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The fiXate Tissue Band is intended to be an accessory to the leads/catheter component of Spinal Cord Stimulator/Pain Pump systems functioning to secure the lead to the fascia or inter- spinous/supra- spinous ligament.

The fiXate Tissue Band consists of an adjustable loop of non- absorbable 2-0 suture (UHMWPE or PET (coated or uncoated) ) with two (2) attached anchors (PEEK Optima LT1 or PET). The construct is provided sterile and preloaded on a disposable delivery instrument. The instrument's needle facilitates placement of the suture by positioning the T-anchors in the sub- layer of tissue.

Here's a breakdown of the acceptance criteria and study information for the fiXate Tissue Band, based on the provided K113805 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document (K113805) describes functional and safety testing as part of the submission to demonstrate substantial equivalence, rather than setting specific numerical acceptance criteria for a direct comparison table. Instead, it relies on conformance to established standards and comparison to a predicate device.

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

• Sample Size: The document does not explicitly state a specific sample size for the "test set." It mentions "tensile testing" and "comparison of fixation strength," which implies testing on a certain number of devices or components. However, the exact number is not provided.
• Data Provenance: The nature of the tests (biocompatibility, tensile, and fixation strength) suggests these were prospective bench tests performed in a laboratory setting. There is no indication of country of origin for test data, but given the US submission, it's reasonable to assume the testing was conducted per US regulatory guidance or by labs compliant with such. There is no mention of patient data (retrospective or prospective) for this specific submission as it appears to be focused on physical and material properties.

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

This type of information is generally not applicable to the non-clinical, bench testing described in this 510(k). The "ground truth" for biocompatibility is conformance to ISO standards, for tensile strength it's USP suture requirements, and for fixation strength, it's a comparative assessment against a predicate device's established performance. These are objective measures rather than expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set:

Not applicable. The tests described are objective physical and chemical evaluations, not subjective clinical assessments requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret medical images or data. The fiXate Tissue Band is a surgical accessory, and its evaluation relies on bench testing and comparison of its physical properties to predicate devices.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone (algorithm only) performance study was not done. This device is a physical medical implant/accessory, not a software algorithm or AI-driven system.

7. Type of Ground Truth Used:

• Biocompatibility: Conformance to ISO 10993-1 standards.
• Tensile Strength: Compliance with USP (United States Pharmacopeia) suture requirements.
• Fixation Strength: Comparative data against the previously cleared fiXate Tissue Band (predicate devices) to demonstrate comparable safety and effectiveness.

Essentially, the "ground truth" for these tests are established engineering and material science standards, and the performance characteristics of an already cleared, substantially equivalent device.

8. Sample Size for the Training Set:

Not applicable. This device is a physical product, not an AI or machine learning model that requires a training set.

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

Not applicable, as there is no training set for this device.

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The fiXate Tissue Band is intended to be an accessory to the leads component of Spinal Cord Stimulator systems functioning to secure the lead to the fascia or inter-spinous/supra-spinous ligament.

The fiXate Tissue Band consists of an adjustable loop of non-absorbable 2-0 suture with two (2) attached anchors. The construct is provided sterile and preloaded on a disposable delivery instrument. The instrument's needle facilitates placement of the suture by positioning the T-anchors in the sub-layer of tissue.

The provided text is a 510(k) summary for the fiXate Tissue Band and does not contain detailed information about specific acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics like sensitivity, specificity, or accuracy. The summary focuses on demonstrating substantial equivalence to a predicate device.

However, based on the information provided, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific numerical acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity) or detailed performance metrics are reported in this document. The document states "Biocompatibility and bench testing were completed and support the safety and effectiveness of the fiXate Tissue Band." This indicates that some form of testing was done to ensure safety and effectiveness, but the specific criteria and results are not detailed.

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

Not applicable. The document does not describe a clinical study or a test set involving patient data where such information would typically be relevant. The testing mentioned appears to be bench testing and biocompatibility testing.

