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The TriTis Tibial Fixation System is intended for use in the fixation of ligament and tendon grafts during anterior cruciate ligament (ACL) reconstruction of the knee.

The TriTis Tibial ACL Reconstruction System consists of a three piece implant designed to provide soft tissue fixation for tibial anterior cruciate ligament (ACL) reconstruction. The graft cleat secures the soft tissue graft in the tunnel. The washer and fixation screw secure the ends of the graft and cleat to the bone. The System includes instrumentation to prepare the bone tunnel and place the device as well as a sterilization tray. The modifications made to the device that are the subject of this submission are: Add a new, 12 mm diameter graft cleat implant size, and a new, 12 mm Dilator instrument. All other device features and instruments remain unchanged.

The provided text describes modifications to the Scandius TriTis™ Tibial ACL Reconstruction System and its substantial equivalence to a predicate device. It does not contain information about the acceptance criteria or a study proving that the device meets specific performance metrics in terms of clinical accuracy, diagnostic performance, or human reader improvement. The device is a physical implant system, not an AI or diagnostic tool.

Therefore, many of the requested fields are not applicable to the provided document.

Here's a breakdown of the information that can be extracted or inferred, and what is not present:

Acceptance Criteria and Device Performance Study Details (Based on K063499)

Given that this device is a physical implant (Scandius TriTis™ Tibial ACL Reconstruction System) and not an AI or diagnostic software, the typical acceptance criteria and study designs for AI/diagnostic devices (e.g., sensitivity, specificity, reader studies, ground truth establishment) are not applicable or described in this 510(k) summary.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, particularly for modifications (addition of a new implant size). This typically involves showing that the safety and effectiveness are maintained, often through bench testing and verification of design integrity, rather than clinical trials with human subjects or diagnostic performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly stated in terms of quantitative performance metrics for clinical acceptance (e.g., accuracy, sensitivity, specificity). The "acceptance criteria" for this type of submission are generally related to demonstrating that the modified device maintains its design integrity and safety and effectiveness as compared to the predicate, as evidenced by the performance data mentioned.

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

• Test Set Sample Size: Not applicable. The "test set" here refers to physical bench tests (simulated use, system strength), not a dataset of patient cases. The document does not specify the number of units tested.
• Data Provenance: Not applicable in the context of patient data. The "data" comes from engineering bench testing.

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

• Not applicable. Ground truth in the context of diagnostic/AI performance is not relevant here. The "ground truth" for the device's mechanical performance would be established by engineering standards and test specifications.

4. Adjudication method for the test set

• Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human reviewers (e.g., radiologists) in diagnostic studies. This document describes mechanical device testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size

• No, an MRMC study was NOT done. This type of study assesses human readers' performance with and without AI assistance, which is irrelevant for a physical surgical implant system.

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

• Not applicable in the AI/diagnostic sense. For the device's mechanical performance, the "ground truth" is defined by engineering specifications and standards for tensile strength, fixation, etc., which are verified through the simulated use and system strength tests.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable. As there is no training set, there is no ground truth for it.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as reported in K063499):

The submission for the Scandius TriTis™ Tibial ACL Reconstruction System (K063499) did not involve a clinical study in the typical sense of measuring patient outcomes or diagnostic performance. Instead, the study that demonstrated the device meets the (implied) acceptance criteria for substantial equivalence consisted of bench testing.

Specifically, the "performance data" generated in support of the substantial equivalence determination included:

• Simulated use test: To confirm that the design integrity of the modified device (including the new 12mm graft cleat and dilator) is maintained.
• System strength test: To confirm that the overall system's design integrity and mechanical strength are maintained.

These tests would have been performed against predetermined engineering specifications to ensure that the modifications did not negatively impact the device's performance compared to the previously cleared predicate device. The document states that "Bench testing demonstrates that any minor technological differences do not raise any new questions of safety and effectiveness." This implies that the tests confirmed the modified device performs comparably and safely.

The 510(k) process for device modifications often relies on such bench testing rather than extensive clinical trials, especially when the changes are minor and the predicate device has a well-established safety and effectiveness profile.

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The TriTis Tibial Fixation System is intended for use in the fixation of ligament and tendon grafts during anterior cruciate ligament (ACL) reconstruction of the knee.

The TriTis Absorbable Tibial Reconstruction System consists of a three piece implant designed to provide soft tissue fixation for tibial anterior cruciate ligament (ACL) reconstruction. The graft cleat secures the soft tissue graft in the tunnel. The washer and fixation screw secure the ends of the graft and cleat to the bone. The System includes instrumentation to prepare the bone tunnel and place the device as well as a sterilization tray. The modifications made to the device that are the subject of this submission are: Add a new, 12 mm diameter graft cleat implant size, and a new, 12 mm Dilator instrument. All other device features and instruments remain unchanged.

