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The StimTrial System is indicated for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for the StimRouter Neuromodulation System's permanent (long term) implant indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy used in a multidisciplinary approach and not intended to treat pain in the craniofacial region.

The StimTrial Neuromodulation System is to be used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) implant for a system indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy used in a multidisciplinary approach and not intended to treat pain of craniofacial nerve origin.

The StimTrial Neuromodulation System is intended to help determine patient candidacy for a permanent implant to help manage pain of peripheral nerve origin. The StimTrial System works by sending electrical impulses from an external stimulator to a lead that is percutaneously placed next to a target nerve. These impulses are intended to interrupt or change the pain signals, inducing the feeling of tingling or numbness (paresthesia), and possibly reducing or replacing the feeling of pain.

The StimTrial Neuromodulation System consists of three main parts - the percutaneous StimTrial Lead, the StimTrial Lead Adaptor Cable, and the StimTrial External Stimulator. The StimTrial Lead is percutaneously placed with the distal, stimulating end located at or near the targeted peripheral nerve and with the proximal end remaining outside of the body for the trial duration. The StimTrial Lead Adaptor Cable is an external cable that directly connects the StimTrial Lead to the StimTrial External Stimulator providing a direct electrical pathway from the External Stimulator to the Lead. The StimTrial External Stimulator is a device which, when connected to the Lead Adaptor Cable and the StimRouter Electrode (a hydrogel patch electrode) attached to the skin near the implant site, generates electrical stimulation pulses that travel to the StimTrial Lead. Accessories for the StimTrial System include the StimRouter Electrode (a disposable electrode patch, cleared most recently in K211965), the StimTrial Clinician Programmer with Software (CPS) and the optional StimTrial Mobile Application (MAPP) installed on a Smartphone.

The StimTrial System incorporates both commercially available and specially designed components. The materials used in the StimTrial Lead have a long history of use in implanted devices; the insertion tools are also constructed from materials with a long history of surgical use. Materials in the external accessories are commonly used in both medical and non-medical applications. The powered components of the StimTrial System use commercially available IEC and UL approval rechargeable batteries. There are no components which are plugged into a wall socket during the use of the system by the patient.

This document outlines the acceptance criteria and the study conducted to prove that the StimTrial Neuromodulation System meets these criteria, based on the provided FDA 510(k) Clearance Letter.

Summary of Device Performance Study Information:

The provided document details various performance tests conducted for the StimTrial Neuromodulation System, but it does not include a clinical study with specific acceptance criteria and reported performance metrics in the format typically used for demonstrating efficacy or performance against a clinical endpoint (e.g., accuracy, sensitivity, specificity, or improvement in patient outcomes).

Instead, the listed "Performance Testing" are focused on engineering, safety, and regulatory compliance aspects:

• Labeling Validation
• Software verification and validation (for External Stimulator, MAPP and CPS software devices)
• EMC, Wireless Co-Existence and Electrical Safety
• Usability testing (for Implanting Physician, Treating Clinician and Patient)
• Bench testing (Tests of the StimTrial Lead, External Stimulator, StimTrial System)
• Animal testing (Acute and Long-term studies in porcine animal model)
• Sterilization and Shelf Life (StimTrial Surgical Kit)
• Biocompatibility (for StimTrial Lead, Insertion Tools and External Stimulator)

This type of submission for a Class II device like a neuromodulation system for trial stimulation often relies heavily on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical performance testing. The purpose of this "StimTrial System" is for trial stimulation to determine efficacy before a permanent implant, meaning its primary function in this context is to safely and effectively deliver electrical stimulation within defined parameters to aid in patient selection for a long-term device. It is not an AI/ML powered device, so many of the questions regarding ground truth, expert adjudication, MRMC studies, and training/test set sample sizes are not directly applicable in the typical sense of an AI/ML performance study.

Given the information, a detailed table of "acceptance criteria and reported device performance" related to clinical efficacy or AI/ML performance metrics cannot be constructed from the provided text. The "acceptance criteria" for a 510(k) clearance in this context primarily revolve around demonstrating that the device is as safe and effective as its predicate devices, which is achieved through the enumerated non-clinical tests and technical comparisons.

However, answering the questions as best as possible based on the implied purpose of such a device and the provided text:

Implied Acceptance Criteria and Study to Prove Device Meets Criteria (Based on information provided)

The "StimTrial Neuromodulation System" is a medical device for trial stimulation. Its acceptance criteria are implicitly tied to demonstrating safety and performance characteristics that are substantially equivalent to legally marketed predicate devices, as this is a 510(k) submission. The study proving this typically involves a combination of bench testing, software validation, biocompatibility, and animal studies, rather than large-scale clinical trials for efficacy.

