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The Spectra Wearable is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Spectra Wearable is intended for a single user.

The SPECTRA WEARABLE is a powered breast pump that is intended to express and collect milk from the breasts of lactating women. This breast pump is intended for use by a single user and can be used to pump breast milk from a single breast (single pumping). It is designed to work in the user's bra and is battery operated so it can be used hands-free without external power cords. The device is provided non-sterile. The SPECTRA WEARABLE allows the user to adjust the vacuum levels. Two suction patterns, massage and expression mode, are pre-programmed with variable levels and cycle speeds. The subject device is powered by a rechargeable Li-polymer battery (3.7 V, 1500 mAh).

The provided text describes the 510(k) summary for the SPECTRA WEARABLE powered breast pump (K220926). This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it focuses on comparing the new device to existing ones and ensuring it meets safety and performance standards, rather than proving its effectiveness through clinical trials with specific acceptance criteria in the way a new therapeutic drug or medical imaging AI might.

Therefore, the requested information regarding acceptance criteria and studies (e.g., sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) is not typically found in these types of submissions for a device like a powered breast pump. The focus is on technical performance, safety, and substantial equivalence to a predicate device, rather than a clinical effectiveness study with defined endpoints and ground truth.

However, based on the provided text, I can extract the following relevant information regarding the non-clinical tests conducted to demonstrate substantial equivalence and general performance.

Acceptance Criteria and Device Performance (Inferred from Non-Clinical Tests)

Here's a breakdown of the specific points requested, based on the absence or presence of information in the document:

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

   • See table above. The "acceptance criteria" are inferred from the standards and tests performed, which aim to ensure safety and performance equivalence to the predicate device. The "reported device performance" is the summary of the test results indicating that these criteria were met.

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 in the document. The testing described is primarily engineering and bench testing (e.g., electrical safety, EMC, biocompatibility, vacuum performance), not a clinical study involving a "test set" of patients or data in the typical sense.

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 and is not applicable to the types of non-clinical, bench testing performed for this device. "Ground truth" in this context would refer to objective measurements and compliance with established engineering and safety standards.

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

   • This information is not provided and is not applicable to the types of non-clinical tests performed.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving human interpretation of imaging, often with AI assistance. The SPECTRA WEARABLE is a powered breast pump, a mechanical device, not a diagnostic tool where "human readers" would be involved in interpreting results.

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

   • This question is not applicable as the device is a mechanical breast pump and does not involve an "algorithm only" or AI component in the sense of image analysis or diagnostic prediction. Its performance is evaluated through physical and electrical testing.

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

   • The "ground truth" for the non-clinical tests described is based on established engineering specifications, regulatory standards, and objective measurements. For example, a vacuum gauge would objectively measure vacuum strength against a specified range, and a timer would measure cycle speed. Biocompatibility is assessed against ISO standard criteria.

8. The sample size for the training set

   • This information is not provided and is not applicable. The device is a mechanical breast pump; it does not utilize a 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 there is no training set for this device.

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The Synergy Gold (SG) Portable (Models MM011450 and MM011460) is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Synergy Gold (SG) Portable (Models MM011450 and MM011460) breast pump is intended for home use by a single user.

The Synergy Gold (SG) Portable is a powered breast pump intended to express and collect milk from the breasts of lactating women. Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time. The user employs buttons to select one or both sides for pumping, to switch from massage mode to expression mode and to control the vacuum levels within those modes. Massage mode consists of 5 suction levels, while expression mode has 12 suction levels. The SG Portable breast pump is capable of providing vacuum levels from 50-270 mmHz with cycling rate or 100 cycles per minute in massage mode and 26 cycles per minute in expression mode. The SG Portable breast pump is powered by a 5V DC adaptor or an internal rechargeable lithium-ion polymer battery.

The SG Portable breast pump is sold in two configurations (with and without breast shield and bottle sets). Model MM011450 includes the SG Portable breast pump, double collection kit (MM12302-C; breast shield set - medium 24 mm), power adapter, and two collection bottles. Model MM011460 includes the SG Portable breast pump and power adaptor: this model is to be used with separately purchased compatible breast shields and bottle sets.

