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Tissu Trans Filtron Syringe Fill is intended to be used with house vacuum and/or cleared pumps, tubing and cannulas, for the collection of aspirated fat, for aesthetic body contouring. If the fat is untreated, it may be reinjected via a cleared injection apparatus.

Tissu Trans Filtron Syringe Fill is used in the aspiration, harvesting, filtering and transferring of autologous tissue.

Tissue Trans Filtron is intended for use in the following surgical specialties when the aspiration of soft tissue is desired:

• Plastic and Reconstructive Surgery
• Neurosurgery
• Gastrointestinal and Affiliated Organ Surgery
• Urological Surgery
• General Surgery
• Orthopedic Surgery
• Gynecological Surgery
• Thoracic Surgery
• Laparoscopic Surgery

Shippert Medical's Tissu Trans Filtron Syringe Fill is an optional accessory to Shippert Medical's Tissu Trans Filtron, K092482. Shippert Medical's Tissu Trans Filtron Syringe Fill is a sterile, single use, disposable device used in the aspiration, harvest, filtering and transferring of autologous tissue. Used by physicians in the harvesting of body tissues, this device is a single use, disposable sterile canister with six enclosed 60cc syringes used for collecting the harvested tissue after harvesting/aspiration.. The harvested tissue is stored in the Syringe Fill syringes and is intended for immediate reinjection of the harvested tissue back into the donor patient.

Here's a breakdown of the acceptance criteria and the study details for the Tissu Trans Filtron Syringe Fill, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample Size Used for Test Set and Data Provenance:

   • Sample Size: Not explicitly stated, though referred to as "clinical testing."
   • Data Provenance: Prospective (clinical testing was "conducted by Ronald D. Shippert, M.D. to validate and verify that the proposed device met all design specifications"). No country of origin is specified beyond it being a U.S. 510(k) submission, implying U.S. based.

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

   • Number of Experts: One, Ronald D. Shippert, M.D.
   • Qualifications: "Ronald D. Shippert, M.D." (presumably a medical doctor, likely a surgeon given the device's application). No specific years of experience are listed.

3. Adjudication Method for the Test Set:

   • Method: Not applicable. The "clinical testing" was conducted by a single physician without mention of additional adjudicators.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • Was it done?: No. The summary describes a single-operator clinical evaluation without a comparative effectiveness study involving multiple readers (human readers with/without AI assistance).
   • Effect Size: Not applicable.

5. Standalone (Algorithm Only) Performance Study:

   • Was it done?: Not applicable. This device is a physical medical instrument (suction lipoplasty system accessory) and does not involve an algorithm or AI.

6. Type of Ground Truth Used:

   • Type: Clinical assessment/expert judgment. The ground truth was established by Ronald D. Shippert, M.D.'s clinical evaluation, where he determined if the device performed as desired, was safe and effective, and met design specifications.

7. Sample Size for the Training Set:

   • Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set. The "clinical testing" referenced serves as the performance evaluation for the device itself.

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

   • Method: Not applicable, as there is no training set for an AI/ML algorithm.

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The Tissu Trans Filtron is intended to be used with house vacuum and/or cleared pumps, tubing and cannulas, for the collection of aspirated fat, for aesthetic body contouring. If the fat is untreated, it may be reinjected via a cleared injection apparatus.

Tissu Trans Filtron is used in the aspiration, harvesting, filtering and transferring of autologous tissue,

Tissu Trans Filtron is intended for use in the following surgical specialties when the aspiration of soft tissue is desired:

• Plastic and Reconstructive Surgery
• Neurosurgery
• Gastrointestinal and Affiliated Organ surgery
• Urological Surgery
• Orthopedic surgery
• Gynecological Surgery
• Thoracic surgery
• Laparoscopic Surgery

The Tissu Trans Filtron is provided in a sterile, two piece packaged assembly: The Tissu Trans Filtron. The Tissu Trans Filtron is a single-use, sterile, disposable device designed to utilize an FDA, cleared house vacuum to create suction within the physician supplied hollow liposuction cannula and remove subcutaneous fatty tissue from the patient and transport the autologous tissue into the collection canister.

The Tissu Trans Filtron is a sterile, single-use, manual device consisting of a medical grade polycarbonate canister, a medical grade polypropylene lid with various ports, medical grade silicone connection tubings for aspiration of waste, harvesting of tissue and transferring of filtered autologous tissue. A polypropylene clamp is included for clamping off the tubing as needed. A medical grade polyester mesh filter lining is contained within the canister.

The provided text is a 510(k) summary for the Shippert Medical Technologies Tissu Trans Filtron, a suction lipoplasty system. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving the device meets them as would be seen in a clinical trial for a new therapeutic device.

