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SportMesh™ Artelon® Tissue Reinforcement is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists.

SportMesh™/ Artelon® Tissue Reinforcement is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons.

SportMesh™ Artelon® Tissue Reinforcement is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the tendon repair. SportMesh™/ Artelon® Tissue Reinforcement reinforces soft tissue and provides a degradable scaffold that is incorporated into the patient's own tissue.

SportMesh™ / Artelon® Tissue Reinforcement is a knitted fabric made from Artelon® fibers. The construction permits the mesh to be cut into any desired shape or size without unraveling. The device is supplied sterile in sheet form in double laver peelable packaging.

The provided text describes a 510(k) premarket notification for a surgical mesh device, not an AI/ML medical device. Therefore, a direct application of the requested acceptance criteria for AI algorithms is not possible. The document focuses on demonstrating substantial equivalence to predicate devices through material composition, intended use, and performance data, rather than AI performance metrics.

However, I can extract the information relevant to the device's "performance" as presented and the study that "proves" it meets the criteria, reinterpreting the request for a non-AI medical device.

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the document. For a physical medical device like this, the "test set" would refer to the samples of the device itself undergoing testing. The document states "A collection of tests has been conducted," but does not specify the number of samples for biocompatibility or mechanical testing. Data provenance is also not specified beyond the general statement that tests were conducted.

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

This concept is not applicable to this type of device submission. Ground truth for a physical medical device typically comes from objective measurements in a lab setting (e.g., mechanical testing, chemical analysis) or animal/human studies for biocompatibility, not expert consensus in the way it's used for AI models to interpret images or other data.

4. Adjudication Method for the Test Set

This concept is not applicable to this type of device submission. Adjudication methods like 2+1 or 3+1 are used in AI performance studies to resolve disagreements among human labelers for establishing ground truth, a process not described here for a surgical mesh.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant to AI systems where the AI's impact on human reader performance is being evaluated. This document pertains to a physical surgical mesh.

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

No, a standalone study was not done. This term specifically refers to the performance of an AI algorithm without human involvement, which is not relevant to a surgical mesh.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance would be derived from:

• Objective Laboratory Measurements: For mechanical properties (e.g., tensile strength, degradation rate – though not explicitly listed as specific metrics, implied by "appropriate mechanical properties").
• Standardized Biocompatibility Assays: According to ISO 10993 standards. This involves in vitro and in vivo tests to assess material interaction with biological systems.
• Material Characterization: Chemical composition and structural analysis to confirm it's "identical" to the predicate device.

8. The Sample Size for the Training Set

This concept is not applicable to this type of device submission. "Training set" refers to data used to train an AI model.

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

This concept is not applicable to this type of device submission.

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ARTELON STT Spacer is intended to be implanted into the scaphotrapeziotrapezioidal (STT) joint as an interpositional spacer between the scaphoid bone and the trapezialtrapezioid bones. The device is intended to be used in thumb disabilities caused by osteoarthritis.

ARTELON STT Spacer is a woven one-piece, L-shaped implant made of ARTELON, a polycaprolactone based polyurethaneurea.

This submission is for a medical device (Artelon STT Spacer), not an AI/ML powered device. Therefore most of the requested information regarding AI/ML powered devices, such as acceptance criteria, sample sizes for test and training sets, expert qualifications, and ground truth establishment, is not applicable.

Here's a breakdown of the relevant information provided:

1. Table of acceptance criteria and reported device performance: Not explicitly stated in the provided text in the format of acceptance criteria and reported performance. The document states, "A collection of tests have been successfully completed. The results from the performance testing demonstrate that ARTELON STT Spacer provides appropriate assurance of safety and effectiveness." However, specific quantitative or qualitative acceptance criteria and their corresponding results are not detailed.

2. Sample size used for the test set and the data provenance: Not applicable. This is a medical device approval summary, not a study report for an algorithm. The testing described is likely mechanical and biocompatibility testing of the physical implant, not a test set for an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML validation does not apply here.

4. Adjudication method: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done as this is a medical device (implant) and not a reader-dependent diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.

7. The type of ground truth used: Not applicable in the context of an AI/ML algorithm. For the device, safety and effectiveness would be established through mechanical testing, biocompatibility studies, and potentially clinical trials (though not detailed here for this 510(k) summary).

