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The Reprocessed HARMONIC 700, 5 mm Diameter Shears with Advanced Hemostasis are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, pediatric, gynecologic, urologic, thoracic procedures, and sealing and transection of lymphatic vessels. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the Advanced Hemostasis hand control button.

The reprocessed HARMONIC 700 with Advanced Hemostasis are designed for soft tissue incisions requiring bleeding control and minimal thermal injury. The instruments serve as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in various procedures, including general, pediatric, gynecologic, urologic, and thoracic surgeries, as well as in the sealing and transection of lymphatic vessels. They enable the coagulation of vessels up to 7 mm in diameter using the Advanced Hemostasis hand control button.

The instruments are available in three (3) shaft lengths: 23cm, 36cm, and 45cm lengths (HAR723, HAR736, and HAR745 respectively). Each shaft length has a diameter of 5 mm. The following features are essential to the control and performance of the device:

• An actuating trigger that closes and releases the clamp arm, securing tissue against the scalpel rod.
• MIN/MAX control buttons that adjust energy levels between minimum and maximum modes on the generator, enabling vessel sealing up to 5 mm.
• An Advanced Hemostasis button that allows the clinician to activate an additional energy mode, enabling vessel sealing up to 7 mm.
• A rotation knob to rotate the shaft 360° unless energy is being delivered.
• A torque wrench, a sterile, single-use component, used to apply the correct amount of torque when attaching the Hand Piece to the device.

The instruments connect to a generator and hand piece, which are essential for the device's functionality but are outside the scope of this submission.
The hand piece is a reusable component that attaches to the device and plugs into the generator, allowing the device to interface with the generator. This component contains the transducer, which converts electrical power to ultrasonic mechanical energy.

The generator is a reusable component that generates the electrical signal. Colored light indicators on the front panel of the generator visually communicate device status information to the user.

This document is a 510(k) premarket notification for reprocessed medical devices, not an AI medical device. Therefore, the questions related to AI device performance, such as MRMC studies, training and test sets, ground truth establishment, and expert adjudication, are not applicable to the content provided.

However, I can extract the acceptance criteria and the study that proves the device meets those criteria from the provided text, focusing on the reprocessed medical device context.

Here's the information based on the provided FDA 510(k) letter for the Reprocessed HARMONIC 700 Shears:

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

The document describes functional performance tests conducted to demonstrate safety and effectiveness. While explicit numerical acceptance criteria values are not provided, the general categories of testing imply the criteria for performance equivalence to the predicate device. The reported performance is that the device meets these criteria and is at least as safe and effective as the predicate.

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

• Sample Size: The document does not specify the exact sample sizes (number of devices or tests) for each bench and laboratory test.
• Data Provenance: The studies were conducted as part of the manufacturer's premarket notification submission to the FDA. They are internal validation studies performed by Stryker Sustainability Solutions. The document does not specify country of origin for the data or whether it was retrospective or prospective, but these studies for 510(k) submissions are typically prospective and specifically designed for the submission.
  • For the preclinical laboratory evaluations, an "animal model" was used.

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

This information is not applicable to traditional reprocessing medical device submissions. Ground truth in this context is established through engineering specifications, material science, and performance testing against established standards and predicate device performance, not expert consensus on medical images or patient outcomes.

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

Not applicable. Adjudication methods like 2+1 or 3+1 refer to human expert review processes for AI model output or image interpretation, which is not relevant for this type of device submission. Device performance is determined through standardized engineering and biological tests.

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 reprocessed surgical instrument, not an AI-assisted diagnostic or therapeutic device. MRMC studies are specific to evaluating human reader performance with and without AI assistance in diagnostic imaging.

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

Not applicable. This is not an AI algorithm. Its performance is inherent to its physical properties and functionality.

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

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

• Engineering specifications and design requirements: The device must meet predefined physical, mechanical, and electrical parameters.
• Performance of the original (new) predicate device: The reprocessed device must demonstrate substantial equivalence in performance to the original, legally marketed predicate device.
• Established industry standards: Compliance with standards like ISO 10993-1 (Biocompatibility) and ISO 11135 (EO Sterilization) serves as a ground truth for safety aspects.
• Preclinical (animal) studies: In vivo performance (e.g., thermal spread, hemostasis) in animal models serves as a proxy for clinical performance.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of a reprocessed medical device. The device itself is manufactured and reprocessed, not "trained" like a machine learning model.

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 Reprocessed HARMONIC 1100 Shears are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, pediatric, gynecologic, urologic, thoracic, sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the Energy button with Advanced Hemostasis.

