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The Compressyn™ Staple is intended for: 1) hand and foot bone fragment and osteotomy fixation and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy, 3) adjunctive fixation of small bone fragments. These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremity; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in the flat bones such as the pelvis, scapula and sternum.

The Compressyn Staple is a fully integrated system that consists of a stainless steel staple preloaded on a handheld ABS and polycarbonate mechanical delivery device. The staple is offered in 14 sizes with barbs to prevent back out. It is a compression staple fixation device that is placed into two tissue segments using pre-drilled holes to provide stabilized fixation. The Compressyn Staple is provided sterile in a disposable tray with a drill bit, drill guide, placement pins and staple sizing guide.

This document describes a 510(k) premarket notification for the "Compressyn™ Staple" device. It is a medical device for bone fixation. Here's an analysis of the provided text in relation to acceptance criteria and study information:

Analysis of Acceptance Criteria and Study Information for Compressyn™ Staple

The provided text is a 510(k) summary for a medical device (Compressyn™ Staple). In the context of a 510(k), "acceptance criteria" for showing substantial equivalence are primarily met by demonstrating that the new device has the same intended use and similar technological characteristics as a legally marketed predicate device, and that any differences do not raise new questions of safety or effectiveness. The "study" in this context refers to the testing performed to support this claim of similarity.

1. Table of Acceptance Criteria and Reported Device Performance

Indications for Use (same as stated on page 2):

1. hand and foot bone fragment and osteotomy fixation and joint arthrodesis
2. fixation of proximal tibial metaphysis osteotomy
3. adjunctive fixation of small bone fragments (in various long, upper, and flat bones). |
   | Technological Characteristics Equivalence: The device's design, materials, and other physical/technical attributes should be substantially similar to the predicate device(s). | "The Compressyn Staple is identical to the predicate and therefore has the same physical and technical characteristics."
   Specifics: "stainless steel staple preloaded on a handheld ABS and polycarbonate mechanical delivery device." Offered in 14 sizes with barbs. |
   | Performance Equivalence: The device should perform in a manner substantially similar to the predicate device, especially regarding critical functions (e.g., compression, delivery). | "The Compressyn Staple was tested for staple delivery and compressive force and was shown to be equivalent to the predicate."
   "Testing to ASTM F564-10 was also performed for the Compressyn Staple, Preloaded Sterile System." |
   | Safety and Effectiveness (implied): Any differences in technological characteristics should not raise new questions of safety or effectiveness. | Not explicitly stated as a separate criterion, but the overall conclusion of "substantial equivalence" implies this was met. |

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "The Compressyn Staple was tested for staple delivery and compressive force" and "Testing to ASTM F564-10 was also performed." However, the exact number of staples or test specimens used for these tests is not specified in the provided text.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). While it's implied the testing was conducted by Dallen Medical, Inc. (USA-based), the location of the testing facility or origin of specific data points is not detailed. The nature of the tests (mechanical performance) suggests laboratory testing rather than clinical data provenance.

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

This information is not applicable and not provided in the context of this 510(k) submission. Mechanical testing (like staple delivery, compressive force, and ASTM F564-10) relies on objective measurements and predefined test standards, not expert clinical assessment or ground truth establishment in the way it would be for diagnostic AI.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As the testing involves mechanical performance, there is no expert adjudication process in the traditional sense. The results are compared against a predicate device or engineering standards.

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

• No, an MRMC comparative effectiveness study was not done.
• Effect Size of Human Reader Improvement: Not applicable, as this device is a surgical staple, not a diagnostic imaging AI algorithm that assists human readers.

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

• No, this is not an AI algorithm, so a standalone study of this nature was not performed. The device itself is a physical medical device (staple system), and its performance is evaluated through mechanical testing.

7. Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is established through:

• Objective Mechanical Measurements: Such as force measurements for staple delivery and compression.
• Adherence to Industry Standards: Specifically, "Testing to ASTM F564-10" refers to a standard test method for metallic bone staples. The ground truth is effectively defined by the requirements and test methodologies outlined in this standard.
• Predicate Device Performance: The performance of the predicate device serves as the benchmark for substantial equivalence.

