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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 ViewFlex Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures, blood flow and other devices within the heart.

The Reprocessed ViewFlex Xtra ICE Catheter is a temporary intracardiac ultrasound catheter intended for use in patients to visualize cardiac structures and blood flow within the heart. The Reprocessed ViewFlex Xtra ICE Catheter is inserted into the heart via intravascular access. The Reprocessed ViewFlex Xtra ICE Catheter shaft is a 9 French catheter with a useable length of 90 cm. The shaft is compatible with a 10 French or larger introducer for insertion into the femoral or jugular veins. The catheter tip is a 64-element linear phased array transducer housed in silicone. The distal portion of the shaft is deflectable in four directions allowing for left-to-right and anteriorto-posterior deflection. The handle of the catheter has two deflection mechanisms that correspond with movement of the distal shaft in the four planes of movement. The Reprocessed ViewFlex Xtra Ice Catheter is compatible with ViewMate Z or ViewMate and Philips CX50 ultrasound consoles via the use of a compatible ViewFlex Catheter interface module.

The provided text does not contain a study that proves the device meets specific acceptance criteria in terms of accuracy or clinical performance. The submission is for a reprocessed medical device (Intracardiac Echocardiography Catheter), and the studies described are primarily focused on demonstrating that the reprocessed device is as safe and effective as the predicate device and operates as originally intended.

Specifically, the document focuses on:

• Bench and laboratory testing: To demonstrate the performance (safety and effectiveness) of the reprocessed device.
• Comparison to a predicate device: Asserting that the reprocessed device is substantially equivalent to legally marketed predicate devices.
• Validation of reprocessing methods: Ensuring cleaning, sterilization, and functional integrity after reprocessing.

Therefore, many of the requested categories for a study demonstrating clinical performance or diagnostic accuracy are not applicable to this submission.

However, I can extract the relevant information regarding the testing performed and the general "acceptance criteria" through comparison to the predicate.

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

1. Table of acceptance criteria and the reported device performance

The document does not provide a table of precise quantitative acceptance criteria (e.g., specific thresholds for image quality metrics) or their exact reported performance values. Instead, it states that the reprocessed device meets the functional and safety requirements to be considered equivalent to the predicate. The "performance" is implicitly "as safe and effective as the predicate" and "operates as originally intended."

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

The document does not specify exact sample sizes for the "test set" (e.g., number of reprocessed catheters tested for each criterion). The testing would have been done on a sufficient number of reprocessed devices to validate the reprocessing methods and ensure consistency. The data provenance is from bench and laboratory testing conducted by Stryker Sustainability Solutions, which is prospective data generation for the purpose of demonstrating substantial equivalence. The country of origin of the data is not explicitly stated but is implied to be within the US (given FDA submission).

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

This information is not applicable/not provided as the submission is for a reprocessed device and describes technical and functional testing, not a clinical study involving diagnostic accuracy with expert-established ground truth.

4. Adjudication method for the test set

This information is not applicable/not provided as the submission is for a reprocessed device and describes technical and functional testing, not a clinical study.

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

No, a MRMC comparative effectiveness study was not conducted or described. The focus is on the substantial equivalence of the reprocessed device to its predicate through engineering and functional testing.

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

This information is not applicable/not provided. The device is an Intracardiac Echocardiography Catheter, not an AI algorithm. The functional testing described is effectively a standalone performance assessment of the physical device.

7. The type of ground truth used

The "ground truth" for the functional and safety testing would be:

• Engineering specifications of the original device.
• Industry standards and regulatory requirements for medical device safety and performance (e.g., biocompatibility standards, sterilization efficacy).
• The performance characteristics of the new/unreprocessed predicate device.

8. The sample size for the training set

This information is not applicable/not provided. There is no "training set" in the context of this device submission, as it relates to a physical medical device and its reprocessing, not a machine learning algorithm.

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

This information is not applicable/not provided for the same reason as above.

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The Reprocessed LF1212A LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/ Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedure may include, but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis.