1. Table of Acceptance Criteria and Reported Device Performance:

Since the document focuses on demonstrating substantial equivalence through technical specifications and non-clinical testing rather than clinical performance metrics, a table of "acceptance criteria" for a clinical outcome (e.g., sensitivity, specificity, accuracy) is not present. The acceptance criteria relate to meeting specific engineering, safety, and biocompatibility standards, and these are largely reported as successful completion of the tests mentioned in Section VII.

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

• Test Set Sample Size: The document does not specify a "test set" in the context of a clinical study for performance evaluation (e.g., accuracy of diagnosis). The "tests" performed are largely engineering validations or animal studies.
  • For Animal Testing, "Acute and Long-term studies in porcine animal model" were conducted. The specific number of animals is not stated.
  • For Usability Testing, the number of "Implanting Physician, Treating Clinician and Patient" participants is not specified.
  • For Bench Testing, the number of units or tests performed is not specified, but it implies a sufficient number to validate performance.
• Data Provenance: Not explicitly stated for any clinical data as it's not a clinical performance study. Animal studies are typically conducted in a controlled lab environment.

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

Not applicable in the typical sense of AI/ML ground truth establishment. The "ground truth" for this device's performance would be established by objective measurements in bench testing (e.g., output electrical parameters matching specifications), and pathological/physiological observations in animal models (e.g., tissue response). These are based on established engineering and biological standards, not human expert consensus on interpretations of images or signals.

4. Adjudication Method for the Test Set:

Not applicable. There is no mention of human-interpreted data that would require an adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Improvement with AI vs. Without AI Assistance:

Not applicable. This device is a neuromodulation system, not an AI/ML algorithm for diagnostic or prognostic purposes, and therefore, an MRMC study comparing human readers with and without AI assistance is not relevant.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Not applicable. This device is a physical neuromodulation system with accompanying software for control, not a standalone algorithm for independent task execution (like image analysis). Its function inherently involves human-in-the-loop operation (clinician programming, patient use).

7. The Type of Ground Truth Used:

The "ground truth" for the various performance tests would be:

• Bench Testing: Engineering specifications and physical measurements (e.g., electrical parameter values, mechanical properties).
• Biocompatibility: ISO standards for medical device materials.
• Sterilization: Sterility assurance levels (SAL) based on validated methods.
• Animal Testing: Histopathological analysis of tissues, physiological responses, and adverse event monitoring.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve a machine learning component that requires a "training set" in the conventional sense.

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

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

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The TalisMann Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The TalisMann Neuromodulation System is not intended to treat pain in the craniofacial region.

The TalisMann Neuromodulation System is intended to provide electrical stimulation via an implanted lead to a target peripheral nerve, for aid in the pain management of adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The TalisMann Neuromodulation System is not intended to treat pain in the craniofacial region.

The TalisMann Neuromodulation System works by providing electrical impulses to a target area in the body. These impulses may interrupt or change the pain signals, inducing the feeling of tingling or numbness (paresthesia), and possibly reducing or replacing the feeling of pain.

The TalisMann Neuromodulation System consists of three main parts – the implantable StimRouter Lead (cleared most recently in K211965), the implantable TalisMann Pulse Generator/Receiver that is connected to the implantable Lead, and the external (to the body) components. The Lead is implanted with the stimulation end located at or near the targeted peripheral nerve, whereas the end with the Pulse Generator/Receiver is located near the skin surface. Accessories for the TalisMann include the Clinician Programmer with Software (CPS), the optional Mobile Application (MAPP) installed on a SmartPhone, the StimRouter Electrode (a disposable electrode patch, cleared most recently in K221965), and the TalisMann External Electrical Field Conductor (E-EFC).

The TalisMann System incorporates both commercially available and specially designed components. The materials used in the TalisMann Pulse Generator/Receiver and Lead have a long history of use in implanted devices; the insertion tools are also constructed from materials with a long history of surgical use. Materials in the external accessories are commonly used in both medical and non-medical applications. The powered components of the TalisMann System use commercially available IEC and UL approval rechargeable batteries. There are no components which are plugged into a wall socket during the use of the system by the patient.

The TalisMann uses the following components unchanged from the StimRouter System (K211965): the StimRouter Lead, the MAPP software, the E-EFC, and the StimRouter (Hydrogel Patch) Electrodes. The new components of the TalisMann System are: the TalisMann Pulse Generator/Receiver, new implant tools, and the updated Clinician Programmer Software (updated to enable TalisMann parameters).

The provided FDA 510(k) clearance letter and summary for the TalisMann Neuromodulation System does not contain the detailed acceptance criteria or a study proving that the device meets specific performance criteria in terms of accuracy, precision, or clinical efficacy.

