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The XPS® 3000 System is intended for the incision and removal of soft and hard tissue or bone in various surgical procedures, general otorhinolaryngology, head and neck and otoneurological surgery.

The XPS 3000 is intended for the incision and removal of soft and hard tissue or bone in general otorhinolaryngology, head and neck, and otoneurological surgerv.

Otology / neurotology indications include aural atresia, cholesteatoma, cochleostomy, development of a suture tunnel for cochlear implant fixation, drainage of petrous apex cyst from endaural and middle-fossa approach, endolymphatic hydrops, extosis lesion removal, facial nerve decompression, mastoidectomy, mastoidotomy, ossicular chain reconstruction (OCR), otosclerosis, removal of ear tumors including acoustic neuroma, tympanoplasty, and vestibular neurectomy.

Sinus indications include septoplasty, removal of septal spurs, polypectomy, antrostomy, ethmoidectomy/sphenoethmoidectomy, frontal sinus trephination and irrigation, frontal sinus drill out, endoscopic DCR, trans-sphenoidal procedures, maxillary sinus polypectomy, circumferential maxillary antrostomy, choanal atresia, sphenoidotomy, and medial, lateral, and posterior frontal sinusotomy.

Nasopharvngeal / laryngeal indications include adenoidectomy, tracheal procedures, laryngeal polypectomy, laryngeal lesion debulking, surgical management of Recurrent Respiratory Papillomatosis (RRP), tonsillectomy, tonsillotomy and removal of endobronchial lesions.

Head and neck (ENT) indications include soft tissue shaving, rhinoplasty (narrowing of the bony vault and revision of the bonv pvramid). removal and shaping of bone during rhinoplasty procedures, removal of adipose tissue (lipo debridement) in the maxillary and mandibular regions of the face, removal of acoustic neuroma, and incision and removal of soft tissue during plastic, reconstructive, and/or aesthetic surgery.

Neurosurgical procedures where removal and aspiration of soft and hard tissue is desired.

The XPS 3000 system using the PowerSculpt handpiece and reciprocating cutting blades / rasps is indicated to cut hard and soft tissue or bone in otorhinolaryngology and head and neck surgery. An integral pump is provided for irrigation, and a second integral pump may be provided for handpiece cooling.

The XPS 3000 system with reciprocating adapter and suction cannula is intended for the removal of soft tissue and fluid during general surgical procedures including suction lipoplasty for aesthetic body contouring.

The XPS 3000 system is indicated for use in orthopedic surgical procedures where the cutting and removal of soft and hard tissue or bone is required. These include spinal and small and large joint arthroscopic procedures.

The XPS® 3000 System consists of power control console, footswitches, connection cables, and assorted handpieces to drive various burs, blades, drills, rasps and cannulae.

This submission expands the device's indications for use in brain tumor removal from the current acoustic neuroma, tympanoplasty and vestibular neurectomy to include such tumors as meningiomas, craniopharyngiomas, pilocytic astrocytomas, some oligodendrogliomas and gangliogliomas, colloid cysts, choroid plexus papillomas, hemangioblastomas and some pineal region tumors such as teratomas, pinealocytomas.

The provided text describes a 510(k) submission for the Medtronic Xomed XPS® 3000 System, which is an electrical surgical shaver and microresector. This submission primarily focuses on expanding the device's indications for use, particularly in brain tumor removal and other surgical procedures.

However, the document is a regulatory submission for a surgical device with expanded indications, not a study describing acceptance criteria and device performance based on a rigorous statistical analysis for an AI or diagnostic tool.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance in the format you've requested (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) because this type of information is not present in the provided 510(k) summary.

The 510(k) process for this type of surgical tool typically relies on demonstrating substantial equivalence to legally marketed predicate devices, rather than conducting new clinical trials with detailed performance metrics like sensitivity, specificity, or reader improvement, which are common for diagnostic or AI-driven devices.

