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The Speed Triad is indicated for: Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.

The Speed Triad is a nitinol implant that comes in a range of sizes for use in extremity bone fragment fixation, osteotomy fixation, and joint arthrodesis of the hand and foot. The implant is delivered to the operating room in an "open" state in a constraining plastic inserter. The implant is then released from the inserter and transformed by ambient temperature and body heat after insertion, and contracts to a "closed" and compressive state. The implants do not require any external heating; they are completely transformed at room temperature. The Speed Triad incorporates design changes from the Speed Shift. The design is changed to include a third leg to provide additional fixation. Importantly, the Speed Triad uses the same raw material as the predicate Speed Shift and the same manufacturing process (heat treatment, surface treatment, and passivation).

This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Speed Triad™ bone staple.

1. Table of Acceptance Criteria and Reported Device Performance

Method: Performed according to ASTM F564-10 (2010), comparing all three sizes of Speed Triad to a comparably sized predicate OSSplate. | Result: The Speed Triad demonstrated substantially equivalent pull-out resistance when compared to the predicate OSSplate implant. |
| Mechanical Strength | Goal: Substantially equivalent bending stiffness compared to the predicate OSSplate.

Method: Performed according to ASTM F564-10 (2010), comparing all three sizes of Speed Triad to a similar-sized predicate OSSplate. | Result: The Speed Triad implants achieved substantially equivalent bending stiffness when compared to the predicate OSSplate. |
| Corrosion Resistance | Goal: Substantially equivalent corrosion resistance compared to the predicate OSSplate and SmartToe.

Method: Performed according to ASTM F2129-08, comparing representative samples of the Speed Triad to the predicate OSSplate and the secondary predicate SmartToe (K070598). | Result: Test results demonstrate the substantially equivalent corrosion resistance of the Speed Triad compared to the predicate OSSplate and SmartToe. |
| Material Composition | Goal: Use of a material that meets established standards and is the same as predicate devices.

Method: Not explicitly described as a specific test, but material specification is provided for comparison. | Result: Nitinol, per ASTM F2063-12 (same as predicate Speed Shift and OSSplate).
Grey PC #5816, SS 17-4, SS-303 (same patient-contacting materials as predicate Speed Shift and OSSplate, with the exception of OSSplate not listing Grey PC #5816). |
| Manufacturing Process | Goal: Use of the same raw material, manufacturing process (heat treatment, surface treatment, and passivation) as the predicate Speed Shift.

Method: Not explicitly described as a specific test, but process equivalence is stated. | Result: The Speed Triad uses the same raw material as the predicate Speed Shift and the same manufacturing process (heat treatment, surface treatment, and passivation).
Surface Finish: Mechanical tumbling, acid cleaning, and chemical passivation (same as Speed Shift, but different from OSSplate which is mechanical tumbling only). |
| Functional State | Goal: Fully transformed at room temperature.

Method: Not explicitly described as a specific test, but functional characteristic is stated. | Result: Fully transformed at room temperature (same as Speed Shift, different from OSSplate which uses an electrical heating unit). |
| Sterilization & Storage | Goal: Sterile packaged and stored at room temperature until used.

Method: Not explicitly described as a specific test, but storage conditions are provided. | Result: Sterile packaged stored at room temp until used (same as both Speed Shift and OSSplate predicates). |

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

The provided text details performance bench testing. For all three types of tests (pull-out strength, mechanical strength, and corrosion resistance), the sample size is described as "Specimens of all three sizes of the Speed Triad were used" and "representative samples of the new Speed Triad." The exact number of specimens per size or per test is not specified.

The data provenance is from bench testing conducted by the manufacturer, BioMedical Enterprises, Inc., in San Antonio, Texas, USA. This is an in vitro study.

