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The PhotonBlade 3 is a monopolar radiofrequency (RF) device coupled with illumination that is indicated for cutting and coagulation of soft tissue during general, plastic and reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, gynecologic, orthopaedic, arthroscopic, spinal, neurological, and breast procedures (including mastectomy and lumpectomy).

The PhotonBlade 3 Smoke Evacuation device is a monopolar RF device coupled with illumination that is indicated for cutting and coagulation of soft tissue during general, plastic and reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, gynecologic, orthopaedic, arthroscopic, spinal, neurological, and breast procedures (including mastectomy and lumpectomy), and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

The PhotonBlade 3 (Model No: 0730-101-000) and PhotonBlade 3 Smoke Evacuation (Model No: 0730-102-000) devices are sterile, single use, electrosurgical devices have a monopolar electrode at the distal end, which delivers radiofrequency (RF) energy for cutting and coagulation of tissue. The electrode is located at the distal end of a rotatable and extendable shaft. The devices have integrated LED-based illumination. In addition, the PhotonBlade 3 Smoke Evacuation features integrated smoke evacuation tubing for removal of smoke generated by electrosurgery when connected to a smoke evacuation universal connector attaches the device to an IEC 60601 compliant electrosurgical generator.

The provided text is a 510(k) Summary for the Stryker Instruments PhotonBlade 3 and PhotonBlade 3 Smoke Evacuation devices. It discusses the regulatory clearance process and comparison to predicate devices, but does not contain the detailed information required to answer your specific questions regarding acceptance criteria and a study proving the device meets those criteria.

While it mentions "pre-defined acceptance criteria for the above tests were met" in the "Performance Testing" section, it does not explicitly state what those acceptance criteria were for each test, nor does it provide a detailed study design or results from such a study.

Therefore, I cannot extract the information requested. The document primarily focuses on establishing "substantial equivalence" to a predicate device based on similar indications for use and technological characteristics, and by referencing compliance with various standards and general performance testing without providing the specific details of a study that directly proves the device meets predefined acceptance criteria for its performance metrics.

To specifically address your questions, the following would need to be present in the document:

1. A table of acceptance criteria and reported device performance: This would require a table explicitly listing criteria (e.g., "minimum lumen output 50 lumens") and the actual measured performance (e.g., "Device A measured 65 lumens").
2. Sample size and data provenance for the test set: The document vaguely mentions "simulated use life testing," "coag verification test," etc., but no sample sizes or origin of data (e.g., animal, human, in vitro, country).
3. Number and qualifications of experts for ground truth: This type of information is usually relevant for studies involving subjective assessment (e.g., image interpretation). For a device like an electrosurgical unit, ground truth often comes from objective measurements or established physical/biological parameters. The document does not provide this.
4. Adjudication method for the test set: Not applicable based on the type of device and testing described.
5. MRMC comparative effectiveness study: Not conducted or mentioned. This type of study is typically for diagnostic aids involving human interpretation.
6. Standalone performance: The described "performance testing" implies standalone testing of the device's physical and electrical characteristics, but the specific metrics and study details are missing.
7. Type of ground truth used: Ground truth would be based on objective measurements against established engineering, physical, and biological standards (e.g., thermal spread in porcine tissue). The document describes what was tested but not the specific "ground truth" values used for comparison or how they were established.
8. Sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
9. How ground truth for the training set was established: Not applicable.

The closest the document comes to providing performance data related to "acceptance criteria" is under "Performance Testing," which states: "All pre-defined acceptance criteria for the above tests were met. Results from the the subject devices perform as intended and support a determination of substantial equivalence to the predicate." However, it fails to specify what those acceptance criteria were or the actual results that met them.

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The PhotonBlade® with Adaptive Smoke Evacuation is a monopolar RF device coupled with illumination that is indicated for cutting and coagulation of tissue during general surgical procedures and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.