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

Not applicable. No expert review or ground truth establishment relevant to an AI/diagnostic device performance study is described.

4. Adjudication Method for the Test Set:

Not applicable. No test set requiring expert adjudication is described.

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

No. The document does not describe an MRMC study or any study where human readers' performance with and without AI assistance was evaluated.

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

Not applicable. The fiXate Tissue Band is a physical medical device (an accessory to Spinal Cord Stimulator systems), not an algorithm or AI device. Therefore, the concept of "standalone performance" for an algorithm is not relevant here.

7. The Type of Ground Truth Used:

Not applicable. As this is not an AI/diagnostic device, the concept of "ground truth" in that context does not apply. The "ground truth" for a physical device like this would be its physical properties, biocompatibility, and mechanical performance, established through bench testing and material analyses.

8. The Sample Size for the Training Set:

Not applicable. As this is a physical medical device, not an algorithm or AI device, there is no "training set" in the context of machine learning.

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

Not applicable. No training set is involved.

Summary of what is available from the document regarding "acceptance criteria" and "study":

• Acceptance Criteria (Implied): The implied acceptance criteria for the fiXate Tissue Band are related to its safety and effectiveness, as demonstrated through biocompatibility and bench testing. The key "acceptance" was the FDA's determination of substantial equivalence to existing predicate devices (K111462 and K112849). This means the device was found to be as safe and effective as the previously cleared devices.
• Study: The document mentions that "Biocompatibility and bench testing were completed and support the safety and effectiveness of the fiXate Tissue Band." This refers to non-clinical studies evaluating the material properties and mechanical performance of the physical device. Specific details about these tests, their protocols, or results are not included in this summary.

In essence, this 510(k) summary focuses on demonstrating that the fiXate Tissue Band is a modified version of an already cleared device and meets the necessary non-clinical standards for safety and performance, rather than presenting a clinical study with detailed performance metrics.

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The fiXate Tissue Band is intended to be an accessory to the leads component of Spinal Cord Stimulator systems functioning to secure the lead to the fascia or inter-spinous/supra-spinous ligament.

The fiXate Tissue Band consists of an adjustable loop of non-absorbable 2-0 suture with two (2) attached anchors. The construct is provided sterile and preloaded on a disposable delivery instrument. The instrument's needle facilitates placement of the suture by positioning the T-anchors in the sub-layer of tissue.

This 510(k) pertains to a medical device, the fiXate Tissue Band, which is an accessory to Spinal Cord Stimulator systems. This type of device does not typically involve AI/ML components or require the extensive validation studies for diagnostic accuracy that are common in AI/ML submissions. Therefore, many of the requested elements (e.g., test set sample size, ground truth establishment, MRMC studies, training set details) are not applicable to this submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative "acceptance criteria" for diagnostic performance, as it is a physical medical device. Instead, the "acceptance criteria" are implied by demonstrating substantial equivalence to a predicate device through functional and safety testing.

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

Not applicable. This is a physical medical device submission, not a diagnostic algorithm. Performance was evaluated through biocompatibility and bench testing, not through a "test set" of patient data.

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

Not applicable. Ground truth, in the context of diagnostic accuracy, is not relevant for this device. Safety and effectiveness are evaluated through engineering and biological testing.

4. Adjudication Method for the Test Set

Not applicable. See above.

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

No. This device is not an AI/ML diagnostic tool, so an MRMC study is not relevant.

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

Not applicable. This is not an algorithm-based device.

7. The Type of Ground Truth Used

Not applicable. Evaluation relies on established engineering and biocompatibility standards, not diagnostic ground truth.

8. The Sample Size for the Training Set

Not applicable. This device does not involve an AI/ML algorithm that requires a "training set."

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

Not applicable. See above.

Study Proving the Device Meets Acceptance Criteria:

The submission states: "Biocompatibility and bench testing were completed and support the safety and effectiveness of the fiXate Tissue Band." It further concludes: "The fiXate Tissue Band is similar in materials, design, and performance characteristics and has the same intended use as the original fiXate Tissue Band (K111462). Substantial equivalence is demonstrated through the detailed device description, performance testing and conformance with voluntary performance standards."

