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Stryker's Precision Thin Reciprocating Blade, 0.010 inch (REF 5100-437-010) is a sterile, single use cutting accessory intended to cut bone in the posterior canal wall during an Otology procedure.

Stryker's Precision Thin Reciprocating Blade, 0.010in is a sterile, single use cutting accessory which is operated by a surgical drill (handpiece). This handpiece moves the Precision Thin Reciprocating Blade, 0.010in. in a reciprocating manner so that the blade removes bone material on the back stroke of its cut. The Precision Thin Reciprocating Blade, 0.010in. has a thickness of 0.010 inches and therefore can be used in surgical procedures where a narrow kerf width is required when cutting bone.

The document describes a 510(k) premarket notification for a medical device called "Precision Thin Reciprocating Blade, 0.010in." This device is a sterile, single-use cutting accessory intended to cut bone in the posterior canal wall during an Otology procedure. The submission argues for its substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document does not explicitly present a table of "acceptance criteria" in the typical sense (e.g., a specific numerical threshold for performance metrics). Instead, it describes performance tests designed to demonstrate functionality, integrity, safety, and effectiveness. The "acceptance criteria" are implied to be satisfactory performance in these tests.

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

• Simulated Use (Cadaveric): 3 ENT surgeons used the device in fresh cadaveric Human temporal bone. The provenance is not explicitly stated (e.g., country of origin for the cadaveric specimens), but it is prospective (a new study conducted for this submission).
• Simulated Use (Model): 8 ENT surgeons used the device with PHACON's Temporal Bone Model. This is also prospective.
• Kerf Width Testing, Life Testing, Temperature Testing: The sample sizes for these specific engineering tests are not provided. The data provenance is implied to be from the manufacturer's internal testing as part of the design validation.

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

For the simulated use studies (both cadaveric and model), 3 ENT surgeons and 8 ENT surgeons, respectively, were involved. Their qualifications are stated as "ENT surgeons," indicating medical specialists in the Ear, Nose, and Throat field. The level of experience is not specified (e.g., "10 years of experience"). For these performance tests, the "ground truth" is not a diagnostic label but rather their expert assessment of the device's functionality and performance during the simulated surgical procedures.

4. Adjudication method for the test set

The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for the simulated use studies. The role of the surgeons was to perform the simulated procedures and contribute to the validation, not necessarily to adjudicate findings. Their collective feedback and successful completion of the tasks would be considered the "acceptance."

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

There is no MRMC comparative effectiveness study mentioned in the document. This is a medical device, not an AI software. The study involves surgeons using the device, not interpreting images with or without AI assistance.

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

This question is not applicable. The device is a surgical instrument (a blade), not an algorithm or AI software. Its performance is always in a "human-in-the-loop" context as it is operated by a surgeon.

7. The type of ground truth used

For the performance section ("Section 5.8 Performance Data"):

• Functional/Performance Ground Truth: The "ground truth" for the Kerf Width, Life, and Temperature testing is based on engineering specifications and acceptable limits for those parameters.
• Clinical Performance Ground Truth: For the simulated use studies, the "ground truth" is the expert assessment and successful completion of the intended surgical task by qualified ENT surgeons in relevant models (cadaveric human temporal bone and PHACON model). This is a form of expert consensus/opinion on functionality and safety in a simulated environment, rather than pathology or outcomes data in a live patient, as no clinical studies were performed.

8. The sample size for the training set

This question is not applicable. The device is a physical surgical instrument, not an AI model requiring a training set.

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

This question is not applicable for the same reason as above.

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The XPS Curved Bur is intended for use in an ear, nose, and throat electric or pneumatic surgical drill for incising or removing bone in the ear, nose, or throat area, and is an accessory to the XPS 3000 System.

The XPS Curved Bur consists of a cutting tip connected to a flexible bur shank which is surrounded by a stationary outer cannula. The flexible shank and cutting tip are rotated by a surgical drill motor.

This document is a 510(k) summary for the Medtronic Xomed XPS Curved Bur. It establishes substantial equivalence to a predicate device, focusing on functional characteristics rather than specific performance metrics that would require a study with acceptance criteria. As such, the provided text does not contain the information requested regarding acceptance criteria and a study to prove the device meets them.

Here's a breakdown of why the requested information cannot be extracted from the given text:

• No Acceptance Criteria or Performance Metrics: The document's purpose is to demonstrate "substantial equivalence" based on similar intended use, technology, and materials, not to define specific performance benchmarks (like accuracy, precision, speed, etc.) that the device must meet through testing.
• No Study Described: There is no description of any study (clinical, laboratory, or otherwise) that was conducted to evaluate the performance of the XPS Curved Bur against predefined acceptance criteria. The "study" mentioned is the 510(k) review itself, which compares the new device to a predicate.
• No Data Provenance, Expert Information, or Ground Truth: Since no performance study is described, there's no mention of sample sizes, data origin, experts involved in establishing ground truth, or adjudication methods.
• No MRMC or Standalone Performance: These terms are relevant to diagnostic or AI-assisted devices, neither of which the XPS Curved Bur is.
• No Training Set Information: This is also not applicable to a purely mechanical surgical instrument.

