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The Reprocessed Harmonic FOCUS™ Scalpels (hereinafter harmonic scalpel) is indicated to be used for cutting soft tissue and providing hemostasis when control of bleeding and minimal thermal injury is desired. The instrument can be used as an adjunct to or a substitute for electrosurgery, lasers, and steel scalpels in abdominal, pediatric, gynecologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures.

SterilMed reprocessed harmonic scalpels are used in combination with a hand piece, generator, torque wrench and grip assist and are intended to be used in soft tissue surgery for simultaneous cutting and coagulation of vessels and tissue. The instrument has a scissor handle with hand control capabilities consisting of MIN and MAX buttons. The handle housing has an integrated mechanism for limiting the force that can be applied when closing the distal mechanism. The instrument has a working length of 9 cm, an active blade of 16 mm and utilizes a curved blade and clamp arm. This device allows for the cutting and coagulation of vessels up to and including 5 mm in diameter. Note: Only the harmonic scalpel is the subject of this submission, the reusable hand piece, generator, and any other related equipment are not included in the scope of this submission.

Device Acceptance Criteria and Study Details

1. Acceptance Criteria and Reported Device Performance

The device under review is the "Reprocessed Harmonic Scalpel," and its acceptance criteria are established through a demonstration of substantial equivalence to its predicate device, the Ethicon Harmonic FOCUS™ Curved Shears (510(k) K063192). The study focuses on demonstrating that the reprocessed device performs functionally and safely as intended, aligning with the predicate device.

The acceptance criteria are not explicitly numerical thresholds for performance metrics (e.g., a specific force or cutting speed). Instead, they are defined by successful completion of a battery of non-clinical tests and functional performance evaluations, which collectively attest to the device's ability to maintain the inherent functional design, materials, indications for use, and methods of construction of the original device.

2. Sample Size and Data Provenance (Test Set)

• Sample Size: The document states that "Representative samples of reprocessed harmonic scalpels were tested." However, the exact numerical sample size for each specific test or for the overall test set is not provided in the summary.
• Data Provenance: The study appears to be entirely retrospective in the sense that it relies on bench testing and comparisons to existing standards and predicate devices. The data provenance can be considered manufacturer-generated data (SterilMed, Inc.) as it describes internal testing and validation processes. No mention of geographical origin for the data is made, implying it was conducted in the manufacturer's testing facilities (likely in the US, given the submission to the FDA).

3. Number of Experts and Qualifications (Test Set Ground Truth)

This study does not involve human expert interpretation of medical images or diagnoses, so the concept of "experts establishing ground truth for the test set" in the context of medical image analysis is not applicable. The "ground truth" for this device is established by adherence to engineering specifications, validated test methods, and comparison to the predicate device's known performance and manufacturing standards. The validation involves certified testing against industry standards (e.g., ISO, ASTM, USP) which are developed by expert committees in their respective fields.

4. Adjudication Method (Test Set)

No adjudication method (e.g., 2+1, 3+1) is mentioned or applicable as this is not a study involving human readers making subjective assessments that require reconciliation. The assessment of performance relies on objective, quantifiable tests and adherence to established standards and specifications.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of medical data (like imaging), comparing human reader performance with and without AI assistance. This submission pertains to a reprocessed surgical instrument, not a diagnostic AI device. Therefore, the concept of "effect size of how much human readers improve with AI vs without AI assistance" is not relevant here.

6. Standalone Performance (Algorithm Only)

No, a standalone (algorithm only) performance study was not done. This device is a physical surgical instrument, not a software algorithm. Therefore, "algorithm only" performance is not applicable.

7. Type of Ground Truth Used

The ground truth used for this study is a combination of:

• Established Industry Standards: Compliance with recognized international and national standards for sterilization (ISO 11135, USP ), biocompatibility (ISO 10993-1), ethylene oxide residuals (ISO 10993-7), packaging (ASTM D4169, ASTM F88, ASTM F1929, ASTM F2096), and shelf life (ASTM 1980-07).
• Predicate Device Performance: The functional design, materials, indications for use, and methods of construction of the Ethicon Harmonic FOCUS™ Curved Shears (510(k) K063192) serve as the benchmark for substantial equivalence.
• Objective Functional Testing: Verified performance "as intended" through simulated use on beef tissue, visual inspection, fatigue testing, and function testing with system checks.

In essence, the ground truth is defined by the demonstrated ability of the reprocessed device to meet the safety and performance specifications of the original device and comply with relevant regulatory and technical standards.