The document primarily focuses on establishing substantial equivalence to predicate devices by comparing technological characteristics and listing the types of performance testing conducted for safety and effectiveness. It does not provide quantitative acceptance criteria for device performance nor the results of studies that would demonstrate the device meets such criteria.

The information provided confirms that the device underwent various forms of testing to demonstrate safety and general performance characteristics relative to its predicates, but not specific performance metrics such as accuracy or efficacy in pain relief that would typically have acceptance criteria.

Therefore, many of the requested fields cannot be filled based on the provided text.

Here's an analysis of what information is available and what is missing:

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

• Not provided. The document does not specify quantitative acceptance criteria for device performance (e.g., a specific percentage reduction in pain, or a certain accuracy for a diagnostic component). It focuses on direct comparisons of design and general safety/electrical parameters to predicate devices.

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

• Not provided for human clinical studies demonstrating efficacy.
• Animal Testing: Mentioned as "Acute and Long-term studies in porcine animal model" but sample size is not specified.
• Provenance: Not specified for any potential clinical data, as no clinical efficacy data is detailed.

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 document discusses performance testing for safety, electrical characteristics, software validation, and usability. It does not describe a test set requiring expert-established ground truth for a diagnostic or efficacy claim. Usability testing involved "Implanting Physician, Treating Clinician and Patient" but specific numbers or qualifications are not given.

4. Adjudication method for the test set

• Not applicable/Not provided. No adjudication method is mentioned as there isn't a stated clinical efficacy or diagnostic performance study requiring ground truth establishment through expert review.

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

• No. This device is a neuromodulation system for pain relief, not an AI-assisted diagnostic or imaging interpretation tool. Therefore, an MRMC study is not relevant and was not conducted.

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

• Not applicable. This device is an implanted neuromodulation system used by a patient, with programming by a clinician. It's not an algorithm that performs a standalone function without human interaction in its therapeutic application. Software verification and validation were performed for the E-EFC, MAPP, and CPS, which are components of the system, but this is a different type of "standalone" than algorithm performance.

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

• Not explicitly stated for efficacy/clinical performance. For safety and engineering tests, the "ground truth" would be established engineering standards, biocompatibility testing results, and functional requirements. For software, it would be validation against specified requirements. No specific clinical outcomes data or pathology as a "ground truth" for device efficacy is mentioned in the context of performance criteria.

8. The sample size for the training set

• Not applicable/Not provided. The device is not described as involving machine learning or AI models that would require a "training set" in the traditional sense for an algorithmic performance claim.

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

• Not applicable/Not provided. (See point 8).

Summary of what is present:

The document outlines a substantial equivalence argument based on:

• Comparison of Indications for Use: Similar to predicates for severe intractable chronic peripheral nerve pain, excluding craniofacial region.
• Comparison of Technological Characteristics: Detailed tables comparing the subject device (TalisMann Neuromodulation System) to three predicate devices (StimRouter, Nalu, Renew) across components like transmitter/receiver, leads, externally worn devices, clinician programmer, and patient remote control. These comparisons highlight similarities in mode of action, implant site, power sources, stimulation parameters (frequency, duration, charge, power), materials, and software configuration.
• Performance Testing Categories: A list of testing performed to support safety and effectiveness, including:
  • Labeling Validation
  • Software verification and validation (for E-EFC, MAPP, and CPS)
  • EMC, Wireless Co-Existence, and Electrical Safety
  • Usability testing (for Implanting Physician, Treating Clinician, and Patient)
  • Bench testing (TalisMann implant, external modules, system testing)
  • Animal testing (Acute and Long-term studies in porcine model)
  • Sterilization and Shelf Life
  • Biocompatibility

Conclusion based on the provided text:

The FDA 510(k) clearance letter focuses on establishing substantial equivalence for the TalisMann Neuromodulation System by demonstrating that its technological characteristics, intended use, and performance testing (with a focus on safety and established engineering principles) are comparable to legally marketed predicate devices. It does not present a study with specific, quantitative acceptance criteria for clinical performance or efficacy metrics against which the device's performance is measured and reported. The "performance testing" described is primarily geared towards validating individual components and system safety/functionality rather than an overarching clinical effectiveness study with defined endpoints and acceptance criteria in the context often seen for diagnostic or AI-driven devices.

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The Allograft Delivery Device is intended to be used for the delivery of hydrated allograft to an orthopedic surgical site.

The Allograft Delivery Device is a sterile, single-use, disposable allograft delivery device intended for the delivery of hydrated allograft bone graft material to an orthopedic surgical site. The delivery device consists of a cannula used for containing and delivering the allograft material to the surgical site and a push rod required for expressing the allograft material from the cannula.

The cannula component is an open bore tube with a male double-threaded lock interface that mates with a pre-existing allograft syringe. The cannula component may be used to dispense allograft to a patient orthopedic surgical site. When used as an ancillary device to orthopedic surgical procedures that require the placement of allograft Delivery Device can deliver a prepared amount of allograft material.