The Reprocessed HARMONIC 1100 Shears instrument is a sterile, single patient used for dissection, grasping, coagulation, and cutting between the blade and clamp arm. It consists of an ergonomic handle with an integrated hand piece and two energy delivery buttons. 1) Energy button for power levels 1-5, and 2) Energy with Advanced Hemostasis button for large vessel sealing. The instrument is available in two shaft lengths (20 cm and 36 cm). An integrated audible and tactile mechanism in the grip housing indicates full trigger closure. The instrument has a clamp and coated curved blade that are designed to work through a 5 mm trocar, through a 5 mm reducer cap in a larger diameter trocar, or through an incision without the use of a trocar. The instrument shafts can be rotated continuously to facilitate visualization and access to targeted tissue. The instrument are intended to represent relative vessel size. The Energy button is in diameter. When the Energy button is used, cutting speed is the fastest. The energy button with Advanced Hemostasis is designed for larger vessels and is indicated for vessels up to 7 mm in diameter. When the Energy button with Advanced Hemostasis is reduced and hemostasis is maximized. The instrument utilizes Adaptive Tissue Technology. This provides the generator with the ability to identify and monitor the instrument during use, which enables the generator to modulate and adjust its power output as well as provide audible feedback to the user as appropriate. The HARMONC 1100 Shears instrument is designed for use exclusively with the Generator 11 (GEN11) software version 2018-1 or later.

The provided text is a 510(k) summary for reprocessed HARMONIC 1100 Shears. It describes the device, its intended use, and a study comparing it to predicate devices. However, it does not contain detailed information about specific acceptance criteria or the study design and results in a format that allows for the extraction of all the requested information.

Here's an analysis of what can be extracted and what is missing:

The submission is for Stryker Sustainability Solutions' Reprocessed HARMONIC 1100 Shears (HAR1120 and HAR1136). The focus of the provided document is the expansion of the indications for use to include coagulation of veins up to and including 7 mm in diameter.

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

• The document states: "Supplemental chronic 21-day survival studies were completed to assess the long-term seal quality of veins up to and including 7 mm in diameter. The data supports the expansion of the include coagulation of vessels up to and including 7 mm in diameter, using the Energy button with Advanced Hemostasis."
• Missing from the text: Specific quantitative acceptance criteria (e.g., minimum seal burst pressure, failure rates) and the precise reported device performance metrics against those criteria are not detailed. The phrase "long-term seal quality" is qualitative without acceptance thresholds.

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

• The study is described as "Supplemental chronic 21-day survival studies." This implies a prospective animal study.
• Missing from the text: The number of animals or vessels tested (sample size) for this study is not provided. The country of origin for the data is also not specified, though it's implied to be a pre-clinical study.

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

• This question is not applicable to this type of device and study. The "ground truth" for vessel sealing devices in pre-clinical studies is typically based on physiological measurements (e.g., burst pressure, histological analysis) rather than expert interpretation of images. The study involved "animal study data," which suggests direct observation and measurement in live subjects.

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

• Not applicable. As noted above, this study is not interpreting images or clinical outcomes that would require an adjudication method by human readers. It's a technical performance study.

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

• Not applicable. This document describes a medical device (surgical shears), not an AI-based diagnostic or assistive technology for human readers.

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

• Not applicable. This document describes a medical device, not an algorithm.

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

• The ground truth in this context would be the directly measured "long-term seal quality of veins" in the animal model. This would likely involve physiological parameters like burst pressure, histological examination of the sealed vessels for integrity, and potentially observation of complications over the 21-day survival period.
• Missing from the text: The specific metrics and methods used to define "long-term seal quality" are not detailed.

8. The sample size for the training set

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

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

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

Summary of available information regarding the device's performance study:

Device: Reprocessed HARMONIC 1100 Shears (HAR1120, HAR1136)

Purpose of Study: To support the expansion of indications for use to include coagulation of veins up to and including 7 mm in diameter.

Study Type: Supplemental chronic 21-day survival studies in an animal model.

Evaluation Focus: Assessment of "long-term seal quality" of veins up to and including 7 mm in diameter.

Conclusion stated: "The data supports the expansion of the include coagulation of vessels up to and including 7 mm in diameter, using the Energy button with Advanced Hemostasis."

Missing Critical Information from the provided text:

• Detailed quantitative acceptance criteria.
• Specific numerical results of the "long-term seal quality" assessment.
• The exact sample size (number of animals or vessels) used in the study.
• Specific ground truth metrics (e.g., burst pressure values, histological findings).
• Details of the study protocol.

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The Reprocessed HARMONIC 1100 Shears are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, pediatric, gynecologic, thoracic, sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of veins up to and including 5 mm in diameter and arteries up to and including 7 mm in diameter, using the Energy button with Advanced Hemostasis.

