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The intended use for the AART Pectoralis Implant is augmentation of the chest to add definition to the pectoralis muscle by placing submuscular. It may also be used for reconstruction of the pectoralis depression caused by Poland's Syndrome (congenitally absent pectoralis muscle).

The AART Pectoralis Implants are manufactured from a medical grade silicone elastomer that has been molded into various convex oval shapes. They are provided in three styles, each with a right and left mirror image. Dimensions of the implants will range from 14.4 cm to 17.6 cm in length with widths from 10.0 cm to 13.5 cm and projection (height) from 1.6 cm to 3.2 cm. The AART Pectoralis Implants are intended to be used for augmentation of the chest by placing the implant submuscular of the pectoralis muscle. They can also be used to reconstruct the pectoralis depression caused by Poland's Syndrome (congenitally absent pectoralis muscle). The surface characteristic of the implants is smooth. The AART Rectoralis. Implants will be offered non-sterile.

The provided document is a 510(k) summary for the AART Pectoralis Implant. It primarily focuses on demonstrating substantial equivalence to predicate devices and does NOT contain information about acceptance criteria, a specific study proving device performance against acceptance criteria, or any of the detailed study parameters requested in your prompt (such as sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance).

The document is a regulatory approval notice based on substantial equivalence, meaning the device is considered safe and effective because it is similar to devices already legally marketed. It does not typically involve detailed performance studies with acceptance criteria in the way you've described for AI models or diagnostic devices.

Therefore, I cannot provide the requested table and study information based on the given text.

However, I can extract the following relevant information:

• Device Name: AART Pectoralis Implant
• Intended Use: Augmentation of the chest to add definition to the pectoralis muscle by placing submuscular. It may also be used for reconstruction of the pectoralis depression caused by Poland's Syndrome (congenitally absent pectoralis muscle).
• Predicate Devices: Pectoralis Implant marketed by Allied Biomedical Corporation and the Seare Biomedical Pectoralis Implant marketed by Seare Biomedical Corp.
• Regulatory Basis: Substantial equivalence based on similarity in function, design, performance, and materials to the predicate devices.

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Seare Biomedical Pectoralis Implants / silicone carving blocks are intended to be used for augmenting the chest by placing the implant in the submuscular space via a trans-axillary incision. They can also be used to reconstruct the pectoralis depression of Poland's Syndrome (Congenitally Absent Pectoralis Muscle).

Searc Biomedical Pectoralis implants are essentially large conceve conver on interestion. They are exponied Device Description: Seare Bromsonally formulated silicone elastomers designed for implantation. They are novided in two (2) orientations for cach of the specially formation and only in the milablity. Surface characterity will way ironton beeks on intended to smooth to varying degrees of lexturing and pornsity. Seare Biometical Pectoralis Implants / silicone carving block same intended to smood for augmenting the chest by placing the inplant in the submuseular space via a trans-axillary incision. The Career Ricer be used to reconstruct the pectoralis depression of Poland's Syndrone Congenitally Absent Pectoralis Muscle). The Seare Biomedical used to reconstition the pectoralis deplession of rolance congramilar - differing in length and proccion. The length of these implants varies from 11.5cm to 20cm. The height varies from 9cm to 18cm and the thickness at the apex varies 1cm to 3.5cm. The Seare Biomedical Pectoralis Implants will be provided sterile and nonsterile.

The provided text is a 510(k) Summary for Seare Biomedical Pectoralis Implants. It focuses on demonstrating substantial equivalence to predicate devices and does NOT contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of an AI/medical device performance evaluation.

Therefore, I cannot extract the requested information. The document explicitly states "Clinical Tests: None" and "Adverse S&E Information: None," indicating that no performance studies of the type you're asking about were conducted or reported in this submission.

This 510(k) submission is for a physical medical device (silicone implants), and the review process primarily assesses material, function, performance, and design equivalence to already marketed devices, rather than AI-driven performance metrics.

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Seare Biomedical Silicone Blocks are intended for use in the cosmetic correction of soft tissue deformities, and is contoured at the surgeon's discretion to create a custom implant to aid in the reconstruction process. The contour carving blocks lend themselves to carving chin implants and malar implants.