The document primarily relies on a table comparing the new device's characteristics to the predicate device's characteristics to demonstrate substantial equivalence, rather than providing a performance study.

Therefore, the table below will be largely empty as the information is not present in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable, as no performance test set is described. The 510(k) submission process did not involve a test set for performance evaluation in the context of this document.
• Data Provenance: Not applicable.

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

• Not applicable, as no performance test set with ground truth established by experts is described.

4. Adjudication method for the test set:

• Not applicable, as no performance test set and corresponding ground truth adjudication are described.

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 MRMC study was done. This device is a surgical bur, not an AI-powered diagnostic or assistance tool, so such a study would not be relevant.

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

• Not applicable. This device is a mechanical surgical instrument, not an algorithm.

7. The type of ground truth used:

• Not applicable, as no performance study requiring ground truth is described. The "ground truth" in the context of this 510(k) summary is the established safety and effectiveness of the legally marketed predicate device to which the XPS Curved Bur is compared.

8. The sample size for the training set:

• Not applicable, as no algorithm or training set is involved.

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

• Not applicable, as no algorithm or training set is involved.

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The ESSential Shaver System is presently intended for the removal of soft tissue and small amounts of bony obstruction secondary to chronic sinus disease. The modification to this system would expand its intended use to the cutting and removal of bone and tissue in general ENT, head & neck, and otoneurologic procedures. Otology procedures could include mastoidectorny and mastoidotomy. Sinus applications would embody septoplasty and procedures such as the removal of septal spurs, polypectomy, antrostomy, ethmoidectomy/sphenoethmoidectomy, frontal sinus trephination and irrigation, frontal sinus drill out, endoscopic DCR and transspehnoidal procedures. Nasopharyngeal/Laryngeal procedures would comprise adenoidectomy, laryngeal lesion debulking and tonsillectomy. Head and neck procedures would encompass soft tissue shaving, rhinoplasty (narrowing of the bony vault and revision of the bony pyramid), removal of fatty (adipose) tissue (lipo debridement) in the maxillary and mandibular regions of the face, and acoustic neuroma removal at the cerebellopontine angle.

The modified ESSential Shaver System that is described in this notification has the same technological characteristics, power modality and mode of operation as the originally cleared device.

The provided document is a 510(k) summary for a medical device called the "Modified ESSential Shaver System." This type of submission to the FDA focuses on demonstrating substantial equivalence to a predicate device rather than conducting new clinical studies with detailed performance metrics against specific acceptance criteria. Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

Here's a breakdown of why the requested information is absent based on the document's content:

• Acceptance Criteria and Reported Device Performance: The document does not list specific acceptance criteria (e.g., precision, accuracy, sensitivity, specificity) for the device's performance in surgical procedures. Instead, it states that the modified system "has the same technological characteristics, power modality and mode of operation as the originally cleared device" and that "Differences between the modified ESSential Shaver System and the predicate devices should not affect the safety or effectiveness." This indicates that the established safety and effectiveness of the existing predicate devices are implicitly the "acceptance criteria."

• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth): There is no mention of any new clinical or performance studies being conducted with test sets, training sets, human experts, or ground truth data. The 510(k) process for this device relies on demonstrating equivalence to already cleared devices, not on proving new performance metrics through independent studies.

In summary, the document states that the modified ESSential Shaver System is considered substantially equivalent to existing predicate devices based on its technological characteristics, power modality, mode of operation, and its ability to meet UL and IEC standards. It does not provide details of a study that would define and then prove the device meets specific performance acceptance criteria for new clinical uses.

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The ACE System is primarily intended for the controlled incision or removal of bone in the ear, nose, throat and other areas of the head and neck. It also has applications in neurosurgery (e.g. cervical laminectomies), hand surgery, and plastic surgery (e.g. facial and mandibular reconstruction)

The ACE System is made up of a console, electric motor handpiece, foot pedal and various accessories. The Console is designed to mount onto an IV pole or to set on a cart and provides control of various functions such as handpiece speed and direction and irrigation. It has the ability to operate one or two handpieces (one selected at a time), angled and straight, and incorporates irrigation capability.

This 510(k) summary for the ACE System does not contain information regarding acceptance criteria, study design, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

The document focuses on:

• Device Description: What the ACE System is (console, handpiece, foot pedal, accessories).
• Intended Use: Controlled incision or removal of bone in ENT, neurosurgery, hand, and plastic surgery.
• Substantial Equivalence: Comparison to other predicate devices, primarily noting that the ACE System has enhanced speed and torque, making its performance equivalent to pneumatic drills but with the controls of electrical systems.

Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory submission for substantial equivalence rather than a detailed performance study report.

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