The device discussed in the provided text is Scandius TriTis™ Absorbable Tibial Reconstruction System, which is a mechanical device, not an AI/ML powered device. As such, several categories from the request (2, 3, 4, 5, 6, 7, 8, and 9) are not applicable as they relate to AI/ML device performance and study design.

Here's the information extracted from the provided text, focusing on the mechanical aspects and the relevant performance data:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
Not applicable for a mechanical device; no "test set" in the context of data for AI/ML. The performance data was generated through "Simulated use test" and "System strength test," which are bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for a mechanical device; no "ground truth" in this context.

4. Adjudication method for the test set
Not applicable for a mechanical device; no "adjudication method" in this context.

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 for a mechanical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable for a mechanical device.

7. The type of ground truth used
Not applicable for a mechanical device. The "ground truth" for a mechanical device is its physical properties and functionality as determined by engineering tests.

8. The sample size for the training set
Not applicable for a mechanical device; no "training set."

9. How the ground truth for the training set was established
Not applicable for a mechanical device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The provided 510(k) summary for the Scandius TriTis™ Absorbable Tibial Reconstruction System indicates that the device's modifications (adding a new 12 mm diameter graft cleat implant size and a new 12 mm Dilator instrument) were assessed through bench testing.

Specifically, the "Performance Data" section states that the following tests were conducted to support the substantial equivalence determination:

• Simulated use test: This test was performed to confirm that the design integrity of the device is maintained.
• System strength test: This test was conducted to also confirm that the design integrity of the device is maintained.

The results of these tests indicated that the design integrity of the device was "maintained" for both simulated use and system strength. The 510(k) clearance by the FDA implies that these performance data were sufficient to demonstrate that the minor technological differences introduced by the modifications "do not raise any new questions of safety and effectiveness" compared to the predicate device. This confirms the device meets the stated acceptance criteria, which revolve around maintaining design integrity under simulated use and strength conditions.

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The Scandius TriTis Absorbable Tibial Reconstruction System is intended for use in the fixation of ligament and tendon grafts during anterior cruciate ligament (ACL) reconstructions of the knee.

The TriTis Absorbable Tibial Reconstruction System consists of a three piece implant designed to fixation soft tissue for tibial ACL reconstruction. The graft cleat secures the soft tissue graft in the tunnel. The washer and fixation screw secures the ends of the graft and cleat to the bone. The System includes instrumentation to prepare the bone tunnel and place the device as well as a sterilization trav.

Here's an analysis of the provided text regarding the Scandius TriTis Absorbable Tibial Reconstruction System, focusing on acceptance criteria and supporting studies:

Acceptance Criteria and Device Performance (Based Solely on Provided Text):

Study Information:

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

   • Test Set Sample Size: Not explicitly stated.
   • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The document mentions "Bench testing," which implies laboratory conditions.

2. 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 given text. "Bench testing" suggests a non-human-reader-based evaluation.

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

   • This is not applicable as the described study is "Bench testing" and does not involve human interpretation or a "test set" in the context of diagnostic performance.

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, an MRMC comparative effectiveness study was not done. This document describes a medical device for surgical reconstruction, not an AI-assisted diagnostic tool.

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

   • Yes, a "standalone" performance evaluation was done in the form of "Mechanical ultimate failure strength" bench testing. This is an assessment of the device's physical properties without human intervention.

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

   • The "ground truth" for the bench testing would be engineering specifications and established biomechanical standards for ultimate failure strength for such devices, likely derived from predicate devices or industry benchmarks.

7. The sample size for the training set:

   • Not applicable. This device is a physical implant, not an AI algorithm that requires a training set.

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

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

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The Scandius TriTis ACL Reconstruction System is intended for use for fixation of ligament and tendon grafts in cruciate ligament reconstructions of the knee.

The TriTis Tibial ACL Reconstruction System consists of a three piece implant designed to fixation soft tissue for tibial ACL reconstruction. The graft cleat secures the soft tissue graft in the tunnel. The washer and fixation screw secures the ends of the graft and cleat to the bone. The System includes instrumentation to prepare the bone tunnel and place the device as well as a sterilization tray.

The provided text describes the 510(k) summary for the Scandius TriTis Tibial ACL Reconstruction System. However, it does not contain the detailed information required to fully answer your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria.

Here's what can be extracted and what is missing based on your questions:

1. Table of acceptance criteria and the reported device performance:

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 simply as "Bench testing," implying laboratory-based mechanical tests rather than clinical data.

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 performance data provided is mechanical bench testing, not clinical data requiring expert review for ground truth.

4. Adjudication method for the test set:

• Not applicable. As the performance data is mechanical bench testing, there would be no adjudication method in the context of expert review or clinical 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. This is a medical device (ACL reconstruction system), not an AI/imaging diagnostic device. An MRMC study is not relevant here.

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

• No. This question is relevant for AI algorithms. The device discussed is a physical implant.