The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectorny, and tonsillectorny) for ligation of vessels, lymphatics and tissue bundles 2-3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands.

The LigaSure system has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

The Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The instrument is intended to be used with Covidien electrosurgical generators that include vessel sealing capability. The instrument can be used on vessels (arteries and veins) up to and including 7 mm. The instrument creates a seal by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue. The following controls are located on the device:

• Scissor like design for opening and closing the instrument jaws and activating RF energy. . The mechanism must be held in the closed position during vessel sealing and cutting.
• . An activation button at the bottom of the handle for generator power to initiate vessel sealing. The button has two stages that provide tactile feedback to the user. The first stage button click does not apply energy, whereas the second stage click begins energy application.
• . A trigger for actuating the blade.

All controls can be operated with either the right or left hand. Vessel sealing can be initiated using the activation button or utilizing a footswitch connected to the generator. The instrument attached to the generator via a cable with a connector that identifies the instrument type to the generator.

The instrument is compatible with the Covidien ForceTriad Energy Platform and Valleylab FT10 Energy Platform.

The scope of the submission only includes the addition of a second reprocessing cycle to the previously cleared Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (K220411) and not the Covidien ForceTriad Energy Platform or Valleylab FT10 Energy Platform that are used to power the device, or the footswitch that connects to the generator. Stryker Sustainability Solutions does not reprocess or market the generators or footswitch.

The provided text is a 510(k) summary for the Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A). It describes the device, its intended use, comparison with predicate devices, and performance data. However, the document does NOT provide detailed acceptance criteria or the specific results of the studies in the format requested. While it lists types of tests performed, it does not specify quantitative acceptance criteria or the reported device performance against those criteria. It also does not explicitly mention sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, or MRMC studies.

Therefore, many of the requested fields cannot be answered from the provided text. I will extract what information is available and state when information is not provided.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists several functional performance tests but does not explicitly state the quantitative acceptance criteria or the numerical reported device performance for each. It mentions "verification/comparative testing (to the predicate device)" and "evaluation of the device's performance and ability to seal and divide vessels from 1mm to 7mm, including burst pressure, maximum jaw temperature, device functionality, and functional attribute tests," suggesting that the reprocessed device performed comparably to the predicate or met general functional expectations for vessel sealing.

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

The document does not explicitly state the sample sizes for any of the test sets (bench, laboratory, or preclinical). It mentions "preclinical laboratory evaluations in an animal model," but does not specify the type or number of animals used. The provenance of the data (e.g., country of origin, retrospective/prospective) is not mentioned.

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

Not applicable/Not provided. The studies described are primarily bench testing and animal model evaluations, which typically do not involve human expert interpretation for "ground truth" in the way a diagnostic imaging study would.

4. Adjudication method for the test set

Not applicable/Not provided. Adjudication methods are typically relevant for studies involving human interpretation where consensus or a tie-breaking mechanism is needed for ground truth. This was not such a 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. The device described is an electrosurgical sealer/divider and not an AI-assisted diagnostic tool.

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

Not applicable. This device is a surgical instrument and requires human operation. The performance studies focused on the instrument's functional characteristics and its ability to achieve its intended effect (sealing vessels).

7. The type of ground truth used

For the bench and laboratory testing, the "ground truth" would be objective measurements and established engineering standards (e.g., force, temperature, burst pressure tolerances, electrical safety standards). For the preclinical animal studies, the "ground truth" would be physiological outcomes observed directly (e.g., successful hemostasis, measured thermal spread, histological analysis) compared against expected performance or predicate device performance.

8. The sample size for the training set

Not applicable. This device is a reprocessed surgical instrument, not a machine learning or AI algorithm, so there is no training set in that context. The "training" here refers to the process qualifications and validation of the reprocessing procedure itself.

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

Not applicable. See point 8.

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The Remanufactured LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedure may include, but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis.

The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectorny, and tonsillectomy) for ligation and division of vessels, lymphatics and tissue bundles 2-3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands.