The Reprocessed HARMONIC 1100 Shears sterile instruments are used for dissection, grasping, coaqulation, and cutting between the blade and clamp arm. Each device model consists of an ergonomic handle, an integrated hand piece, and two energy delivery buttons:

• Energy Button - User can adjust power levels from 1-5
• Energy button with Advanced Hemostasis – For larger vessel sealing; user cannot adjust.
  The instruments are available in two shaft lengths, 20 cm and 36 cm. An integrated audible and tactile mechanism in the handle indicates full trigger closure. The instrument has a clamp arm and coated curved blade that are deigned to work through a 5 mm trocar, through a 5mm reducer cap in a larger diameter trocar, or through an incision without the use of a trocar. The instrument shafts can be rotated continuously to facilitate visualization and access to targeted tissue. The two dashes on the instrument are intended to represent relative vessel size. The energy button is indicated for vessels up to 5 mm in diameter. When the energy button is used, cutting speed is the fastest. The energy button with Advanced Hemostasis is designed for larger vessels and is indicated for vessels up to 7 mm in diameter. When the Energy button with Advanced Hemostasis in used, cutting speed in reduced and hemostasis is maximized. The instrument utilizes Adaptive Tissue Technology. This provides the generator with the ability to identify and monitor the instrument during use, which enables the generator to modulate and adjust its power output as well as provide audible feedback to the user as appropriate.

This document is a 510(k) premarket notification decision letter from the FDA regarding the Reprocessed HARMONIC 1100 Shears. It states that the device is substantially equivalent to a legally marketed predicate device. This type of FDA clearance does not involve an AI/ML component, and therefore, the information requested in your prompt regarding acceptance criteria and studies for AI/ML devices is not applicable to this document. The document describes physical and performance tests for a reprocessed surgical instrument, not an AI-powered diagnostic or therapeutic device.

Therefore, I cannot provide the information requested in your prompt based on the provided text.

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The Reprocessed HARMONIC ACE®+7, 5 mm Diameter Shears with Advanced Hemostasis are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter, using the Advanced Hemostasis hand control button.

Reprocessed HARMONIC ACE®+7, 5mm Diameter Shears with Advanced Hemostasis are used for coagulation and mechanical transection of soft tissue during laparoscopic and open procedures. The devices consist of an ergonomic handle and 3 hand-controlled activation buttons. The handle includes a mechanism that provides both audible and tactile feedback indicating full closure. The instruments utilize Adaptive Tissue Technology which provides the generator with the ability to identify and monitor the instrument during use and enables the generator to modulate and adjust its power output as well as provide audible feedback to the user as appropriate. Each instrument is shipped with one sterile, single-use, disposable torque wrench.

The provided text describes a 510(k) premarket notification for a reprocessed medical device, specifically "Reprocessed HARMONIC ACE®+7, 5 mm Diameter Shears with Advanced Hemostasis". This document details the comparison to a predicate device and various tests conducted to demonstrate substantial equivalence, rather than a clinical study evaluating a diagnostic or AI-driven device's performance against specific acceptance criteria like accuracy, sensitivity, or specificity.

Therefore, the requested information regarding acceptance criteria, reported device performance in those terms, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, and types of ground truth for a diagnostic AI device is not applicable to this document.

The document focuses on demonstrating that the reprocessed surgical shears are as safe and effective as the original, legally marketed predicate device through a series of engineering and performance tests.

Here's what can be extracted regarding the device's performance demonstration:

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines functional performance tests and other validations, rather than specific diagnostic accuracy metrics. The "acceptance criteria" are implied to be achieving performance comparable to the predicate device and meeting safety standards.

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

• This document does not specify exact sample sizes for each test. It generally states that "Bench and laboratory testing was conducted" and includes "verification/comparative testing (to the predicate device)."
• Data provenance: Not explicitly stated, but assumed to be internal laboratory testing by Stryker Sustainability Solutions. It is not clinical data from specific countries or indicated as retrospective/prospective in a diagnostic sense.

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

• Not applicable. This is not a diagnostic device relying on expert interpretation for ground truth.

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

• Not applicable. This is not a diagnostic device requiring adjudication of interpretations.

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 reprocessed surgical instrument, 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 is a reprocessed surgical instrument, not an algorithm.

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

• For the performance tests, the "ground truth" would be established by engineering specifications, validated test methods, and comparison against the performance of the original, new predicate device. For animal studies, the "ground truth" would be physiological outcomes observed by veterinarians or pathologists.

8. The sample size for the training set:

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

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

• Not applicable. See point 8.

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The Medline ReNewal Harmonic ACE+7 Shears are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gyneoologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter using the Advanced Hemostasis hand control button.

The Medline ReNewal Reprocessed Harmonic ACE+7 Shears (models HARH23, HARH36, and HARH45) are used for coagulation and mechanical transection of soft tissue during laparoscopic and open procedures. The devices allow the surgeon to grasp, coagulate, and transect soft tissue with a single instrument. The devices are hand-actuated with a shaft and tissue effector that can be rotated. The energy delivery can be activated with hand activation or with an optional generator foot switch.