The PhotonBlade® with Adaptive Smoke Evacuation (PB2SE) is a single use, sterile, electrosurgical device with a light and adaptive smoke evacuation attachment. The device has a monopolar electrode at the distal tip, which delivers Radiofrequency (RF) energy for cutting and coagulation of tissue. The electrode tip is located at the distal end of a rotatable and extendable shaft. The adaptive smoke evacuation attachment connects to the telescoping shaft and the cable of the PhotonBlade. It incorporates a barb connector at the end of the tubing to allow connection to a secondary suction hose connected to a smoke evacuation system. The device handle is integrated with controls for cut, coagulation, and illumination (light). A universal cable attaches the device to a 510(k) cleared electrosurgical unit.

The provided text describes a 510(k) submission for the "PhotonBlade® with Adaptive Smoke Evacuation" device. This is a premarket notification for a medical device seeking substantial equivalence to a legally marketed predicate device, rather than a novel AI/software as a medical device (SaMD) cleared through a de novo or PMA pathway.

Therefore, the document does not contain the information typically sought for a study proving device performance against acceptance criteria for an AI/SaMD. Specifically:

• No acceptance criteria table for AI performance: The document focuses on performance testing for an electrosurgical device (e.g., electrical safety, mechanical/functional testing, biocompatibility, smoke evacuation flow rate).
• No mention of AI/algorithm: The device is described as a monopolar RF device with illumination and adaptive smoke evacuation. There is no indication of an AI component.
• No data provenance, expert ground truth, adjudication, MRMC studies: These elements are characteristic of studies evaluating AI performance in interpreting medical images or other data, which is not applicable here.
• No standalone algorithm performance or training set information: Again, these are specific to AI/machine learning models.

Based on the provided text, the device is an electrosurgical tool, and the "study" described is a set of engineering and bench tests, not a clinical study to prove AI performance.

Therefore, it is not possible to describe the acceptance criteria and study as requested, because the provided input does not pertain to an AI/SaMD.

However, I can extract the acceptance criteria and performance data for the electrosurgical device itself as described in the 510(k) summary:

Acceptance Criteria and Device Performance (for the electrosurgical device, not AI/SaMD)

The document frames the "acceptance criteria" and "performance" in terms of confirming the device meets design specifications, safety, and effectiveness compared to predicates, rather than statistical performance metrics for an AI system.

1. Table of Acceptance Criteria and Reported Device Performance (as inferred from the text):

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

• Sample Size: Not explicitly stated in numerical terms for each test. The text mentions "conditioned samples" for mechanical and functional testing, and "the material" for biocompatibility. This suggests standard engineering test samples, not patient cohorts.
• Data Provenance: Not applicable in the context of clinical data for AI/SaMD. The studies are bench/engineering tests conducted by the manufacturer. No country of origin for "data" in the sense of patient data is relevant here. The studies are retrospective in the sense that they are performed on manufactured devices to support the submission.

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

• Not Applicable. This is an electrosurgical device, not an AI system that interprets medical data. Ground truth in this context refers to engineering specifications and performance standards established through generally accepted methods in medical device testing. There are no human "experts" establishing a clinical ground truth for image interpretation or disease diagnosis.

4. Adjudication Method for the Test Set:

• Not Applicable. As there are no human experts classifying or interpreting data for decision-making (as in AI/SaMD evaluations), there is no adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

• No. MRMC studies are specific to evaluating the clinical performance of diagnostic or screening devices, often involving human readers with and without AI assistance. This device is an electrosurgical tool, and such a study is not relevant to its function.

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

• Not Applicable. This device does not have a standalone algorithm for diagnostic or interpretative purposes. "Standalone performance" in this context would refer to the device's electrosurgical and smoke evacuation functions on their own, which are indeed what the performance tests cover (e.g., flow rate, electrical safety).

7. The Type of Ground Truth Used:

• For this device, the "ground truth" is defined by:
  • Engineering Specifications: Defined by the manufacturer's design inputs.
  • International Standards: e.g., IEC 60601 series for electrical safety, ISO 10993 for biocompatibility.
  • Predicate Device Performance: Benchmarking against the previously cleared PhotonBlade® and reference devices for function (e.g., smoke evacuation flow rate).
  • Intended Use/Design Requirements: Verification that the device performs as intended (cutting, coagulation, smoke removal) without affecting electrosurgical function.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/machine learning device; therefore, there is 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 model, there is no ground truth establishment process for it.

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The PhotonBlade is a monopolar RF device coupled with illumination that is indicated for cutting and coagulation of tissue during general surgical procedures.