The LigaSure system has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

The Remanufactured LigaSure Exact Dissector Without Nano-coating (LF2019) is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The instrument is intended to be used with Covidien electrosurgical generators that include vessel sealing capability. The instrument can be used on vessels (arteries and veins) up to and including 7 mm. The instrument creates a seal by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue. The following controls are located on the device:
. Scissor like design for opening and closing the instrument jaws and activating RF energy. The mechanism must be held in the closed position during vessel sealing and cutting.
. An activation button at the bottom of the handle for generator power to initiate vessel sealing. The button has two stages that provide tactile feedback to the user. The first stage button click does not apply energy, whereas the second stage click begins energy application.
. A trigger for actuating the blade.

All controls can be operated with either the right or left hand. Vessel sealing can be initiated using the activation button or utilizing a footswitch connected to the generator. The instrument attached to the generator via a cable with a connector that identifies the instrument type to the generator.

For the LF2019, the Original Manufacturer applies a non-stick coating the jaws of the device to reduce tissue sticking. When remanufacturing the LF2019, Stryker Sustainability Solutions will not apply a non-stick coating to the jaws of the device.

The instrument is compatible with the Covidien Valleylab FT10 Energy Platform.

The scope of the submission only includes the addition of a second reprocessing cycle to the previously cleared Remanufactured LigaSure Exact Dissector Without Nano-coating (K220481) and not the Covidien Valleylab FT10 Energy Platform that is used to power the device, or the footswitch that connects to the generator. Stryker Sustainability Solutions does not reprocess or market the generators or footswitch.

The provided text is a 510(k) summary for a remanufactured medical device, the LigaSure Exact Dissector. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance metrics. As such, the information needed to fully answer your request regarding specific acceptance criteria values and detailed study methodology and results is not present in the given text.

However, I can extract and infer some information based on the typical content of a 510(k) summary and the general nature of medical device premarket notifications.

Here's a breakdown of what can and cannot be answered from the provided text:

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

The document lists various tests performed but does not provide specific numerical acceptance criteria or the quantitative results achieved for each. For example, it lists "Burst Pressure" as a test, but doesn't say "acceptance criteria: >X mmHg, reported performance: Y mmHg."

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

• Sample Size for Test Set: Not specified in the document for any of the performance tests.
• Data Provenance: The studies were conducted by Stryker Sustainability Solutions, a company based in Tempe, Arizona, USA. The nature of the studies (bench, laboratory, and preclinical animal model) suggests they were prospective, specifically designed for this submission.

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

This question is not applicable in this context. The device is a surgical instrument, not an AI diagnostic tool. Ground truth in this context would generally refer to objective physical measurements (like burst pressure, temperature, force) and clinical observations in an animal model, not expert interpretation of diagnostic data.

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

Not applicable for a physical medical device performance study. Adjudication methods like 2+1 or 3+1 are typically used in AI/diagnostic studies where there's an element of human interpretation that needs to be resolved.

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 physical 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.

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

The "ground truth" for this type of device performance study would be:

• Objective physical measurements: Electrical safety parameters, electrosurgical compatibility (IEC standards), mechanical forces (blade actuation, clamp arm force, jaw clamp force), geometrical measurements (jaw opening angle, blade excursion), and in-vitro performance (burst pressure, maximum jaw temperature).
• Preclinical animal model observations: Direct observation of hemostasis, thermal spread, and absence of adverse events (acute and chronic survival studies).

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI algorithm that requires a training set. The term "training set" is relevant for AI/machine learning.

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

Not applicable.