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

Additional Information from the document:

• Device Name: Artelon® STT Spacer
• Intended Use: "ARTELON STT Spacer is intended to be implanted into the scaphotrapeziotrapezioidal (STT) joint as an interpositional spacer between the scaphoid bone and the trapezialtrapezioid bones. The device is intended to be used in thumb disabilities caused by osteoarthritis."
• Comparison to Predicate Devices: The submission states that the Artelon STT Spacer is substantially equivalent to:
  • K040070 Artelon® CMC Spacer (Artimplant AB)
  • Swanson Trapezium Implant (Dow Corning Wright - a pre-amendment device)
• Basis for Equivalence: The Artelon STT Spacer is made of the same material (ARTELON) and has the same basic design as the Artelon CMC Spacer. It also serves a similar function (space-filling for osteoarthritis) to the Swanson Trapezium Implant.
• Conclusion: The FDA determined the device is substantially equivalent to legally marketed predicate devices, and therefore presents no new concerns of safety and effectiveness.

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Artelon® CMC Spacer Arthro intended to be implanted into first carpometacarpal joint (CMC-I) as an interpositional spacer between the trapezial bone and the first metacarpal bone. The device is intended to be used in thumb disabilities caused by osteoarthritis.

ARTELON CMC Spacer Arthro is a woven textile device made of ARTELON fibres. ARTELON is a biocompatible, degradable material made of polycaprolactone-based polyurethaneurea. ARTELON CMC Spacer Arthro is designed to act as an interposition part in the joint. The purpose of the vertical portion is to separate the surfaces of the arthritic joint from each other. The purpose of the horizontal portion of ARTELON CMC Spacer Arthro is to fixate the device. ARTELON CMC Spacer Arthro is a single-use device packaged in double sterile barriers. The ARTELON CMC Spacer Arthro wings are fixed in place using commercially available suture anchors (non-absorbable, diameter approximately 2 mm) in combination with two double-armed class I nonabsorbable USP size 1 sutures.

The provided text is a 510(k) summary for the ARTELON CMC Spacer Arthro. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain a study that demonstrates the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or accuracy.

Instead, the submission relies on bench testing to demonstrate performance and substantial equivalence to a previously cleared device.

Therefore, many of the requested details about acceptance criteria and study design for measuring device performance cannot be extracted from this document because such a study was not performed or reported in this summary.

Here's a breakdown of the information that can be extracted or inferred based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. No clinical "test set" in the context of a performance study (e.g., measuring disease detection accuracy) was conducted for this 510(k) submission. Performance was assessed via bench testing and comparison to a predicate device.
• Data Provenance: Not applicable for a clinical performance study. The submission describes bench testing which would typically be conducted in a laboratory setting.

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

• Not applicable. No ground truth establishment by experts for a clinical performance study was reported.

4. Adjudication Method for the Test Set

• Not applicable. No clinical performance study requiring adjudication was reported.

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

• No, a MRMC comparative effectiveness study was not done. The document does not describe any human-in-the-loop performance evaluation or comparison with AI assistance.

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

• No, a standalone (algorithm only) performance study of this nature was not done. The device is a physical implant, not an algorithm. Performance was assessed through engineering bench tests and comparison to a predicate device.

7. Type of Ground Truth Used

• For demonstrating equivalence: The "ground truth" was the performance and characteristics of the predicate device (ARTELON CMC Spacer, K040070), along with compliance to recognized standards (ISO 10993, ISO 14971, etc.) through bench testing.
• For clinical outcomes: Not applicable, as detailed clinical outcomes data from a specific study for this device's 510(k) submission are not provided.

8. Sample Size for the Training Set

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

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

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

Summary of the 510(k) Approach:

The 510(k) submission for the ARTELON CMC Spacer Arthro focused on demonstrating substantial equivalence to a previously cleared device (ARTELON CMC Spacer, K040070). This involved:

• Bench Testing: Ensuring the new device met the same "release specifications" as the predicate device and complied with relevant ISO and AAMI standards for biocompatibility, sterilization, packaging, and risk management.
• Comparison of Features: Highlighting the similarity in dimensions, materials, basic design, and intended use between the new device and the predicate.

This type of submission typically does not include de novo clinical studies with specific performance metrics like sensitivity or specificity, or studies involving human readers or AI algorithms for diagnostic purposes. The "acceptance criteria" here are primarily around meeting engineering specifications and demonstrating equivalency to a device already deemed safe and effective by the FDA.

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Sportmesh™ is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. Sportmesh™ is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, limited to the supraspinatus, during rotator cuff repair surgery.

Sportmesh™ is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide mechanical strength for the tendon repair. Sportmesh™ reinforces soft tissue and provides a degradable scaffold that is incorporated in the patient's own tissue.

Sportmesh™is a knitted fabric made from ARTELON fibers. This construction permits the mesh to be cut into any desired shape or size without unraveling. The device is supplied in sheet form in sterile double layer peelable packaging.

