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Stitch Cerclage - Suture Tapes are indicated in orthopedic surgeries as bone fixation cerclage, specifically:

• Sternotomy indications including the "rewiring" of osteomized sternums;
• Repair of long bone fractures due to trauma or reconstruction.

Stitch Cerclage - Suture Tapes are indicated in orthopedic surgeries for internal fixation of discontinued bone structures. The product are not to be used in conjunction with other bone fixation implants, like plates. The surgical sutures and tapes are made of UHMWPE (ultra-high molecular weight polyethylene), the needles are made in AISI300 steel series, according to the standard ASTM F899 and cerclage is assembled on an ABS loader, additional instruments may be used as well. Those materials are identical to those used in other cleared GMReis devices like the reference device cleared under K223114. It is provided in sterile condition sterilized by Ethylene Oxide.

Based on the provided FDA 510(k) clearance letter for the Stitch Cerclage - Suture System, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

Important Note: The provided document is an FDA 510(k) clearance letter, which means the device has already been cleared. This letter summarizes the regulatory decision and mentions that studies were performed, but it does not contain the detailed study protocols, results, or data itself. Therefore, I will extract all available information and explicitly state when information is not present in this document.

Acceptance Criteria and Device Performance Study Summary

The acceptance criteria for this device are largely implied through the comparison to a predicate device and the successful completion of specified mechanical tests. The performance study focused on demonstrating substantial equivalence to the predicate device, particularly in mechanical properties relevant to its intended use as a bone fixation cerclage.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample sizes (e.g., number of test specimens, number of cycles for fatigue) used for the mechanical testing. It mentions "chemical composition, creep test, tension static and fatigue tests."
• Data Provenance: The studies were conducted by the manufacturer, GM Dos Reis Industria e Comercio Ltda, which is based in Campinas, Brazil. The data is based on mechanical testing, not clinical data, and therefore is not characterized as retrospective or prospective in the usual clinical sense. It's laboratory-based performance data.

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

• For this type of mechanical device clearance, "ground truth" is established through engineering standards, validated test methodologies, and comparison to the known performance of predicate devices.
• The document does not mention the use of human experts (like radiologists) for "ground truth" establishment as would be common for AI/imaging device clearances. The "experts" involved would be engineering and quality control personnel at the manufacturer and potentially external testing laboratories, ensuring compliance with test methodologies.

4. Adjudication Method for the Test Set

• Since this is a mechanical device performance study, no explicit "adjudication method" in the sense of clinician consensus on medical images is applicable or mentioned. The "adjudication" is inherent in the adherence to established mechanical testing protocols and statistical analysis of the results to demonstrate equivalence to the predicate.

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

• No MRMC study was done. This type of study is specifically relevant for imaging devices or AI algorithms where human readers' performance is being evaluated or augmented. The Stitch Cerclage Suture System is a physical medical device, not an imaging or AI diagnosis system.
• The document explicitly states: "No clinical data were included in this submission."

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

• Not applicable. This concept pertains to AI algorithms. The Stitch Cerclage Suture System is a physical product and does not have an "algorithm-only" performance component.

7. Type of Ground Truth Used

• The "ground truth" for this device type is established through objective, quantifiable mechanical properties and material composition, compared against established industry standards (where available) or the performance of a legally marketed predicate device.
• Specifically, the study compared "chemical composition, creep test, tension static and fatigue tests" to information from a published article ("Cerclage Performance Analysis – a Biomechanical Comparison of Different Techniques and Materials", L. M. Hägerich, et al, Musculoskeletal Disorders (2022)) and to the predicate device.

8. Sample Size for the Training Set

• Not applicable / Not mentioned. This device is a physical product, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The design and manufacturing process would involve internal validation and verification activities, but this is distinct from training an AI model.

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

• Not applicable. As there is no AI "training set," there is no ground truth established for one. The "ground truth" for the device's design and manufacturing is derived from engineering principles, relevant material standards (e.g., ASTM F899 for steel), and performance expectations set by the predicate device.

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Arthrex FiberTape and Tiger Tape Cerclage sutures and Arthrex Radiopaque FiberTape Cerclage sutures are intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair.