Summary of available information related to performance:

The document states that the following tests were conducted:

• Biocompatibility
• Validation of Reprocessing
• Sterilization
• Electrical Safety and Electromagnetic Compatibility: In accordance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2.
• Functional Performance Tests:
  • Blade Trigger Actuation Force
  • Clamp Arm Closing and Seal Button Force
  • Clamp Arm Opening Force
  • Clamp Arm Deflection
  • Jaw Clamp Force
  • Blade Excursion
  • Jaw Opening Angle
  • Burst Pressure (evaluated ability to seal and divide vessels from 1mm to 7mm)
  • Maximum Jaw Temperature
  • Device Reliability
  • Functional Attribute Testing
  • Generator Software Compatibility
• Preclinical laboratory evaluations in an animal model: Acute and chronic survival studies to evaluate thermal spread and ability to achieve hemostasis of vessels.

Conclusion stated: "The results of bench testing and preclinical laboratory evaluations demonstrate that the Remanufactured LigaSure Exact Dissector Without Nano-coating is at least as safe and effective as the predicate and perform as well as the identified legally marketed predicate device as described herein."

In essence, the document confirms that various performance tests were performed and demonstrated that the remanufactured device is "at least as safe and effective" as the predicate, which is the standard for 510(k) clearances. However, it does not disclose the specific quantitative acceptance criteria or the detailed numerical results from these tests.

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The Reprocessed RD SET pulse oximeter sensors are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediatric, and infant patients during non-motions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.

In a clinical setting, a pulse oximeter sensor measures the oxygen saturation of arterial blood (SpO2). A pulse oximeter sensor is composed of a light emitting diode (LED) and a sensor that are placed on opposite sides of a patient's finger or foot. The LED contains a red light and an infrared light that are differentially absorbed by oxygenated and deoxygenated hemoglobin. Based on the relative absorption of the two wavelengths that is determined by the sensor, the POX determines the relative amount of oxygenated and deoxygenated hemoglobin, which is calculated as SpO2. In order to make the SpO2 calculation independent of skin color, finger size, etc., the pulse oximeter sensor uses only the time varying light absorption component generated by the patient's pulse. The sensor also uses the period of pulsation to measure patient pulse rate. The pulse oximeter can estimate the amount of oxygen in the blood without having to draw a blood sample.

The primary components of an oxygen transducer, or Pulse Oximeter (POX) Sensor, are lightemitting diodes (red and infrared LED) and a photo sensor. These components (with their wiring system) are embedded within a taping system designed for wrapping the POX Sensor around a patient's finger, foot, or hand so that the LED and photo sensor are directly opposite to each other. As the lights are emitted and received across a vascular bed, the rates of absorption at the two wavelengths vary depending upon the ratios of oxygenated and deoxygenated hemoglobin within the blood.

As part of the reprocessing manufacturing process, we collect used devices from hospitals, replace required components, clean the devices and test the functional performance of the devices to ensure they meet or exceed requlatory requirements and the expectations of our customers.

The provided text describes the 510(k) summary for reprocessed pulse oximeter sensors. It outlines the device, its intended use, comparison to predicate devices, and testing performed to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

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The Remanufactured LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedure may include, but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis.

The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectorny, and tonsillectorny) for ligation of vessels, lymphatics and tissue bundles 2-3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands.

The LigaSure system has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

The Remanufactured LigaSure Exact Dissector. Without Nano-coating (LF2019) is a bipolar electrosurgical instrument intended for use in open surqical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The instrument is intended to be used with Covidien electrosurgical generators that include vessel sealing capability. The instrument can be used on vessels (arteries and veins) up to and including 7 mm. The instrument creates a seal by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue. The following controls are located on the device:

• Scissor like design for opening and closing the instrument jaws and activating RF energy. The mechanism must be held in the closed position during vessel sealing and cutting.
• . An activation button at the bottom of the handle for generator power to initiate vessel sealing. The button has two stages that provide tactile feedback to the user. The first stage button click does not apply energy, whereas the second stage click begins energy application.
• . A trigger for actuating the blade.
  All controls can be operated with either the right or left hand. Vessel sealing can be initiated using the activation button or utilizing a footswitch connected to the generator. The instrument attached to the qenerator via a cable with a connector that identifies the instrument type to the qenerator.

