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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 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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