When used as bone fixation cerclage the sutures are intended for:

• · Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty)
• · Sternotomy indications including the "rewiring" of osteomized sternums
• · Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring
• · Treatment of anterior glenoid bone loss using the Latarjet or bone block procedure (allograft or autograft)
• · Repair of long bone fractures due to trauma or reconstruction
• · Provide fixation during the healing process following syndesmotic trauma. such as fixation of acromioclavicular separation due to coracoclavicular ligament
• · Spinal applications including sublaminar and intrafacet wiring of the spinal column

The Arthrex Radiopaque FiberTape Cerclage sutures are non-absorbable braided sutures composed of Ultra High Molecular Weight Polyethylene (UHMWPE) which incorporates Bismuth Trioxide (Bi2O3), and Polyester yarns over a core of suture also made with Ultra High Molecular Weight Polyethylene (UHMWPE) with Bismuth Trioxide (Bi2O3), and Polyester. Dyes include D&C Blue No. 6. The UHMWPE is naturally yellow due to the addition of Bismuth Trioxide (Bi2O3). The sutures are assembled on an ABS loader. The sutures may also contain a FiberLink shuttling suture that is used for passing only.

The Arthrex FiberTape and TigerTape Cerclage Sutures are non-absorbable braided sutures composed of Ultra High Molecular Weight Polyethylene, polyester, and possibly nylon yarns over a core of FiberWire or TigerWire Suture (each made of UHMWPE and polyester). FiberTape differs from TigerTape in color and materials. FiberTape is blue/white suture consisting of UHMWPE and polyester. TigerTape suture is white/black consisting of UHMWPE, polyester, and nylon. Additional materials include cyanoacrylate at the suture ends which are cut off during the procedure. Dyes include D&C Blue No. 6 and Logwood Black. For the loop assembly the looped end of the suture is tied as a hitch over a sheath that secures a double loop or tied over the post of an ABS loader.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Arthrex FiberTape and TigerTape Cerclage Sutures and Arthrex Radiopaque FiberTape Cerclage Sutures:

Device: Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures

The provided document is a 510(k) Premarket Notification summary, indicating a submission to expand and align the indications for the Arthrex Radiopaque FiberTape Cerclage Sutures and Arthrex FiberTape & TigerTape Cerclage Sutures. The primary purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices.

Based on the available text, the study presented focuses on demonstrating mechanical equivalence and biocompatibility, not clinical performance with human-in-the-loop for diagnostic accuracy. Therefore, several of the requested sections (e.g., MRMC studies, expert qualifications, adjudication methods, training set details) are not applicable or cannot be extracted from this document, as they pertain to AI/diagnostic device performance studies.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes mechanical testing and biocompatibility testing, not a clinical study on patient data.

• Mechanical Testing: The sample size for dynamic tensile fatigue testing is not explicitly stated in terms of the number of sutures tested, only the duration/cycles (5 million cycles). The provenance of the "test set" (i.e., the sutures themselves) would be from the manufacturer (Arthrex Inc.).
• Biocompatibility (Bacterial Endotoxin): The sample size for this testing is also not explicitly stated (e.g., how many units were tested), only the method.

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

Not applicable. This device is a surgical suture, not a diagnostic device requiring expert interpretation of results to establish ground truth from a test set. The validation relies on engineering and biological testing standards.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the context of diagnostic interpretation requiring adjudication.

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 device is a surgical suture, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a surgical suture, not an algorithm.

7. The Type of Ground Truth Used

• Mechanical Performance: The "ground truth" is defined by established engineering standards for suture performance (e.g., ability to withstand 5 million fatigue cycles) and substantial equivalence to predicate devices with a known safety and effectiveness profile. This is typically determined by physical measurements and adherence to pre-defined mechanical property specifications.
• Biocompatibility/Pyrogenicity: The ground truth is defined by established biological safety standards (e.g., EP 2.6.14/USP pyrogen limits) to ensure the device does not cause adverse biological reactions.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI model requiring a training set.

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

Not applicable. As above, no AI model or training set is applicable here.

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The Mbrace Cable is designed as a cerclage system for long bones and to reattach the greater trochanter in case of fractures or osteotomies. The device is intended for long-term implantation inside the human body for single use only. The Mbrace Cable is not intended for use as a suture cable in soft tissue approximation and/or ligation.

The Mbrace cable is an implantable flexible braided cable made of UHMWPE and designed as a cerclage bone system. The Mbrace cable is provided individually packed, sterile and single-use.