8. Sample Size for the Training Set

This information is not applicable and not provided. This device is a physical medical instrument, not a machine learning model, so there is no "training set."

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

This information is not applicable and not provided, as there is no "training set" for this device.

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The subject device is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. Specifically, the Tensyn Plug is intended to provide fixation during the healing process following:

• A syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures
• -Acromioclavicular separations due to coracoclavicular ligament disruptions
• Syndesmotic trauma, such as fixation of dorsal distal radiolunar ligament (DRUL) disruptions;
• -Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and
• -Hallux Valgus reconstruction (correction) by providing for the reduction of 1st metatarsal -2nd metatarsal intermetatarsal angle.

The Tensyn Plug, when used for fixation of bone-to-bone or soft-tissue to- bone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, the Tensyn Plug is indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the suspension of the thumb metacarpal during the healing process of hematoma distraction arthroplasty by providing stabilization at the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.

The Tensyn Plug is a knotless system for fixation of syndesmosis disruptions, acromioclavicular repair, tarasometatarsal injury, hallux valgus reconstruction, and carpal metacarpal joint arthroplasty. The Tensyn Plug is a low profile system comprised of a coated flat polyethylene terephthalate (PET) suture band tensioned and secured between a narrow button and a locking cap assembly. The Tensyn Plug is available in stainless steel and titanium.

This document is a 510(k) premarket notification for the Tensyn™ Plug, a medical device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a study where the device meets acceptance criteria. Therefore, much of the requested information regarding specific acceptance criteria metrics, detailed study design, and performance outcomes for a device that "meets acceptance criteria" in terms of clinical accuracy or diagnostic performance is not present in this regulatory filing.

However, I can extract information related to the device's performance testing which serves to establish substantial equivalence.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state numerical "acceptance criteria" in a table format that would typically be seen for diagnostic or AI-based devices. Instead, it refers to performance testing conducted to demonstrate substantial equivalence to predicate devices. The implicit acceptance criterion is that the Tensyn™ Plug performs similarly or equivalently to the predicate devices in the described tests.

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

The document refers to "testing" performed but does not specify the sample size for the test set (e.g., number of devices tested, number of simulated applications). It also does not mention data provenance (e.g., country of origin, retrospective/prospective) as the testing appears to be primarily mechanical performance testing on the device itself, rather than clinical data from human subjects.

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

Not applicable. This type of information is relevant for studies involving human interpretation or diagnostic accuracy. The testing described (rotational loading, cyclic loading, ultimate load, load at 3mm, and shear test) is mechanical and likely involves engineering analysis and measurements, not human expert consensus for "ground truth."

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like "2+1" or "3+1" are used when multiple readers/experts are involved in establishing ground truth, which is not the case for the mechanical performance testing described.

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

No. An MRMC comparative effectiveness study is typically performed for diagnostic devices to assess how much human readers improve with AI assistance. This document describes a mechanical fixation device, and an MRMC study is not relevant to its regulatory submission for substantial equivalence.

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

Not applicable. The Tensyn™ Plug is a mechanical implant, not an algorithm. The "standalone performance" refers to the device's mechanical integrity and strength under various loads.

7. The Type of Ground Truth Used:

For the mechanical performance tests, the "ground truth" would be established by physical measurements and engineering standards for mechanical properties (e.g., specific load at which failure occurs, displacement at a certain load). This is not expert consensus, pathology, or outcomes data in the usual clinical sense.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm 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 mechanical device.