Here's a breakdown of why the requested information cannot be found:

1. Acceptance Criteria and Reported Device Performance (Table): Not applicable in this context. The document describes the intended use and indications for use of a surgical device but does not present specific quantitative performance metrics (e.g., accuracy, precision) that would be evaluated against acceptance criteria in a study. The "performance" for a surgical shaver relates to its physical characteristics, safety, and ability to cut tissue, which are likely demonstrated through preclinical testing (e.g., bench testing for cutting efficiency, material biocompatibility) and comparison to existing predicate devices, not typically in a clinical study with reported numerical outcomes.

2. Sample Size and Data Provenance (Test Set): Not mentioned. There is no reporting of a "test set" in the context of evaluating a diagnostic or AI device's performance.

3. Number and Qualifications of Experts for Ground Truth: Not applicable. Ground truth, in the context of diagnostic or AI studies, involves experts labeling data. For a surgical device, "ground truth" would relate to its physical properties and surgical efficacy, which are established through engineering design, material science, and established surgical practices.

4. Adjudication Method: Not applicable. There's no diagnostic output to adjudicate.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned. This type of study assesses the impact of a diagnostic tool on human reader performance, which is not relevant for a surgical shaver.

6. Standalone Performance: Not applicable. The device is a surgical tool used by a human surgeon, not an algorithm performing a task independently.

7. Type of Ground Truth Used: Not applicable in the same sense as for diagnostic AI. The "truth" for this device is its safe and effective function in surgery, benchmarked against existing devices.

8. Sample Size for Training Set: Not applicable. This device is not an AI algorithm that undergoes a training phase with a dataset.

9. How Ground Truth for Training Set Was Established: Not applicable.

In summary, the provided document is a regulatory filing for a physical medical device (a surgical shaver), focusing on its intended use and indications, and demonstrating substantial equivalence to previously cleared devices. It is not a scientific publication detailing a study to demonstrate performance against specific quantitative metrics typically associated with AI or diagnostic device evaluation.

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The XPS 3000 is intended for the incision and removal of soft and hard tissue or bone in general otorhinolaryngology, head and neck, and otoneurological surgery.

Otology / neurotology indications include aural atresia, cholesteatoma, cochleostomy, development of a suture tunnel for cochlear implant fixation, drainage of petrous apex cyst from endaural and middle-fossa approach, endolymphatic hydrops, extosis lesion removal, facial nerve decompression, mastoidectomy, mastoidotomy, ossicular chain reconstruction (OCR), otosclerosis, removal of ear tumors including acoustic neuroma, tympanoplasty, and vestibular neurectomy.

Sinus indications include septoplasty, removal of septal spurs, polypectomy, antrostomy, ethmoidectorny/sphenoethmoidectorny, frontal sinus trephination and irrigation, frontal sinus drill out, endoscopic DCR, trans-spheniodal procedures.

Nasopharyngeal / laryngeal indications include adenoidectomy, tracheal procedures, laryngeal polypectomy, laryngeal lesion debulking, tonsillectomy.

Head and neck (ENT) indications include soft tissue shaving, rhinoplasty (narrowing of the bony vault and revision of the bony pyramid), removal and shaping of bone during rhinoplasty procedures, removal of adipose tissue (lipo debridement) in the maxillary and mandibular regions of the face, removal of acoustic neuroma, and incision and removal of soft tissue during plastic, reconstructive, and/or aesthetic surgery.

The XPS 3000 system using the PowerSculpt handpiece and reciprocating cutting blades / rasps is indicated to cut hard and soft tissue or bone in otorhinolaryngology and head and neck surgery. An integral pump is provided for irrigation, and a second integral pump may be provided for handpiece cooling.

The XPS 3000 system with reciprocating adapter and suction cannula is intended for the removal of soft tissue and fluid during general surgical procedures including suction lipoplasty for aesthetic body contouring.

The XPS 3000 system is indicated for use in orthopedic surgical procedures where the cutting and removal of soft and hard tissue or bone is required. These include spinal and large joint arthroscopic procedures.

The XPS 3000 system consists of a power control console, footswitches, connection cables, and assorted handpieces to drive various burs, blades, drills, and rasps.

The provided document is a 510(k) summary for the Medtronic XPS 3000 System, dated June 4, 2004. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study data for new acceptance criteria.

