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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 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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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.

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 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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