Searc Biomedical Silicone Blocks are made from specially formulated silicone elastomers designed for implantation, LSR soft implant grade silicone elastomer. The intended use of the Seare Biomedical silicone block is for caring a finished device by the surgeon for his or her own custom use. The square or rectangular blocks are designed for carving flater devices for use in bone onlay for correction of surface defects resulting from skeletal anomalies such as depressions secondary to trauma or cancer resection. The curved blocks are generally used for carved devices such as malar and chin implants. The Seare Biomedical Silicone Blocks will be provided sterile. The appearance is described as clear to slightly opaque. Pigments will optionally be added such as Iron Oxide, to create opacity to light and Radiographic exam.

The provided text is a 510(k) premarket notification for a medical device called "Seare Biomedical Silicone Blocks." This document primarily focuses on establishing substantial equivalence to predicate devices and does NOT contain information about specific acceptance criteria, performance studies, or AI-assisted improvements.

Therefore, many of the requested details about acceptance criteria, study methodology, and AI integration cannot be extracted from this document.

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

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

• Acceptance Criteria: Not explicitly stated as quantifiable metrics. The primary criterion is "substantial equivalence in material, function, performance, and design" to predicate devices.
• Reported Device Performance:
  • Material: Made from specially formulated silicone elastomers designed for implantation, LSR soft implant grade silicone elastomer.
  • Function: For carving a finished device by the surgeon for custom use. Designed for carving flatter devices for bone onlay or curved blocks for malar and chin implants.
  • Appearance: Clear to slightly opaque. Optionally, pigments (e.g., Iron Oxide) can be added for opacity to light and radiographic exam.
  • Sterility: Will be provided sterile.

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

• None. The document explicitly states "Clinical Tests: None." This suggests no formal test set or clinical study was conducted for this premarket notification.

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 clinical tests or ground truth establishment based on expert review were conducted or reported.

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

• Not applicable. No test set or adjudication process was 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

• None. There is no mention of AI assistance or MRMC studies in this document.

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

• Not applicable. This device is a silicone block for implantation, not an algorithm.

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

• Not applicable. No ground truth was established as no clinical studies were performed. The basis for approval is substantial equivalence to legally marketed predicate devices, not clinical performance data from the device itself.

8. The sample size for the training set

• Not applicable. This device is a physical product, not an AI/ML algorithm requiring 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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The intended use of the Hanson Pectoralis Implant is augment or reconstruct the male chest by inserting the implant under the pectoralis muscle usually through a transaxillary incision. The proposed device can also be used for the correction of surface defects resulting from congenital anomalies such as depressions secondary to Poland's Syndrome. This product will be delivered non sterile.

Silicone Carving Blocks are to be used for augmenting the chest by placing the implant in the submuscular space via a trans-axillary incision. They can also be used to reconstruct the pectoralis depression of Poland's Syndrome (Congenitally Absent Pectoralis Muscle)

The Hanson Pectoralis Implant is made from the same Silicone liquid elastomer materials and manufacturing processes as the predicate device. The physical properties of this device are the same as the predicate device in that the same materials or equivalent materials will be used. These raw materials are the LSR 30 of Applied Silicone and the MED 4211 unrestricted silicone fluid of Nusil Technologies. The durometers or hardness (Shore A) will range from 5 to 30. The appearance is described as clear to slightly opaque. The raw materials for these blocks will be Applied Silicone's LSR series and Nusil Unrestricted MED 4211. Tensile strength from lot to lot average 600 PSI or greater. The percent elongation is over 400 percent. Each lot is certified and tested for compliance to the parameters set for in the raw material certifications for each lot tested by the manufacturer. The Chemical components of this device are polysiloxanes catalyzed by a two part system.

The provided text is a 510(k) summary for the Hanson Medical Pectoralis implant. It states that the device is substantially equivalent to a predicate device, meaning it's similar enough to an existing legally marketed device that it does not require significant new testing or data.

Therefore, this document does not describe acceptance criteria for device performance or a study proving the device meets said criteria. Instead, it focuses on demonstrating equivalence to an already approved device based on material composition, manufacturing processes, and intended use.

Here's an explanation of why the requested information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: Not present. The submission focuses on equivalence rather than establishing new performance criteria.
2. Sample size used for the test set and the data provenance: Not applicable. No test set or performance data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth or expert review is mentioned for performance.
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 silicone implant, not an AI-powered diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a silicone implant.
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. This device does not involve a training set for an algorithm.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a regulatory submission for substantial equivalence based on material and intended use similarity, not a performance study with acceptance criteria.

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