Here's an analysis based on the provided text, addressing your points where information is available:

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

The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it relies on demonstrating substantial equivalence to existing, legally marketed predicate devices. The "reported device performance" is summarized as being "safe and effective," and performing "as desired," implying it met the functional expectations for a device of its type and was comparable to the predicates in terms of safety and efficacy.

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Tissu-Trans™ is intended to be used when harvesting, filtering and transferring of autologous fat is desired.
Tissu-Trans™ is a piston syringe used in the aspiration harvesting, filtering and transferring of autologous tissue.

Tissue-Trans™ is a sterile, single use, disposable syringe device used in the harvesting, filtering and transferring of autologous fat. Used by acinso asounding procedures,Tissue Trans™ simplifies and reduces the steps prysiolane in the collection and transfer of the autologous fat. In so doing, the harvested fat is less traumatized and risk of contamination is lowered because the fat never leaves the harvesting syringe until re-injection.
Tissu-Trans™ is a piston syringe device comprised of a small 10cc syringe with Luer Lock tip that has small holes drilled into its barrel. This small10cc syringe is placed inside a larger 60cc barrel type tube, which is attached to a medical grade tubing and aspiration machine. As the autologous fat is collected into the 10cc syringe, the waste products are strained through the holes in the 10cc syringe into the large 60cc barrel tube and suctioned into a waste container. The small syringe is removed from the large 60cc tube, a sleeve is attached to the small 10cc syringe around the barrel and the autologous fat is re-injected into the patient at desired locations.

The provided document is a 510(k) summary for a medical device called Tissu-Trans™ by Shippert Medical Technologies. It focuses on demonstrating substantial equivalence to existing devices rather than presenting a performance study with detailed acceptance criteria and results. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics for the device itself is not available in this type of submission.

Here's an attempt to answer the questions based on the provided text, while also noting what information is not available in this type of regulatory document.

Explanation of the Submission Type:
A 510(k) premarket notification is submitted to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device. This process often relies on comparisons of technological characteristics, intended use, and materials to show that the new device is as safe and effective as the predicate. It does not typically require extensive clinical trials or performance studies with detailed acceptance criteria and ground truth validation for the new device as would be seen for novel technologies or higher-risk devices.

Acceptance Criteria and Study Details for Shippert Medical Technologies Tissu-Trans™

Given the nature of a 510(k) premarket notification, the "acceptance criteria" for the device itself in terms of specific performance metrics (like accuracy, sensitivity, specificity, or error rates) are not explicitly stated or demonstrated through a formal performance study with a test set, ground truth, or expert adjudication as one might see for an AI/CAD system. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices. This means that if the new device has similar technological characteristics, intended use, and materials to a legally marketed predicate, it is deemed acceptably safe and effective.

The study that "proves" the device meets these criteria is primarily the comparison to predicate devices described in the 510(k) submission.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable / Not Provided: For a 510(k) submission based on substantial equivalence to an existing device, there isn't typically a "test set" in the sense of a dataset used to validate performance metrics like accuracy or error rates for the new device. The "test" is the comparison to the predicate device's design, materials, and intended use. No specific data provenance (country, retrospective/prospective) is relevant to this type of comparison.

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 / Not Provided: As there is no "test set" with performance metrics requiring ground truth in this 510(k) summary, no experts were involved in establishing ground truth for a performance study of the Tissu-Trans™ device. The FDA reviews the provided information to determine substantial equivalence.

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

• Not Applicable / None: No adjudication method was used for a test set, as no such performance study is described in this 510(k) summary.

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 is not an AI/CAD device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.

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

• No: This is not an AI/CAD device. Therefore, no standalone algorithm performance study was done.

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

• Not Applicable / None: No ground truth was established for a performance study of the Tissu-Trans™ device itself. The "ground truth" for a 510(k) is effectively the established safety and effectiveness of the predicate device(s).

8. The sample size for the training set

• Not Applicable / None: This is not a machine learning or AI device that would require a training set.

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

• Not Applicable / None: As there is no training set for this device, no ground truth was established for it.

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The Expandacell™ Anti-Fog Instrument Wipe is identical to an existing medical device, K923843/A and K791736. These Anti-Fog Instrument Wipes, marketed by Xomed/ Merocel and Dixide, Inc. have a proven track record that establishes this product line as safe and effective for use in surgery.

The Expandacell™ Anti-Fog Instrument Wipe is identical to an existing medical device, K923843/A and K791736. These Anti-Fog Instrument Wipes, marketed by Xomed/ Merocel and Dixide, Inc. have a proven track record that establishes this product line as safe and effective for use in surgery. There is no modification in the proposed device and the predicate devices that alters safety and effectiveness. The proposed product is identical in intended use, materials, anatomical sites, target population, physical safety, biocompatibility and performance to the predicate device stated.