Here's a breakdown of the acceptance criteria and study information based on the provided text, categorized as requested. It's important to note that the document primarily describes the non-clinical performance testing conducted to demonstrate substantial equivalence, rather than a clinical effectiveness study with human subjects.

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

The document doesn't explicitly state "acceptance criteria" in a quantitative table format. Instead, it describes performance tests conducted and the general outcomes. The acceptance criteria can be inferred from the stated goals of the tests.

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: The document does not specify the exact number of devices or test samples used for the quasi-static load, dynamic resistance, pyrogenicity, or biocompatibility tests. It only mentions that the tests were conducted. For the Design Validation, it states "sawbone workshop," implying physical models were used, but the quantity of models or devices tested within the workshop is not detailed.
• Data Provenance: Not explicitly stated. The manufacturer, Medacta International SA, is located in Switzerland, but the location where the tests were performed or the origin of any raw data used in validation is not mentioned. Given these are non-clinical hardware tests, "retrospective or prospective" doesn't directly apply in the same way it would to clinical patient data. The tests are prospective in the sense that they were planned and executed to support the submission.

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. This device is a bone fixation cable, and the performance data presented is from non-clinical mechanical, material, and sterilization tests. The "ground truth" for these types of tests is established by industry standards, engineering principles, and validated test methods, rather than expert consensus on medical images or patient outcomes. The "sawbone workshop" likely involved surgical or biomechanical experts, but their number and specific qualifications are not detailed.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly for diagnostic devices where multiple human readers interpret data to establish a ground truth or resolve discrepancies. These methods are not relevant for the non-clinical hardware validation tests described.

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 (bone fixation cable), not an AI/CAD system. Therefore, an MRMC study or AI assistance evaluation is not relevant or applicable.

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

Not applicable. This is a medical device, not a software algorithm.

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

For the non-clinical tests described:

• Mechanical Performance: Ground truth derived from established engineering and biomechanical principles, material science, and relevant ISO/ASTM standards (implied, though not explicitly cited beyond "written protocols"). The predicate device's performance often serves as a benchmark for comparison.
• Biocompatibility: Ground truth from established biocompatibility standards (e.g., ISO 10993 series, though not explicitly cited).
• Pyrogenicity/Sterilization: Ground truth from pharmacopoeial standards (European Pharmacopoeia §2.6.14, USP , USP ).

8. The sample size for the training set

Not applicable. This is a medical device for which non-clinical performance data is provided, 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 type of device.

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The Smith & Nephew ACCORD Cable System is indicated for use in general orthopaedic repair procedures including general cerclage of the femur, trochanteric reattachment, fixation of fractures in conjunction with intramedullary prosthesis (i.e., femoral stem) and screw fixation techniques.

The ACCORD Cable System includes cables (with or without clamps), trochanteric grips, and plates. (K223762).
The Smith & Nephew ACCORD Cable System consists of Cobalt Chrome cables (without clamps) to be used with the ACCORD Titanium trochanteric grips or ACCORD Titanium plates and also Stainless Steel and Cobalt Chrome cables with clamps to be used alone. These materials are identical to the material that has been previously cleared in K223762, K031162, and K993106.
The implants within this system are single-use and are Gamma sterilized.

The provided document is an FDA 510(k) clearance letter and an accompanying 510(k) summary for the Smith & Nephew ACCORD Cable System. It does not describe a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device.

Instead, this submission is for labeling updates to an existing, previously cleared medical device (ACCORD Cable System). The core assertion is that there are no significant changes in design, technological characteristics, function, sterilization, or packaging as a result of these labeling updates. Therefore, no performance testing (bench, animal, clinical) was required for this specific 510(k) submission (K233949).

Consequently, I cannot extract the information required to answer your prompt, as the prompt is designed for a study demonstrating the performance of a new or significantly modified device, particularly one involving AI/ML and associated acceptance criteria. The document explicitly states:

• "There is no significant change in design, technological characteristics, function, sterilization or packaging of the devices as a result of this submission."
• "The subject Smith & Nephew ACCORD Cable System devices are identical in function, design features, materials, packaging, sterilization, manufacturing methods and operational principles to what was previously 510(k) cleared (K223762, K031162). These labeling updates do not affect the safety and effectiveness of the subject devices when used as labeled."
• "Therefore, since there are no changes to the design features, or manufacturing methods of the subject ACCORD Cable System devices, no performance testing (bench, animal, clinical) was required."