Therefore, the document does not contain the acceptance criteria or a study proving the device meets new acceptance criteria for the following reasons:

• 510(k) Submissions for Substantial Equivalence: The primary objective of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing technological characteristics, intended use, and safety/effectiveness data to the predicate device, not necessarily defining and meeting new, specific quantitative performance acceptance criteria through clinical trials.
• Focus on Expanded Indications: In this specific 510(k), Medtronic Xomed is seeking clearance for expanded indications for use for the XPS 3000 system. The comparison table directly addresses the expanded indications against the previously cleared XPS 3000 (K002224) by showing that the "operating principle, technology, overall design, function, and materials" are similar, and that "Clinical evaluation and risk analysis reveal no new safety or efficacy issues in the expanded indications for use." This implies a comparison of the new indications' safety and efficacy to existing knowledge/data related to the predicate and current device, not a new study with defined performance metrics.
• Lack of Quantitative Performance Data: The document provides specifications like RPMs for different handpieces and blade sizes, but it does not present quantifiable performance metrics (e.g., tissue removal rate, precision of cut, etc.) with corresponding acceptance criteria and study results.

Therefore, I cannot populate the requested table or answer the specific questions about the study design, sample sizes, expert qualifications, or ground truth establishment because this information is not present in the provided 510(k) summary.

The summary states: "Clinical evaluation and risk analysis reveal no new safety or efficacy issues in the expanded indications for use." This suggests that the substantial equivalence argument relies on prior knowledge, risk assessment, and possibly non-clinical testing supporting no new issues, rather than a new comparative effectiveness study or standalone performance study against pre-defined acceptance criteria.

If this were a PMA (Premarket Approval) application or a more complex 510(k) that required clinical studies to demonstrate new performance claims, these details would be included. However, for an expanded indications 510(k) demonstrating substantial equivalence, such detailed performance studies with dedicated acceptance criteria are often not required or presented in the summary.

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The XPS 3000 is intended for the incision and removal of soft and hard tissue or bone in general otorhinolaryngology, head and neck, and otoneurological surgery.

Otology / neurotology indications include mastoidectomy, mastoidotomy, and acoustic neuroma.

Sinus indications include septoplasty, removal of septal spurs, polypectomy, antrostomy, ethmoidectomy/sphenoethmoidectomy, frontal sinus trephination and irrigation, frontal sinus drill out, endoscopic DCR, trans-sphenoidal procedures, maxillary sinus polypectomy, circumferential maxillary antrostomy, choanal atresia, sphenoidotomy, and medial, lateral, and posterior frontal sinusotomy.

Nasopharyngeal / laryngeal indications include adenoidectomy, tracheal procedures, laryngeal polypectomy, laryngeal lesion debulking, tonsillotomy for obstructive tonsillar disease, removal of endobronchial lesions, and the surgical management respiratory papillomatosis (RRP).

Head and neck (ENT) indications include soft tissue shaving, rhinoplasty (narrowing of the bony vault and revision of the bony pyramid), removal and shaping of bone during rhinoplasty procedures, removal of adipose tissue (lipo debridement) in the maxillary and mandibular regions of the face, removal of acoustic neuroma, and incision and removal of soft tissue during plastic, reconstructive, and/or aesthetic surgery.

The XPS 3000 system using the PowerSculpt handpiece and reciprocating cutting blades / rasps is indicated to cut hard and soft tissue or bone in otorhinolaryngology and head and neck surgery.

The XPS 3000 system with reciprocating adapter and suction cannula is intended for the removal of soft tissue and fluid during general surgical procedures including suction lipoplasty for aesthetic body contouring.

The XPS 3000 system is indicated for use in orthopedic surgical procedures where the cutting and removal of soft and hard tissue or bone is required. These include spinal and large joint arthroscopic procedures.

An integral pump is provided for irrigation, and a second integral pump may be provided for handpiece cooling.

The XPS 3000 system consists of a power control console, footswitches, connection cables, and assorted handpieces to drive various burs, blades, drills, and rasps.

The provided document is a 510(k) summary for the Medtronic Xomed XPS 3000 System, which describes an electrical surgical shaver and microresector. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study for novel performance claims.

