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The Micro/Mini N-PK Bone Anchor is intended for the reattachment of soft tissue to bone for the following indications: Foot and Ankle - . Hallux valgus repairs - Medial or lateral instability repairs/reconstructions . - Achilles tendon repairs/reconstructions - . Midfoot reconstructions - Metatarsa} ligament/tendon repairs/reconstructions . - . Bunionectomy

The Micro/Mini N-PK(F) Bone Anchor consists of an adjustable loop of non-absorbable suture (Sizes 2, 0 and 2-0) with one (1) or two (2) attached anchors. The bone anchor is a two part system, one part nickel-titanium (nitinol) and the second part polyetheretherketone (PEEK). The PEEK part resides within the nitinol sleeve and retains the suture. The nitinol part expands upon delivery providing resistance to pullout. The construct is provided sterile and preloaded on a disposable delivery instrument.

The provided text describes a medical device, the Micro/Mini N-PK(F) Bone Anchor, and its substantial equivalence to predicate devices, but it DOES NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of AI/ML device performance.

The document is a 510(k) summary for a physical medical device (a bone anchor) and focuses on demonstrating substantial equivalence through materials, technological characteristics, and performance testing typically associated with mechanical medical devices (biocompatibility, corrosion, tensile, fixation strength, cyclic fatigue).

Therefore, I cannot extract the requested information using the provided text. The questions you've asked are relevant to the evaluation of AI/ML-driven medical devices, which this document does not cover.

To elaborate on why the requested information cannot be found:

1. A table of acceptance criteria and the reported device performance: The document mentions "Functional and Safety Biocompatibility testing," "Corrosion testing," "Tensile testing," and "fixation/static disassembly strength and cyclic fatigue performance." However, it does not provide specific acceptance criteria (e.g., minimum tensile strength value, maximum corrosion rate) or the quantitative results of these tests in a table. It only states that these tests were "conducted" or "performed to verify compliance" or "support safety and effectiveness."
2. Sample size used for the test set and the data provenance: Not applicable, as this is not an AI/ML device study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/ML sense. For a mechanical device, "ground truth" would be the measured physical properties or performance under stressed conditions.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

This document describes a traditional medical device submission, not one for an AI/ML-enabled product.

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The Micro/Mini N-PK Bone Anchor is intended for the reattachment of soft tissue to bone for the following indications: Elbow, Hand and Wrist - Biceps tendon reattachment - Ulnar or lateral collateral ligament reconstruction . - ◆ Scapholunate ligament reconstruction - . Lateral epicondylitis repair

The Micro/Mini N-PK(H) Bone Anchor consists of an adjustable loop of non-absorbable suture (Sizes 2, 0 and 2- 0) with one (1) or two (2) attached anchors. The bone anchor is a two part system, one part nickel-titanium (nitinol) and the second part polyetheretherketone (PEEK). The PEEK part resides within the nitinol sleeve and retains the suture. The nitinol part expands upon delivery providing resistance to pullout. The construct is provided sterile and preloaded on a disposable delivery instrument.

This 510(k) summary describes the Micro/Mini N-PK(H) Bone Anchor, a device intended for the reattachment of soft tissue to bone. The study focuses on demonstrating substantial equivalence to predicate devices through functional and safety testing.

1. 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 sizes used for each specific test (biocompatibility, corrosion, tensile, fixation/static disassembly, cyclic fatigue). The data provenance is not specified either (e.g., country of origin, retrospective or prospective). These tests are typically performed in a laboratory setting.

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

Not applicable. The study involves laboratory-based functional and safety testing of a medical device, not a diagnostic or prognostic assessment requiring expert interpretation of results. Therefore, there is no "ground truth" in the clinical sense established by experts.

4. Adjudication method for the test set

Not applicable, as this is laboratory testing.

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 is a 510(k) submission for a bone anchor, not an AI-based diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.

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

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

7. The type of ground truth used

For the functional and safety testing, the "ground truth" is defined by the established industry standards and requirements against which the device's performance is measured:

• Biocompatibility: ISO 10993-1 standards.
• Corrosion: ASTM F2129 standards.
• Tensile testing: USP suture requirements.
• Fixation/Static disassembly strength and Cyclic fatigue performance: Comparison testing to predicate devices, implying that the performance of the predicate devices serves as the benchmark or "ground truth" for acceptable performance.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for this type of medical device testing. The device's design and materials are tested against established performance standards and predicate device performance.

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

Not applicable, as there is no training set involved. The ground truth for the device's performance is established by recognized international and industry standards (ISO, ASTM, USP) and the performance characteristics of legally marketed predicate devices.

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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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Versaclose is indicated for use in soft tissue approximation for procedures such as general and orthopedic surgery.

The Versaclose implant is comprised of one (1) Peek Optima (LT1) Toggle-anchor, connected to an adjustable 2-0 braided suture loop, made of ultra high molecular weight polyethylene (UHMWPE) force fiber suture. The suture component conforms to USP requirements. The construct is provided sterile and preloaded on a disposable delivery instrument.