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

This information is not applicable to the provided document. The "ground truth" in this context refers to the absolute physical properties (e.g., pull-out strength, bending stiffness, corrosion resistance) measured through standardized ASTM methods, not through expert human interpretation of medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable to the provided document. Adjudication methods (like 2+1, 3+1) are typically used for studies involving human interpretation or clinical endpoints where there's a need to resolve discrepancies among observers. This study involves standardized mechanical and material property testing, where the results are quantitative and directly measured.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This study solely focuses on the mechanical and material characteristics of the device through bench testing, comparing it to predicate devices. It does not involve human readers, case interpretations, or an assessment of human performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

This information is not applicable as the device (Speed Triad™) is a physical bone staple, not an algorithm or AI software. Therefore, there is no "algorithm only" performance to evaluate. The study assesses the standalone physical characteristics of the device.

7. Type of Ground Truth Used

The "ground truth" used for this study is based on objective, quantitative measurements of physical properties, specifically defined and validated by industry standards:

• ASTM F564-10 (2010) for pull-out strength and mechanical strength (bending stiffness).
• ASTM F2129-08 for corrosion resistance.

These standards provide the methodology for determining the "true" physical performance of the device under specific test conditions.

8. Sample Size for the Training Set

This information is not applicable as the device is a physical bone staple, not an AI or machine learning model that requires a training set.

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

This information is not applicable as the device is a physical bone staple, not an AI or machine learning model.

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The Speed XLTM is indicated for: Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.

The Speed XLTM is for use in fracture and osteotomy fixation and joint arthrodesis of the hand and foot. The implant is designed so that it is delivered to the operating room in an "open" martensitic state. The implant is then transformed by room temperature after insertion, and contracts to a "closed" austenitic state. The implant does not require any external heating; it is completely transformed by room temperature. This configuration change for the Speed XL™ consists of a change in device shape, including flattened bridge with wider dimension to be used in hand and foot procedures.

This document describes the Speed XLTM bone staple and its substantial equivalence to a predicate device, the Speed ShiftTM.

Here's an analysis of the provided text based on your request:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as quantitative thresholds in the provided text. Instead, the approach taken for the Speed XLTM is based on demonstrating "substantial equivalence" to a legally marketed predicate device (Speed ShiftTM) through performance bench testing. The reported device performance is measured against this predicate.

2. Sample Size and Data Provenance

• Sample Size for Test Set:
  • For the pull-out strength test (ASTM F564-10), "Two lots with three samples each (n=3)" were compared for the Speed XLTM to the predicate. This refers to 3 samples for each of the two different lots of Speed XLTM, compared against similarly sized Speed ShiftTM predicates.
  • For the bending strength test (ASTM F564-10), "The largest and smallest Speed XL™ sizes were tested" and compared to similar Speed Shift™ predicates. The exact number of samples for each size isn't specified, but it's likely a small number similar to the pull-out test based on the context of bench testing for substantial equivalence.
  • For corrosion resistance (ASTM F2129-08), "representative samples of the new Speed XLIM" were compared to the predicate. The exact number of samples isn't specified.
• Data Provenance: The data is from "Performance Bench Testing" conducted by the manufacturer (BioMedical Enterprises, Inc.). This is prospective testing specifically for the 510(k) submission. The country of origin is implicitly the USA, where the submitting company is based and where the FDA approval process occurred.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This submission is for a medical device (bone staple) and relies on objective, repeatable physical and mechanical bench testing according to established ASTM standards, not on expert interpretation of data or images to establish ground truth.

4. Adjudication Method for Test Set

Not applicable. As this is bench testing of a physical device, there is no expert adjudication of results in the traditional sense. The results are obtained from standardized laboratory tests.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic devices where human readers interpret medical images or data. The Speed XLTM is a bone staple, a physical implant.

6. Standalone Performance Study (Algorithm Only)

Not applicable. This is not an algorithm or AI device.

7. Type of Ground Truth Used

The ground truth for the performance tests (pull-out strength, bending stiffness, corrosion resistance) is based on objective, quantifiable measurements obtained through standardized ASTM (American Society for Testing and Materials) test protocols. These standards define the methods for measuring these properties.

8. Sample Size for Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI. The design and manufacturing processes are likely informed by engineering principles and previous device designs, but not in a "training set" manner.