For the LF2019, the Original Manufacturer applies a non-stick coating the jaws of the device to reduce tissue sticking. When remanufacturing the LF2019, Stryker Sustainability Solutions will not apply a non-stick coating to the iaws of the device.

The instrument is compatible with the Covidien Valleylab FT10 Enerqy Platform.

The scope of the submission only includes the Remanufactured LigaSure Exact Dissector. Without Nano-coating and not the Valleylab FT10 Energy Platform that is used to power the device, or the footswitch that connects to the generator. Stryker Sustainability Solutions does not reprocess, remanufacture, or market the generators or footswitch.

The provided text describes the acceptance criteria and the study conducted for the Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019). Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" for each test with numerical thresholds. However, it states that the device was evaluated against the predicate device and that the results "demonstrate that the Remanufactured LigaSure Exact Dissector, Without Nano-coating is at least as safe and effective as the predicate and perform as well as the identified legally marketed predicate device."

Therefore, the implicit acceptance criteria are that the remanufactured device performs comparably to the predicate device in the specified tests, particularly regarding safety and effectiveness.

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

• Sample Size: The document does not specify the exact sample size for each bench test or the number of animals used in the preclinical studies. It generally refers to "bench and laboratory testing" and "preclinical laboratory evaluations in an animal model."
• Data Provenance: The document does not provide details on the country of origin of the data. The studies appear to be prospective as they were conducted specifically to demonstrate the performance of the remanufactured device.

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

This information is not provided in the document. The studies described are primarily performance and comparative tests against a predicate device, rather than subjective evaluations requiring expert consensus for ground truth.

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

This information is not applicable/not provided. The performance data described are objective measurements (e.g., forces, temperatures, burst pressure) or observations in animal models that do not typically involve an adjudication method by multiple human readers.

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. The device described is a surgical instrument (Electrosurgical Cutting and Coagulation Device), not an AI-powered diagnostic or imaging tool. Therefore, an MRMC study related to human reader
improvement with AI is irrelevant to this device.

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

This is not applicable. The device is a physical surgical instrument; it is not an algorithm, and its performance inherently involves human-in-the-loop operation.

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

The "ground truth" for the tests appears to be based on:

• Predicate Device Performance: The primary method for establishing effectiveness is comparison against the legally marketed predicate device (LigaSure Exact Dissector, Nano-coated LF2019, K173281). The remanufactured device needed to perform "as well as" the predicate.
• Established Engineering and Medical Standards: Compliance with electrical safety and electromagnetic compatibility (IEC 60601 series).
• Direct Physical Measurements: For functional performance tests (e.g., force, temperature, burst pressure).
• Biological Outcomes: In the animal model, the ground truth would be the observed hemostasis and thermal spread characteristics.

8. The sample size for the training set:

This is not applicable. The device is a remanufactured physical instrument, not an AI model that requires a training set.

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

This is not applicable as there is no training set for this type of device.

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The Reprocessed LF1212A LigaSure Sealer/Divider is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/ Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and in such surgical specialties as urologic, thoracic, plastic, and reconstructive. Procedure may include, but are not limited to, bowel resections, gall bladder procedures, Nissen fundoplication, and adhesiolysis.

The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectorny, and tonsillectorny) for ligation of vessels, lymphatics and tissue bundles 2-3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands.

The LigaSure system has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

The Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The instrument is intended to be used with Covidien electrosurgical generators that include vessel sealing capability. The instrument can be used on vessels (arteries and veins) up to and including 7 mm. The instrument creates a seal by application of radiofrequency (RF) electrosurgical energy to vascular structures (vessels and lymphatics) or tissue bundles interposed between the jaws of the instrument. A blade within the instrument is surgeon actuated to divide tissue. The following controls are located on the device:

• Scissor like design for opening and closing the instrument jaws and activating RF energy. The mechanism must be held in the closed position during vessel sealing and cutting.
• An activation button at the bottom of the handle for generator power to initiate vessel sealing. The button has two stages that provide tactile feedback to the user. The first stage button click does not apply energy, whereas the second stage click begins energy application.
• A trigger for actuating the blade.
  All controls can be operated with either the right or left hand. Vessel sealing can be initiated using the activation button or utilizing a footswitch connected to the generator. The instrument attached to the generator via a cable with a connector that identifies the instrument type to the generator.

