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1. Hand and foot bone fragment and osteotomy fixation and joint arthrodesis of the hand and foot bones.

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I am sorry, but the provided text does not contain information regarding acceptance criteria, device performance, or any studies related to the Biopro Memory Staple. The document is a 510(k) premarket notification letter from the FDA, confirming the device's substantial equivalence to legally marketed predicate devices and outlining regulatory requirements. It does not include details on testing, clinical trials, or performance metrics.

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reVERTO™ Shape Memory Staples are intended for use in:

Fixation of Osteotomies of the Hand, Foot and Tibia

Arthrodesis of the Joints of the Hand and Foot

Fixation of Soft Tissue to Bone, as in the case of the Anterior Cruciate Ligament

reVERTO™ Shape Memory Staples are also indicated for adjunctive fixation of Small Bone Fragments of:

The Upper Extremity, such as the Radius, Ulna, Humerus, Clavicle and Scapula

The Lower Extremity, such as the Tibia, Fibula and the Femur

The Upper Torso, such as the Sternum and the Ribs

reVERTO™ Shape Memory Staples are dynamic compression implants that use shape memory metal nickel-titanium alloy called NiTinol (see below for more information on NiTinol). The NiTinol construction causes the legs of the implant to deflect, thereby creating a compressive force across the site of fixation. reVERTO Shape Memory Staples are advantageous to screws and plates in that they require less disruption of the surrounding bone for implantation and provide a 'low-profile' fixation. The most important factor related to the use of NiTinol is its ability to maintain a compressive force across the site of fixation during the healing process.

This document is a 510(k) summary for the reVERTO™ Shape Memory Staples and does not include performance data from a specific study to demonstrate the device meets acceptance criteria. The submission focuses on establishing substantial equivalence to previously cleared predicate devices based on intended use, materials, and operational principles, rather than presenting a detailed clinical or performance study with acceptance criteria and results.

Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets those criteria from the provided text. The document does not describe such a study or present a table of acceptance criteria and reported device performance.

Here's a breakdown of why the requested information is not available in the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The 510(k) summary is for regulatory clearance based on substantial equivalence, not a detailed performance study report.
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, as no such test set or study data is described.
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, as no test set requiring ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) 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. The device is a physical bone fixation staple, not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical bone fixation staple, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): 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.

The provided document is a regulatory submission demonstrating substantial equivalence, which is a different type of submission than one detailing a clinical or performance study with specific acceptance criteria and results for a novel device.

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The MEMOMETAL MEMORY STAPLES (MEMOCLIP, EASYCLIP and FOR FUSION) are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.

MEMOMETAL MEMORY STAPLES are single-use bone fixation appliances intended to be permanently implanted. Memory staples are bipodal or quadripodal compression staples made of shape memory nickel titanium alloy.

The provided text describes the regulatory clearance of a medical device (MEMOMETAL MEMORY STAPLES) and includes performance data based on adherence to industry standards, rather than a study against a specific set of acceptance criteria with reported device performance metrics in the format requested.

Here's an attempt to structure the information based on the request, extracting what is available and noting what is not:

1. Table of Acceptance Criteria and Reported Device Performance

No information is available for the following points as the document pertains to a 510(k) submission for a physical medical device, not an AI/software device requiring a clinical study with image data and expert review.

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 for this type of device and submission. Performance is based on compliance with material and mechanical standards.

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.

4. Adjudication method (e.g. 2+1, 3+1, none) 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 device is a physical bone staple, not an AI/software for interpretation.

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 (expert consensus, pathology, outcomes data, etc)

• Not applicable. The "ground truth" here is compliance with established engineering and material standards.

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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1. Hand and foot bone fragment and osteotomy fixation and joint arthrodesis of the hand and foot bones.
2. Fixation of soft tissue to bone such as anterior cruciate reconstruction

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I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for a device called "Biopro Memory Staple," indicating that the device has been found substantially equivalent to a predicate device.

The letter discusses:

• The trade/device name and regulation information.
• The substantial equivalence determination by the FDA.
• General controls and potential additional controls applicable to the device.
• Requirements for marketing the device.
• Contact information for further inquiries.
• Indications for Use for the Biopro Memory Staple.

There is no mention of:

• Specific acceptance criteria (e.g., performance metrics, thresholds).
• A study design, methodology, or results demonstrating performance against any criteria.
• Details regarding sample sizes, data provenance, expert qualifications, ground truth establishment, or comparative effectiveness studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the text provided.

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Memory 12 and Memory 20 staples are implants intended for fixation of the foot.