The provided text describes a 510(k) premarket notification for the Sportmesh™ device. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than proving that the device meets specific acceptance criteria through a traditional clinical study with defined endpoints and acceptance thresholds.

Therefore, the document does NOT contain information regarding:

• A table of acceptance criteria and reported device performance in the way typically found for novel device approvals.
• Sample sizes for a test set, data provenance, number of experts for ground truth, adjudication methods, or MRMC studies.
• Standalone algorithm performance.
• Training set size or how ground truth for a training set was established.

Instead, the submission relies on:

Acceptance Criteria and Device Performance (as demonstrated for 510(k) pathway):

The "acceptance criteria" in this context are primarily demonstrating equivalence to already approved predicate devices concerning safety and effectiveness. The "performance" is shown through the successful completion of specific tests and comparisons.

• Biocompatibility safety studies: Conducted according to ISO 10993 standards.
• Mechanical testing: Conducted in accordance with the "Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh; Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance."
  The results "demonstrate that Sportmesh™ provides appropriate mechanical properties for its use in soft tissue repair."
  Based on these comparisons and performance tests, the conclusion is that Sportmesh™ is substantially equivalent and "presents no new concerns about safety and effectiveness." |

Study Details (as per the provided document):

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

   • Not applicable/Not provided. The document describes premarket notification for a Class II medical device (Sportmesh™) via the 510(k) pathway. This pathway establishes substantial equivalence to predicate devices, and typically does not require a formal "test set" with a specified sample size in the context of clinical performance evaluation in the same way a PMA (Premarket Approval) submission would. Instead, testing focused on biocompatibility and mechanical properties. The data provenance is implied to be from Artimplant AB's internal testing as part of their submission process.

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

   • Not applicable/Not provided. Ground truth in the sense of expert consensus on clinical outcomes for a "test set" is not detailed in this 510(k) summary. The "ground truth" for the performance tests would be the established ISO 10993 standards for biocompatibility and specific mechanical test parameters outlined in the FDA's guidance for surgical mesh, which are objectively measurable, rather than expert-derived clinical ground truth.

3. Adjudication method for the test set:

   • Not applicable/Not provided. No clinical adjudication method is described.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • No, an MRMC comparative effectiveness study was not done.

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

   • Not applicable. This is a surgical mesh, not a software algorithm.

6. The type of ground truth used:

   • The "ground truth" for the performance evaluation primarily consisted of established regulatory standards and guidance documents. For biocompatibility, this was ISO 10993 standards. For mechanical properties, it was FDA guidance for surgical mesh. These are objective, measurable criteria, not expert consensus or pathology on a clinical dataset.

7. The sample size for the training set:

   • Not applicable/Not provided. The concept of a "training set" is not relevant for this type of device and submission, which involves physical material testing and comparison to predicates, not machine learning.

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

   • Not applicable/Not provided. See point 7.

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Artelon® Surgical Suture is intended for use in general soft tissue approximation and/or ligation during surgery.

ARTELON Surgical Sutures are nonabsorbable sterile surgical sutures (i.e. braided threads) prepared from ARTELON (polycaprolactone based poly (urethane urea)) in a multifilament form intended for soft tissue approximation. Due to limited stiffness of the sutures, they appear stretchy during handling. Although ARTELON sutures are nonabsorbable, they degrade slowly over time; the degradation occurs over a prolonged period of time with a gradual reduction of tensile strength of approximately 20% per year. ARTELON Surgical Sutures are uncoated and undyed. The sutures are supplied sterile.

The provided text describes the ARTELON Surgical Suture and its substantial equivalence to a predicate device but does not contain any information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. MRMC comparative effectiveness study details.
6. Standalone performance study details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document focuses on regulatory compliance through substantial equivalence, referencing general standards and a predicate device (ARTELON Surgical Suture, K032160) rather than providing specific performance data from new studies. It lists compliance with:

• ISO 10993 standards (Biological evaluation of medical devices)
• ISO 14971 (Medical devices - Application of risk management to medical devices)
• USP 26 (United States Pharmacopoeia standards for nonabsorbable surgical sutures)
• Class II Special Control Guidance, Surgical Suture; Guidance for Industry and FDA, June 3, 2003

These are general standards or guidance documents, not performance results. The claim is that "The product meets all requirements established by the United States Pharmacopoeia (U.S.P) for nonabsorbable surgical sutures," but no specific performance metrics like tensile strength retention over time or knot security are presented in quantifiable terms against acceptance criteria within this summary.

