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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 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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