8. Sample Size for the Training Set

This submission describes the testing and re-processing of a physical medical device. It does not involve machine learning algorithms or AI, and therefore, the concept of a "training set" is not applicable. The 'training' for this device is the established reprocessing protocol itself, and its validation.

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

Since there is no "training set" in the context of machine learning for this device, this question is not applicable. The "ground truth" for the reprocessing protocol itself is established through extensive engineering and scientific validation to ensure that the reprocessed device is safe, sterile, and performs identically to its new counterpart. This includes developing and validating cleaning, sterilization, and inspection methods based on scientific principles and regulatory requirements.

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The reprocessed harmonic scalpels are indicated to be used for cutting of soft tissue and providing hemostasis when control of bleeding and minimal thermal injury is desired. The instrument can be used as an adjunct to, or a substitute for, electrosurgery, lasers, and steel scalpels in abdominal, pediatric, gynecologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures.

SterilMed reprocessed harmonic scalpels are used in combination with a hand piece, generator and torque wrench and are intended to be used in soft tissue surgery for simultaneous cutting and coagulation of vessels and tissue. The instrument has a scissor handle with hand control capabilities consisting of MIN and MAX buttons. The handle housing has an integrated mechanism for limiting the force that can be applied when closing the distal mechanism. The instrument has an 18 cm shaft length, 8.5 mm shaft diameter, active blade length of 18 mm, and utilizes a straight blade and clamp arm. Note: Only the harmonic scalpel is the subject of this submission, the reusable hand piece, generator, and any other related equipment are not included in the scope of this submission.

The provided text describes a 510(k) premarket notification for a Reprocessed Harmonic Scalpel by SterilMed, Inc. This submission focuses on demonstrating substantial equivalence to a predicate device, not on proving the de novo effectiveness of a new device through clinical trials. Therefore, much of the information typically requested for AI/algorithm performance studies (like sample size for test/training sets, expert qualifications, MRMC studies, etc.) is not applicable to this type of regulatory submission.

The "acceptance criteria" here refer to the demonstration of functional and safety characteristics for the reprocessed device to be deemed substantially equivalent to the original predicate device.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document states "Representative samples of reprocessed harmonic scalpels were tested." However, specific sample sizes for functional, cleaning, sterilization, or packaging validation tests are not provided in this summary.
• Data Provenance: The studies were conducted by SterilMed, Inc. However, the country of origin for the data (e.g., where the testing was physically conducted) is not explicitly stated. The nature of the testing (functional, cleaning, sterilization, packaging) indicates this would be prospective testing conducted specifically for this submission, rather than retrospective clinical data.

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

• Not Applicable. This submission is for a reprocessed medical device, not an AI/algorithm-based diagnostic or clinical decision support system. "Ground truth" in the context of expert consensus, pathology, or outcomes data is not relevant here. The ground truth would be established by objective measurements and validated processes (e.g., microbial load counts for sterilization, force measurements for functional testing, material analysis).

4. Adjudication method for the test set

• Not Applicable. As this is not a diagnostic AI system, expert adjudication for resolving discrepancies in interpretations is not relevant. The studies involve objective measurements and validation of physical, chemical, and functional properties.

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 physical device, not an AI or imaging diagnostic tool. Therefore, MRMC studies and the concept of human readers improving with AI assistance are irrelevant to this submission.

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

• Not Applicable. This is a reprocessed physical device, not an algorithm or software. Standalone algorithm performance is not relevant.

7. The type of ground truth used

• Objective Measurements and Validated Processes: The "ground truth" for the device's performance is established through:
  • Validated functional testing: Objective measurements against predefined specifications for cutting, coagulation, and mechanical integrity, likely benchmarked against predicate device performance.
  • Validated cleaning processes: Demonstrating reduction of contaminants to acceptable levels.
  • Validated sterilization processes: Achieving a specified sterility assurance level (e.g., 10^-6 for terminally sterilized devices).
  • Validated packaging integrity: Ensuring sterile barrier and physical protection.
  • Visual inspection and manufacturing quality controls: Conformance to physical and material standards.

8. The sample size for the training set

• Not Applicable. As this is not an AI/algorithm-based device, there is no "training set." The focus is on verifying the performance of the reprocessed devices against established specifications and predicate device characteristics.

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

• Not Applicable. As there is no training set, this question is not relevant.