The SG Portable breast pump and associated breast pump kits are intended for a single user.

The provided document is a 510(k) Premarket Notification from the FDA for a powered breast pump (Synergy Gold (SG) Portable). This type of document focuses on establishing substantial equivalence to a predicate device based on non-clinical testing, rather than extensive clinical studies or acceptance criteria for an AI/ML device.

Therefore, the document does not contain the information requested regarding acceptance criteria for an AI/ML device, a study proving it meets those criteria, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment methods for an AI/ML context.

The document primarily details:

• Device Name: Synergy Gold (SG) Portable (Models MM011450 and MM011460)
• Regulation Number: 21 CFR 884.5160
• Regulation Name: Powered Breast Pump
• Product Code: HGX
• Regulatory Class: II
• Predicate Device: K191208 Spectra Cashmere Breast Pump
• Intended Use: For lactating women to express and collect milk from their breast, intended for home use by a single user.
• Non-Clinical Testing Summarized: Electrical Safety (ANSI/AAMI ES60601-1:2005+A1:2012, IEC 60601-1-11:2015, IEC 62133:2012), Risk Analysis (ISO 14971:2007), Electromagnetic Compatibility (IEC 60601-1-2:2014), Biocompatibility (by reference to predicate), Software Validation ("Moderate" level of concern per FDA Guidance 2005), Bench Testing (vacuum, cycles, AC/battery power, various breast shield sizes, backflow protection), Battery and pump use-life testing.

The "acceptance criteria" discussed in this document refer to the device meeting its performance specifications through bench testing and compliance with electrical safety and EMC standards, a standard process for a physical medical device. It does not relate to the performance metrics of an AI/ML algorithm.

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The Spectra Q is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Spectra Q is intended for home use by a single user.

The Spectra Q breast pump is comprised of a Spectra Q pump, breast shield (20, 24, 28, 32 mm), backflow protector, silicone valve, tubing, bottles (including the nipple, cap, cover, and disk), 2-wav connector (for double pumping), and power adapters. The breast pump is provided with one 24 mm and one 28 mm breast shield. Optional components include a small cap converter, assembled with the feeding bottle, the 20 and 32 mm breast shields, and a wide bottle stand. The Spectra Q breast pump is used by lactating women to express and collect milk from their breasts. The pump is intended for home use by a single user. Pumping with the Spectra Q breast pump can be performed on one breast (single pumping) or on both breasts at the same time (double pumping). The Spectra O breast pump allows the user to adjust the vacuum levels. Two suction patterns, massage and expression mode, are pre-programmed with variable vacuum levels and cycle rates (pump speed). The powered breast pump is capable of providing vacuum levels from -50 to -270 mmHq with cycle rates up to 110 cycles per minute. The device is powered by a 6 V AC/DC power adapter or a 5 V USB C type power adapter. The device is provided non-sterile.

The provided text is related to the K191109 510(k) clearance for the Spectra Q breast pump. It describes the device, its intended use, and its substantial equivalence to a predicate device (Spectra 9Plus).

However, the document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of AI/ML or diagnostic performance. The non-clinical tests mentioned are primarily related to:

• Electrical Safety/Electromagnetic Compatibility: Compliance with standards like AAMI / ANSI ES60601-1, IEC 60601-1-2, and IEC 60601-1-11.
• Software Validation: In accordance with FDA Guidance for software in medical devices (May 11, 2005).
• Biocompatibility: Evaluation based on ISO-10993 and compliance of milk-contacting components with 21 CFR 177.1520, leveraging information from the predicate device.
• Bench Performance Testing: Confirming minimum/maximum vacuum levels and cycle rates, and demonstrating sustained specifications over its use life.

These tests are standard for a breast pump and focus on physical and electrical safety and performance parameters, not on the diagnostic accuracy or classification capabilities that would typically require the kind of "acceptance criteria" table and study details (sample size, ground truth, expert consensus, MRMC studies) you've requested.

Therefore, I cannot fulfill your request for the specific information regarding AI/ML device acceptance criteria and studies from this document. The document does not describe such a device or study.

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The Spectra Cashmere breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Spectra Cashmere breast pump is intended for multiple users in a hospital setting. It is also intended for home use by a single user.

