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The intelliFat Disposable Adipose Tissue Harvesting and Transfer or BOD Kit is a sterile medical device intended for the closed-loop processing of lipoaspirate tissue in medical procedures involving the harvesting, and transferring of autologous adipose tissue harvested with a legally marketed lipoplasty system. The device is intended for use in the following surgical specialties when the transfer of harvested adipose tissue is desired: orthopedic surgery, arthroscopic surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, gynecological surgery, thoracic surgery, laparoscopic surgery, and plastic and reconstructive surgery when aesthetic body contouring is desired. Only legally marketed accessory items, such as syringes, should be used with the system. If harvested fat is to be transferred, the harvested fat is only to be used without any additional manipulation.

The intelliFat Disposable Adipose Tissue Harvesting and intelliFat BOD Kits are sterile single-use, disposable suction lipoplasty systems that are intended for closed-loop processing of lipoaspirate tissue in various medical procedures involving harvesting autologous adipose tissue. These kits contain stand-alone components that are assembled by the physician user. Primary components include: cannulae, filters, resizer, luer adapters, and syringe caps. The intelliFat Kits accommodate minimal handling of adipose tissue. These devices may be used in combination with FDA-cleared device such as syringes.

The provided text is a 510(k) premarket notification for a medical device called the "intelliFat Disposable Adipose Tissue Harvesting and Transfer Kit" (and "intelliFat BOD Kit"). This document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance in a clinical setting.

Specifically:

• No table of acceptance criteria and reported device performance is provided. The document is a regulatory filing for substantial equivalence, not a performance report.
• No sample size for a test set or data provenance is mentioned for proving clinical performance. The "nonclinical testing" section describes lab-based tests (biocompatibility, sterilization, packaging, nucleated cell viability), not clinical or performance outcome studies.
• No information about experts used for ground truth, adjudication methods, or MRMC studies is present. These are typically relevant for AI/imaging device evaluations, which this device is not.
• No standalone (algorithm-only) performance is discussed as this is a physical medical device, not an AI algorithm.
• No type of ground truth is specified for clinical performance, as no clinical performance study demonstrating efficacy is detailed.
• No training set sample size or ground truth establishment for a training set is mentioned. This information would be relevant for machine learning models, which this device is not.

The document explicitly states: "Clinical testing was not required to support a substantial equivalence determination for the intelliFat Kits." This means the FDA cleared the device based on its similarity in intended use and technological characteristics to existing devices, and not on new clinical performance data from the manufacturer.

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The Millennium Medical Technologies, Inc. Autoclavable Suction Jars and Lids are used in conjunction with hospital or surgery center 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.

The Millennium Medical Technologies line of Fat Collection and Transfer Devices consist of the following:

1. Autoclavable Suction Jars and lids with Luer Lock extension and extraction tub - 250, 500, 1,000, 2,000 and 3,000 ml
2. Suction Jar without Luer Lock extension 1,500 and 2,500 ml
3. Sterile 1,500 and 2,500 ml Lids with Conical patient connection 6-10 and overflow protection

The Millennium Medical Technologies Collection Jars are Suction Canisters molded from medical grade polycarbonate. The 250, 500, 1,000, 2,000 and 3,000 ml canisters have a stainless steel luer fitting at its base to facilitate the transfer of untreated fat back into the patient using a cleared injection apparatus. The 1,500 and 2.500 ml canisters are designed to interface with the Lid with Liner and do not have a fitting at the base of the canister. All of the Collection Jars are provided non-sterile and are autoclavable.

The Millennium Medical Technologies Small and Large Lids are molded from medical grade polypropylene and have various ports, medical grade silicone tubing and a liner to contain all waste. The Large Lid has a 6-10 tapered cone for the 2,500 ml canister and the Small Lid has a 6-10 tapered cone for the 1,500 ml canister. The Lids with Liner are provided sterile.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance in the specific format you've outlined.