This document is a 510(k) summary for the Medline ReNewal Reprocessed Harmonic ACE+7 Shears, which is a reprocessed medical device. It aims to demonstrate substantial equivalence to a legally marketed predicate device.

Acceptance Criteria and Device Performance (Based on the document):

The document primarily focuses on demonstrating substantial equivalence to the predicate device (Ethicon Harmonic ACE+7 Shears, K132612) through comparisons of various characteristics and performance testing. The "acceptance criteria" here implicitly refer to meeting the performance and safety profiles of the original device after reprocessing.

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance testing conducted to ensure equivalency after reprocessing. The acceptance criteria are implied to be achieving results comparable to or within acceptable ranges of the original, new device.

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

The document broadly states that the functional characteristics were "evaluated." It does not specify the exact sample sizes (N) for each of the performance tests listed. The data provenance is implied to be from prospective testing conducted by Medline ReNewal as part of their 510(k) submission process for the reprocessed device. There is no indication of country of origin for the testing, other than the submitting company being based in the USA.

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

This document describes technical and functional performance testing of a physical medical device, not an AI/algorithm-based diagnostic device. Therefore, the concept of "experts used to establish ground truth" (e.g., radiologists, pathologists) for interpreting test results is not applicable in the same way as for diagnostic AI. The "ground truth" for the device's performance is established by the direct measurements and results of the physical and biological tests against established engineering and safety standards. The individuals conducting and analyzing these tests would be qualified engineers, technicians, and potentially toxicologists/biologists. The document doesn't specify how many or their exact qualifications.

4. Adjudication Method for the Test Set:

Not applicable in the context of this device's performance testing. Adjudication methods like 2+1 or 3+1 are typical for human interpretation of medical images or data, not for direct physical performance measurements. The results of the tests would be objectively measured and compared to predefined criteria.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for evaluating the impact of an AI system on human reader performance in diagnostic tasks, which is not the subject of this 510(k) submission for a reprocessed surgical instrument.

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

This is not applicable as the device is a physical surgical instrument (Harmonic ACE+7 Shears), not an AI algorithm. Its performance is inherent to the reprocessed device itself.

7. The type of ground truth used:

The "ground truth" for this reprocessed device is established through various physical, electrical, mechanical, and biological measurements against established engineering specifications and safety standards for the original device and similar devices. This includes:

• Direct measurements of cutting time, burst pressure, and other functional parameters.
• Results from standardized cleaning and sterilization validation protocols.
• Outcomes of biocompatibility testing.
• Comparisons against the performance data of the original predicate device (implicitly serving as a benchmark for acceptable "ground truth" performance).

8. The sample size for the training set:

Not applicable. This device is a physical reprocessed medical instrument and does not involve AI or machine learning models that require training sets.

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

Not applicable, as there is no training set for this device.

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The Reprocessed HARMONIC FOCUS® Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, otorhinolaryngologic (ENT), plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures.

The Reprocessed Harmonic FOCUS Shears + Adaptive Tissue Technology is a sterile, single-patient use surgical instrument consisting of a soft grip scissor handle housing assembly with two hand controls (MIN for minimum power level and MAX for maximum power level). The instrument's working length is 9 cm in length with a 16 mm active blade length. The instrument allows for the cutting and coagulation of vessels up to and including 5 mm in diameter.

The provided text describes the regulatory clearance for a reprocessed medical device, specifically the "Reprocessed HARMONIC FOCUS® Shears + Adaptive Tissue Technology." It details the device's indications for use, its characteristics, and the non-clinical tests performed to demonstrate its substantial equivalence to an original predicate device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

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

The document does not explicitly present a table of "acceptance criteria" with quantitative targets and reported performance in the format typically seen for AI device studies (e.g., sensitivity, specificity thresholds). Instead, for this reprocessed surgical instrument, the acceptance criteria are implicitly defined by demonstrating that the reprocessed device performs as "originally intended" and is "substantially equivalent" to the original predicate device through a series of functional, safety, and sterilization tests.

From the "Summary of Non-Clinical Tests Conducted" section, the performance tests conducted include:

The overall conclusion states: "Performance testing shows the Harmonic FOCUS Shears + Adaptive Tissue Technology performs as originally intended." and "Results demonstrated substantial equivalence to the predicate devices with respect to safety and effectiveness."

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

The document does not specify the exact sample sizes used for each performance test. It mentions "Reprocessed devices were tested" and "Each device and accessory are marked and tracked through the reprocessing cycle." The testing appears to be conducted on samples of the reprocessed devices. The provenance is not explicitly stated in terms of country of origin of data or whether it was retrospective or prospective. It is implied to be prospective testing of reprocessed devices manufactured by SterilMed.

