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Phasor EVAC™ is indicated when access to and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The EVAC system is intended for drainage of subdural fluid accumulations such as hygromas and chronic or subacute hematomas to an external suction reservoir. The EVAC system is also intended for draining air and fluids from the subdural space immediately following craniotomy procedures performed to remove a chronic or subacute subdural hematoma.

Phasor EVAC™ subdural evacuation system is indicated when access to the subdural space and evacuation of a cranial subacute or chronic hematoma or hygroma is necessary. The EVAC system consists of surgical instruments and accessories used for draining subdural fluid accumulations such as hygromas and chronic or subacute hematomas to an external suction reservoir without touching the brain. Utilizing a minimally invasive technique, the EVAC system components are designed to promote gradual brain re-expansion by creating a low homogeneous negative pressure throughout the subdural space as fluid is drained to an external suction reservoir.

This 510(k) clearance letter for the EVAC device (K243205) indicates that it is a central nervous system fluid shunt and components and it's regulated under 21 CFR 882.5550. While the letter confirms the device's substantial equivalence to predicate devices and states that various tests were conducted, it does not provide detailed information about specific acceptance criteria, study methodologies (like sample size, ground truth establishment, expert qualifications, or MRMC studies), or actual performance data in the format requested.

The document primarily focuses on explaining why the device is considered substantially equivalent to existing devices based on its intended use, indications for use, and technological characteristics. It mentions that "Various tests including for biocompatibility, packaging, sterility, safety, and performance were conducted and passed successfully," and that "testing for a closed system with firm purchase into bone was established and verified by testing." However, it does not disclose the specific data or criteria for these tests. It explicitly states, "No clinical testing was needed or performed otherwise."

Therefore, based on the provided FDA 510(k) clearance letter, I cannot populate the detailed table and answer all the specific questions about acceptance criteria and study proving device performance as requested, because this information is typically contained in the actual 510(k) submission, not the clearance letter itself. The clearance letter summarizes the FDA's decision, but not the detailed technical data from the submission.

Here's what can be inferred or explicitly stated from the provided document, with notes where information is not present:

Acceptance Criteria and Device Performance (Based on Inferred Safety and Effectiveness)

The acceptance criteria for a 510(k) cleared device are implicitly that it demonstrates substantial equivalence to a predicate device, meaning it is as safe and effective while having the same intended use. For this device, the "performance" described is its ability to meet the design intent and demonstrate equivalence through bench testing, rather than clinical efficacy.

Table 1: Inferred Acceptance Criteria and Reported Device Performance

Study Details (Based on Available Information)

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

   • The document states "No clinical testing was needed or performed otherwise." This indicates that the "test set" for demonstrating substantial equivalence was primarily based on bench testing and engineering evaluations of the device components and system.
   • Specific sample sizes for these bench tests are not provided in the clearance letter.
   • Data provenance (country of origin, retrospective/prospective): Not applicable or specified for bench testing.

2. 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):

   • Given that "No clinical testing was needed or performed," there's no mention of expert panels establishing ground truth in a clinical context. The "ground truth" for the engineering tests would be derived from accepted engineering standards and specifications.

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

   • Not applicable, as no clinical study or human reader evaluation requiring adjudication was performed.

4. 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. The device is a surgical system (shunt and components), not an AI-assisted diagnostic tool.

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

   • This question is more pertinent to software/AI devices. The EVAC system is a mechanical device. Its "performance" refers to its physical functioning (e.g., maintaining a closed system, firm purchase into bone), not an algorithmic output. The "Phasor Drill" component is explicitly stated to have been previously cleared (K161704), indicating its standalone performance was established previously.

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

   • For this device, the "ground truth" for its functional performance was based on engineering specifications, material science standards, and mechanical testing requirements (e.g., ability to form a "closed system with firm purchase into bone"). There's no mention of clinical ground truth (like pathology or outcomes data) because no clinical study was performed.

7. The sample size for the training set:

   • Not applicable. This is a hardware device, not an AI/machine learning algorithm requiring a "training set."

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

   • Not applicable for the same reason as above.

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To obtain percutaneous core biopsy samples from soft tissue and tumors of such organs as the liver, spleen, kidney, prostate, lung, breast, and lymph nodes. When used for breast biopsy, the product is for diagnosis only.

The extent histological abnormality in breast tissue cannot be reliably determined from mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not guarantee the complete removal of the affected tissue. When the sampled abnormality is not benign, it is necessary that the tissue margins be examined to ensure that the area of suspicion (e.g., malignancy) has been completely removed using standard surgical procedures.

The Evacore Fully Disposable Vacuum Assist Biopsy Device is a gamma sterilized, single-use percutaneous biopsy device. The working end of the device consist of a stainless steel outer needle with a lateral aperture for sample acquisition (sample aperture), a stainless steel inner cutting cannula with a sharp edge, and a solid stainless steel stylet located inside the cutting cannula. The handle of the device contains (2) release buttons, a reset handle for the vacuum generator (thumb), a reset handle for the cutting cannula (two fingers), and a needle hub to adjust the needle aperture orientation based on the location of the lesion. When the release buttons are depressed (consecutively or concurrently) a vacuum is generated at the needle sample aperture drawing tissue into the needle, then the cutting cannula is activated automatically, traversing across the sample aperture dissevering the tissue sample. The solid stainless steel stylet prevents the tissue sample from migrating towards the handle once it has been separated from the patient. The device is then removed from the patient and reset via the reset handles allowing the tissue sample to be removed.

The provided text describes a 510(k) premarket notification for the "Evacore Fully Disposable Vacuum Assist Biopsy Device." This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study report of the device's performance against specific clinical acceptance criteria.