The PhotonBlade is a single use, sterile, electrosurgical device with a light. The PhotonBlade has an electrode at the distal tip, which delivers RF energy for cutting and coagulation of soft tissue. The electrode tip is located at the distal end of a rotatable and extendable shaft. The device handle is integrated with controls for cut, coagulation, and illumination (light). A universal cable attaches the device to a 510(k) cleared electrosurgical unit.

The provided text describes the PhotonBlade device, an electrosurgical device with illumination, and its comparison to predicate devices for FDA 510(k) clearance. However, it does not contain information about acceptance criteria, a specific study proving the device meets those criteria, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, or MRMC studies for AI devices.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through engineering and bench testing, rather than clinical trials or AI performance evaluations.

Given the information provided in the text, I can only report what is included:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics. Instead, it lists various performance tests conducted to demonstrate compliance with product requirements, safety, efficacy, and substantial equivalence to the predicate devices. These tests generally assess the device's capability to perform its stated functions.

• IEC 60601-1 3rd Edition
• IEC 60601-2-2 |
  | Operational Testing | Conducted on PhotonBlade devices exposed to EO sterilization and simulated transportation to demonstrate compliance with product requirements. (Specific operational metrics are not detailed, but it implies the device functions as intended for cutting and coagulation, and illumination.) |
  | Ex-vivo Thermal Effects on Tissue Comparisons | Conducted to demonstrate safety and efficacy. (Specific results or comparisons are not detailed, but the aim is to show comparable or acceptable thermal effects to predicate devices. The document states: "PhotonBlade and PlasmaBlade both have insulated electrodes that extend and rotate. Both devices utilize blade electrodes where only the edge of the blade is exposed or active. As such, the principles of operation involved in cutting and coagulation of tissue are the same on either device.") |
  | Biocompatibility | Demonstrated compliance with ISO 10993-1. |
  | Packaging Evaluation | Conducted to demonstrate compliance with product requirements. |
  | Sterilization | Sterile-Ethylene Oxide. |
  | Illumination Output | PhotonBlade: 28 lumens (n=29)
  PARE Surgical NOVA ES: 30 lumens (n=1)
  (This is a comparison point, not an acceptance criterion, but it shows the measured output for the illumination feature). |
  | Shelf Life Studies | Product Shelf Life studies for 7 months and 37 months will be conducted. (This indicates ongoing or planned studies, not necessarily completed ones with reported performance for final acceptance in this document.) |
  | Overall Conclusion | The data submitted support the substantial equivalence claim for the proposed indications for use; the PhotonBlade is as safe and effective as the predicate device(s). Invuity Inc. considers the PhotonBlade device to be substantially equivalent to the legally marketed predicate device(s) with respect to the device function, intended use, and patient population. Any differences in technological characteristics between the PhotonBlade device and the predicate device(s) do not raise any new issues of safety and effectiveness. |

Missing Information (Not found in the provided text):

2. Sample size used for the test set and the data provenance:
* Not specified in the provided text. The document refers to "Performance testing was conducted on PhotonBlade devices" but does not detail sample sizes for specific tests or the origin of any data (e.g., country of origin, retrospective/prospective). The illumination output mentioned "n=29" for the PhotonBlade, which refers to the number of devices measured for that specific attribute.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable. This document is for a traditional surgical device, not an AI device requiring expert ground truth for classification/diagnosis.

4. Adjudication method for the test set:
* Not applicable. This document is for a traditional surgical device, not an AI device.

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 is for a traditional surgical device, not an AI device. No MRMC study was conducted or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This document is for a traditional surgical device, not an AI device.

7. The type of ground truth used:
* Not applicable in the context of AI algorithms. The "ground truth" for the device's performance relies on engineering specifications, physical measurements, and comparison to the established performance of predicate devices, as demonstrated through bench testing and ex-vivo studies.

8. The sample size for the training set:
* Not applicable. This document is for a traditional surgical device, not an AI device. No training set is mentioned.

9. How the ground truth for the training set was established:
* Not applicable. This document is for a traditional surgical device, not an AI device. No training set or ground truth establishment method for it is mentioned.

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