasive Devices 3.5mm ROC EZ Suture Bone Fastener (plastic). All devices are marketed by Innovasive Devices.
• Comparison to Predicate Devices: The key difference is the material (stainless steel for the proposed device vs. plastic for predicates). The Indications for Use are identical to the predicate 3.5mm ROC EZ.
• Regulatory Outcome: The FDA reviewed the 510(k) notification and determined the device is substantially equivalent to devices marketed prior to May 28, 1976. This allows the device to be marketed.

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