This 510(k) relies on the substantial equivalence to its predicate devices (K223762, K031162, K993106), which would have had their own studies to demonstrate safety and effectiveness at the time of their clearance. However, those studies are not detailed in this document.

Therefore, I cannot provide the requested information based on the provided text. The document describes a regulatory filing for a non-AI/ML device that did not require new performance studies due to the nature of the submission (labeling updates only).

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The VariTrax Sternal CircumFixation system is indicated for primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion.

The VariTrax Sternal CircumFixation System consists of polyetheretherketone (PEEK) locking bands with a detachable stainless-steel needle and a PEEK buttress plate. They are single-use devices provided in a sterile kit. The VariTrax bands are placed in peristernal fashion through the intercostal space with the help of the detachable needle. Once inserted, the needle is removed and the VariTrax implants are attached and locked to the VariTrax buttress plate, then tightened and secured in place to provide stable fixation of the sternum.

The provided document is a 510(k) premarket notification for a medical device (VariTrax Sternal CircumFixation System), not a study report or a publication detailing acceptance criteria and study results for an AI/ML powered device. Therefore, it does not contain the information requested in the prompt.

The document discusses various tests for the device, such as biocompatibility and mechanical performance (lateral distraction, longitudinal shear, static tensile band, four-point bend, and needle pull out) to demonstrate substantial equivalence to predicate devices. However, this is for a physical medical device, not an AI/ML software.

The concepts of "acceptance criteria," "reported device performance," "sample sizes for test and training sets," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," and "type of ground truth" are typically relevant for the evaluation of AI/ML-powered medical devices. Since the VariTrax Sternal CircumFixation System is a physical bone fixation device, these specific metrics for AI/ML evaluation are not applicable and thus not present in the provided text.

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Arthrex Radiopaque FiberTape cerclage sutures are intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair.

When used as bone fixation cerclage the sutures are intended for:
• Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty)
• Sternotomy indications including the “rewiring” of osteomized sternums
• Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring

• Treatment of anterior glenoid bone loss using the Latarjet or bone block procedure (allograft or autograft)
  • Repair of long bone fractures due to trauma or reconstruction

The Arthrex Radiopaque FiberTape Cerclage sutures are non-absorbable braided sutures assembled on an ABS loader. The Radiopaque FiberTape Cerclage implant is hitched around the post of the ABS loader which allows the nitinol wire to pass through the knot. The devices are manufactured from a polyblend of Ultra High Molecular Weight Polyethylene (UHMWPE) which incorporates Bismuth Trioxide (Bi2O3), and polyester materials.

This document pertains to the 510(k) premarket notification for Arthrex Radiopaque FiberTape Cerclage sutures, a medical device. The information provided outlines the regulatory clearance and briefly mentions performance data, but it does not contain the detailed study information regarding acceptance criteria, sample sizes for test/training sets, expert qualifications, or the methodologies for ground truth establishment or MRMC studies that would be typically found in a clinical study report for an AI/ML-based device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance based on the provided text, nor can I answer questions about MRMC studies, standalone algorithm performance, or detailed ground truth establishment as these details are not present.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on material composition, intended use, and general performance testing (tensile strength, cyclic displacement, creep displacement, and bacterial endotoxin testing), rather than a clinical study demonstrating AI performance.

Here's what can be extracted and what cannot:

What can be extracted from the document:

• Device Name: Arthrex Radiopaque FiberTape Cerclage sutures
• Intended Use: Soft tissue approximation and/or ligation, and as bone fixation cerclage for specific indications (e.g., trochanteric reattachment, sternotomy, trauma, glenoid bone loss, long bone fractures).
• Basis for Clearance: Substantial Equivalence to predicate devices (K221485: Arthrex FiberTape and TigerTape Cerclage Sutures and K143716: DSM Biomedical DRP Cable).
• Performance Data Mentioned (not detailed acceptance criteria):
  • Tensile strength
  • Cyclic displacement
  • Creep displacement
  • Bacterial Endotoxins Test (BET) per EP 2.6.14/USP to meet pyrogen limit specifications. This is a sterility/biocompatibility test, not a performance metric for the device's functional use in approximating tissue or fixing bone in a clinical context.