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The Artimplant Artelon® Spacer CMC-I The Artelon™ Spacer CMC-I is intended to be implanted into the first carpometacarpal joint as an interpositional spacer between the trapezium and first metacarpal.

The device is intended to be used in thumb disabilities because of osteoarthritis.

The Artelon™ Spacer CMC-I is a one-piece device intended to be implanted into the CMC-I joint and serve as an interpositional spacer between the trapezium bone and the first metacarpal bone.

It is composed of Artelon™, a polycaprolactone based poly(urethane urea), in multifilament form.

The Artelon™ Spacer CMC-I will be offered sterile.

This submission describes a 510(k) premarket notification for the Artelon™ Spacer CMC-I, a wrist joint carpal trapezium polymer prosthesis. The document focuses on demonstrating substantial equivalence to a predicate device, the Avanta Orthopedics TRL Trapezium Soft Skeletal Implant (K964381).

Here's an analysis of the provided information, focusing on acceptance criteria and supporting studies, while noting the limitations of the provided text in addressing all requested points for a typical AI/ML device study:

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

The provided text does not explicitly define specific, quantitative acceptance criteria for the Artelon™ Spacer CMC-I. Instead, it relies on demonstrating substantial equivalence to an existing predicate device. The performance is assessed through various tests and comparisons.

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

The document mentions "clinical evaluation" but does not provide details on the sample size or data provenance (country of origin, retrospective/prospective nature) for any specific clinical test set. The focus is on technical and clinical performance in general to establish substantial equivalence.

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

This information is not provided in the document. Given that this is a medical device (implant) and not an AI/ML diagnostic tool, the concept of "ground truth" established by experts in the context of an AI/ML study is not directly applicable here. The "ground truth" for a medical implant would be its safety and effectiveness in patients, assessed through clinical trials and post-market surveillance.

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

This information is not provided and is not relevant for this type of medical device submission. Adjudication methods are typically used in studies involving subjective assessments, especially in AI/ML performance evaluation where multiple human readers might disagree.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC study is not mentioned, and it is not applicable to this medical implant device. MRMC studies are designed to evaluate the impact of a diagnostic aid (like AI) on human reader performance, which is not the purpose of this submission.

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

A standalone performance evaluation (as understood for an AI algorithm) was not done, and it is not applicable to this medical implant device.

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

For this medical implant, the "ground truth" for its performance would implicitly be:

• Biocompatibility test results: Demonstrating no adverse biological reactions.
• Mechanical test results: Verifying structural integrity and performance under stress.
• Clinical outcomes data: Assessed through the "clinical evaluation," likely involving patient follow-ups to determine pain relief, improved function, absence of complications, etc. However, specific details of this "clinical evaluation" and its outcomes are not provided.

8. The sample size for the training set

This is not applicable as the Artelon™ Spacer CMC-I is a physical medical implant, not an AI/ML algorithm that requires a training set.

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

This is not applicable for the same reason as point 8.

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The Artelon™ Surgical Suture is intended for use in general soft tissue approximation and/or ligation.

Artelon™ Surgical Suture is a nonabsorbable braided surgical suture, which is supplied sterile. It is composed of Artelon™, a polycaprolactone based poly(urethane urea), in multifilament form. The Artelon™ Surgical Suture will be offered uncoated and undyed and without needle.

The product meets all requirements established by the United States Pharmacopoeia (U.S.P) for nonabsorbable surgical sutures.

This document describes the Artelon™ Surgical Suture and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of AI/ML performance. Therefore, many of the requested fields are not applicable. However, I can extract the relevant information regarding performance testing that was conducted.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable (N/A). This document does not detail a clinical study with a test set of data. The "performance testing" refers to in-vitro and material characteristic tests rather than performance against a clinical dataset.

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

• N/A. Ground truth is not established in the context of clinical data for this type of device submission. Performance is measured against established physical and biological standards.

4. Adjudication method for the test set:

• N/A. No adjudication method for a test set of data is mentioned as this is not a clinical study.

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:

• N/A. No MRMC study was conducted, as this device (surgical suture) is not an AI/ML-powered diagnostic or assistive tool for human readers.

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

• N/A. Not an AI/ML device.

7. The type of ground truth used:

• For biocompatibility: ISO 10993 standards.
• For physical characteristics (diameter, tensile strength, pliability, handling): USP 26 requirements.
• For regulatory compliance: Guidance for surgical suture documents.

8. The sample size for the training set:

• N/A. This device does not involve machine learning; therefore, no training set or sample size for training is relevant.

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

• N/A. No training set for machine learning. The "ground truth" for the device's performance is established by recognized international and national standards (ISO, USP, FDA guidance).

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