The document is a 510(k) premarket notification for "MMT Autoclavable Suction Jars and Lids." It primarily focuses on demonstrating substantial equivalence to a predicate device, not on presenting a detailed study with acceptance criteria for a novel device's performance characteristics in the way you've described for AI/algorithm-based studies.

Here's why I cannot fulfill your request based on the provided text:

• No specific acceptance criteria or performance metrics are provided for the device itself. The document mentions "Performance testing has demonstrated that the products' efficacy and effectiveness is substantially equivalent to the predicate device," but it does not quantify this efficacy or effectiveness with specific numerical targets.
• The device is a physical medical device (suction jars and lids), not an AI algorithm. Therefore, concepts like "test set," "training set," "ground truth established by experts," "adjudication method," "MRMC comparative effectiveness study," or "standalone (algorithm only) performance" are not applicable in this context.
• The "studies" mentioned are nonclinical tests related to biocompatibility, leakage, sterilization validation, and cleaning validation, which are standard for physical medical devices but are not performance studies in the sense of accuracy, sensitivity, or specificity that would have acceptance criteria for an AI diagnostic tool.
• No human readers or experts were involved in establishing ground truth for a diagnostic outcome, as this is a device for collecting fat, not for making a diagnosis.

The information available regarding studies is:

• Nonclinical Tests:
  • Biocompatibility tests: ISO MEM Elution, ISO Intracutaneous Irritation Test, ISO Acute Systemic Injection Test, ISO Guinea Pig Maximization Sensitization Test.
  • Leakage and compatibility of Collection Jars with Lids and Liners.
  • Accuracy comparison of MMT Fat Collection and Transfer Devices to the comparative predicate device (no specific metrics or methodology provided).
  • Gamma Irradiation Sterilization Validation (ISO 11137-1:2006; Amd. 1, 2013).
  • Cleaning Validation (AAMI O TIR30:2011 Guidance document).
  • Sterilization Validation for a gravity autoclave (TIR N0. 12-2004 and ISO 17665-1:2006/(R) 2013).
• Clinical Tests: "Not applicable."
• Conclusion: "Performance testing has demonstrated the product's efficacy." and "The MMT Fat Collection and Transfer Devices have been demonstrated to be substantially equivalent to the predicate device."

Without a document describing a performance study with defined acceptance criteria and specific outcomes (like sensitivity, specificity, AUC, etc.) for a diagnostic or AI-driven device, I cannot generate the table or answer the specific questions you've posed.

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Liposuction cannulas are indicated for aesthetic body countering and tissue aspiration

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called "Lipo Cannula." It concerns the regulatory classification and substantial equivalence of the device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

Therefore, I cannot provide the requested information based on the provided text. The letter primarily addresses administrative changes to the device's product code and confirms its substantial equivalence to previously marketed devices.

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Percutaneous Compression Wire system for the fixation of osseous fragments or fractures of small bones, including:

• Scaphoid fractures
• Lunate fractures
• Capitate
• Carpal fractures & non-unions
• Capitellum fractures
• Humeral head fractures
• Trapezial fractures
• Metacarpal and metatarsal fractures
• Phalangeal fractures
• Distal radial fractures
• Ulnar styloid fractures
• Osteo-chrondral fractures
• Small joint fusions
• Glenoid fractures
• Intercarpal fusions
• Interphalangeal fractures
• Metatarsal osteotomies
• Tarsal fusions
• Malleolar fractures
• Hammer toe fixation

The PCW" is supplied as a single length threaded stainless steel wire or pin. The pin is selftapping and self-cutting and does not vary in length or diameter. The engineering drawings include diameter and length information. However, the pins are nominally six inches in length and fifty-nine thousandths diameter. The pins are intended for small bone applications (fractures and osteotomies) including distal fragments of long bones. The principal areas of use are the upper extremity and the hands and feet. The pins may be used for selected fractures elsewhere in the body so long as medically indicated and bone mass compatible. The primary use of the wires is percutaneous, that is, without the need for an external fixatior as in the case of "hammer-toes" or similar phlangeal or small bone losteotomies. The secondary use of the wires is in association with the use of an external fixation device as a means to secure and fix small fragments until healing is complete. MMT supplies instrumentation designed specifically to interface with this implant system. Their use of general manual orthopaedic instrumentation is not recommended for the insertion of this device. The screws are made from stainless steel alloy.