The Spectra Cashmere is a powered breast pump intended to express and collect milk from the breasts of lactating women. Two models are available:

• Model MM010035 is the retail model, which includes the breast pump Part # IMP-0034, double collection kit, ac adapter, and 2 collection bottles.
• MM010035-H is multi-user hospital grade model, which includes the breast pump . Part # IMP-0034 and ac adapter only.
  The Spectra Cashmere component(s) consist of:
• Spectra Cashmere pump with ABS housing, .
• Breast shield set, includes polypropylene flange (size 20, 24, 28 and 32 mm), . backflow protector, valve, tubing,
• 12V AC power adapter, ●
• Bottle set (bottle, nipple, cap, disk, cover). .
  Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time. The user employs buttons to select one or both sides for pumping, to switch from massage mode to expression mode and to control the vacuum and cycle levels within those modes. Massage mode consists of 5 suction levels and 5 cycling speed options, while expression mode has 15 suction levels and 5 cycle speed levels.
  The Spectra Cashmere includes a diaphragm pump using two motors, one for each breast, to generate vacuum for breastmilk expression. Backflow protection is provided by the breast pump set's backflow protector. The silicone membrane backflow protector serves as a barrier between the breast shield and collection bottle (user side) and the tubing connected to the pump (pump side) to prevent the introduction of any fluids into the tubing or the pump's housing, thus preventing cross-contamination between users.
  The Spectra Cashmere breast pump is capable of providing vacuum levels from 50-270 mmHg with cycling rates up from 38 to 76 cycles per minute. The Spectra Cashmere breast pump is powered by a 12V DC adaptor.
  The Spectra Cashmere breast pump is a non-sterile device intended for repeated use by multiple users in a hospital setting. It is also intended for repeated use in the home use by a single user.
  Kits used with the Spectra Cashmere are intended for a single user in either the home or hospital environment. The polypropylene breast shields used with the Spectra Cashmere breast pump have direct contact with the user's intact skin. Contact duration is prolonged considering cumulative use of the device.
  The Spectra Cashmere breast pump includes software.

It appears there's a misunderstanding regarding the provided document. The submitted text is a 510(k) premarket notification for a breast pump, the Spectra Cashmere. It is not a document describing a study on an AI/ML-driven medical device, nor does it contain acceptance criteria or performance data related to AI/ML algorithms, expert ground truth, or MRMC studies.

Therefore, I cannot provide the detailed information requested in your prompt based on the given text. The document focuses on demonstrating substantial equivalence of the Spectra Cashmere breast pump to a predicate breast pump (Spectra S3 Plus) in terms of its mechanical and electrical function, rather than an AI's diagnostic or predictive performance.

However, I can still extract information related to the device itself and its non-clinical testing for completeness.

Here's what I can tell you about the Spectra Cashmere breast pump based on the provided document:

Device Description:

• Device Name: Spectra Cashmere
• Common/Usual Name: Breast Pump
• Regulation Number: 21 C.F.R. § 884.5160
• Regulatory Class: Class II
• Product Code: HGX
• Indications for Use: To be used by lactating women to express and collect milk from their breast. Intended for multiple users in a hospital setting and for home use by a single user.
• Key Features:
  • Powered breast pump with a diaphragm pump using two motors (one for each breast) for independent control of vacuum.
  • Backflow protection provided by a silicone membrane backflow protector.
  • Massage mode (5 suction levels, 5 cycling speed options) and Expression mode (15 suction levels, 5 cycle speed levels).
  • Vacuum levels: 50-270 mmHg.
  • Cycling rates: 38-76 cycles per minute.
  • Software included (though no details on its function beyond controlling the pump settings).

Non-Clinical Performance Testing (not AI/ML related):

1. Acceptance Criteria and Reported Device Performance: This document does not present acceptance criteria in a quantitative table format related to AI performance. Instead, it states that the device "complies with voluntary standards for electrical safety, electromagnetic compatibility, use in the home healthcare environment and usability" and that "The Spectra Cashmere breast pump performed equivalently to predicate Spectra S3 Plus breast pump in all test cases."

