(46 days)
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.
| Characteristic | Acceptance Criteria (Predicate Device: XPS 3000 K002224) | Reported Device Performance (XPS 3000 Expanded Indications) |
|---|---|---|
| Intended Use / Indications for use | Cutting soft tissue and bone (See page 6) | Cutting soft tissue and bone (See page 7) |
| Magnum / Straightshot Microresector FWD/REV (Default) | 6,000 RPM | 6,000 RPM |
| Magnum / Straightshot Microresector FWD/REV (Max) | 6,000 RPM | 6,000 RPM |
| Magnum / Straightshot Microresector Oscillation Speed (Default) | 3,000 RPM | 3,000 RPM |
| Magnum / Straightshot Microresector Oscillation Speed (Max) | 3,000 RPM | 3,000 RPM |
| Magnum II / M4 Microresector FWD/REV (Default) | 6,000 RPM | 6,000 RPM |
| Magnum II / M4 Microresector FWD/REV (Max) | 15,000 RPM | 15,000 RPM |
| Magnum II / M4 Microresector Oscillation Speed (Default) | 3,000 RPM | 3,000 RPM |
| Magnum II / M4 Microresector Oscillation Speed (Max) | 5,000 RPM | 5,000 RPM |
| Steam autoclavable handpieces | Yes | Yes |
| Blade sizes (O.D.) | 2.0 mm - 6mm | 2.0 mm - 6mm |
| Direct patient contacting materials (Burs / Blades) | Stainless Steel and medical polymer | Stainless Steel and medical polymer |
| Blades / burs biocompatible | Yes | Yes |
| Peristaltic pumps | Not explicitly stated/compared for predicate | 2 pumps, 1 for irrigation and 1 optional for handpiece cooling |
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.
§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.