The provided text describes a medical device, the PCW™ Percutaneous Compression Wire, and its 510(k) premarket notification. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics.

The document focuses on:

• Device Identification: Trade name, common name, classification, establishment information.
• Regulatory Compliance: References to ISO standards (ISO 9001-2000, ISO-5832-3,1996(E)) for manufacturing and materials, and general controls for Class II devices.
• Labeling: Warning and caution statements.
• Equivalent Devices: Comparison to predicate devices (Synvasive k-wires, Miltex Steinmann pins) based on basic design, features, and intended use.
• Device Description: Material (316 LVM, ASTM F138), dimensions, and general application (small bone fractures and osteotomies).
• Intended Use: A comprehensive list of specific fracture types and fusions for which the device is intended.
• FDA Communication: A letter from the FDA confirming substantial equivalence to legally marketed predicate devices and authorizing marketing, subject to general controls.

Key Missing Information:
The document does not include:

• Quantitative acceptance criteria for device performance.
• Details of any performance study (e.g., mechanical testing, clinical trials, usability studies).
• Data provenance, sample sizes, or expert qualifications for any testing.
• Information on MRMC studies or standalone algorithm performance.
• The type or establishment of ground truth for any evaluation.

Therefore, I cannot populate the requested table or answer most of the questions because the necessary details are not present in the provided text. The FDA's substantial equivalence determination for this device relies on its similarity to existing, legally marketed predicate devices, implying that its performance is implicitly accepted as equivalent to those devices, rather than through a new, explicit performance study described in this submission.

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Headless bone screw system for the fixation of osseous fragments or fractures including:

HBS - MINI: Scaphoid fractures, Lunate fractures, Capitate, Trapezial fractures, Metacarpal and metatarsal fractures, Phalangeal fractures, Radial head fractures, Ulnar styloid fractures, Osteo-chrondral, Small joint fusions

HBS - STANDARD: Scaphoid fractures, Carpal fractures & non-unions, Capitellum fractures, Metacarpal fractures, Phalangeal fractures, Distal radial fractures, Radial head fractures, Ulnar styloid fractures, Small joint fusions, Humeral head fractures, Glenoid fractures, Intercarpal fusions, Interphalangeal fractures, Metatarsal osteotomies, Tarsal fusions, Malleolar fractures, Patellar fractures, Osteo-chrondral fractures, Odontoid fractures, Mandibular fractures

The HBS™ (Headless Bone Screw) and the mini HBS™ are supplied as two series of cannulated bone screws varying in length and diameter. Both systems are intended for small bone applications and are thus considered a single system. Indeed, both systems are intended for use primarily in the hands and feet. The systems may be used for selected fractures elsewhere in the body so long as medically indicated and bone mass compatible.

Available screws and instrumentation are available as two individually boxed sets offered in the following sizes:

MINI HBS™: 1.5mm shaft diameter, 3.2mm proximal thread diameter, 2.5mm distal thread diameter. 10mm through 30mm length in one millimeter increments.

STANDARD HBS™: 3.0mm shaft diameter, 4.7mm proximal thread diameter, 4.0mm distal thread diameter. 10mm through 30mm length in one millimeter increments.

The screws are made from titanium alloy.

The provided document is a 510(k) Premarket Notification Summary for the HBS™ Headless Bone Screw. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, and ground truth establishment is not available in these documents.