2. Sample Size and Data Provenance: Not applicable for an AI/ML study. The testing described is for the mechanical and electrical performance of the breast pump. The document mentions "Tests were conducted for 20 minutes to simulate a typical pumping session." No 'data provenance' in the sense of patient data is relevant here.

3. Number of Experts and Qualifications: Not applicable. This is not an AI/ML diagnostic or predictive device.

4. Adjudication Method: Not applicable.

5. MRMC Comparative Effectiveness Study: Not applicable. This is not an AI/ML device that assists human readers.

6. Standalone Performance: The non-clinical performance testing described seems to be a standalone evaluation of the pump's physical and electrical characteristics (vacuum, cycles, safety, EMC).

7. Type of Ground Truth: Not applicable in the context of an AI/ML device. For a breast pump, "ground truth" would be its physical specifications and operation according to engineering and safety standards.

8. Sample Size for Training Set: Not applicable. This refers to software verification and validation, not training an AI model.

9. How Ground Truth for Training Set was Established: Not applicable for an AI/ML model. For the breast pump's software, it states: "Software verification and validation testing verified each output generated by the software and validated that the software performs in a manner that meets the user needs and intended use."

In summary, the provided text describes the regulatory clearance of a standard medical device (a breast pump) and its non-clinical performance testing against safety and engineering standards, not the performance evaluation of an AI/ML medical device.

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The Spectra 3 Plus Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breast. The Spectra 3 Plus Breast Pump is intended for multiple users in a hospital setting. It is also intended for home use by a single user.

The Spectra S3 Plus is a powered breast pump intended to express and collect milk from the breasts of lactating women. Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time. The user employs buttons to switch from massage mode to expression mode, and to control the vacuum and cycle levels within those modes. Massage mode consists of 5 suction levels and 1 cycling speed option, while expression mode has 12 suction levels and 5 cycle speed levels. The Spectra S3 Plus is capable of providing vacuum levels from 50-270 mmHg with cycling rates up to 70 cycles per minute. The Spectra S3 Plus is powered by a 12V DC adaptor or rechargeable lithium battery. The Spectra S3 Plus breast pump can be used by multiple users. Kits used with the Spectra S3 Plus breast pump, however, are labeled for a single user.

This is a summary of the provided text, focusing on acceptance criteria and study details.

The document is a 510(k) premarket notification for the Spectra S3 Plus Breast Pump. It aims to demonstrate substantial equivalence to a predicate device (Spectra S1 Plus Breast Pump, K150476).

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly outline specific "acceptance criteria" in a quantitative, pass/fail table format with reported performance. Instead, it states that the conducted tests demonstrate the device "meets specifications" or "demonstrates" certain functionalities. The comparison table with the predicate device implies that functional equivalence to the predicate is the primary acceptance criterion for most features, with specific new tests for the multi-user aspect.

Here's an interpreted table based on the provided "Summary of Non-Clinical Tests" and the predicate comparison:

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

The document does not specify the sample size for any of the non-clinical tests performed. It also does not directly state the data provenance (e.g., country of origin, retrospective/prospective). However, given that Uzinmedicare Co. is located in South Korea and it's a 510(k) submission to the FDA, the testing was likely conducted by or for the manufacturer. The tests are non-clinical (engineering/performance tests), not human clinical trials.

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

Not applicable. The tests performed are non-clinical engineering/performance tests, not studies requiring expert interpretation of ground truth in a clinical context (e.g., image reading).

4. Adjudication Method for the Test Set:

Not applicable. As these are non-clinical performance tests, there's no "adjudication method" in the sense of resolving conflicting expert opinions. The tests would likely involve measuring physical parameters against predefined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The study is a non-clinical evaluation of a breast pump, not an AI-assisted diagnostic device.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done:

Not applicable. This is a physical medical device (breast pump), not an algorithm or AI system.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" would be established specifications and physical measurements, rather than clinical outcomes or expert consensus. For example, a vacuum test would measure the actual vacuum generated and compare it to the specified range (50-270 mmHg).

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

Not applicable. There is no training set for this device.

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The Spectra 9Plus is a single user, powered breast pump intended to express and collect milk from the breasts of lactating women.