The provided document is a 510(k) summary for the Allograft Delivery Device (OFAC-C), which is a medical device and not an AI/ML-driven software. Therefore, the document does not contain information typically associated with AI/ML device testing and acceptance criteria, such as diagnostic performance metrics (e.g., sensitivity, specificity, AUC), clinical study designs (e.g., MRMC studies), ground truth establishment by experts, or training/test set details for AI algorithms.

The acceptance criteria and supporting studies presented in this document are focused on the physical and biological performance of a medical device (a delivery syringe), not an AI algorithm. The performance data provided relates to:

• Sterilization and Shelf-life: Validation that the device remains sterile and functional over time.
• Biocompatibility Testing: Confirmation that the device materials are safe for human contact.
• Functional Verification: Mechanical tests to ensure the device operates as intended (e.g., cannula buckling, plunger force, connection strength, no fluid separation, durability, push rod function).
• Shipping/Transit: Testing to ensure the device withstands transport conditions.
• Usability Testing: Evaluation of how easily and effectively users can safely operate the device.

Since the request asks for details specific to AI/ML device evaluation, and this document pertains to a physical medical device, I cannot extract the requested information. The document does not describe:

1. A table of acceptance criteria for AI performance or reported device AI performance.
2. Sample sizes for AI test sets or data provenance for AI.
3. Number/qualifications of experts for AI ground truth.
4. Adjudication method for AI ground truth.
5. MRMC studies or effect sizes of human reader improvement with AI.
6. Standalone AI algorithm performance.
7. Type of ground truth for AI (e.g., pathology, outcomes data).
8. Sample size for AI training set.
9. How AI training set ground truth was established.

Therefore, I must state that the provided text does not contain the information required to answer your query regarding AI/ML device acceptance criteria and study details.

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SIGNAFUSE Bioactive Strip (SBS) is a bone graft substitute intended for use in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or result from traumatic injury to the bone. SIGNAFUSE Bioactive Strip (SBS) is indicated to be combined with autologous bone marrow aspirate and packed into osseous defects of the extremities, pelvis, posterolateral spine, and intervertebral disc space. When used in the posterolateral spine, SIGNAFUSE Bioactive Strip (SBS) is to be used as an autograft extender. When used in intervertebral disc space. SIGNAFUSE Bioactive Strip (SBS) is to be used as an autograft extender with an intervertebral body fusion device cleared by FDA for use with a bone void filler. The device resorbs and is replaced by host bone during the healing process.

SIGNAFUSE Putty is a bone void filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. SIGNAFUSE Putty is indicated to be packed gently into bony voids or gaps of the skeletal system (i.e., extremities, pelvis, posterolateral spine, and intervertebral disc space fusion procedures). SIGNAFUSE Putty can also be used with autograft as a bone graft extender in the posterolateral spine. When used in intervertebral body fusion procedures, SIGNAFUSE Putty can used on its own or as a bone graff extender, and with an intervertebral body fusion device cleared by FDA for use with a bone void filler. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process.

SIGNAFUSE Bioactive Strip (SBS) is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in a porous type I collagen matrix, and it identical to the device cleared in K193513. SIGNAFUSE Putty is a bioactive bone graft substitute comprising biphasic mineral granules and 45S5 bioactive glass suspended in an alkylene oxide polymer (AOP) resorbable carrier and is identical to the device cleared in K132071. The SIGNAFUSE Family of devices are single use implants in contact with bone that are sterilized by irradiation with a sterility assurance level (SAL) of 106. This submission expands the SIGNAFUSE Family indication to include use in the intervertebral space.

The provided text is a 510(k) summary for medical devices (SIGNAFUSE Bioactive Strip (SBS) and SIGNAFUSE Putty), focusing on their substantial equivalence to predicate devices and an expanded indication for use in the intervertebral disc space.

Based on the information provided, it states that:

• No new acceptance criteria or clinical studies (beyond leveraging previous clearances and providing clinical rationale) were conducted for this specific 510(k) submission regarding device performance metrics in the way one might expect for a novel AI device or a new clinical endpoint.
• The performance assessment for this submission relies heavily on previous clearances (K193513 and K132071), which established the device's sterility, shelf-life, endotoxin, biocompatibility, and characterizations/bench performance.
• The expanded indication for use in the intervertebral body space was supported by a "clinical rationale of bone grafting materials in the intervertebral space," rather than a new clinical study with defined acceptance criteria and performance data for this specific submission.

Therefore, the requested information regarding detailed acceptance criteria, a specific study proving the device meets these criteria, sample size, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment for this specific submission is not present in the provided document.