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Tensyn Plug is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures which have been properly stabilized and which allow stable placement of the Tensyn Plug apart from any other fixation hardware. For fixation during the healing process of acromioclavicular separations due to coracoclavicular ligament disruptions, the Tensyn Plug is used in conjunction with, but not connected to, supplemental fixation. The subject device is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. Specifically, the Tensyn Plug is intended to provide fixation during the healing process following: 1) Syndesmotic trauma, such as fixation of dorsal distal radiolunar ligament (DRUL) disruptions; 2) Tarasometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); and 3) Hallux Valgus reconstruction (correction) by providing for the reduction of 1st metatarsal -2nd metatarsal intermetatarsal angle. The Tensyn Plug, when used for fixation of bone-to-bone or soft-tissue-to-bone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, the Tensyn Plug is indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the suspension of the thumb metacarpal during the healing process of hematoma distraction arthroplasty by providing stabilization at the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.

The Tensyn Plug is a knotless system for fixation of syndesmosis disruptions, acromio-clavicular repair, tarasometatarsal injury, hallux valgus reconstruction, and carpal metacarpal joint arthroplasty. The Tensyn Plug is a low profile system comprised of a coated flat polyethylene terephthalate (PET) suture band tensioned and secured between a narrow button and a locking cap assembly. The Tensyn Plug is available in stainless steel.

The provided document is a 510(k) summary for the Tensyn™ Plug, a medical device for fixation during healing processes. It discusses the device's indications for use, technical characteristics, and performance data for demonstrating substantial equivalence to predicate devices. However, the document does not include specific acceptance criteria, detailed results of the studies, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, or details about multi-reader multi-case studies.

Therefore, I cannot provide the requested information in the format specified because the necessary details are not present in the provided text.

Here's an overview of what is available and what is missing:

What is present in the document:

• Device Name: Tensyn™ Plug
• Device Description: Knotless system for fixation, comprised of a coated flat polyethylene terephthalate (PET) suture band tensioned and secured between a narrow button and a locking cap assembly, available in stainless steel.
• Indications for Use: Detailed for various conditions (syndesmotic trauma, acromioclavicular separations, fracture repair, Lisfranc injury, Hallux Valgus reconstruction, Carpal Metacarpal (CMC) joint arthroplasty).
• Predicate Devices: Tensyn Band (K141264, K131850), Arthrex, Inc. Mini TightRope Repair Kit (K061925), Arthrex, Inc. CMC Mini TightRope (K140328), Biomet, Inc. ToggleLoc System (K083070).
• Types of Performance Testing: Rotational loading, cyclic loading, ultimate load, load at 3mm, and shear test.
• Conclusion from Testing: "The testing demonstrated that the Tensyn Plug is substantially equivalent to the predicate devices."

What is missing from the document (and therefore cannot be provided in the answer):

1. Table of Acceptance Criteria and Reported Device Performance: While types of tests are listed, the specific quantitative acceptance criteria (e.g., "ultimate load must be > X N") and the numerical results obtained for the Tensyn™ Plug are not provided.
2. Sample Size Used for the Test Set and Data Provenance: No information is given regarding the number of devices or units tested for each performance test, nor the origin or nature (retrospective/prospective) of any clinical data, as this is a mechanical testing report, not a clinical study report.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications: Not applicable, as this involves mechanical testing, not a diagnostic or AI-driven device requiring expert adjudication of ground truth from images or clinical data.
4. Adjudication Method for the Test Set: Not applicable for mechanical testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No information is provided about such a study. This is a mechanical device, not an AI or imaging diagnostic tool that would typically involve human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study: No information is provided about such a study. This is not an algorithm-driven device.
7. Type of Ground Truth Used: For mechanical testing, the "ground truth" would be the measured physical properties or failure points, not expert consensus, pathology, or outcomes data. The document does not detail the specific ground truth metrics or methods used for "ultimate load," "load at 3mm," etc.
8. Sample Size for the Training Set: Not applicable, as this is a mechanical device, not an AI system that requires a "training set."
9. How the Ground Truth for the Training Set was Established: Not applicable.