The acceptance criteria and reported device performance are related to the physical characteristics of the biopsy samples obtained, specifically their volume or mass.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states that the testing was "Simulated and supported with bench testing." It does not specify the sample size (number of tests or tissues) used for the bench testing or the origin/provenance of the data (e.g., country, retrospective/prospective).

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

The document does not mention the use of experts to establish a ground truth for the bench testing. The "ground truth" in this context appears to be the quantitative measurement of sample volume/mass from the bench tests.

4. Adjudication Method for the Test Set

No adjudication method is mentioned, as the testing described is direct mechanical/physical measurement rather than subjective interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done. This device is a biopsy instrument, not an diagnostic imaging or interpretation device that would typically involve human readers.

6. Standalone Performance Study

Yes, a standalone performance assessment was conducted through "empirical testing" and "bench testing" focusing on the physical characteristics of the biopsy samples (volume/mass).

7. Type of Ground Truth Used

The ground truth used was based on quantitative physical measurements (average volume or mass) of samples obtained during simulated bench testing.

8. Sample Size for the Training Set

The document does not mention a training set. The descriptions of performance testing relate to a physical device, not an algorithm that would typically require a training set.

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

Not applicable, as no training set is discussed for this type of device and testing.

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The ArthroCare ENT Plasma Wands are indicated for ablation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:

• · Adenoidectomy
• Cysts
• · Head, Neck, Oral, and Sinus Surgery
• Mastoidectomy
• · Myringotomy with Effective Hemorrhage Control
• · Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
• Nasopharyngeal/Laryngeal Indications including Tracheal Polypectomy, and Laryngeal Lesion Debulking
• Neck Mass
• · Papilloma Keloids
• · Submucosal Palatal Shrinkage
• Submucosal Tissue Shrinkage
• · Tonsillectomy (including palatine tonsils)
• · Traditional Uvulopalatoplasty (RAUP)
• Tumors
• · Tissue in the Uvula/Soft Palate for the Treatment Of Snoring

The ArthroCare ENT Plasma Wands are bipolar, high frequency electrosurgical devices designed for use in otorhinolaryngology (ENT) surgery. The Wands consists of a single or multiple active electrode(s) located on the distal end of the shaft, a suction line, a saline line, and an injection molded, medical grade plastic handle with integrated cable at the proximal end of the wand. A cable connector is attached to the end of the cable, which connects the wand directly to the ArthroCare Coblator II Controller (CII Controller). The EVac 70 Xtra and PROcise XP Wands with Integrated Cable (EVac 70 Xtra and PROcise XP Wands) are a part of the ENT Plasma Wand family previously cleared under 510(k) K070374 for a change in indications; the integrated cable design was first cleared under 510(k) K033257.

Consistent with the predicate cleared under 510(k) K070374, the ENT Plasma Wands are only compatible with the CII Controller. The controller is designed to deliver radiofrequency energy to the active electrode(s) at the distal end of the wand. Each Wand is designed for soft tissue procedures where tissue resection, ablation, coagulation, and hemostasis are desired. The Wands are provided sterile, and are intended for single use.

This 510(k) seeks clearance for the following changes:

• 트 Addition of an Electronic Use-Limiting (EUL) feature to the integrated cable which will limit the re-use of these single-use disposable Wands.
• 트 A change in the design of the cable connector which mates with the Controller.
• 트 Implementation of Ethylene Oxide (EO) sterilization in lieu of e-Beam sterilization.

This document does not contain the detailed acceptance criteria or a study that precisely defines performance metrics with specific numerical targets. Instead, it is a 510(k) premarket notification summary for a medical device (ArthroCare ENT Plasma Wands) that seeks to establish substantial equivalence to a predicate device.

The core of this submission is to demonstrate that the modified device (EVac 70 Xtra and PROcise XP Wands with Integrated Cable) is as safe and effective as the previously cleared predicate device (ENT Plasma Wands, K070374), despite some minor changes.

Here's an attempt to extract and infer the information based on the provided text, while acknowledging that many specific details requested are not present in this type of FDA submission summary:

Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide specific numerical acceptance criteria. Instead, it states that various tests "met the required specifications" or "perform as intended" or are "substantially equivalent."

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

• Sample Size: Not explicitly stated for specific tests. The performance data section vaguely mentions "animal tissue" for ablation and coagulation testing.
• Data Provenance: "Animal tissue" is mentioned, implying in vivo or ex vivo animal studies. The country of origin is not specified but is implicitly within the scope of ArthroCare Corporation's operations (Austin, TX, USA). The studies are prospective in the sense that they were conducted for this 510(k) submission to demonstrate the equivalence of the modified device.

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

Not applicable. This document describes bench testing and animal tissue testing (likely performed by engineers/scientists), not studies requiring human expert adjudication of clinical outcomes or images for ground truth.

4. Adjudication Method for the Test Set

Not applicable. This was primarily bench and animal tissue testing, not a study requiring human adjudication.

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

No. This type of study is not mentioned as it is not typically required for a 510(k) submission seeking substantial equivalence for minor device modifications, especially when clinical data is explicitly stated as "not required."

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

Not applicable. This device is a medical instrument (electrosurgical wand), not an AI algorithm. Its performance is inherent in its physical and functional characteristics.

7. The Type of Ground Truth Used

For the ablation and coagulation testing (the closest thing to a performance evaluation of its intended effect), the "ground truth" seems to be the observable tissue effects in animal tissue, which were then compared to the effects produced by the predicate device. The fundamental assumption is that if the new device produces similar tissue effects, it is equivalent.

8. The Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is a physical medical device and not an AI/machine learning system.

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

Not applicable. No training set was used.

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