The document is a regulatory submission demonstrating substantial equivalence, not a detailed report of a new clinical performance study for an AI/software as a medical device (SaMD) or a new physical device requiring novel clinical endpoint demonstration. The 'performance' section refers to leveraging previously established data and providing a clinical rationale, not new trials to meet defined (and quantified) acceptance criteria for efficacy or diagnostic performance.

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The Misonix Inc. neXus® Ultrasonic System is intended for the fragmentation, emulsification and aspiration of both soft and hard (i.e., bone) tissue.

The indications for use for the Standard Handpiece in combination with BoneScalpel® and SonicOne® OR probe kit accessory configurations, the SonaStar® Long and Short handpieces in combination with SonaStar® probe kit accessory configurations, the BoneScalpel Access® handpiece with BoneScalpel Access® probe kit accessory configurations, and the SonaStar Elite Handpiece with probe kit accessory configurations are listed below.

Standard Handpiece with BoneScalpel Probe Kit
Indicated for use in the fragmentation, emulsification of soft and hard (e.g., bone) tissue in the following surgical specialties:

• · Neurosurgery
• · Gastrointestinal and Affiliated Organ Surgery
• · Urological Surgery
• · Plastic and Reconstructive Surgery
• · General Surgery
• · Orthopedic Surgery
• · Gynecology
  External genitalia - condyloma - benign tumors (lipomas, fibromas, and leiomyomas) - malignant primary and metastatic tumors of all types and the following cystic lesions: Bartholin's cysts, Vestibular adenitis, Inclusion cysts, Sebaceous cysts
  Abdominal area - any abnormal growth, cystic or solid, benign or malignant, involving the ovary, fallopian tube, uterus, or the supporting structures of the uterus except as contraindicated for uterine fibroids.
• · Thoracic Surgery
  Limited pulmonary resection such as segmentectomical subsegmentectomies and metastatectomies. · Wound Care
  The neXus Ultrasonic Surgical Aspirator is also indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement.

Standard Handpiece with SonicOne Probe Kits
Indicated for use in the fragmentation and aspiration of soft and hard tissue (i.e. bone) in the following surgical specialty:
· Wound Care
The neXus Ultrasonic Surgical Aspirator is also indicated for use in the debridement of wounds, such as, but not limited to, burn wounds, diabetic ulcers, bedsores and vaginal ulcers, soft tissue debridement and cleansing of the surgical site in applications in which, in the physician's judgment would require the use of an ultrasonic aspirator with sharp debridement. · Plastic and Reconstructive Surgery

neXus SonaStar Handpieces with SonaStar Probe Kits
Indicated for use in the fragmentation and aspiration of both soft and hard (i.e., bone) tissue in the following surgical specialties:
· Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy
· Urological Surgery - including removal of renal parenchyma during nephrectomy or partial nephrectomy

• · Plastic and Reconstructive Surgery
  · General Surgery - including removal of benign or malignant tumors or other unwanted tissue in open or minimally invasive general surgical procedures
• · Orthopedic Surgery
• · Gynecological Surgery except as contraindicated for uterine fibroids.
• · Thoracic Surgery
  · Laparoscopic Surgery – including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy
  · Thoracoscopic Surgery
  The SonaStar Handpieces may also be combined with electrosurgery using optional RF surgery interface components.

Bone Scalpel Access Handpiece with BoneScalpel Access Probe Kits
Indicated for use in the fragmentation of soft and hard (e.g., bone) tissue in the following surgical specialties:

• · Neurosurgery
• · Gastrointestinal and Affiliated Organ Surgery
• · Urological Surgery
• · Plastic and Reconstructive Surgery
• · General Surgery
• Orthopedic Surgery
• · Gynecology
  External genitalia - condyloma - benign tumors (lipomas, and leiomyomas) - malignant primary and metastatic tumors of all types and the following cystic lesions: Bartholin's cysts, Vestibular adentis, Inclusion cysts, Sebaceous cysts Abdominal area - any abnormal growth, cystic or solid, benign or malignant, involving the ovary, fallopian tube, uterus, or the supporting structures of the uterus except as contraindicated for uterine fibroids.
  · Thoracic Surgery
  Limited pulmonary resection such as segmentectomical subsegmentectomies and metastatectomies.