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Tensyn ™ Band is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures which have been properly stabilized and which allow stable placement of the Tensyn™ Band apart from any other fixation hardware. For fixation during the healing process of acromioclavicular separations due to coracoclavicular ligament disruptions, the Tensyn™ Band is used in conjunction with, but not connected to, supplemental fixation.

The Tensyn™ Band is a knotless system for fixation of syndesmosis disruptions and AC joint in the shoulder. The Tensyn™ Band is a low profile system comprised of a polymer coated flat polyethylene terephthalate (PET) suture band tensioned and secured between a narrow button and a lock. The Tensyn™ Band is available in titanium and stainless steel.

This document is a 510(k) premarket notification for the Tensyn™ Band, a medical device. It does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically seen in an AI/ML device submission.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices, which is the regulatory pathway for Class II devices like the Tensyn™ Band. The "Performance Data" section briefly describes the types of tests performed but does not provide specific acceptance criteria or detailed results.

Therefore, I cannot provide the requested information from the provided text. The document states:

• Performance Data: "All necessary testing has been performed with the Tensyn™ Band to assure substantial equivalence to the predicate devices. Testing included rotational loading, cyclic loading, ultimate load, load at 3 mm and shear test. The testing demonstrated that the Tensyn™ Band is substantially equivalent to the predicate devices."

This indicates that mechanical and physical performance tests were conducted to show the new device performs similarly to existing, legally marketed predicate devices, rather than meeting specific pre-defined quantitative acceptance criteria in the context of an AI/ML study.

To directly answer your numbered points based only on the provided text, I must state that the relevant information is not present or applicable in the context of an AI/ML device study:

1. A table of acceptance criteria and the reported device performance: Not provided. The document states testing was performed to assure substantial equivalence, but no specific performance metrics or acceptance criteria are listed.
2. Sample sized used for the test set and the data provenance: Not provided. The performance data refers to mechanical testing, not a clinical test set with human 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 mechanical fixation device, not an AI/ML diagnostic tool requiring expert ground truth.
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, 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/ML device.
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): Not applicable in the AI/ML context. For a mechanical device, "ground truth" would be engineering specifications and validated test methods.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The Compressyn™ Staple is intended for: 1) hand and foot bone fragment and osteotomy fixation and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy, 3) adjunctive fixation of small bone fragments. These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremity; the humerus. ulna or radius in the upper extremities; the clavicle and ribs; and in the flat bones such as the pelvis, scapula and sternum.

The Compressyn™ Staple is a fully integrated system that consists of a stainless steel staple preloaded on a handheld ABS and polycarbonate mechanical delivery device. The staple is offered in several sizes with barbs to prevent back out. It is a compression staple fixation device that is placed into two tissue segments using pre-drilled holes to provide stabilized fixation. The Compressyn™ Staple is provided sterile in a disposable tray with a drill bit and drill guide.

The provided text describes Dallen Medical's Compressyn™ Staple (K140358) and its substantial equivalence to previously cleared devices (K122871, K132875). However, it does not contain any information regarding specific acceptance criteria, a study proving device performance against those criteria, or details about sample sizes, ground truth establishment, or expert involvement.

The document primarily focuses on the device's description, indications for use, and a declaration of substantial equivalence based on the device being "identical to the predicate and therefore has the same physical and technical characteristics." It mentions some testing of the preloaded mechanical delivery device for "impact force, staple delivery, compressive force and bond strength," but it does not provide any quantitative results or acceptance criteria for these tests.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I provide information about the study design elements you asked for, as this data is not present in the provided text.

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Tensyn™ Band is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures which have been properly stabilized and which allow stable placement of the Tensyn band apart from any other fixation hardware.

The Tensyn™ Band is a knotless system for fixation of syndesmosis disruptions. The Tensyn "M Band is a low profile system comprised of a polymer coated flat polyethylene terephthalate (PET) suture band tensioned and secured between a narrow button and a lock. The Tensyn™ Band is available in titanium and stainless steel.

The provided text, K133858, describes a 510(k) submission for the Tensyn™ Band, a medical device for syndesmosis fixation. The information focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study data with specific acceptance criteria and performance metrics for a diagnostic or AI-driven device.