The instrument is compatible with the Covidien ForceTriad Enerqy Platform and Valleylab FT10 Energy Platform.

The scope of the submission only includes the Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider and not the Covidien ForceTriad Energy Platform or Valleylab FT10 Energy Platform that are used to power the device, or the footswitch that connects to the generator. Stryker Sustainability Solutions does not reprocess or market the generators or footswitch.

This document is a 510(k) premarket notification for a reprocessed medical device, the Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A). It demonstrates substantial equivalence to a predicate device.

Important Note: The provided document is for a reprocessed surgical instrument, not an AI-based diagnostic or therapeutic device. Therefore, the questions related to AI-specific criteria (such as multi-reader multi-case studies, expert consensus for ground truth, training set information, effects of AI assistance on human readers) are not applicable to this submission. The "acceptance criteria" discussed in this document refer to the performance of the reprocessed physical device, not an AI algorithm's performance against clinical endpoints.

Here's an analysis based on the provided text, addressing the relevant points and indicating where information is not applicable:

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

The document does not present acceptance criteria and reported device performance in a formal table with specific numerical thresholds. Instead, it lists the types of tests conducted to demonstrate substantial equivalence to the predicate device. The general acceptance criterion for this 510(k) submission is that the reprocessed device performs "at least as safe and effective as the predicate" and "as well as the identified legally marketed predicate device."

Here's a summary of the performance tests conducted, implying the "reported device performance" met the equivalence standard for each:

Acceptance Criteria (Implied: Performance comparable to or equivalent to the predicate device for safe and effective use)

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

• Sample Size: The document does not specify exact numerical sample sizes for each test conducted (e.g., number of devices tested for each functional performance metric, number of animals in preclinical studies). It generally refers to "bench and laboratory testing" and "preclinical laboratory evaluations in an animal model."
• Data Provenance: The tests were conducted by Stryker Sustainability Solutions, a U.S. company. The data would primarily originate from their internal testing facilities. The nature of the testing (bench, in-vitro, and animal studies) is prospective for the purpose of this 510(k) submission.

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

• Not Applicable: This pertains to an AI/imaging device. For this reprocessed surgical instrument, "ground truth" is established through engineering and performance testing against predefined mechanical, electrical, and functional specifications, as well as comparative performance in an animal model. There is no concept of expert human image interpretation or "ground truth" in the AI sense for this device.

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

• Not Applicable: This pertains to an AI/imaging device where human readers might disagree. For a physical device, testing involves quantitative measurements and observations against specifications. Any discrepancies would be handled through standard engineering quality control and retesting protocols, not through expert adjudication in a clinical reading context.

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 specific to AI devices and their impact on human reading performance. This document is for a reprocessed surgical instrument.

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

• Not Applicable: This is specific to AI algorithms. This is a physical surgical device.

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

For this physical device, the "ground truth" is based on:

• Engineering Specifications and Benchmarking: Mechanical properties (e.g., force, angles, excursion), electrical properties, and material integrity tested against established standards and the performance of the predicate device.
• Physiological Performance in Animal Models: "Thermal spread and the ability to achieve hemostasis of vessels" in an animal model serve as a form of "ground truth" for the device's functional performance in a biological system, compared to the expected performance of new devices or the predicate.

There is no "expert consensus" or "pathology" as "ground truth" in the context of clinical endpoints for an AI system.

8. The sample size for the training set

• Not Applicable: This question relates to AI model training. This document is about a reprocessed physical device, which does not have a "training set" in the machine learning sense. The device is re-manufactured and tested, not "trained."

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

• Not Applicable: As above, this pertains to AI model training.

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