SonaStar Elite Handpiece with SonaStar Elite Probe Kits
Indicated for use in the fragmentation of soft and hard (e.g., bone) tissue in the following surgical specialties:

• · Neurosurgery
  · Gastrointestinal and Affiliated Organ Surgery - including removal of benign or malignant tumors or other unwanted tissue, including hepatic parenchyma, in open or laparoscopic procedures, hepatic resection, tumor resection, lobectomy or trisegmentectomy, or removal of tissue during liver allotransplantation and donor hepatectomy
• · Urological Surgery including removal of renal parenchyma during nephrectomy or partial nephrectomy
• · Plastic and Reconstructive Surgery
  · General Surgery - including removal of benign or malignant tumors or other unwanted tissue in open or minimally invasive general surgical procedures
• Orthopedic Surgery
• · Gynecological Surgery except as contraindicated for uterine fibroids.
• · Thoracic Surgery
  · Laparoscopic Surgery – including removal of hepatic parenchyma in laparoscopic hepatic resection, lobectomy or trisegmentectomy, in laparoscopic donor hepatectomy or laparoscopic cholecystectomy or laparoscopic pancreatic jejunostomy, or pancreatectomy, or laparoscopic appendectomy, laparoscopic colon resection or laparoscopic partial gastrectomy
  · Thoracoscopic Surgery
  The system may also be combined with electrosurgery using optional RF surgery interface components.

The neXus Ultrasonic Surgical Aspirator System is intended for fragmentation, emulsification and aspiration of both soft and hard (i.e.bone) tissue. The system includes a generator housed inside the console. A reusable handpiece is plugged directly into the front panel of the console.

The generator and handpiece are compatible with various single use disposable "probes" which are selected and attached to the handpiece by the end user. An irrigation system provides sterile irrigant to the operative site. An aspiration system removes the fragmented, emulsified material and waste liquids from the operative site.

Accessories include a wireless footswitch, various probe tip combinations, sterilization trays, probe covers, assembly & disassembly wrenches, irrigation tubing sets, disposable electrocautery cable, and waste collection canisters.

Here's an analysis of the provided text to fulfill your request regarding acceptance criteria and device performance.

Important Note: The provided document is an FDA 510(k) K231117 clearance letter for the "neXus Ultrasonic Surgical Aspirator System." This type of document is a summary of the FDA's decision and the manufacturer's provided information. It does not present a detailed study report that would typically include all the specific parameters requested (like sample size for test/training sets, experts, adjudication methods, MRMC studies, effect sizes, etc.).

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K221235). The "performance data" section primarily refers to verification and validation activities rather than a comparative clinical trial or large-scale evaluation of a new AI algorithm.

Therefore, for many of your requested points, the answer will be "Not Applicable" or "Information Not Provided in this Document," as this submission is for a modified traditional medical device, not an AI/ML-driven diagnostic or treatment planning system that would typically undergo the stringent evaluation methods you've outlined.

Acceptance Criteria and Reported Device Performance

The core of this submission is to demonstrate that the modified neXus Ultrasonic Surgical Aspirator System is substantially equivalent to its predicate device (K221235). The "acceptance criteria" here are implicitly tied to maintaining the safety and effectiveness profile of the predicate device, particularly regarding the added "Pulsed Wave, NEW" feature for the vibration system and "DTC (DYNAMIC TISSUE RESPONSE)" capability.

1. Table of Acceptance Criteria and Reported Device Performance:

Given the nature of this 510(k) summary, the acceptance criteria are not presented in a quantitative table with specific targets as one might see for an AI/diagnostic device. Instead, they are framed as demonstrating continued functionality, safety, and equivalence to the predicate. The "reported device performance" is largely qualitative, indicating that the new features function as intended and that the overall system still meets the established performance of the predicate.

Key Difference/New Feature: Vibration System: "Pulsed Wave, NEW" (p. 10).
New GUI Setting: "DTC (DYNAMIC TISSUE RESPONSE): Off" (default) and adjustable range 1-6 (p. 16). |
| Biocompatibility | No new patient-contacting materials; existing biocompatibility data remains valid. | "Not applicable. There have been no modifications related to patient contacting materials, therefore the biocompatibility testing submitted under K221235 remains valid." (p. 17) |
| Electrical Safety & EMC | Continued compliance with relevant safety and EMC standards; minor software update does not impact electrical safety or EMC. | "No re-testing required. The change to the neXus console is considered a minor software update only. The safety and performance of the device has been validated and verified through software testing in accordance with IEC62304. There have been no device modifications related to the construction of the console or handpiece, therefore the electrical safety and EMC testing submitted under K221235 remains valid." (p. 18) |
| Software V&V | Software performs as intended, new features function correctly, regression testing confirms no adverse impact elsewhere. Software classification remains "major level of concern." | "Software verification and validation testing was conducted and a summary of testing provided."