Therefore, many of the requested elements for acceptance criteria and study details for an AI/diagnostic device are not available in the provided text. The submission primarily relies on demonstrating similar technical characteristics and performance through mechanical testing compared to existing predicate devices.

However, I can extract the information that is present and indicate where information is not provided.

Acceptance Criteria and Study for Tensyn™ Band (K133858)

The submission for the Tensyn™ Band focuses on demonstrating substantial equivalence to predicate devices through mechanical performance testing, rather than establishing specific diagnostic acceptance criteria or conducting a clinical study with human readers, as would be typical for an AI or diagnostic device.

1. Table of Acceptance Criteria and Reported Device Performance

• Rotational loading performance
• Cyclic loading performance
• Ultimate load
• Load at 3mm
• Shear test performance | "All necessary testing has been performed with the Tensyn™ Band to assure substantial equivalence to the predicate devices. Testing demonstrated that the Tensyn™ Band is substantially equivalent to the predicate devices." (Specific numerical performance metrics are not provided in the summary.) |
  | Similar Technical Characteristics:
• Physical characteristics
• Design
• Materials | "The Tensyn™ Band has similar physical and technical characteristics to the predicate devices since all devices achieve fixation through a suture between two metal fasteners." |
  | Intended Use:
• Fixation of syndesmosis disruptions in ankle fractures. | "Tensyn™ Band is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures which have been properly stabilized and which allow stable placement of the Tensyn band apart from any other fixation hardware." |

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

• Sample Size: Not specified. The studies mentioned are mechanical performance tests on the device itself, not a test set of patient data.
• Data Provenance: Not applicable in the context of mechanical testing. The testing would have been conducted in a laboratory setting by Dallen Medical, Inc.

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

• This is not applicable. The "ground truth" for mechanical testing is based on established engineering standards and measurements, not expert clinical interpretation.

4. Adjudication method for the test set

• This is not applicable. Mechanical testing results are objective measurements against predefined 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

• No, an MRMC comparative effectiveness study was not conducted. This is not an AI or diagnostic device as described in the submission.

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

• No, a standalone algorithm performance study was not done. This is not an AI device.

7. The type of ground truth used

• The "ground truth" for this device, in the context of demonstrating substantial equivalence, is based on established mechanical engineering test standards and performance of predicate devices. The aim is to show that the Tensyn™ Band performs mechanically in a comparable manner to legally marketed devices for the same intended use.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the sense of machine learning. The design and manufacturing would be based on engineering principles and material science.

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

• Not applicable. This device does not involve a "training set" for an algorithm.

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The Compressyn™ Staple is intended for: 1) hand and foot bone fragment and osteotomy fixation and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy, 3) adjunctive fixation of small bone fragments. These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremity; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in the flat bones such as the pelvis, scapula and sternum.

The Compressyn™ Staple consists of a stainless steel staple held on a carriage delivered by a pneumatic delivery device. The staple is offered in several sizes with barbs to prevent back out. It is a compression staple fixation device that is placed into two tissue segments using pre-drilled holes to provide stabilized fixation. The Compressyn Staple is provided sterile in a kit with accessories.

This 510(k) submission for the Compressyn™ Staple does not include a study that proves the device meets specific acceptance criteria in terms of performance metrics.

Instead, the submission relies on demonstrating substantial equivalence to an existing legally marketed device. The core argument is based on the Technical Characteristics and Performance Data section, which states: "The Compressyn™ Staple is identical to the predicate and therefore has the same physical and technical characteristics."

This means that the device's acceptance is based on the assumption that if it is identical to a predicate device, it inherently meets the acceptance criteria previously established for that predicate.

Therefore, the requested information cannot be fully provided as a performance study with specific acceptance criteria and results is not present in the provided document.

Here's a breakdown of what can be gleaned:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not applicable, as no new performance test data is presented. The substantial equivalence relies on the established performance of the predicate device.
• Data Provenance: Not applicable.