The Spectra 9Plus is a single-user, powered breast pump intended to express and collect milk from the breasts of lactating women. The device is intended to be a single patient reusable device. The device is capable of single and dual pumping.

The Spectra 9Plus is powered by a 9V DC adaptor or rechargeable Lithium ion battery. It is composed of materials commonly found in medical devices such as polypropylene, ABS, and silicone. All milk-contacting components are constructed out of food-grade materials that are compliant with 21 C.F.R. parts 174-179.

The Spectra 9Plus is considered a skin-contacting device with a limited (≤24 hours) contact duration.

The user employs buttons to switch from massage mode to expression mode and to control the vacuum and cycle levels within those modes. Massage mode consists of 5 suction levels and 1 cycling speed, while expression mode has 10 suction levels and 10 cycling speeds. The Spectra 9Plus is capable of providing vacuum levels from 50-270 mmHg with cycling rates up to 70 cycles per minute.

The provided text is a 510(k) Summary for a breast pump, not a diagnostic AI device. Therefore, it does not contain the specific information requested in the prompt regarding acceptance criteria, study details, expert ground truth, or MRMC studies for an AI device.

However, I can extract the relevant information about the non-clinical tests performed to demonstrate substantial equivalence for the Spectra 9Plus breast pump.

Here's a summary of the non-clinical tests conducted, which serve as the "studies" to prove the device meets acceptance criteria related to safety and performance:

1. Table of Acceptance Criteria and Reported Device Performance (as inferred from the non-clinical tests):

The following information is NOT available in the provided document, as it pertains specifically to AI device evaluation, which is not relevant to this breast pump 510(k) summary:

2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
4. Adjudication method for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

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The Spectra S1 Plus and Spectra S2 Plus are single-user, powered breast pumps intended to express and collect milk from the breasts of lactating women.

The Spectra S1 Plus and Spectra S2 Plus are single-user, powered breast pumps intended to express and collect milk from the breasts of lactating women. Pumping can be performed on one breast (single pumping) or both breasts (double pumping) at the same time. The user employs buttons to switch from massage mode to expression mode and to control the vacuum and cycle levels within those modes. Massage mode consists of 5 suction levels and 1 cycling speed option, while expression mode has 12 suction levels and 5 cycle speed levels. The Spectra S1 Plus and Spectra S2 Plus are capable of providing vacuum levels from 50-280 mmHg with cycling rates up to 70 cycles per minute. The Spectra S1 Plus is powered by a 12V DC adaptor or rechargeable lithium battery. The Spectra S2 Plus is powered only by a 12V DC adaptor.

The provided document is a 510(k) summary for the Spectra S1 Plus and Spectra S2 Plus powered breast pumps. As such, it reports on a comparison to a predicate device and does not describe a study to prove a device meets acceptance criteria in the manner typically seen for AI/ML devices or diagnostic tools. The acceptance criteria here are related to regulatory compliance and equivalence to a predicate, rather than performance metrics like sensitivity, specificity, or AUC for a diagnostic task.

Therefore, many of the requested fields cannot be directly answered because the type of study described in the document is a regulatory submission for substantial equivalence based on non-clinical testing, not a performance study of a device that "reports device performance" in a quantitative diagnostic sense.

Here's an analysis based on the information provided:

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

The document does not present acceptance criteria and performance in a standard table format for diagnostic accuracy. Instead, it describes compliance with various standards and successful operation within specified ranges, demonstrating equivalence to the predicate device.

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

This document describes non-clinical testing of the physical device and its software, not a study involving patient data or a "test set" in the context of diagnostic performance. There is no patient sample size or data provenance in this context. The tests performed are engineering and safety tests.

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. "Ground truth" in the diagnostic sense is not relevant for this type of regulatory submission for a breast pump. The "ground truth" for the non-clinical tests would be the established engineering and safety standards.

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

Not applicable. There is no "test set" requiring adjudication in a clinical or diagnostic sense for this device.

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/ML device or a diagnostic device involving human readers.

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

Not applicable. This is not an AI/ML algorithm. The performance testing was for the physical device's specifications.

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

The "ground truth" for the non-clinical tests involves established international and national standards for electrical safety, electromagnetic compatibility, biocompatibility, risk management, and software development, as well as the manufacturer's own design specifications (e.g., vacuum level ranges, cycle rates).