Specific verification tests conducted: "DTC DSP pulse mode verification," "DTC GUI verification," "Fault detection and response test using the SonaStar Elite handpiece," "neXus test and calibration (Regression testing)," "System performance verification (Regression testing)," "SonaStar Elite GUI verification (Regression testing)." (p. 18) |
| Bench Testing | New features function as intended and device maintains performance characteristics (e.g., tissue removal) of the predicate. | "Tissue removal test using the SonaStar Elite handpiece," "DTC mode vibration test using the SonaStar Elite handpiece." (p. 18) |

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

• Sample Size: Not explicitly stated in terms of number of "cases" or "samples" as might be seen for a diagnostic AI. For a surgical aspirator, "test set" typically refers to the physical devices and materials (e.g., tissue phantoms, actual tissue samples for bench testing) used for verification and validation. The document does not specify the quantity of these for bench testing.
• Data Provenance: Not applicable in the conventional sense of patient data. The "data" here comes from internal engineering and quality testing (software V&V, electrical safety, biological compatibility assessments, and bench performance testing). These are typically conducted in a controlled lab environment by the manufacturer. No country of origin for a patient dataset. The tests are prospective as they are conducted specifically for this submission.

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

• Number of Experts/Qualifications: Not applicable for this type of device submission. Ground truth for a surgical tool's performance is established through engineering specifications, physical measurements, and performance against defined test methods (e.g., how effectively it removes tissue from a phantom, its vibration amplitude). Clinical "experts" (like radiologists) are not used to establish this type of ground truth.

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

• Adjudication Method: Not applicable. This concept applies to human consensus on complex subjective data (e.g., image interpretation). For an ultrasonic surgical aspirator, performance testing involves objective measurements (e.g., output power, vibration frequency, tissue removal efficiency, software function).

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

• MRMC Study: No. This is not an AI-driven diagnostic or image-interpretation device, so MRMC studies are not relevant. This device is a surgical tool.
• Effect Size of Human Improvement with AI: Not applicable for this device.

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

• Standalone Performance: Not applicable as this is not an AI algorithm but a physical medical device. The "software" component is for controlling the device's functions (e.g., vibration, irrigation, aspiration). The software's performance is verified through testing its functionalities and its impact on the device's physical outputs, but not as a "standalone" interpretation tool.

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

• Type of Ground Truth: For this device, ground truth is established through:
  • Engineering specifications and design requirements: The device's components and software features are designed to meet specific physical and functional performance parameters.
  • Validated test methods: Performance is measured against established procedures using instruments and materials (e.g., tissue phantoms) to quantify characteristics like vibration, flow rates, and tissue ablation effectiveness.
  • Comparison to predicate device: The predicate device itself acts as a "ground truth" for acceptable performance for the intended use.
  • Compliance with recognized standards: Adherence to standards like IEC62304 for software and electrical safety standards.

8. The sample size for the training set:

• Sample Size: Not applicable. This is not an AI/ML device that requires a "training set" of data for model development. The software is deterministic control software, subject to traditional software development and verification processes.

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

• Ground Truth Establishment: Not applicable, as there is no training set in the context of AI/ML.

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SIGNAFUSE Bioactive Bone Graft is a bone graft substitute intended for use in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or result from traumatic injury to the bone. SIGNAFUSE Bioactive Bone Graft is indicated to be combined with autologous bone marrow aspirate and packed into osseous defects of the extremities, pelvis and posterolateral spine. When used in the posterolateral spine, SIGNAFUSE Bioactive Bone Graft is to be used as an autograft extender. The device resorbs and is replaced by host bone during the healing process.

SIGNAFUSE Bioactive Bone Graft is a bioactive bone graft substitute comprising biphasic mineral granules and 4555 bioactive glass suspended in a porous type I collagen matrix. The device is provided sterile and is to be combined with autologous bone marrow aspirate prior to use to facilitate packing into bony defects. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.

The provided text describes the regulatory clearance of a medical device, SIGNAFUSE Bioactive Bone Graft, and not a software-driven AI/ML medical device. Therefore, the information required to answer the specific questions about acceptance criteria, study design for AI/ML performance (e.g., sample size for test/training sets, expert adjudication, MRMC studies, standalone performance, ground truth establishment) is not present in the provided document.

The document focuses on the substantial equivalence of the SIGNAFUSE Bioactive Bone Graft to existing predicate devices based on its intended use, materials, and performance in a rabbit model.

However, I can extract the information that is relevant to the device's performance assessment as described in the document, which pertains to its biological and physical characteristics rather than an AI/ML algorithm.

Here's what can be inferred about the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this specific bone graft device:

Acceptance Criteria and Device Performance (for SIGNAFUSE Bioactive Bone Graft - a physical device)

The acceptance criteria for this physical device are primarily related to its biocompatibility, sterility, shelf-life, and in vivo performance (osteoconductivity and resorption) comparable to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Sample Size: Not explicitly stated for the rabbit model. The document mentions "a posterolateral spine fusion rabbit model" and "testing performed in K160446," implying a set of rabbits were used, but no specific count is provided.
• Data Provenance: The study was an in vivo animal study based on a "posterolateral spine fusion rabbit model," indicating animal data. The location/country of the study is not specified in the provided text. It was a comparative study ("in comparison to the MCP Bone Putty predicate device, as well as a control group").