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

• Not applicable, as no new performance study with a test set requiring expert ground truth was conducted for this submission.

4. Adjudication method for the test set:

• Not applicable.

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 medical device (staple) for fixation, not an AI-assisted diagnostic or imaging device.

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:

• Not applicable, as substantial equivalence relies on the existing performance data of the predicate device.

8. The sample size for the training set:

• Not applicable, as this is not an AI/algorithm-based device.

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

• Not applicable.

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The Tensyn™ Band is intended to provide fixation during the healing process following a isolated syndesmotic trauma, such as fixation of syndesmosis disruptions).

The Tensyn™ Band is a knotless system for fixation of syndesmosis disruptions. The Tensyn™ Band is a low profile system comprised of a flat polyethylene terephthalate (PET) suture band tensioned and secured between a narrow button and a lock. The Tensyn™ Band is available in stainless steel.

The Tensyn™ Band is a medical device intended for fixation of syndesmosis disruptions during the healing process following isolated syndesmotic trauma. The device's performance was evaluated through various mechanical tests to demonstrate its substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify the exact sample sizes used for each mechanical test. The data provenance is not explicitly stated in terms of country of origin but is implicitly from Dallen Medical, Inc. The nature of the testing (mechanical tests on the device itself) means it is not retrospective or prospective in the clinical sense, but rather laboratory-based testing on the device prototypes.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. The ground truth for this device's performance is established through mechanical engineering principles and laboratory testing, not expert clinical consensus or interpretation of medical images.

4. Adjudication Method for the Test Set:

Not applicable. As the device evaluation is based on mechanical testing, there is no need for expert adjudication of results in the traditional sense. The results are quantitative measurements against predefined specifications.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of medical images or data. The Tensyn™ Band is a surgical implant, and its performance is evaluated through mechanical testing.

6. Standalone (Algorithm Only) Performance:

Not applicable. This device is a mechanical implant and does not involve an algorithm. The performance is the inherent mechanical properties of the device itself.

7. Type of Ground Truth Used:

The ground truth used is based on mechanical engineering principles and physical measurements from laboratory testing. The device's performance is compared against the known performance characteristics of legally marketed predicate devices.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a training set. The performance evaluation focuses on the physical properties and mechanical behavior of the device.

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

Not applicable. There is no training set for this type of medical device.

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The Compressyn™ Band is intended for use in stabilization of anterior chest wall fractures including sternal fixation subsequent to sternotomy and sternal reconstructive procedures.

The Compressyn™ Band System consists of a stainless steel coupler preloaded with a polymer coated polyester fiber band. It is a cerclage fixation device that is placed around or through the sternum and locked in place to provide stabilized fixation.

This Dallen Medical, Inc. 510(k) submission (K130431) describes the Compressyn™ Band, a cerclage bone fixation device. The submission focuses on demonstrating substantial equivalence to a predicate device (Compressyn™ Band, K101484) rather than establishing new performance criteria.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states that the device has "similar physical and technical characteristics to the predicate device" and that "all necessary verification and validation testing has been performed... to assure substantial equivalence to the predicate device." The acceptance criteria were not quantitative, but rather qualitative: demonstrating substantial equivalence to the previously cleared predicate device for the specified performance tests.

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

• Sample Size: The document does not specify the sample size used for the sternal compression, static, or cyclic performance tests. It simply states "Comparative testing."
• Data Provenance: Not specified, but implied to be laboratory testing conducted by or for Dallen Medical, Inc. (retrospective in relation to the submission date). No human patient data is mentioned; the "performance data" refers to mechanical testing.

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

Not applicable. This device's performance was evaluated through mechanical, engineering-based tests, not through expert-reviewed clinical or imaging data. The "ground truth" was established by the physical and mechanical properties of the predicate device, against which the new device was compared.