Here's an analysis of the provided text regarding the Versaclose™ device, focusing on the acceptance criteria and supporting study information:

Based on the provided document, the Versaclose™ device's regulatory submission (K100572) is primarily focused on demonstrating substantial equivalence to a predicate device (K061386 - Anchor Band Suturing System) rather than proving performance against specific, quantitative acceptance criteria through a clinical or performance study as might be expected for an AI/diagnostic device.

Key takeaway: This document describes a device modification where the primary evidence for meeting acceptance criteria is through design verification and validation activities, specifically tensile testing to confirm compliance with USP suture requirements. It is not a clinical study of the type often associated with AI performance evaluations.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide the specific numerical values for USP suture requirements (e.g., minimum tensile strength for a 2-0 braided suture) or the specific numerical results obtained from the tensile testing. It only states that compliance was confirmed.

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

• Sample Size: Not explicitly stated. The document mentions "tensile testing" but does not specify the number of samples or lots tested.
• Data Provenance: Not applicable in the context of a retrospective/prospective study with human subjects. The testing described is a physical characterization of the device itself.

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

• Not applicable. The "ground truth" for this type of submission is defined by the USP (United States Pharmacopeia) standards for sutures, which are published material specifications, not expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

• Not applicable. There is no human adjudication process described for the tensile testing or USP compliance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement

• No. This type of study (MRMC) is generally performed for diagnostic or AI-assisted interpretation devices to assess the impact on human readers. This submission is for a surgical implant/suturing system, and such a study is not relevant here.

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

• No. This is not an algorithm or AI device. The described testing is a standalone device performance test in a laboratory setting (tensile testing) to confirm material properties, not an algorithm's classification performance.

7. The Type of Ground Truth Used

• Material Specification / Standard: The ground truth for the "acceptance criteria" is the USP (United States Pharmacopeia) requirements for sutures. These are pre-defined, standardized physical and mechanical properties that sutures must meet.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of this device submission for a physical medical device. The "training" here would be related to the development and refinement of the device design, which is not described in terms of a data set.

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

• Not applicable. As there is no training set in the AI/diagnostic sense, there is no ground truth established for one. The "ground truth" for the device's design and manufacturing is adherence to general engineering principles, material specifications, and quality systems.

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The Xclose™ Tissue Repair System is indicated for use in soft tissue approximation for procedures such as general and orthopedic surgery.

The modified Xclose™ Tissue Repair System consists of two (2) non-absorbable braided surgical 3-0 suture (Ultra High Molecular Weight Polyethylene, UHMWPE) and T-anchor (polyethylene terephthalate, PET) assemblies, connected together with a loop of green 2-0 suture (PET). The 2-0 suture loop is used to facilitate tightening, drawing the 3-0 suture/anchor assemblies together, thereby re-approximating the tissue. The suture components conform to USP requirements The construct is provided sterile and preloaded on a disposable delivery instrument.

The provided text describes a 510(k) submission for the Anulex Xclose™ Tissue Repair System. This is a medical device for soft tissue approximation, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device performance evaluation (such as sample size for test/training sets, ground truth establishment for AI, MRMC studies, etc.) are not applicable to this document.

The document focuses on demonstrating substantial equivalence to a predicate device (K062307 - Xclose Tissue Repair System) through design control processes and specific testing, primarily tensile testing to confirm compliance with USP suture requirements.

Here's an attempt to answer the applicable questions based on the provided text, while clearly stating when information is not present or relevant to this type of device submission.

Acceptance Criteria and Device Performance for Xclose™ Tissue Repair System

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 specified in the provided text. The statement "tensile testing was performed" does not include details on the number of samples tested.
• Data Provenance: Not specified, but generally, such testing for regulatory submissions is conducted in-house by the manufacturer (Anulex Technologies, Inc. in Minnetonka, MN, USA) or by a contracted testing lab. This would be prospective testing as part of design verification.

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 device is not an AI/ML diagnostic or predictive tool, but rather a physical surgical device. The "ground truth" for its performance is objective mechanical testing (tensile strength, material properties) and verification of its physical function. There are no "experts" establishing a "ground truth" in the way a clinical image might be adjudicated.

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

• Not applicable. This device does not involve subjective assessment or interpretation of results by multiple experts that would require an adjudication method. Performance is measured against engineering specifications and USP standards.

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 is a physical surgical device, not an AI-powered diagnostic or assistive tool. MRMC studies are used for evaluating the performance of diagnostic devices, especially those involving human interpretation.

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

• Not applicable. This device does not contain an algorithm; it is a physical surgical instrument.

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

• The "ground truth" in this context refers to established engineering standards and material specifications, specifically "USP suture requirements." Performance is measured against these objective, pre-defined criteria. There is no biological "ground truth" (like pathology or outcomes data) being directly evaluated in this specific submission summary for the device modifications.

8. The sample size for the training set

• Not applicable. This is a physical device, not an AI/ML 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 an AI/ML model, the concept of establishing ground truth for it does not apply. The development of the device itself would follow established engineering design and manufacturing principles, with "ground truth" for its individual components being their adherence to material and mechanical specifications.