Therefore, many of the requested elements for a study proving device performance against acceptance criteria are not explicitly present in this document because they are generally not required for a 510(k) submission of this nature. The document highlights functional equivalence to a previously cleared device (K002224).

Here's an attempt to answer your request based on the provided text, while also noting where information is not available:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

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

The submission demonstrates substantial equivalence to a predicate device (K002224) by comparing key functional characteristics. The "acceptance criteria" here are implied to be the performance specifications of the predicate device, which the new device matches or exceeds.

Note: The "acceptance criteria" for the new device are inherently benchmarked against the predicate device's performance to establish substantial equivalence. New product features (like the second optional pump) are provided but their specific "acceptance criteria" related to a performance study are not detailed in this summary.

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

This document does not describe a performance study with a "test set" sample size in the context of clinical data. The comparison is based on device specifications and indications for use. No data provenance (country, retrospective/prospective) is applicable here as clinical data is not presented.

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

Not applicable. This submission does not involve clinical data requiring expert review for ground truth establishment.

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

Not applicable. This submission does not involve a test set 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 device is a surgical instrument, not an AI-powered diagnostic tool. MRMC studies 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 surgical device, not an algorithm.

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

Not applicable. The "ground truth" for this submission are the established technical specifications and performance characteristics of the predicate device, which the new device is shown to match for substantial equivalence regarding safety and effectiveness.

8. The sample size for the training set

Not applicable. This submission describes a physical medical device, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set described.

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Ask a specific question about this device

The XPS 3000 system with reciprocating adapter and suction cannlua is intended for the removal of soft tissue and fluid during general surgical procedures including suction lipoplasty for aesthetic body contouring.

The XPS 3000 system consists of a power control console, footswitches, connection cables, and assorted handpieces to drive various burs, blades, drills, rasps, and reciprocating cannulae.

Product: XPS 3000 System With Reciprocating Adapter And Suction Cannulae

Based on the provided FDA 510(k) summary (K010666), this document outlines the acceptance criteria and study information for the XPS 3000 System.

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

The provided document (K010666) is a 510(k) premarket notification for a medical device seeking substantial equivalence to a predicate device. It does not present specific quantitative acceptance criteria or detailed performance data from a dedicated study demonstrating how the device individually meets such criteria. Instead, the core of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device.

The study described is a substantially equivalent comparison.

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

The 510(k) summary does not describe a specific test set, its sample size, or data provenance in the way a clinical trial would. The "study" here is a comparison demonstrating substantial equivalence, not a performance study involving patient data or a specific test set of cases. The comparison is based on the technical specifications and intended use of the device against a known predicate.

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

Not applicable. This type of information is generally found in clinical performance studies with diagnostic or AI devices, not in a substantial equivalence filing for a surgical tool where "ground truth" is a functional comparison, not an expert-annotated dataset.

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

Not applicable, as there is no described test set requiring expert adjudication for ground truth.

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

Not applicable. The XPS 3000 system is a surgical device for tissue removal, not an AI-assisted diagnostic or imaging interpretation tool that would involve human readers or MRMC studies.

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

Not applicable. The XPS 3000 system is a direct-use surgical tool, not an algorithm. Its performance is tied directly to its mechanical and electrical function, operated by a human surgeon.

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

For a 510(k) for a surgical device like the XPS 3000, "ground truth" relates to the established safety and effectiveness of the predicate device. The "ground truth" for the new device is its ability to perform its intended function safely and effectively, which in a 510(k) is demonstrated by its substantial equivalence to a device that has already met these criteria. This often involves:

• Bench testing: Verifying mechanical and electrical performance specifications.
• Biocompatibility testing: Ensuring materials are safe for human contact.
• Performance testing: Demonstrating the device can remove tissue and fluid as intended, often by comparing operational parameters (e.g., speed, torque, suction capabilities) to the predicate device.
• Prior clinical use history: The predicate device has a history of safe and effective use.

The document does not detail specific "ground truth" data types for the XPS 3000 but rather asserts its equivalence to the predicate, which would inherently have met these types of performance standards.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm requiring a training set.

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

Not applicable.

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