9. How Ground Truth for Training Set was Established

Not applicable, as there is no training set mentioned or implied for this physical device.

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The HammerLock® is indicated for: Small bone reconstruction and fusion such as inter-digital fusion of fingers and toes.

The Hammerlock is a nitinol implant that comes in a range of sizes to provide intramedullary fixation for fingers and toes. The Hammerlock device is situated in the intramedullary space and the prongs extending into the cancellous bone. When the device is warmed by body temperature. the prongs deflect outward to create an anchoring force. This configuration change for the Hammerlock involves minor configuration changes and adding new sizes to the product line for surgeon choice to better conform to patient anatomy.

The provided text describes a 510(k) premarket notification for a medical device called HammerLock. This is a regulatory submission for a medical device seeking clearance to market, demonstrating substantial equivalence to a legally marketed predicate device. This type of submission does not typically include detailed studies proving device performance against specific acceptance criteria in the way a clinical trial for a new drug or a novel AI software would.

Instead, the "study" mentioned here is primarily bench testing to demonstrate that the upgraded device maintains the same mechanical and material properties as its predicate.

Therefore, many of the requested fields (like sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance of an algorithm, or ground truth for training) are not applicable to this type of regulatory submission as they pertain to clinical or AI performance evaluations, which are not detailed here.

Here's a breakdown based on the information provided:

Acceptance Criteria and Reported Device Performance

1. Table of acceptance criteria and the reported device performance:

Study Details

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

• Sample Size: Not specified for the bench tests. Typically, these involve a small number of representative samples for mechanical and material testing.
• Data Provenance: Not applicable. The "data" here refers to physical properties measured in a laboratory setting, not patient data.

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. Bench testing does not involve human experts establishing ground truth in the clinical sense. The "ground truth" is defined by the objective physical properties and standards (ASTM F382-99, ASTM F2129-08).

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

• Not Applicable. Adjudication methods are relevant for subjective human assessments, not direct physical measurements in bench testing.

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 a physical medical implant, not an AI or imaging device involving human readers or AI assistance.

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

• No. This is a physical medical implant, not an algorithm.

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

• For mechanical and corrosion resistance: Objective physical measurements against established ASTM standards and comparison to predicate devices' measured properties.

8. The sample size for the training set:

• Not Applicable. This device did not involve a "training set" in the context of machine learning or clinical trials. Bench testing does not have a training phase; it's a direct evaluation of manufactured samples.

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

• Not Applicable. As there is no training set mentioned, this question is not relevant.

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The OSStaple™ Chill is indicated for: Fracture and osteotomy fixation and joint arthrodesis of the hand and foot and, Fixation of proximal tibial metaphysis osteotomy.

The OSStaple M Chill is a nitinol implant that comes in a range of sizes and models for use in extremity bone fragment fixation, osteotomy fixation, and joint arthrodesis. The implant is delivered to the operating room in an "open" martensitic state. The implant is. then transformed by body heat after insertion, and contracts to a "closed" austenitic state. The OSStaple TM Chill differs from the OSStaple TM in that the staples:do not require any external heating; they are completely transformed by body heat. The OSStaple! 100 Chill also includes staples with smooth and barbed legs to achieve increased pull-out resistance: All other characteristics of the implant are identical to the OSStapleTM predicate.

This is a medical device 510(k) premarket notification for a bone staple. It does not contain information about the acceptance criteria and study proving a device meets acceptance criteria related to software or AI/ML performance. Therefore, I cannot provide the requested information about AI/ML device performance.

The document describes the OSStaple™ Chill, a nitinol implant for bone fixation. The "Device Description and Testing" section mentions "Bench testing of the OSStaple™ Chill showed that the implants remain in their open martensitic state at operating room temperatures (20°C - 24°C), and fully transform to their closed shape by body temperature (37°C). Testing also showed that both the smooth and barbed versions of the OSStaple™ Chill achieve equivalent or superior pullout resistance to the OSStaple™."