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

This is a physical medical device, not an AI or imaging device that requires expert interpretation for ground truth. Therefore, the concept of "experts" establishing ground truth in this context is not applicable. The performance is assessed through objective engineering and biological tests, not human interpretation of data.

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

Not applicable, as this is objective performance testing of a physical device, not an interpretative task 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 is not an AI or imaging device, and there is no human reader component. The study compares the performance of the reprocessed device against its original predicate device.

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

Not applicable, as this is a physical surgical instrument, not an algorithm. The "standalone performance" in this context refers to the device's functional integrity and safety.

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

The "ground truth" for this device's reprocessed performance is established by:

• Predicate Device Performance: The original HARMONIC FOCUS® Shears + Adaptive Tissue Technology (Ethicon K133314) serves as the benchmark for expected performance.
• Accepted Standards: Compliance with various international and national standards (e.g., ISO 10993-7, ISO 10993-1, IEC 60601, ASTM D4169, ASTM F88, ASTM F2096, ASTM 1980-07) for sterilization, biocompatibility, packaging, and electrical safety.
• Engineering Specifications: The device's original design specifications for grasping force, seal burst, tissue adhesion, jaw pad life, removal force, thermal spread, and transection time.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device 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 Sterilmed Reprocessed HARMONIC ACE®+ 7 Shears with Advanced Hemostasis are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter using the Advanced Hemostasis hand control button.

The Sterilmed Reprocessed HARMONIC ACE+7 Shears with Advanced Hemostasis are used for coagulation and mechanical transection of soft tissue during laparoscopic and open procedures. The devices allow the surgeon to grasp, coagulate, and transect soft tissue with a single instrument. The devices are hand-actuated with a shaft and tissue effector that can be rotated. The energy delivery can be activated with hand activation or with an optional generator foot switch. The two models are identical to each other in materials, form, fit and function except for the length of the shafts which are 23cm and 36 cm.

This document describes the validation of reprocessed HARMONIC ACE®+ 7 Shears with Advanced Hemostasis, demonstrating their substantial equivalence to the original equipment manufacturer (OEM) predicate device. Given that the provided text is a 510(k) summary for a reprocessed medical device (surgical shears), the acceptance criteria and study design are focused on demonstrating that the reprocessed device performs as safely and effectively as the original device. This is a non-clinical submission, thus the information regarding AI/human reader studies, expert consensus on images, etc., is not applicable here.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for a reprocessed device are fundamentally centered on demonstrating that it performs equivalently to the new, original device in terms of safety and functional effectiveness. The performance of the reprocessed device is compared against the OEM predicate device. Specific quantitative acceptance criteria or threshold values are not explicitly listed in this summary, but the general principle is that the reprocessed device "performs as originally intended" and is "substantially equivalent" to the predicate.

Study Details

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

• Sample Size: The document states that "representative samples of reprocessed devices were tested," and for functional testing, "all products produced" undergo visual and validated functional testing. However, specific numerical sample sizes for each test (e.g., how many devices were tested for vein seal burst, or fatigue testing) are not provided in this summary.
• Data Provenance: The testing was conducted by Sterilmed, Inc., a reprocessor based in Plymouth, MN, and Maple Grove, MN, USA. The data is from prospective bench testing and validation studies of their reprocessed devices. It is not human clinical data.

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

This information is not applicable as this is a submission for reprocessed surgical shears based on non-clinical, bench testing, and engineering validation, not an AI or imaging-based device. No "experts" in the sense of medical professionals interpreting images were used to establish ground truth for the device's functional performance. Ground truth was established through validated engineering and laboratory test methods, often comparing performance against the OEM predicate.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving multiple human readers interpreting data, typically in diagnostic imaging. For a reprocessed surgical device, the "adjudication" is inherent in the robust, validated test methods and comparison to established predicate performance. If a test failed, it would need to be investigated and resolved, but there isn't a "reader-based" adjudication process.

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:

This is not applicable. MRMC studies are specific to diagnostic imaging devices, often involving AI, where human readers evaluate cases. This submission is for reprocessed surgical shears, which do not involve human readers for diagnostic interpretation.

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

This is not applicable. This device is a mechanical/ultrasonic surgical instrument, not an algorithm.

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

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

• Engineering specifications and performance characteristics of the OEM predicate device (Ethicon HARMONIC ACE®+7 Shears with Advanced Hemostasis, K132612).
• Validated industry standards and test methods (e.g., ISO 10993, ASTM standards for packaging, electrical safety).
• Successful functional performance benchmarks (e.g., vein/artery seal burst pressure, thermal spread, grasping force), which show the device "performs as originally intended."
  In essence, the ground truth is that the reprocessed device must meet or exceed the safety and functional performance of the new, original device.