Memory 12 staples are indicated for osteotomies of the first phalanx of the foot. Memory 20 staples are indicated for arthrodesis of the first metatarsal phalangeal joint.

The patient's anatomy and skeleton must be capable of receiving the selected implant.

The Memory Staple is a single-use, bone fixation appliance intended to be implanted in the foot. It is a bicortical compression staple manufactured from a Nickel-Titanium alloy.

The provided text is a 510(k) Summary for a medical device called the "Memory™ Staple." It details the device's description, intended use, indications for use, and a statement of substantial equivalence to a predicate device.

However, the document does not contain information related to acceptance criteria or a study proving the device meets acceptance criteria. This type of information would typically be found in a performance data section, which is absent from this summary.

Therefore, I cannot fulfill your request for the specific points listed (Table of acceptance criteria, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, ground truth types, training set details) because the provided text does not contain any of this information.

The document primarily focuses on establishing substantial equivalence to a previously cleared device (DePuy Memory Staple, K964226) based on similarities in intended use, indications for use, materials, and design. This suggests that the regulatory submission relied on the established safety and effectiveness of the predicate device rather than presenting new clinical or performance study data for the new device itself.

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The Groupe Lepine EIS dynamic memory staples system was designed and is intended to be used for the fixation of fractures by compressing two bones together after a osteotomy. The staples are intended for bone fixation after corrective osteotomy of the big toe, interphangeal fusion, fractures of the scaphoid or small trauma injuries.

The indications for use of the screw system are as follows: to secure the two sections of bone after an osteotomy caused by osteoarthritis, rheumatoid arthritis, post-traumatic arthritis or arthritis secondary to a variety of diseases or anomalies or trauma fracture.

EIS Dynamic Memory Staples System

This is a 510(k) clearance letter for the EIS Dynamic Memory Staples System, a medical device. The letter states that the device is substantially equivalent to legally marketed predicate devices, and therefore, can be marketed.
However, this document does not contain any information about acceptance criteria, device performance, study details, or ground truth establishment relevant to an AI/ML device. It only provides regulatory clearance for a physical medical device (staples system). Therefore, I cannot extract the requested information.

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For Fixing the osteotomies and arthrodesis of the mid fout bones, the metatarsals, the phalanges, and associated joints of the foot.

The Memory Staple is a single use bone fixation appliance intended to be permanently implanted. It is a bicortical compression staple made of a shape memory Nickel-Titanium alloy.

The provided text describes the "Memory Staple™" device and a study performed to demonstrate its substantial equivalence to predicate devices, but it does not detail acceptance criteria in the typical sense of a diagnostic device or AI algorithm, nor does it present a study that proves the device meets specific performance thresholds in that context.

Instead, the document is a 510(k) summary, focusing on demonstrating substantial equivalence for a medical device. The "study" mentioned here is a mechanical test and a clinical observation that supports this claim, rather than a clinical trial designed to prove diagnostic performance against set criteria for an AI tool.

Therefore, many of the requested categories for AI/diagnostic studies (like MRMC, ground truth establishment, training set details) are not applicable to this submission.

Here's an attempt to answer based on the provided text, adapted to the context of a medical device submission demonstrating substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable as an "AI/diagnostic acceptance criteria" table. The substantial equivalence argument for the Memory Staple relies on:

• Intended Use: Similar to predicate devices.
• Material: Nickel-Titanium shape memory alloy (similar to one predicate).
• Mechanical Strength: Demonstrated to be stronger than a predicate device.
• Clinical Use Observation: Successful in a reported series.

Since this is not an AI/diagnostic study, the following points are largely not applicable.

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

• Mechanical Test: "Prong separation tests were performed on the Memory Staple and the Landos Standard Staple." The sample size for these tests is not specified in the document.
• Clinical Observation: 315 osteotomies of the great toe.
• Data Provenance: The document does not specify the country of origin for the clinical observation data, but it refers to a report by "Barouk in 1994." It is retrospective, as it covers use between 1991-1994.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For the mechanical test, the "ground truth" is a measurement of force. For the clinical observation, "successful use" would likely be determined by the treating physician (Barouk). No panel of experts for ground truth establishment is mentioned.

4. Adjudication method for the test set
Not applicable. No adjudication method is mentioned for the mechanical tests or the clinical observation.

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 device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI device.

7. The type of ground truth used

• Mechanical Test: Direct physical measurement (prong separation strength).
• Clinical Observation: Physician-reported "successful clinical use," which implicitly refers to positive patient outcomes in the context of the device's function.

8. The sample size for the training set
Not applicable. This is not an AI device and does not have a "training set."

9. How the ground truth for the training set was established
Not applicable. This is not an AI device.

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