Here's an analysis of the provided text regarding acceptance criteria and a hypothetical study, followed by detailed answers to your questions based on the actual information in the K964334 document:

Analysis of the Provided Text (K964334):

The provided text for K964334 is a 510(k) summary for a device called "Expandacell™ Anti-Fog Instrument Wipe." Crucially, this document does not describe a study involving specific acceptance criteria or performance metrics for the device itself. Instead, it relies on the concept of substantial equivalence to predicate devices.

The core argument is that the Expandacell™ Anti-Fog Instrument Wipe is identical to previously cleared devices (K923843/A and K791736) in terms of:

• Intended use
• Materials
• Anatomical sites
• Target population
• Physical safety
• Biocompatibility
• Performance

Because the device is claimed to be identical to predicate devices that already have a "proven track record that establishes this product line as safe and effective," the submission asserts that no new safety and effectiveness concerns are raised, and therefore, no new performance study is needed to demonstrate new acceptance criteria are met.

Therefore, for many of your questions, the answer will be that this information is not applicable or not provided in this type of 510(k) submission, as it's not a performance study report but a substantial equivalence claim.

Detailed Answers to Your Questions (Based on K964334):

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

   • Acceptance Criteria: Not explicitly stated as performance metrics in this document. The implicit acceptance criterion is that the device is "identical" to predicate devices that are already deemed safe and effective.
   • Reported Device Performance: No specific performance metrics (e.g., fogging duration, clarity improvement percentage) are reported for the Expandacell™ Anti-Fog Instrument Wipe itself in this document. Its performance is assumed to be equivalent to the predicate devices due to its identical nature.

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

   • Sample Size: Not applicable. No new test set or performance study was conducted or reported in this 510(k) summary for the Expandacell™ Anti-Fog Instrument Wipe.
   • Data Provenance: Not applicable.

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. No new ground truth validation was performed as no new performance study was conducted.

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

   • Not applicable. No new performance study was conducted.

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 is an anti-fog instrument wipe, not an AI-assisted diagnostic device. An MRMC study is not relevant to this type of product.

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

   • No. This product is an instrument wipe, not an algorithm.

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

   • Not applicable. The "ground truth" for the Expandacell™ Anti-Fog Instrument Wipe's safety and effectiveness relies on the historical "proven track record" and regulatory clearances of the predicate devices.

8. The sample size for the training set

   • Not applicable. This is not an AI/algorithm-based device and does not involve a training set.

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

   • Not applicable. No training set was used.

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This device is used in the treatment and management of muscle spasm and muscle tension.

The proposed changes to an already approved and marketed device does in no way alter the safety and effectiveness of this medical device. The modifications of design change of "S" shape, adding roller beads and handles, adding interchangeable massage balls and adding a collapsible feature does not change the safety or effectiveness of this device.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "MUSCLE WANDEM" device, based on the given sections:

It's important to note that the provided text is a 510(k) summary for a medical device modification, specifically for the "MUSCLE WANDEM." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than performing de novo clinical trials to establish new safety and effectiveness criteria. As such, many of the requested data points (like detailed acceptance criteria with performance metrics, sample sizes for test/training sets, expert qualifications, etc.) are not typically included or required in a 510(k) summary for a device modification of this nature. The summary's primary argument is that the modifications do not alter the safety or effectiveness already established by the predicate device.

Analysis of Provided Information:

Based on the provided text, the device is the "MUSCLE WANDEM," which is a modification of a predicate device, the "Thera-Cane K903820." The submission argues that the modifications do not change the safety or effectiveness.

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

   • Acceptance Criteria: The document implies the acceptance criteria are maintaining the safety and effectiveness of the predicate device. Specific quantitative performance metrics are not provided. The key criteria are that the device, with its modifications, "does in no way alter the safety and effectiveness" of the predicate.
   • Reported Device Performance: The document claims that the device, with its modifications, continues to be safe and effective, based on the predicate's established track record. No new performance data from a specific study is reported for the "MUSCLE WANDEM" as a result of these modifications.

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

   • Sample Size: Not applicable/Not provided. The document does not describe a new "test set" being used for a study comparing the MUSCLE WANDEM with the predicate. Its argument relies on the historical performance of the predicate device.
   • Data Provenance: The "proven track record" of the predicate device ("Thera-Cane K903820") is the basis. The document does not specify the country of origin of this historical data or whether it was retrospective or prospective. It refers to the predicate being "sold OTC since 1990."