8. The sample size for the training set:

This is not applicable. This is not an AI/machine learning device; there is no "training set" in the computational sense. The "training" for the manufacturing process involves process validation and quality control measures to ensure consistent reprocessing.

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

This is not applicable for the same reason as point 8. The "ground truth" for the overall manufacturing and reprocessing process is established through rigorous validation of cleaning, sterilization, packaging, and functional testing protocols to ensure the device is consistently reprocessed to meet its intended performance specifications.

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The Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector model SCD13 is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The device can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures. The Sonicision Cordless Ultrasonic Dissection Device can be used to coagulate isolated vessels up to 5 mm diameter.
The Sonicision 13-cm device is also indicated for use in otorhinolaryngologic (ENT) procedures.

The Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector model SCD13, is a sterile, single-use component to which the Sonicision Reusable Generator and Reusable Battery Pack attach. (The Sonicision Reusable Generator and Reusable Battery Pack are not included in this submission and will not be reprocessed by Medline ReNewal.) This component provides control for device functions such as selecting power levels, blade placement and position, grasping, coagulating and dissecting tissue. The Cordless Ultrasonic Dissection Device can coagulate vessels up to 5 mm in diameter. Furthermore, it is designed to be inserted and extracted through a compatible 5 mm trocar, when used endoscopically.

The provided FDA 510(k) summary for the Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector, model SCD13 (K173627), does not contain information about acceptance criteria and the study that proves the device meets those criteria in the format requested, particularly for AI/ML-based devices. This submission is for a reprocessed surgical instrument and focuses on demonstrating substantial equivalence to a predicate device through functional, performance, and biocompatibility testing, rather than presenting clinical study results with acceptance criteria typical for diagnostic or AI-powered devices.

However, I can extract information related to performance testing and the type of evidence used to support the substantial equivalence claim. Since this is not an AI/ML device, many of the requested fields (like effect size with/without AI, sample size for test set/training set for AI, number of experts for ground truth, adjudication method, etc.) are not applicable.

Here's an adaptation of the requested table and information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a reprocessed device demonstrating substantial equivalence to a predicate, the "acceptance criteria" are implicitly that the reprocessed device performs comparably to the original predicate device across various functional and safety aspects. The reported performance aims to show this comparability.

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

The document does not specify a "sample size" in the context of a "test set" for diagnostic performance, as this is a surgical instrument.
For the performance testing:

• Bench tests: The number of devices or trials tested for each bench criterion (e.g., simulated use, grasping force, cutting effectiveness, cleaning, drop test, device integrity, tissue sticking, prolonged cutting/coagulation evaluation, thermal spread) is not explicitly stated in the summary.
• Acute ex vivo: Tissue types and vessel sizes evaluated are listed (Hypogastric, Short Gastric, Gastrosplenic, Ovarian Pedicle for A/V Bundle, Splenic, Renal for Isolated Arteries or Veins, all up to 5mm diameter), but the number of vessels or tissue samples tested is not provided.
• Chronic in vivo: A single 21-day chronic in vivo study was conducted using a porcine model. The number of animals used is not specified.

Data Provenance: The studies are described as bench tests, ex vivo (tissue samples, likely animal or cadaveric), and in vivo (porcine model). The country of origin for these studies is not specified in the provided summary.

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

There is no mention of "experts" establish a "ground truth" for a diagnostic test set, as this is related to a surgical instrument's functional performance and reprocessing safety. The evaluation would have been performed by qualified laboratory personnel and veterinary surgeons (for in vivo studies), but not "experts" in the context of diagnostic interpretation.

4. Adjudication Method for the Test Set

Not applicable, as this is not a diagnostic test requiring adjudication of interpretations.

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 reprocessed surgical instrument, 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 is not an algorithm or AI device. The device's performance is standalone in the sense that its functional capabilities are evaluated independently, but it is ultimately used by a human surgeon.

7. The type of ground truth used

The "ground truth" for this type of device is established through:

• Direct measurement: For physical properties (e.g., grasping force, cutting effectiveness, device integrity, cleaning efficacy).
• Histopathology/Morphometry: For tissue effects like thermal spread and absence of injury in collateral structures.
• Direct observation and assessment: For simulated use and in vivo studies (e.g., visual assessment of vessel sealing, absence of hemorrhage).
• Laboratory assays: For biocompatibility (cytotoxicity, endotoxins).
• Comparison to predicate device: The ultimate "ground truth" for substantial equivalence is demonstrating that the reprocessed device performs as safely and effectively as the original, legally marketed predicate device.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI, and therefore has no "training set."

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

Not applicable, as there is no training set for an AI/ML model for this device.

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The Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissection Devices models SCD 391 and SCD 396 are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The devices can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures. The Sonicision Cordless Ultrasonic Dissection Devices can be used to coagulate isolated vessels up to 5 mm diameter.