What cannot be extracted from the document (as it's not present):

1. A table of acceptance criteria and the reported device performance (in the context of clinical or AI performance): The document mentions "performance data" but only lists types of mechanical/biocompatibility tests. It does not provide specific acceptance criteria values (e.g., "tensile strength > X N") or the measured performance values from these tests. Critically, there's no mention of performance criteria relevant to an AI/ML device (e.g., sensitivity, specificity, AUC).
2. Sample size used for the test set and the data provenance: Not mentioned. The performance data mentioned (tensile, cyclic, creep, BET) would have sample sizes, but these are for material properties, not for a clinical evaluation or an AI model's test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not mentioned. This device is not an AI/ML imaging device that would require expert-established ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not mentioned.
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/not mentioned. This is a physical medical device (suture), not an AI/ML system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/not mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/not mentioned in the context of an AI/ML model.
8. The sample size for the training set: Not applicable/not mentioned. There is no AI model involved.
9. How the ground truth for the training set was established: Not applicable/not mentioned.

Conclusion:

The provided FDA letter and 510(k) summary are for a conventional medical device (sutures), not an AI/ML-driven device. Therefore, the detailed information typically associated with acceptance criteria and study designs for validating AI/ML performance (e.g., test/training set sizes, expert ground truth, MRMC studies) is not present in this document. The "performance data" mentioned refers to mechanical and biocompatibility testing of the suture materials, which are relevant for a physical device's safety and effectiveness compared to a predicate.

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The STRETTO™ Cable System is indicated for use in: general orthopedic trauma surgery (e.g., fractures of the olecranon, patella, femur - including periprosthetic, pelvis, acetabulum, humerus and ankle, and acromioclavicular dislocations); prophylactic banding during total joint procedures; and, temporary reduction techniques for ORIF (Open Reduction Internal Fixation) procedures.

STRETTO™ Screw Anchors are indicated for fractures that may not be securely held by either a screw or a cerclage device alone, and where cerclage is used in combination with bone screws and/or plates to provide internal fixation of fractured bone.

STRETTO™ Press-In Anchors are indicated for use with a cerclage cable and plate to augment long bone fracture fixation, particularly when the use of screws would be inhibited, as in the presence of intramedullary implants.

The STRETTO™ Cable System implants are comprised of cables, crimps and anchors. Anchors include a thru hole for the cables to pass through, and are available in multiple styles. Press-in anchors mate with ANTHEM fracture plates and screw anchors mate with the hex recess of ANTHEM screws. The cable is secured with the crimp and may be used with the anchors. STRETTO™ Implants are manufactured from titanium alloy, commercially pure titanium, cobalt chromium alloy, cobalt chromium molybdenum alloy, or stainless steel.

The provided text is a 510(k) summary for the STRETTO™ Cable System to the FDA. It details the device, its indications for use, and a brief summary of performance data to establish substantial equivalence to predicate devices. However, it does not contain the specific information requested about acceptance criteria, detailed study results, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and data provenance
3. Number of experts used to establish ground truth
4. Adjudication method
5. MRMC comparative effectiveness study details (effect size, improvement)
6. Standalone performance 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 states:

• Performance Data: "Mechanical testing (static and dynamic tension) was conducted using ASTM E8 as a guide. Performance data demonstrate substantial equivalence to the predicate devices. An engineering analysis was conducted for the anchors to demonstrate substantial equivalence to the predicate devices. Bacterial endotoxin testing (BET) was conducted in accordance with ANSI/AAMI ST72:2011."

This indicates that mechanical and endotoxin testing were performed, and the results demonstrated substantial equivalence. However, the specific acceptance criteria, detailed test results, actual performance metrics, sample sizes, or methods for establishing ground truth (which would be relevant for clinical or diagnostic AI/ML devices but not typically for mechanical implants) are not provided in this summary.

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HS Fiber Cerclage sutures are indicated for use in general soft tissue approximation and/or ligation. These sutures may be used in cardiovascular surgeries, and orthopedic surgeries using allograft tissue. When used as a bone fixation cerclage, the sutures are intended for:

• · Trauma surgery indications including olecranon, ankle, patella, and some shoulder rewiring.
• · Repair of long bone fracture due to trauma or reconstruction.

The Riverpoint Medical HS Fiber® Cerclage sutures are non-absorbable, sterile, surgical sutures composed of multiple single strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HS Fiber Cerclage sutures are available in common sizes and lengths with or without pre-attached needles. Suture supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. The device is sterilized by ethylene oxide gas, and is provided sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.