Here's a breakdown of the information that can be extracted or deduced from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify formal acceptance criteria for device performance in the context of a clinical study, as it's a 510(k) for substantial equivalence. The "performance" discussed is primarily in terms of biomechanical properties and material specifications, which are compared to predicate devices for equivalence.

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

This document does not describe a clinical "test set" for performance evaluation in the way one would for an AI/diagnostic device. The biomechanical testing mentioned is likely laboratory-based. No patient-specific data or data provenance (country of origin, retrospective/prospective) is provided.

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

Not applicable. This is not a study assessing diagnostic performance or requiring expert ground truth in that sense. The "ground truth" for biomechanical performance would be the experimental measurements themselves.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set requiring adjudication 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 diagnostic device, and no MRMC study is mentioned.

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

Not applicable. This is a surgical implant, not an algorithm.

7. The Type of Ground Truth Used

For the biomechanical testing, the "ground truth" is the empirically measured force values (e.g., 200N, 165N) obtained from testing the screws. For material and manufacturing, the ground truth is compliance with relevant ISO standards.

8. The Sample Size for the Training Set

Not applicable. No training set for an algorithm is mentioned in this document.

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

Not applicable. No training set is mentioned.

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The Wristore Fixator is intended to provide external fixation of the upper extremity. External fixation devices allow for three plane (axial, AP & medio/lateral) control over fractures and bone segments.

The materials utilized for the construction of the external elements of the Wristore Fixator are medical grade polyetherimide resin. This material is the identical material utilized to construct the Articulating Distal Radius Fixator (K984498). The materials utilized in the instruments and pin guides are instrument grade stainless steel. The pins and K-wires used to fix the fractured bones are produced from implant grade stainless steel (316L). The Wristore Fixator utilizes legally marketed commercially available fixation pins and/or K-wires. Once the provided K-wires and pins have been properly placed, the poly-resin external frame is tightened and the fracture(s) stabilized. Typical orthopaedic instrumentation is provided to place, tighten and adjust the fixator.

The provided document describes a 510(k) premarket notification for the "Wristore Fixator," an external fixator for upper extremity fractures. The focus of the document is on demonstrating substantial equivalence to legally marketed predicate devices, rather than on a clinical study proving specific performance criteria. Therefore, most of the requested information cannot be extracted directly from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

This information is not provided in the document. The document focuses on comparing design, materials, and intended use with predicate devices to establish substantial equivalence, not on pre-defined performance acceptance criteria and their fulfillment through a study.

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

This information is not provided. As no clinical study is detailed, there is no mention of a test set, sample size, or data provenance.

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):

This information is not provided. There is no mention of a test set requiring ground truth established by experts.

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

This information is not provided. There is no test set or adjudication method 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:

This information is not provided. No MRMC study or AI component is mentioned.

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

This information is not provided. The device is a physical external fixator, not an algorithm.

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

This information is not provided. There is no clinical study described that would require a ground truth.

8. The sample size for the training set:

This information is not provided. There is no mention of a training set as this is not a machine learning device.

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

This information is not provided. There is no mention of a training set.

Summary of what is provided regarding the device:

• Device Name: Wristore Fixator
• Intended Use: External fixation of the upper extremity for Colles, mid, and proximal fractures. Allows for three-plane control (axial, AP & medio/lateral) over fractures and bone segments.
• Classification: Class II
• Substantially Equivalent Devices:
  • K003397, Colles C Series Frame (DePuy, Inc.)
  • K984498, Articulating Distal Radius Fixator (Synthes, Inc.)
• Materials: Polyetherimide resin (external elements), stainless steel (instruments, pin guides, pins, K-wires).
• Sterilization: Supplied NON-STERILE; validated steam sterilization cycle: Gravity, 250° F (121° C) for 30 minutes.

The document primarily serves to demonstrate that the Wristore Fixator is substantially equivalent to existing devices based on its design, materials, and intended use, rather than presenting data from a performance study against specific acceptance criteria.

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