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The Rimclose Bone Anchor is intended for fixation of suture to bone. This product is intended for the following indications:

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

The Rimclose Bone Anchor consists of one (1) bone anchor assembly, pre-loaded on a disposable delivery tool. The Bone Anchor is packaged with a disposable Bone Awl to facilitate placement of the device. The device is provided in one size only.

The bone anchor assembly is comprised of one (1) titanium (Ti-6Al-4V ELI) toggle-anchor, connected to an adjustable polyethylene terephthalate (PET) 2-0 braided suture loop, via an intermittent length of size 0 ultra high molecular weight polyethylene (UHMWPE) Force Fiber suture.

The device's titanium component conforms to ASTM F-136. The device's polyethylene terephthalate (PET) and ultra high molecular weight polyethylene (UHMWPE) suture components conform to USP requirements. The constructs are provided sterile and preloaded on disposable delivery instruments.

The provided text is a 510(k) summary for the Rimclose Bone Anchor. It describes the device, its intended use, and states that substantial equivalence to a predicate device was established through biocompatibility and bench testing. However, it does not contain detailed information about specific acceptance criteria or a study that proves the device meets those criteria in the way typically found for AI/ML devices or diagnostic tools.

Therefore, many of the requested sections will be answered as "Not applicable" or "Information not provided in the document."

Here's the breakdown 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: Information not provided in the document. The document refers to "bench testing," which typically involves mechanical tests rather than human patient data.
• Data Provenance: Information not provided. Since it's bench testing, country of origin or retrospective/prospective is not applicable in the context of 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)

• Information not provided. For a physical device undergoing bench testing, "ground truth" and "experts" in the context of clinical interpretation are not applicable. The performance is typically measured against engineering specifications or known material properties.

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

• Information not applicable. Adjudication methods are relevant for subjective assessments, typically in clinical studies or expert consensus. For bench testing of a bone anchor, performance metrics are typically quantitative and objective.

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, this is not an AI/ML device or an imaging/diagnostic tool, so MRMC studies are not applicable.
• Effect Size: Not applicable.

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

• Not applicable. This is a physical medical device (bone anchor), not an algorithm or AI system.

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

• The "ground truth" for this device's testing would likely be based on:
  • Engineering specifications/standards: For material properties, dimensions, and mechanical strength (e.g., tensile strength, fixation strength).
  • Predicate device performance: For comparison of equivalent fixation strength.
  • USP requirements and ASTM standards: For material conformance.

8. The sample size for the training set

• Not applicable. This is a physical medical device, and the concept of a "training set" is not relevant in the context of its testing for 510(k) clearance, which relies on bench testing and biocompatibility.

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

• Not applicable.

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The Xclose™ Tissue Repair System is indicated for use in soft tissue approximation for procedures such as general and orthopedic surgery.

The Xclose™ Tissue Repair System consists of two (2) non- absorbable braided surgical 3-0 suture and T-anchor assemblies, connected together with a loop of green 2-0 suture. The 2-0 suture loop is used to facilitate tightening, drawing the 3-0 suture assemblies together, thereby re-approximating the tissue. The device construct is composed of polyethylene terephthalate (PET) and conforms to USP requirements. The construct is provided sterile and preloaded on a disposable delivery instrument.

The provided text is related to a 510(k) submission for the Xclose™ Tissue Repair System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria, a study proving device performance against those criteria, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

The document states:
"The modifications to the Anchor Band Suturing System were conducted in accordance with the Anulex Design Control System. Accordingly, the risk analysis identified necessary design verification and validation activities. As a result of this analysis, tensile testing was performed to confirm compliance to USP suture requirements."

This indicates that tensile testing was performed to verify compliance with USP suture requirements. While this is a verification activity, the document does not provide the specific "acceptance criteria" for tensile strength (e.g., minimum tensile strength in Newtons) or the "reported device performance" against those criteria in a tabular format. It also doesn't detail the study design for this tensile testing (e.g., sample size, methodology).

Therefore, based solely on the provided text, I cannot complete most of the requested fields. I can only infer that "USP suture requirements" were the general acceptance criteria for tensile strength, and "tensile testing was performed to confirm compliance" is the study description, but without specifics.

Here is what can be extracted and what cannot:

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

• Acceptance Criteria: USP suture requirements (for tensile strength).
• Reported Device Performance: "Tensile testing was performed to confirm compliance to USP suture requirements." (No specific numerical performance is reported in this document beyond compliance).

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: Not specified (likely internal testing by Anulex Technologies, Inc. based in Minnetonka, MN, USA, but this is not explicitly stated as the origin of data). Not specified if retrospective or prospective.

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 as this is a physical device testing (tensile strength) and not an interpretive task requiring expert ground truth in the medical imaging or diagnostic sense.

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

• Not applicable for this type of physical device testing.

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 an AI/imaging device.

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

• No. This is not an AI/imaging device.

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

• The "ground truth" for tensile testing would be the measured tensile strength compared against the specified USP requirements. It's an objective measurement, not an expert consensus or pathology.

8. The sample size for the training set

• Not applicable. This device does not use a "training set" in the context of machine learning.

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

• Not applicable.

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