Here's a breakdown of the acceptance criteria and study information for the Riverpoint Medical HS Fiber® Cerclage, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not explicitly state the sample sizes used for each specific test set. It broadly mentions tests performed, but not the number of units or samples involved in, for example, the tensile strength or fatigue strength testing.

Regarding data provenance, the study appears to be non-clinical, laboratory-based testing conducted by the manufacturer, Riverpoint Medical, LLC. No information is given about the country of origin of the data beyond the manufacturer's location in Portland, Oregon, USA. The studies are retrospective in the sense that they are conducted on manufactured devices as part of the submission process, not on a prospective cohort of patients.

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

This information is not applicable as the studies described are non-clinical, mechanical, and material characteristic tests, not studies requiring expert interpretation of medical images or patient data to establish a ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

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 comparative effectiveness study was not done. The device is a physical medical device (suture) and not an AI/software-based medical device that would involve human readers or AI assistance.

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

A standalone performance study was not done. Again, this is a physical medical device, not an algorithm.

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

The "ground truth" for the non-clinical performance studies were:

• Established standards and specifications: United States Pharmacopeia (USP) requirements for sutures (primarily for needle attachment and tensile strength), and various ISO and EN standards for sterilization, biocompatibility, packaging, and usability.
• Predicate device performance: Comparative testing was conducted against a predicate device (Arthrex FiberTape Cerclage - K170206) to demonstrate comparable performance in areas like tensile strength, fatigue strength, creep, and wear debris.

8. The Sample Size for the Training Set

This information is not applicable as there is no "training set" for this type of physical medical device. The device is manufactured based on design specifications and then tested against these specifications and regulatory standards.

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

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

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The STERN FIX Sternal Stabilization System is intended for closure and stabilization of the sternum following sternotomy, through the intercostal spaces, in order to promote its fusion.

The STERN FIX is a long-term implantable postoperative sternal stabilization system that closes and stabilizes the sternum after a sternotomy. The STERN FIX is a clamping device consisting of two parts, male and female, which match telescopically with one another to form the sternal stabilization system. Both male and female parts have a curved arm that catches one of the two halves of the sternum laterally and approximates them until the sternum is securely fixed. Five sizes of the STERN FIX are available for use with different sternum thicknesses. The STERN FIX can be cut and removed for emergent, and long-term, re-entry through the sternum. The predicate device was originally made of PEEK-OPTIMA™. This 510(k) introduces a new variant of the product made of carbon-fiber reinforced (CFR) PEEK-OPTIMA™. This new variant also presents some minor geometry changes with respect to the predicate device, to adapt the product to the new material.

The provided document is a 510(k) Premarket Notification for the STERN FIX Sternal Stabilization System and primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device (K211613). It does not present acceptance criteria or detailed study results for a medical device that relies on AI/ML or requires extensive clinical performance testing with human readers.

The device in question is a physical implant used for sternal closure, not a diagnostic or AI-powered imaging device. Therefore, many of the requested criteria (such as multi-reader multi-case studies, ground truth establishment for AI/ML, and training/test set sample sizes for algorithms) are not applicable to this type of medical device submission.

The document discusses performance testing but this refers to biomechanical and functional testing of the physical implant, not a study evaluating an AI algorithm's performance on a dataset. The "conclusions" under "Test" describe whether the physical components meet specifications.

Here's how the information provided in the document relates to your request, with an emphasis on what is not present given the nature of the device:

Device: STERN FIX Sternal Stabilization System

Date of Submission: June 16, 2022
FDA Review Date: October 19, 2022

Type of Device: Long-term implantable postoperative sternal stabilization system. It's a physical device, not an AI/ML diagnostic or assistive tool.

Purpose of Submission: To introduce a new variant of the product made of carbon-fiber reinforced (CFR) PEEK-OPTIMA™ with minor geometry changes, demonstrating substantial equivalence to the predicate device (STERN FIX Sternal Stabilization System - K211613).

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

The document describes performance testing for the physical device. The "acceptance criteria" are implied to be "meeting the specifications," and the "reported performance" is a general statement that the device meets these specifications. No specific quantitative criteria or numerical results are provided in the summary.

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

• Sample Size: Not specified for any of the performance tests. The document only states "All tested samples."
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This is typically lab-based testing of manufactured units, not 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 is a physical device. Ground truth, in the context of an AI/ML device, would involve expert labeling of medical images or data. For this device, "ground truth" relates to material properties and mechanical performance, established through engineering specifications and test standards.