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable. Since there is no training set, this question is not relevant.

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The Spectra electric breast pump is Single user product and intended to express breast milk from the breast of lactating woman.

The Spectra Series Breast Pump is operated by AC motor, The device's motor drives a Piston pump, creating a vacuum to express breast milk. Passing through an air tubing to breast shield, the vacuum is used to comfortably draw out the breast milk.

This device operates with power ON at the same time. Also, vacuum regulate operates, and I adjust a vacuum. ON, OFF of a device means opening of absorption and end.

Regular this which is international or foods of FDA shall obey it to safe sanitary rules etc. related to contacts of mother's milk that I faced it to things come in contact on matter or human chest etc.

The provided document is a 510(k) summary for the UZINMEDICARE CO. Spectra Series Breast Pump. It focuses on establishing substantial equivalence to predicate devices rather than directly presenting acceptance criteria and a detailed study proving the device meets those criteria in the way a clinical trial for a diagnostic algorithm would.

Therefore, many of the requested sections about acceptance criteria and study details (like sample size, experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not explicitly provided in this type of regulatory submission for a breast pump.

Here's the information that can be extracted and a clear indication of what is not present:

Acceptance Criteria and Device Performance

The "acceptance criteria" for this device, in the context of a 510(k) submission for a breast pump, are primarily related to its functional specifications and ensuring it performs similarly to legally marketed predicate devices without raising new questions of safety or effectiveness. The comparison chart among devices serves as a de facto demonstration of performance against these implied criteria.

Table of Acceptance Criteria (Implied by Predicate Device Comparison) and Reported Device Performance:

Note: The reported performance for the Spectra Series Breast Pump is presented against specifications of predicate devices rather than against explicit, quantified acceptance criteria like sensitivity/specificity for a diagnostic device. The "Highest Vacuum Setting" for the Spectra is stated as "400 Less than," which seems to be a typo and likely means a maximum of 400 mmHg or less than 400 mmHg. Given the other predicate values, it's probably intended to mean its maximum vacuum is less than 400 mmHg.

Study Details

1. Sample size used for the test set and the data provenance:

   • Not Applicable / Not Provided. This document describes a 510(k) premarket notification, which relies on demonstrating substantial equivalence to predicate devices through technical comparisons and non-clinical testing, rather than a clinical study with a "test set" of patients in the context of, for example, a diagnostic algorithm. The testing mentioned is "non-clinical."

   • Data Provenance: Not applicable.

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

   • Not Applicable / Not Provided. No human ground truth establishment for a test set is described.

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

   • Not Applicable / Not Provided. No human adjudication process is described.

4. 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 / Not Provided. This device is a breast pump, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance comparisons are irrelevant in this context.

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

   • Not Applicable / Not Provided. This device is a mechanical breast pump. "Standalone performance" in the context of an algorithm is not relevant. The device operates independently to express milk.

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

   • Not Applicable / Not Provided. The "truth" for a breast pump is its functional operation (e.g., vacuum levels, cycle speed, safety features) to express milk, rather than a diagnostic ground truth like pathology. The "ground truth" here is adherence to engineering specifications and safety standards, demonstrated through non-clinical testing.

7. The sample size for the training set:

   • Not Applicable / Not Provided. There is no "training set" in the context of an AI/machine learning algorithm for this mechanical device.

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

   • Not Applicable / Not Provided. No training set or associated ground truth establishment is relevant for this mechanical device.

Summary regarding the study:

The document states under "Discussion of Non Clinical Tests": "All testing of this subject device has demonstrated that the Spectra Series breast pump meets established requirements when used in the manner and environment specified in product labeling."

This implies that standard non-clinical performance and safety testing (e.g., electrical safety, electromagnetic compatibility, material biocompatibility, vacuum accuracy, durability, and functional testing to ensure it meets its specifications and performs similarly to predicate devices) was performed. However, the document does not provide details of these specific tests, their methodologies, or the precise results beyond the comparative table. The study is a "non-clinical" comprehensive device evaluation against engineering and safety standards, not a human reader or AI performance study.

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