4. Adjudication Method for the Test Set

Not applicable, as this was a mechanical engineering study, not a clinical study requiring adjudication of expert opinions.

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

No. This is a medical device (cerclage band) and the performance data described is mechanical testing. MRMC studies are typically used for diagnostic devices (e.g., AI algorithms for image interpretation).

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 or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation was the established mechanical performance and characteristics of the predicate device (Compressyn™ Band, K101484). The goal of the study was to demonstrate that the new device performed equivalently to the predicate.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a training set as this is a mechanical device, not a machine learning model.

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

Not applicable. See point 8.

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The Compressyn™ Staple is intended for: 1) hand and foot bone fragment and osteotomy fixation and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy, 3) adjunctive fixation of small bone fragments. These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremity; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in the flat bones such as the pelvis, scapula and sternum.

The Compressyn™ Staple consists of a stainless steel staple held on a carriage delivered by a pneumatic delivery device. The staple is offered in several sizes with barbs to prevent back out. It is a compression staple fixation device that is placed into two tissue segments using pre-drilled holes to provide stabilized fixation.

The provided text describes a medical device, the Compressyn™ Staple, and its 510(k) submission for substantial equivalence to predicate devices. However, the document does not contain explicit acceptance criteria in terms of specific performance metrics or thresholds, nor does it detail a clinical study with human patients, diagnostic performance metrics (e.g., sensitivity, specificity), or comparisons of AI-assisted vs. unassisted human performance.

The submission focuses on technical characteristics and bench testing to demonstrate substantial equivalence against predicate devices.

Here's an analysis based on the provided text, while acknowledging the limitations of the input regarding acceptance criteria and detailed study information:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The "acceptance criteria" here are implied as the standards and comparative performance metrics used to establish "substantial equivalence," not explicit, quantitative thresholds typical for AI or diagnostic device performance. The device is a physical implant, and its performance is evaluated against engineering standards and direct comparison to existing devices.

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

The document does not detail a "test set" in the context of diagnostic or AI performance evaluation. The "testing" referred to is mechanical and physical verification testing of the staple itself.

• Sample Size for Testing: Not specified, but generally, mechanical testing involves a statistically significant number of samples of the device to ensure consistency and meet specified standards.
• Data Provenance: Not applicable in the context of patient data. The testing is laboratory-based, evaluating the physical properties of the staple.

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

Not applicable. This device is not a diagnostic tool that requires human experts to establish "ground truth" from images or patient data. Its "truth" is its mechanical properties validated through engineering tests.

4. Adjudication Method for the Test Set

Not applicable. There's no human interpretation or adjudication described for the mechanical and physical tests performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance

Not applicable. The Compressyn™ Staple is a medical implant, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related performance metrics are relevant to this submission.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the established engineering standards, material properties, and mechanical performance characteristics defined by ASTM F564-10 and the performance of the legally marketed predicate devices. The device's performance is measured against these objective, quantifiable physical parameters.

8. The Sample Size for the Training Set

Not applicable. This is not an AI or machine learning device that requires a "training set."

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

Not applicable.

Summary of Device Acceptance:

The Compressyn™ Staple gained acceptance (510(k) clearance) based on demonstrating substantial equivalence to existing, legally marketed predicate devices. This was achieved through:

• Conformance to Industry Standards: The device was tested and found to conform to ASTM F564-10, a standard specification and test method for metallic bone staples.
• Comparative Performance Testing: Comparative compression force testing was performed, showing the Compressyn™ Staple to be substantially equivalent to the predicate devices in this critical performance aspect.
• Similar Technical Characteristics: The device was shown to have physical and technical characteristics similar to the predicate devices.

The "study" that proves the device meets the (implied) acceptance criteria is the verification testing described under "Performance Data," which confirmed adherence to ASTM F564-10 and substantial equivalence in comparative compression force. This type of submission relies on engineering and in vitro (bench) testing, rather than clinical trials with patient outcomes or diagnostic performance evaluations, because it is a physical implant deemed similar to existing devices.

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