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The reprocessed harmonic scalpels are intended for use in soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or a substitute for electrosurgery, lasers, and steel scalpels in abdominal, pediatric, gynecological and other endoscopic procedures.

Harmonic scalpels are part of an ultrasonic system and are intended to be used in soft tissue surgery for simultaneous cutting and hemostasis. The system consists of a generator/foot switch, handle, connecting hose, and a scalpel blade. Only the handle and scalpel blade are reprocessed. The generator/foot switch and hose components of the device are not included as part of this submission.

Harmonic scalpels can be manufactured using aluminum with a nickel chrome alloy edge or a titanium alloy (with or without a coating). These scalpels are available in a variety of lengths, outer circumferences, angles and sharpness.

The provided document is a 510(k) premarket notification for reprocessed ultrasonic scalpels. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on functional and safety testing. However, it does not contain the detailed information typically found in a scientific study report, especially regarding acceptance criteria, specific performance metrics, sample sizes, expert involvement, or any comparative effectiveness studies with human readers.

Therefore, I cannot extract the requested information in full. I can provide what is available, which is very limited for most of your points.

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

• Cannot be fully provided. The document states, "Representative samples of harmonic scalpels underwent bench testing to demonstrate appropriate functional characteristics. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device's packaging. In addition, the manufacturing process includes visual and functional testing of all products produced."
• No specific acceptance criteria or quantitative performance results (e.g., in terms of cutting efficiency, thermal injury, or lifespan) are reported in this summary. The summary only generally states that testing was done to "demonstrate appropriate functional characteristics."

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

• Sample size for test set: Not specified. The document only mentions "Representative samples."
• Data provenance: Not specified, but generally, 510(k) testing for US market approval is conducted in the US or according to internationally recognized standards. The document doesn't specify if it was retrospective or prospective.

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 / Not specified. This type of information is typically relevant for studies involving human interpretation (e.g., imaging studies where experts label data). For a physical medical device like a reprocessed scalpel, "ground truth" would be established through engineering specifications, material science testing, and functional performance benchmarks rather than expert consensus on interpretive data.

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

• Not applicable / Not specified. Adjudication methods are usually for resolving discrepancies in expert interpretations, which is not relevant here. Device testing would follow standardized protocols.

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 scalpel, not an AI diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

• Not applicable. This device is a reprocessed surgical scalpel, not an algorithm.

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

• Not explicitly stated in detail. The "ground truth" for a reprocessed medical device would generally come from:
  • Original device specifications: Performance parameters of the new, original (predicate) devices.
  • Material properties: Chemical and physical analyses of the reprocessed materials.
  • Sterility and cleanliness tests: Microbiological and cleanliness standards.
  • Functional performance standards: Bench testing against established engineering and clinical performance criteria for cutting, coagulation, and overall integrity.
• The document mentions "Functional and Safety Testing" and "Process validation testing," implying these standards were used.

8. The sample size for the training set

• Not applicable for this type of device. "Training set" refers to data used to train machine learning models. This is a physical medical device, not an AI/ML product.

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

• Not applicable for this type of device.

Summary of what is available (with caveats):

Specifics: No quantitative acceptance criteria or detailed performance metrics are provided in this summary. |
| Sample Size (Test Set) & Data Provenance | Sample Size: "Representative samples" (exact number not specified).
Data Provenance: Not specified (e.g., country, retrospective/prospective). |
| Number & Qualifications of Experts | Not applicable; device testing involved engineering/technical assessment, not expert interpretation of data. |
| Adjudication Method | Not applicable for this type of device testing. |
| MRMC Comparative Effectiveness Study | Not applicable; this is a physical surgical device, not an AI diagnostic tool. |
| Standalone Performance (Algorithm Only) | Not applicable; this is a physical surgical device, not an algorithm. |
| Type of Ground Truth Used | Implied to be based on: Original predicate device specifications, material properties, sterility/cleanliness standards, and functional performance benchmarks (e.g., cutting, coagulation efficiency). |
| Sample Size (Training Set) | Not applicable; this is a physical surgical device, not an AI/ML product. |
| How Ground Truth for Training Set Established | Not applicable; this is a physical surgical device, not an AI/ML product. |

In conclusion, the provided FDA 510(k) summary is designed to establish substantial equivalence for a reprocessed device based on general safety and effectiveness. It does not contain the detailed study design, acceptance criteria, and specific performance results that would be found in a comprehensive clinical or engineering study report. For such specifics, one would typically need to review the full 510(k) submission or associated test reports, which are not included here.

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