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The Arthrosurface Total Toe Resurfacing System is a two-piece implant that is intended to be used as prosthesis for the metatarso-phalangeal joint (MTP). The device is intended for cemented use only.

Indications for use include:

• Painful degenerative metatarso-phalangeal joint change .
• . Hallus rigidus stage 3 and 4
• . Hallux valgus and hallux rigidus
• Hallux limitus with painful arthrofibrosis .
• Revisions after moderate proximal phalanx resection .

The Arthrosurface® Total Toe System consists of a metatarsal component and a phalangeal component designed for resurfacing the 15 metatarsal head and the base of the proximal phalanx. These two implants replace the metatarso-phalangeal joint by complete functional preservation of the joint and maintaining of the sesamoid complex.

The Metatarsal Implant incorporates a CoCrMo articular resurfacing component per ASTM F799 with CP Ti Plasma Spray coating per ASTM F1580 and a Ti-6AI-4V ELI alloy fixation component per ASTM F136 that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/prosthetic interface. The device is 15mm articular implant with a dorsal flange feature for additional implant coverage in the dorsal plane.

The Proximal Phalanx Implant consists of a Ti-6Al-4V ELI alloy fixation component per ASTM F136 with CP Ti Plasma Spray coating per ASTM F1580 and an Ultra High Molecular Weight Polyethylene inlay per ASTM F648.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Arthrosurface® Total Toe - Proximal Phalanx Implant:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantifiable acceptance criteria such as "the device must achieve X performance metric." Instead, the document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

The acceptance criteria can be inferred from the list of non-clinical tests performed, with the implication that the device's performance in these tests was acceptable and comparable to the predicate devices.

Explanation: The document explicitly states: "The results have demonstrated the safety and effectiveness of the Arthrosurface® Total Toe - Proximal Phalanx Implant along with substantial equivalence to the predicate devices." This is the overarching performance claim based on the non-clinical tests.

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

The provided text describes non-clinical (bench) testing, not clinical studies involving human subjects or data. Therefore:

• Sample Size for Test Set: Not specified in terms of human subjects or patient data. For bench testing, the sample size would refer to the number of physical devices or components tested, which is not provided.
• Data Provenance: Not applicable as it's non-clinical testing. It's not retrospective or prospective patient data from any specific country.

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

Not applicable. This device underwent non-clinical bench testing to establish its performance and substantial equivalence. "Ground truth" in the context of expert consensus regarding patient data or images is not relevant here. The ground truth for the engineering tests would be the established scientific and engineering principles, material properties, and test standards (e.g., ASTM standards referenced).

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or image review where inter-rater variability needs to be managed for establishing ground truth. This was non-clinical bench testing.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses how human readers perform with and without AI assistance, which is irrelevant for a physical orthopedic implant undergoing non-clinical testing for substantial equivalence.

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

No, a standalone algorithm performance study was not done. This type of study refers to the performance of an AI algorithm independent of human interaction, which is not applicable to a physical medical device like an orthopedic implant.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests conducted would be based on:

• Established engineering standards and methodologies: (e.g., ASTM F799, ASTM F1580, ASTM F136, ASTM F648 for material properties).
• Physical measurements and observations during the wear, contact, assembly, bending, and strength tests.
• Computational models and simulations for the Finite Element Analysis.

8. Sample Size for the Training Set

Not applicable. There is no mention of a training set as this is not an AI/ML device that requires a training data set.

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

Not applicable. As there is no training set mentioned, there's no ground truth establishment for it.

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The Ascension® MOVEMENT™ Great Toe System, Total Arthroplasty is a twopiece implant that is intended to be used as prosthesis for the metatarsophalangeal joint (MTP). The device is intended for cemented use only. Indications for use include:

• Painful degenerative metatarso-phalangeal joint change .
• Hallux rigidus stage 3 and 4 ◆
• Hallux valgus and hallux rigidus .
• Hallux limitus with painful arthrofibrosis .
• Revisions after moderate proximal phalanx resection .