7. The type of ground truth used:

• For the mechanical ultimate failure strength, the "ground truth" would be the measured mechanical properties of the device under specific test conditions, and comparison to predefined engineering specifications or predicate device performance. These are established through standardized mechanical testing protocols.

8. The sample size for the training set:

• Not applicable. This device is a mechanical implant, not an AI system that requires a "training set."

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

• Not applicable. As above, no training set is relevant here.

Summary of Missing Information:

The provided 510(k) summary is very high-level and only states that "Bench testing demonstrates that any minor technological differences do not raise any new questions of safety and effectiveness" for "Mechanical ultimate failure strength." It lacks specific quantitative acceptance criteria, actual performance values, detailed methodology of the bench tests, the number of samples tested, or any clinical study details. For a full answer to your request, more detailed engineering and device testing documentation would be required.

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The Scandius Absorbable ACL Reconstruction System is intended for use in fixation of ligament and tendon grafts in cruciate ligament reconstructions.

The Absorbable ACL Reconstruction System consists of a two piece implant. The femoral implant is designed to maintain the graft block in the femoral tunnel. A screw placed transversely to the femoral tunnel secures the graft block in place. The System includes instrumentation to create the bone tunnel and place the device as well as a sterilization tray.

The provided document is a 510(k) summary for the Scandius Absorbable ACL Reconstruction System, submitted to the FDA in 2004. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, primarily through performance data like bench testing. It is not a clinical study report for an AI/ML powered device, and therefore does not contain the information requested in the prompt regarding acceptance criteria, expert ground truth, sample sizes for training/test sets, or MRMC studies.

The document explicitly states:

• "Bench testing demonstrates that any minor technological differences do not... [raise] new questions of safety and effectiveness." (page 2 of 2)
• "The following performance data was provided in support of the substantial equivalence determination: Mechanical ultimate failure strength. In-Vitro Analysis." (page 2 of 2)

Therefore, I cannot provide the requested information for an AI/ML powered device study. The document only details mechanical and in-vitro performance data for a medical implant.

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The Scandius ACL Reconstruction System is intended for use in fixation of ligament and tendon grafts in cruciate ligament reconstructions.

The ACL Reconstruction System consists of a two piece implant designed to fixation soft tissue for ACL reconstruction. The graft block secures the soft tissue graft. A fixation pin placed transversely to the femoral tunnel secures the graft block in place. The System includes instrumentation to create the bone tunnel and place the device as well as a sterilization tray.

This 510(k) premarket notification (K041749) for the Scandius ACL Reconstruction System focuses on substantial equivalence to a predicate device, the Depuy Linx HT, rather than establishing de novo acceptance criteria and performing a detailed study to prove the device meets these.

Here's an analysis based on the provided text, addressing your points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a table with explicit, quantifiable acceptance criteria. Instead, it states:

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

• Sample Size: Not specified. The document only mentions "Bench testing."
• Data Provenance: Not specified, but generally, bench testing for medical devices is conducted in a laboratory setting. No country of origin for the data is mentioned, and it's inherently prospective in the sense that the tests are performed on the device being submitted.

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

• Number of Experts: Not applicable. For mechanical bench testing, ground truth is established through validated testing methodologies and equipment, not typically by expert consensus in the way a clinical study's ground truth would be.
• Qualifications of Experts: Not applicable. The "experts" in this context would be the engineers or technicians performing the mechanical tests.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. Since this involves mechanical bench testing and not subjective interpretation, there is no need for an adjudication method.

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

• MRMC Study: No. This submission is for a medical device (an ACL reconstruction system) and not an imaging or diagnostic device that would typically involve human readers interpreting cases.

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

• Standalone Performance: Not applicable. This device is an implantable surgical system, not an algorithm.

7. Type of Ground Truth Used:

• Type of Ground Truth: The ground truth for the "ultimate failure strength" would be the objectively measured force at which the device fails, determined by established mechanical testing standards and protocols.

8. Sample Size for the Training Set:

• Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training set" concept does not apply to the mechanical testing of a surgical implant.

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

• How Ground Truth Established: Not applicable, as there is no training set.

Summary of Acceptance Criteria and Study Approach in K041749:

The core of this 510(k) submission relies on demonstrating substantial equivalence to a predicate device (Depuy Linx HT). The primary "acceptance criterion" is implicitly that the Scandius ACL Reconstruction System performs at least as well as or similarly to the predicate device in terms of mechanical properties and does not raise new questions of safety or effectiveness.

The "study" conducted for this purpose was bench testing, specifically focusing on "Mechanical ultimate failure strength." The outcome of this testing likely showed that the Scandius system's mechanical strength was comparable to the predicate device, thereby fulfilling the requirement for substantial equivalence. The FDA's letter confirms substantial equivalence, indicating that they were satisfied with the provided performance data in comparison to the predicate.

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