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

   • Not applicable/Not provided. No new ground truth establishment is described for a test set. The submission relies on the established safety and effectiveness of the predicate device which has been "proven safe" and "an asset" over time.

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

   • Not applicable/Not provided. No new test set or adjudication process is 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:

   • Not applicable. This is not an AI-assisted device, nor does the document describe an MRMC study. It's a physical therapy aid.

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

   • Not applicable. This is not an algorithmic device.

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

   • The "ground truth" for the claims of safety and effectiveness appears to be based on the historical marketing and regulatory approval of the predicate device ("Thera-Cane K903820") and its "proven track record" as an "asset to the patient experiencing muscle spasm and/or muscle tension" since 1990. This effectively points to market experience and presumably, lack of adverse event reporting, alongside initial regulatory clearance, rather than a specific, controlled outcomes study for this modification.

8. The sample size for the training set:

   • Not applicable/Not provided. The concept of a "training set" is not relevant to this type of device modification submission.

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

   • Not applicable/Not provided.

Summary of Study (Based on 510(k) Approach):

The "study" described in this 510(k) summary is not a traditional clinical trial or performance study comparing the modified device to the predicate. Instead, it's a justification of substantial equivalence.

The core argument is:

• The predicate device (Thera-Cane K903820) has a "proven track record" of safety and effectiveness since 1990.
• The "MUSCLE WANDEM" introduces design modifications ("S" shape, roller beads, handles, interchangeable massage balls, collapsible feature).
• These modifications do not alter the device's intended use, materials, anatomical sites, target population, physical safety, biocompatibility, or performance.
• Therefore, the safety and effectiveness established by the predicate device are maintained for the "MUSCLE WANDEM."

No specific new study data is presented for the MUSCLE WANDEM's performance as an acceptance criterion. The acceptance is based on the argument of non-alteration of existing, established safety and effectiveness.

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Not Found

Expandacell Injecto-Pak Foam Pack

The provided "SMDA SUMMA for Safety and Effectiveness" document does not contain information about acceptance criteria, device performance metrics, or any studies, human or otherwise, that would typically be associated with modern medical device clearances, especially for devices involving AI or diagnostic performance. Instead, it is a summary for a 510(k) submission for a physical medical device (Expandacell Injecto-Pak Foam Pack) from 1994, focusing on demonstrating substantial equivalence to predicate devices.

Therefore, I cannot provide the requested information. The document explicitly states:

• "This proposed change to an already approved and marketed device does in no way alter the safety and effectiveness of this medical device."
• "The proposed product is identical in intended use, materials, anatomical sites, target population, physical safety, biocompatibility and performance to the predicate devices stated."

This indicates that the submission is based on the substantial equivalence of device characteristics and intended use to previously cleared devices, rather than a new study demonstrating performance against specific acceptance criteria.

To address each point in your request:

1. A table of acceptance criteria and the reported device performance: Not applicable. No performance metrics or acceptance criteria are listed.
2. Sample size used for the test set and the data provenance: Not applicable. No test set or data provenance mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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 document predates widespread AI in medical devices and does not describe such a study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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The Expandacell Instrument Wipe is a sterile, soft, lintless instrument wipe used to clean delicate instruments during a surgical procedure.

The Expandacell Instrument Wipe is a sterile, soft, lintless instrument wipe.

I am sorry, but based on the provided text, there is no information about acceptance criteria, study details, sample sizes, ground truth, or an MRMC comparative effectiveness study.

The document consists of a 510(k) premarket notification letter from the FDA to Shippert Medical Technologies Corporation regarding their EXPANDACELL™ Instrument Wipe. It primarily addresses the device's regulatory classification and substantial equivalence to existing devices.

The key points from the provided text are:

• Device Name: EXPANDACELL™ Instrument Wipe
• Regulatory Classification: Class I
• Product Code: GEC (Manual surgical instrument for general use)
• Substantial Equivalence: The FDA determined the device is substantially equivalent to devices marketed prior to May 28, 1976.
• Basis for Equivalence: The summary of safety and effectiveness information (page 4) states that the device is "identical to existing medical devices" (K920355, K791736, and others by Ultracell, SomedMerocel, and Smith and Nephew) and is "identical in intended use, materials, anatomic model... population, physical safety, biocompatibility and performance to the predicate device."
• Indication for Use: "The Expandacell Instrument Wipe is a sterile, soft, lintless instrument wipe used to clean delicate instruments during a surgical procedure."

The document does not contain the specific information requested about acceptance criteria, study design, sample sizes, expert qualifications, or detailed performance metrics. It relies on the claim of substantial equivalence to previously cleared devices rather than providing new performance study data.

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