The Sonicision Cordless Ultrasonic Dissector Device, models SCD391 and SCD396, are sterile, single-use components to which the Sonicision Reusable Generator and Reusable Battery Pack attach. (The Sonicision Reusable Generator and Reusable Battery Pack are not included in this submission and will not be reprocessed by Medline ReNewal.) This component provides control for device functions such as selecting power levels, blade placement and position, grasping, coagulating and dissecting tissue. The Cordless Ultrasonic Dissection Devices can coagulate vessels up to 5 mm in diameter. Furthermore, they are designed to be inserted and extracted through a compatible 5 mm trocar when used endoscopically.

Here's an analysis of the acceptance criteria and study information based on the provided text:

The document is a 510(k) premarket notification for a reprocessed medical device, specifically the Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector, Models SCD 391 and SCD 396. The core of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving novel clinical effectiveness or superiority. Therefore, the testing described focuses on demonstrating that the reprocessed device performs as intended and is as safe and effective as the original, rather than establishing new performance benchmarks for all surgical devices.

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

The document doesn't provide a direct table of specific numerical acceptance criteria alongside reported performance for each test. Instead, it lists types of performance tests conducted to establish equivalence. The general acceptance criterion for all the tests is that the reprocessed device must demonstrate equivalence to the predicate device in terms of safety and effectiveness.

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

• Sample Size: The document does not specify the exact sample sizes (N numbers) used for each individual performance test. It only states that the functional characteristics "have been evaluated."
• Data Provenance: The data provenance is not explicitly stated. However, since this is a submission for a reprocessed device by Medline ReNewal, the testing would have been conducted by Medline ReNewal or their contracted testing facilities. Given the nature of performance testing for medical devices, it's generally done in a controlled laboratory environment. The origin of the reprocessed devices themselves would be from various healthcare facilities where they were originally used before being sent for reprocessing. The testing itself is prospective in the sense that Medline ReNewal performed these tests on their reprocessed devices.

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

This type of information (expert consensus, qualifications) is typically relevant for studies involving subjective interpretation, like imaging diagnostics or clinical endpoints, where human experts establish ground truth. For this submission, which is about the functional and safety equivalence of a reprocessed surgical instrument, the "ground truth" is established by direct physical and chemical testing against defined specifications or comparison to the performance of the new predicate device. Therefore, information about "experts establishing ground truth" in the clinical sense is not applicable or provided in this document.

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

Adjudication methods (like 2+1, 3+1) are typically used in clinical trials or diagnostic accuracy studies where multiple readers interpret cases and disagreements are resolved. This document pertains to performance testing of a reprocessed surgical instrument, which involves objective laboratory measurements and comparisons to predetermined specifications or predicate device performance. Therefore, an adjudication method in this context is not applicable and 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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic aids, especially those involving AI interpretation, where human readers interact with a system to make diagnoses. The Medline ReNewal device is a surgical instrument, not an AI diagnostic tool.
• Effect Size of AI assistance: Not applicable, as this is not an AI-assisted diagnostic device.

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

• Standalone Performance: Not applicable. This is a physical surgical instrument, not an algorithm or software. Its performance is inherent to its mechanical, electrical, and material properties when used by a surgeon.

7. The type of ground truth used

The ground truth for evaluating the safety and effectiveness of the reprocessed device is established through:

• Comparison to the predicate device's known performance: The fundamental scientific technology and intended use are considered identical to the predicate.
• Pre-defined specifications and standards: Each performance test (e.g., grasping/pulling force, cutting effectiveness, cleaning, biocompatibility, sterilization) would have acceptance criteria based on established engineering standards, regulatory requirements, and the expected performance of a new device.
• Objective laboratory measurements: Physical, chemical, and biological tests are performed to directly measure different aspects of the device's function and safety.

Essentially, the "ground truth" is objective measurement against established requirements and comparison to the original device's performance.

8. The sample size for the training set

This concept of a "training set" is relevant for machine learning or AI models. Since this is a physical medical device and not an AI or software product, there is no training set in the traditional sense. The development and validation of the reprocessing procedure would involve internal process development and verification, but it's not a "training set" for an algorithm.

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 Reprocessed HARMONIC FOCUS® Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, otorhinolaryngologic (ENT), plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures.

Reprocessed HARMONIC FOCUS® Shears + Adaptive Tissue Technology are a sterile, single patient use instrument consisting of a soft grip scissor handle housing assembly with two hand controls (MIN for minimum power level and MAX for maximum power level). The instrument has a curved blade and clamp arm with Teflon pad. The instrument is 9 cm in length with a 16 mm active blade length. The Reprocessed HARMONIC FOCUS®+ Shears instrument allows for the cutting and coagulation of vessels up to and including 5 mm in diameter. Each Reprocessed HARMONIC FOCUS®+ Shears instrument is packaged with one sterile, single patient use, disposable Torque Wrench.