The study that proves the device meets the (implied) acceptance criteria is the biocompatibility and bench testing. The details of these tests (e.g., specific protocols, results, number of samples tested for each bench test) are not provided in this 510(k) summary but would have been submitted to the FDA as part of the full application. The key outcome presented is that these tests confirmed the device is safe and effective and that it is substantially equivalent to its predicate device (K111462).

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The fiXate Tissue Band is intended to be an accessory to the leads component of Spinal Cord Stimulator systems functioning to secure the lead to the fascia or inter-spinous/supra-spinous ligament.

The fiXate Tissue Band consists of an adjustable loop of non-absorbable 2-0 suture with two (2) attached anchors. The construct is provided sterile and preloaded on a disposable delivery instrument. The instrument's needle facilitates placement of the suture by positioning the T-anchors in the sub-layer of tissue.

Here's an analysis of the provided information regarding the fiXate Tissue Band (K111462) from the perspective of acceptance criteria and supporting studies:

Based on the provided K111462 summary, there is no specific performance study involving a test set, ground truth established by experts, or AI performance reported. This device clearance is based on substantial equivalence to predicate devices, supported by functional and safety (benchtop) testing and biocompatibility assessments.

Therefore, I cannot populate most of the requested fields as they pertain to clinical or algorithm performance studies that were not conducted or reported in this 510(k) summary.

However, I can extract information relevant to the device's functional and safety testing, which implicitly serves as the "study that proves the device meets acceptance criteria" within the context of a 510(k) based on substantial equivalence.

Acceptance Criteria and Device Performance (Based on Provided Information)

Explanation of "Acceptance Criteria" in this Context: For a 510(k) submission seeking substantial equivalence, the "acceptance criteria" are generally met when the new device can demonstrate that it is as safe and effective as a legally marketed predicate device. This is primarily achieved through showing similarity in intended use, technology, design, materials, and performance characteristics, often supported by bench testing and biocompatibility studies rather than complex clinical efficacy trials. The "reported device performance" is essentially the conclusion that these similarities have been demonstrated.

Additional Study Information (Based on Provided Document)

1. Sample size used for the test set and the data provenance: Not applicable. The summary mentions "bench testing" but does not provide details on sample sizes or data provenance. This is typical for bench-top mechanical/functional tests, which are not usually reported with "test sets" in the clinical sense.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set requiring expert-established ground truth was reported.
3. Adjudication method for the test set: Not applicable. No clinical test set requiring adjudication was reported.
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: Not applicable. This is not an AI device, and no MRMC study was reported.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device, and no algorithm-only performance study was reported.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No clinical ground truth was used or reported. The "ground truth" for this device's clearance is its demonstrated equivalence to known safe and effective predicate devices, supported by engineering tests.
7. The sample size for the training set: Not applicable. This is not an AI/machine learning device.
8. How the ground truth for the training set was established: Not applicable. This is not an AI/machine learning device.

Summary of Device Evaluation for K111462:

The fiXate Tissue Band received 510(k) clearance based on demonstrating substantial equivalence to existing predicate devices (Anulex Technologies Versaclose, Anulex Technologies Xclose™ Tissue Repair System, and Advanced Neuromodulation Systems Swift-Lock Anchor). The "study" proving it meets acceptance criteria consists of:

• Bench Testing: To assess functional performance, safety, and mechanical properties.
• Biocompatibility Testing: To ensure the materials are safe for implantation.
• Comparative Analysis: A detailed comparison of the new device's intended use, materials, design, and performance characteristics with those of the predicate devices.

The conclusion drawn by the FDA is that these tests and comparisons demonstrate the new device is as safe and effective as the predicates, thereby meeting the requirements for 510(k) clearance. Clinical studies involving human subjects with defined test sets, expert ground truth, or AI performance metrics were not part of this submission's basis for clearance.

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