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

• Not applicable / Information not provided. This device is a physical bone graft, not an AI/ML algorithm requiring human expert review for ground truth establishment. The ground truth for its performance is based on in vivo animal histology, imaging, or physical outcomes (e.g., fusion success), evaluated by researchers/veterinarians, not by human radiologists/experts determining image-based diagnoses for an AI.

4. Adjudication Method for the Test Set:

• Not applicable / Information not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies for diagnostic accuracy, especially with human readers or AI outputs, where there might be disagreement in interpretations. This is not relevant for the in vivo animal study described for a physical bone graft.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:

• No. An MRMC study is designed to assess the diagnostic performance of human readers, often with and without AI assistance, across multiple cases. This is irrelevant for evaluating a physical medical device like a bone graft.

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

• No. This refers to AI algorithm performance. SIGNAFUSE Bioactive Bone Graft is a physical device, so this question is not applicable.

7. The Type of Ground Truth Used:

• Animal study outcomes: The performance was evaluated using an "established posterolateral spine fusion rabbit defect model (Boden, ASTM F2307-17)." This implies that the ground truth for in vivo performance was based on biological outcomes observed in the rabbits, likely through histological analysis, radiography, or other methods specific to bone fusion assessment in animal models. It is a biological/physiological ground truth.

8. The Sample Size for the Training Set:

• Not applicable. This device is not an AI/ML algorithm, therefore, there is no "training set" in the context of machine learning.

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

• Not applicable. As above, there is no "training set" for an AI/ML algorithm.

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MCS Bone Graft is a bone graft substitute intended for use in bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or result from traumatic injury to the bone. MCS Bone Graft is indicated to be hydrated with autologous bone marrow aspirate and packed into osseous defects of the extremities, pelvis and posterolateral spine. When used in the posterolateral spine, MCS Bone Graft is to be used as an autograft extender. Following implantation, the graft resorbs and is replaced by host bone during the healing process.

MCS Bone Graft is a bone graft substitute comprising biphasic mineral granules suspended in a porous, bovine type I collagen matrix. The biphasic granules are 60% hydroxyapatite (HA) and 40% beta tri-calcium phosphate (betaTCP). The device is provided in a strip form and is supplied terminally sterile for single patent use. The device is designed to be combined with autologous bone marrow aspirate prior to facilitate packing into bony defects and is used with autologous bone in the posterolateral spine. The device provides an osteoconductive scaffold that resorbs and guides host bone regeneration during the healing process.

The provided document is a 510(k) summary for the MCS Bone Graft device. It describes the device, its intended use, and provides a summary of performance testing and substantial equivalence. However, it does not contain specific acceptance criteria, a detailed study description with sample sizes, or information on human reader studies (MRMC or standalone), which are typically associated with artificial intelligence/machine learning devices. The MCS Bone Graft is a medical device, specifically a bone graft substitute, and its evaluation focuses on biocompatibility, material properties, and in-vivo animal studies, not AI performance.

Therefore, the requested information cannot be fully extracted from the provided text in the context of an AI/ML device. I will answer based on the information that is present about the MCS Bone Graft as a physical medical device.

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

The document does not specify quantitative acceptance criteria in a table format, nor does it present device performance in terms of metrics like sensitivity, specificity, or accuracy that are typical for AI/ML devices. Instead, it refers to compliance with standards and successful outcomes in animal studies.

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 mentions a "critical-size rabbit femoral defect study" and a "rabbit posterolateral spine fusion study." It does not specify the exact number of animals used in these studies.
• Data Provenance: The studies are animal studies (rabbits), specifically in vivo performance testing. There is no information on the country of origin of the data or whether it was retrospective or prospective, though animal studies are typically prospective by nature.

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 this device submission. The MCS Bone Graft is a physical medical device, not an AI/ML diagnostic tool. Ground truth was established through scientific methods such as radiographic, microCT, biomechanical, and histological endpoints in animal models, not by human expert assessment of AI output.

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

This information is not applicable. The device is a bone graft substitute, and its performance evaluation does not involve human adjudication of diagnostic outputs.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic devices where human readers interpret medical images with or without AI assistance. The MCS Bone Graft is a therapeutic bone graft substitute.

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

No, a standalone performance study (algorithm only) was not done. This is not relevant for a physical bone graft device.

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

For the animal in vivo performance testing, the ground truth was established using:

• Radiographic endpoints
• MicroCT (micro-computed tomography) endpoints
• Biomechanical endpoints
• Histological endpoints (examination of tissue microstructure)

8. The sample size for the training set

This information is not applicable. The MCS Bone Graft is a physical medical device, not an AI/ML algorithm that requires a training set.

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

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

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