The provided text describes a 510(k) premarket notification for a reprocessed medical device, the "Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology." This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the de novo effectiveness of a novel device. Therefore, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as typically applied to AI/ML or diagnostic devices with quantifiable performance metrics (like sensitivity, specificity, AUC) is not directly applicable in the same way.

However, we can interpret acceptance criteria in the context of this 510(k) as demonstrating that the reprocessed device performs as well as the original predicate device, and that the reprocessing itself does not introduce new safety or effectiveness concerns.

Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided document for each specific point:

Acceptance Criteria and Study for Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology

In the context of this 510(k) submission for a reprocessed device, the "acceptance criteria" are implicitly tied to demonstrating that the reprocessed device is substantially equivalent to the original predicate device and that the reprocessing process does not compromise safety or effectiveness. The "study" refers to the performance data submitted to the FDA to support this claim.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a reprocessed device, the acceptance criteria are not explicitly defined as numerical thresholds for specific performance metrics like those for a diagnostic AI. Instead, they are comparative, aiming to show that the reprocessed device performs equivalently to the new, original device.

• Electrical Safety: Compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2.
• Electromagnetic Compatibility: Compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2.
• Functional Performance (Comparative): Evaluation of ability to seal and divide vessels up to 5mm, including:
  • Thermal spread
  • Transection time
  • Burst pressure
  • Device functionality
  • Device reliability
• Preclinical Laboratory Evaluations (Animal Model): Acute and chronic survival studies to evaluate thermal spread and ability to achieve hemostasis. |
  | Biocompatibility | Testing was conducted. (Assumed acceptance: demonstrates no new biocompatibility risks after reprocessing). |
  | Validation of Reprocessing | Testing was conducted. (Assumed acceptance: demonstrates the reprocessing method effectively cleans, restores, and prepares the device for reuse without degradation or contamination). The description mentions "removal of adherent visible soil and decontamination." |
  | Sterilization Validation | Testing was conducted. (Assumed acceptance: demonstrates the reprocessed device is sterile). |
  | Packaging Validation | Testing was conducted. (Assumed acceptance: demonstrates packaging maintains sterility and device integrity). |

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

The document does not explicitly state the numerical sample sizes for the "bench and laboratory testing" or the "preclinical laboratory evaluations." It mentions "animal model" but not the number of animals or trials. The data provenance is internal to the manufacturer's testing, presumably conducted at their facilities or certified labs. No indication of country of origin of data beyond where Stryker Sustainability Solutions operates (Tempe, Arizona). The studies are inherently prospective in nature, as they involve testing the reprocessed devices under controlled conditions.

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

This information is not applicable and not provided in the document. For a reprocessed surgical instrument, "ground truth" is not established by expert consensus on image interpretation, but rather by objective physical, chemical, and biological testing as outlined above (e.g., burst pressure measurements, bacterial counts, visual inspection criteria, etc.). There would be engineers, microbiologists, and other technical experts involved in conducting and interpreting these tests, but they are not "experts establishing ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert interpretation of data (e.g., medical images) to establish a consensus ground truth. For instrument performance testing, the results are typically quantitative measurements or pass/fail criteria based on defined specifications, not subjective interpretation requiring adjudication among experts.

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

Not applicable. MRMC studies are conducted for diagnostic devices (often AI-assisted) to assess how human readers' performance (e.g., diagnostic accuracy) changes with or without AI assistance. This document is for a physical surgical instrument, not a diagnostic tool where human interpretation is involved.

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

Not applicable. There is no AI algorithm being evaluated for its standalone performance in a diagnostic capacity. The "Adaptive Tissue Technology" refers to algorithms within the generator that communicate with the device to optimize energy delivery, but this is an integrated system functionality, not a standalone diagnostic algorithm. The functional performance tests implicitly evaluate the device's performance, which includes the integrated technology, without specific focus on "algorithm-only" performance as a separate entity.

7. Type of Ground Truth Used

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

• Physical and Mechanical Measurements: Such as thermal spread, transection time, burst pressure, device functionality, and reliability, measured against predetermined specifications or compared to the predicate device's performance.
• Biological/Chemical Testing: Biocompatibility, sterilization validation (e.g., sterility assurance level), and validation of cleaning (e.g., residual protein levels, visual cleanliness).
• Preclinical (Animal Model) Outcomes: Evaluation of hemostasis and thermal spread in vivo.
  This is distinct from "expert consensus," "pathology," or "outcomes data" in the context of diagnostic performance.

8. Sample Size for the Training Set

Not applicable. This is a reprocessed physical device, not an AI/ML algorithm that learns from a "training set" of data.

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

Not applicable, as there is no training set for an AI/ML algorithm in this submission.

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