This relates to the physical and mechanical properties of the staple, not to an AI/ML device.

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The HammerLock™ is indicated for small bone reconstruction and fusion such as inter-digital fusion of fingers and toes.

The HammerLock™ is an addition to the OSSPlate™ line and is designed for use as an intramedullary bone fixation device. The OSSPlate™ is situated on the bone with the prongs extending through the cortex and in its final configuration the prongs are deflected inward to create a clamping force. With the HammerLock™ the device is situated in the intramedullary space with the prongs extending into the cancellous bone and in the final configuration the prongs are deflected outward to create a compressive force. Two models of the HammerLock™ are provided for physician choice, the HammerLock™ X-Type and HammerLock™ Loop. Both exhibit similar test results to the predicate devices. The HammerLock™ models transformed to their final configuration by body heat alone.

The provided text is a 510(k) summary for the OSSplate™ HammerLock™ Product. This document is related to a medical device for bone fixation, not a software or AI-based device, and therefore does not contain information about acceptance criteria or studies in the context of device performance metrics like sensitivity, specificity, or reader studies.

The document focuses on demonstrating substantial equivalence to a predicate device (Memometal Technologies (MMI-USA) SmartToe™) to classify it as a Class II medical device. This type of regulatory submission primarily relies on comparing the new device's technological characteristics, materials, and intended use to a legally marketed predicate device, rather than performance studies with defined acceptance criteria for diagnostics or AI.

Therefore, the requested information, which pertains to the performance evaluation of a diagnostic or AI device (e.g., acceptance criteria for metrics like sensitivity/specificity, sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone performance, ground truth establishment), is not present in the provided text.

The document states: "Both exhibit similar test results to the predicate devices." This is the closest it comes to mentioning performance, but it doesn't provide specific data, acceptance criteria, or details regarding those "similar test results."

In summary, none of the requested information regarding acceptance criteria and performance studies for a diagnostic or AI device can be extracted from this document because it describes a physical medical implant device's 510(k) submission based on substantial equivalence.

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The BioWarm" is indicated for use as an ancillary device for the OSStaple" staple system.

The BioWarm™ represents a modification to the Warmsystem currently in use with the OSStaple" bone staple system. The BioWarm has an on/off switch and two user adjusted controls. A user adjusted current and user adjusted time controls are on the front of the console. The controls are set to the requirements of a specific staple size and configuration. The BioWarm" gives both visual and audible indications of current delivery and an audible signal upon automatic completion of current delivery. The BioWarm", on the electrode handle, also provides visual indication of positive contact between the electrode and staple to be heated and visual indication of actual current flow. Current is activated with a button switch on the handle of the BioWarm electrode and will cease if the button is released prior to the automatic cessation by the circuitry

I am sorry but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The text describes modifications to a bone staple heating system and its substantial equivalence to previously approved devices. It does not include details on acceptance criteria, device performance results, study methodologies, sample sizes, ground truth establishment, or expert involvement for performance evaluation.

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The Memograph® Staple is intended for:

l ) hand and foot bone fragment and osteotomy fixation and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy and 3) fixation of soft tissue to bone such as anterior cruciate reconstruction.

The Memograph® Staple system consists of two and four prong staples for 1) hand and foot bone fragment and osteotomy fixation and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy and 3) fixation of soft tissue to bone such as in anterior crucate ligament reconstruction. The staple is fabricated from Nitinol. The staple's prongs are parallel during insertion. Application of an electrical current from the Warmsystem to the staple causes its prong to deflect inward. This inward deflection causes staple retention and compression across the osteotomy or arthrodesis site.

This document K993714 details the 510(k) summary for the Memograph® Staple System. However, it does not contain the information required to populate the acceptance criteria and study details as requested. This document is a regulatory submission for premarket notification, focusing on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results or effect size.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The provided text focuses on the device description, intended use, and substantial equivalence to legally marketed predicate devices, which is typical for a 510(k) submission. It does not include information about specific performance studies with detailed acceptance criteria, test sets, or ground truth establishment.

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