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

• Not Applicable. Pertains to expert review of data/images for AI/ML.

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/ML device. "Clinical testing" was explicitly stated as "No clinical testing was performed to support this submission."

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

• Not Applicable. This is not an AI/ML device.

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

• For this physical device, the "ground truth" is defined by engineering specifications and recognized consensus standards (e.g., ASTM F2026-17, ISO 14971, ISO 14630 for general requirements, biomechanical behavior, and risk management). The tests performed (breaking strength, fatigue, lateral distraction) are designed to confirm compliance with these pre-defined standards and specifications, which serve as the "ground truth" for performance.

8. The sample size for the training set:

• Not Applicable. This is a physical device, not an AI/ML algorithm requiring a training set.

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

• Not Applicable. As above, no training set for an AI/ML algorithm.

Summary:

This 510(k) submission successfully demonstrated substantial equivalence of a modified physical sternal stabilization system to a predicate device. The evidence provided focused on material composition changes, minor geometry adjustments, and performance testing (functional and biomechanical) against established engineering specifications and recognized consensus standards. Since the device is not an AI/ML system, the typical acceptance criteria and study designs associated with AI/ML (e.g., MRMC studies, ground truth for image labeling, training/test set details) are irrelevant to this submission and are therefore not present. No clinical testing, in the sense of human subject trials, was performed or required for this 510(k).

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The STERN FIX Sternal Stabilization System is intended for closure and stabilization of the sternum following sternotomy, through the intercostal spaces, in order to promote its fusion.

The STERN FIX is a long-term implantable postoperative sternal stabilization system that closes and stabilizes the sternum after a sternotomy. The STERN FIX is a clamping device consisting of two parts, male and female, which match telescopically with one another to form the sternal stabilization system. Both male and female parts have a curved arm that catches one of the two halves of the sternum laterally and approximates them until the sternum is securely fixed. Five sizes of the STERN FIX are available for use with different sternum thicknesses. The STERN FIX can be cut and removed for emergent, and long-term, re-entry through the sternum.

Here's an analysis of the provided text regarding the Stern Fix Sternal Stabilization System, focusing on acceptance criteria and study details.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally framed as the device meeting "specifications" and demonstrating "adequate performance." The document does not provide a specific table of quantitative acceptance criteria with numerical targets. Instead, it offers qualitative conclusions based on performance testing.

2. Sample Sizes and Data Provenance

The document does not specify the exact sample sizes used for the functional, biomechanical, or cadaveric testing. It consistently refers to "All tested samples," but the number of samples is not provided.

• Test Set Sample Size: Not specified.
• Data Provenance: The studies appear to be in-house or contracted laboratory testing based on the context. No country of origin is mentioned, nor is it specified if the data is retrospective or prospective. Given the nature of the testing (functional, biomechanical, cadaveric), it's inherently prospective data generation for this submission.

3. Number of Experts and Qualifications for Ground Truth of Test Set

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

For the cadaver testing, it mentions "Correct devices implantation is verified in a simulated real-life situation," which implies assessment by individuals with expertise in surgical procedures or device implantation, but their specific qualifications or number are not detailed. For the other tests (breaking strength, fatigue, lateral distraction), "ground truth" refers to the measured physical properties against established engineering specifications, rather than expert interpretation of medical images or observations.

4. Adjudication Method for the Test Set

Not applicable. The tests described are objective measurements of physical properties (e.g., breaking strength, fatigue resistance) or direct observation of device implantation in cadavers, not subjective interpretations requiring adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical testing was performed to support this submission." The studies were limited to performance testing (functional, biomechanical, cadaveric) in a non-clinical setting.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The Stern Fix Sternal Stabilization System is a physical medical device (an implant for sternal closure), not an AI algorithm. Therefore, "standalone (algorithm only)" performance is not relevant to this device.

7. Type of Ground Truth Used

• Functional and Biomechanical Testing: The ground truth is based on engineering specifications and physical measurements (e.g., in a material testing machine) which determine if the device meets required strength, durability, and resistance parameters.
• Cadaver Testing: The ground truth is the successful and correct implantation of the device in a simulated real-life situation, likely assessed by observing the implementation and stability of the device during and after placement. This would be observed performance against an expected surgical/mechanical outcome.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, 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 no training set was used.

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