The Ascension® MOVEMENT Great Toe System, Total Arthroplasty device is an anatomically designed, semi-constrained, two-piece device designed for resurfacing of the base of the 1st metatarso-phalangeal (MTP) joint. The device couples with the Ascension metatarsal hemi-arthroplasty device to allow total arthroplasty of the 1st MTP joint. The device is designed for cemented fixation. The device is boxed individually and delivered sterile for single use. The device incorporates four anatomically designed base geometries with appropriately sized stems. The stem is cylindrical with tapered ribs to provide rotational as well as axial stability of the seated implant. System instrumentation is designed to offer precise implant preparation.

The provided text describes the Ascension® MOVEMENT™ Great Toe System, a total arthroplasty device. The submission focuses on establishing substantial equivalence to predicate devices based on testing and geometrical comparison, rather than clinical performance or AI/software system evaluation. Therefore, many of the requested categories are not applicable to this submission.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

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

Not applicable. The submission is for a medical device (great toe implant) and relies on mechanical testing and geometrical comparison, not a test set of data typically used for AI or diagnostic devices.

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

Not applicable. Ground truth for a test set is not relevant for this type of device submission.

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

Not applicable. Adjudication methods are not relevant for this type of device submission.

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.

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

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

7. The type of ground truth used

Not applicable in the context of clinical "ground truth" as typically defined for diagnostic or AI devices. The "ground truth" for this device's acceptance would be established by validated engineering and biomechanical testing standards for orthopedic implants.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

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The Merete ToeMobile™ Anatomical Great Toe Resurfacing System is a two-piece implant that is intended to be used as prosthesis for the metatarso-phalangeal joint. The device is intended for cemented use only. Indications for use include:

• Painful degenerative metatarso-phalangeal joint change
• Hallux rigidus stage 3 and 4
• Hallux valgus and hallux rigidus
• Hallux limitus with painful arthrofibrosis
• Revisions- after moderate proximal phalanx resection

The Merete ToeMobile™ Anatomical Great Toe Resurfacing System is a two-piece prosthesis that replaces the metatarso-phalangeal joint by complete functional preservation of the joint and maintaining of the sesamoid complex.
The prosthesis consists of an anatomically shaped and polished metatarsal implant, made of CoCrMo, which glides on a polyethylene inlay that is preassembled on a conically shaped phalangeal component made of titanium alloy Ti-6AI-4V.
Metatarsal and Phalangeal implant are intended for cemented use only.

The provided text describes a medical device, the Merete ToeMobile™ Anatomical Great Toe Resurfacing System, and its regulatory clearance process, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting new performance study data against defined acceptance criteria.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be stated based on the provided text:

• Acceptance Criteria and Reported Device Performance: This information is not present in the document. The document focuses on demonstrating substantial equivalence based on similar design, materials, and intended use to previously cleared predicate devices.

• Study Details (Sample Size, Ground Truth, etc.): No specific study is described in terms of sample size, data provenance, ground truth establishment, or expert involvement. The 510(k) pathway for this type of device often relies on non-clinical performance data (material testing, mechanical testing) and clinical history of predicate devices rather than a new clinical study with acceptance criteria for a novel device performance.

• Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not mentioned, as no clinical study with human readers is described.

• Standalone Performance Study: Not mentioned, as no clinical study with the algorithm (device) alone is described.

• Type of Ground Truth Used: Not applicable, as no study with a defined ground truth is described.

• Training Set Sample Size and Ground Truth for Training Set: Not applicable, as no machine learning algorithm or AI is mentioned, and thus no training set is relevant.

In summary, the provided text does not contain the information requested about acceptance criteria and a study proving the device meets those criteria. The document is a regulatory submission for substantial equivalence based on material and design similarity to existing devices, not a performance study report.

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